June 08, 2023     Andrew Kantor

Hormones: Don’t swallow, rub

Taking estrogen might cause high blood pressure, but here’s the kicker: only in pill form. So found a study published by the American Heart Association of 112,000 women* 45 and older. Given transdermally, it’s no problemo. In fact, the safest way to get it is, um, down yonder:

Oral estrogen was associated with a 14% higher risk of high blood pressure compared to transdermal estrogen creams and a 19% greater risk of high blood pressure compared to vaginal estrogen creams or suppositories.

Why so? Because the oral form is metabolized via the liver, which has an effect on blood sugar levels.

If you feel like channeling Santa from Miracle on 34th Street, you could refer your patients taking oral estrogen to a compounding pharmacist, or at least suggesting they monitor their BP.

* “a large group of [more than]112,000 women,” as opposed to a small group of 112,000 women. Or a group of 112,000 large women.

Support Buddy at the convention!

Coming to the Georgia Pharmacy Convention? Get out your checkbooks and come to the fundraiser for Buddy Carter’s 2024 reelection campaign.

The deets:

Saturday, June 17, 2023, 2:15 – 3:15 pm Sapelo Room at the Omni Amelia Island Resort

  • Sponsor $3,3,00 per person
  • Friend $1,000 per person
  • Attendee $250 per person

Click here for the reservation/contribution form.

 

Women skip their meds

Seguéing from women’s health to medical finances, we have this: Based on CDC data (the National Health Interview Survey), women are more likely than men to skip their meds because they can’t afford them.

[I]n 2021, 9.2 million adults ages 18 to 64 — about 1 in 10 — reported skipping, delaying or using less medication than prescribed over the past year to save money. Women led men when it came to this nonadherence: 9.1% versus 7%.

Takeaway: If you have patients you know are having trouble affording their meds, maybe take a little time — we know, we know — to help them find a co-pay program or even check whether the cash price is better than their co-pay.

 

So about those “non-profit” hospitals

It seems that, rather than using their proceeds to help people in need, non-profit hospitals are fattening their cash reserves — this while 41% of Americans have some form of medical debt. That’s what a study out of Rice University found by going over the financial records of 2,800 hospitals across the country.

It found that even when they took in more money, non-profit hospitals didn’t change their spending on charity care — they just added to their reserves. In contrast, higher profits in for-profit hospitals translated into more spending on charity care.

Cash reserves are important, of course, for weathering financial storms and keeping a good bond rating (read: easier to raise money), but it does raise the question of what “non-profit” is supposed to mean.

More bluntly, as the Rice press release puts it, this “calls into question the justification for nonprofit hospitals’ tax-exempt status.”

 

When dosage is fat-dependent

Just because infliximab doesn’t work for a patient with inflammatory bowel disease doesn’t actually mean it doesn’t work. (Your line is “Huh?”)

It seems that people with a high level of visceral adipose tissue (VAT) might require a larger dose — in fact, it might seem like the standard dose doesn’t work at all.

[C]linicians may need to reconsider prematurely discontinuing infliximab treatment in “non-responders” with higher VAT burden and instead consider adjusting the dose to achieve a higher drug concentration before declaring nonresponse.

To be clear, it’s not a matter of body mass or BMI, but specifically of the amount of VAT they carry.

 

Short Takes

Semaglutide is so good for diabetes….

A study from an Ohio State University and a group of those shifty Danes found that “oral semaglutide is more effective than empagliflozin, sitagliptin, or liraglutide in terms of reducing HbA1c together with body weight in patients with type 2 diabetes.”

Sea cukes for blood sugar

Eating sea cucumbers can help fight diabetes by reducing advanced glycation end products (AGEs), according to Aussie researchers.

“We found that processed dried sea cucumber with salt extracts and collagen can significantly inhibit AGEs by lowering a range of sugar related metabolites in the body and reducing the risk of diabetes.”

Yummy!

 

June 07, 2023     Andrew Kantor

Can a heart med help hot flashes?

Ladies, if you’ve had hot flashes, chances are you’ve thought, “I wonder if nitroglycerin would help with that?” The good folks at UC San Francisco thought the same thing.

The logic is that nitroglycerin helps with chest pain by increasing blood flow, but over the long term it might “prevent or suppress the type of rapid, increased blood flow under the skin that causes sensations of heat and flushing during hot flashes.”

Alas, bad news: The women they treated with nitroglycerin patches saw some improvement briefly, but after a few months it was no better than a placebo. But hey, they tried!

GCSU gets fast track to Mercer

Good news for students at Georgia College & State University: If they’re looking to get a PharmD at Mercer, their applications will get priority reviews thanks to a transfer admission agreement between the schools.

The students will do their prereqs at GCSU, then enroll in Mercer’s PharmD program. Their first year of Mercer credits will transfer back to GCSU so they end up earning their bachelor’s degrees a year early. It’s like fuzzy math!

Reversing MS

For mice with multiple sclerosis, a big breakthrough from Johns Hopkins: “the ability to reverse — and in many cases, completely alleviate — MS-like symptoms.”

MS is caused by (to be overly simplistic) some of the body’s immune cells mistakenly attacking the myelin that protects nerve cells. What the Hopkins folks did is find a way to reduce the number of those errant cells (called effectors) in favor of “regulatory T cells, or T regs, that modulate the immune system and have been shown to prevent autoimmune reactions.”

How? By using payload-carrying microparticles injected near lymphatic tissues. (If you’ve seen the news, microparticles have a habit of getting into things — in this case it’s in a good way.) Once inside, the particles, um, do science. Result:

[I]n all of our mice, the T regs stopped the autoimmune activity of the effectors against myelin, prevented further damage to the nerves and gave them the time needed to recover.”

Oh, and 38% of the mice were completely cured. Next up: More tests!

Merck sues feds over price negotiations

Merck is suing the federal government in order to prevent it from negotiating the prices of medication.

The company’s argument: By allowing Medicare government to negotiate prices (rather than pay whatever the companies feel like charging), “[T]he law allows the government to force drugmakers to sell their property without ‘just compensation,’ which the company argues violates the Fifth Amendment.”

Yes, apparently the Constitution protects drug company profits. Who knew?

All snideness aside, it’s a nut that needs to be cracked. A transaction requires an agreement between the buyer and the seller, and forcing either one to agree to the other’s demands is either bad for taxpayers or for the pharma companies.

But unlike, say, buying a car, in this case both sides have tremendous power: pharma companies because Medicare has to buy their meds, and Medicare because it commands so much of the market. For the moment it’s up to the courts.

In related news…

States — not Georgia yet — are looking at their Medicaid budgets and starting to look at drug payments the way they look at utility and transportation payments: something the state needs to set the rates for. They’re called ‘drug price boards.’

Beyond price caps, states are considering capped co-pays, reference pricing and so-called “Netflix-model” subscription arrangements to cut the costs of prescription drugs.

Some boards have teeth, others don’t, but the message is clear: States are willing to pay fair value, but not any price, and regulation is coming. Of course, the pharma industry provided its usual measured response: “This spells disaster for patients as they could face barriers to obtaining life-saving medication.”

Tiny carriers of doom

A study of about 850,000 households found that children, far from being the sweet innocent bringers of joy, are more likely the bringers of Covid-19.

Of all households transmissions, 70.4% began with a child, with the proportion fluctuating weekly between 36.9% and 87.5%.

And the smaller they were, the more typhoid and the less Mary:

Children aged 8 years and younger were more likely to be the source of transmission than those aged 9 to 17 (7.6% vs 5.8%).

But it looks good on paper

A toothless safety board that’s been handicapped from the get-go? That’s the idea behind a “National Patient Safety Board” akin to the National Transportation Safety Board, but for unsafe medical care, e.g., what can happen in a hospital.

The problem: It would require the permission and cooperation of the facilities it wants to investigate. And even if investigators were allowed in, their reports couldn’t name the facilities. Why not? As one patient advocate put it, ‘public reporting would compromise data integrity by leading hospitals to scrub records to hide bad events.’

Short Takes

Don’t self-treat those bumps

The FDA is warning people not to treat molluscum — small skin bumps also known as water warts — with anything that claims to treat it.

Do not use products that claim to treat molluscum, even if they say they are “FDA-approved” or “made in an FDA facility.” There are no FDA-approved products to treat molluscum.

Just deal with it. “Molluscum eventually goes away on its own without treatment, usually in six to 12 months.”

One shot spaying

Instead of surgery to spay kittens, researchers at Mass General Hospital have developed a single shot that effectively does it via chemistry — they use a harmless virus to deliver a gene called AMH to the kittens’ ovaries; it prevents the ovaries from creating eggs.

[T]he treated cats did not ovulate. And when they were placed in a room with a male for several hours a day over a 4-month period—an experiment repeated both 8 months and 20 months after the gene therapy—none became pregnant. Four of the females refused to mate; the other two mated but could not conceive.

The elevated AMH levels remained for at least five years, but more work will need to be done before the research is out of the preliminary stage. But if it pans out, it could make a huge difference, especially to spay-and-release programs.

June 06, 2023     Andrew Kantor

The influencers’ Ozempic alternative

When a story begins with “The latest health trend on TikTok….” you know to get out a big grain of salt.

In this case it’s berberine, an over-the-counter isoquinoline alkaloid related to morphine. And — if you believe the “influencers”*it’s a great substitute for Ozempic.

In fact, some small and questionable studies have shown that yeah, for extremely overweight women berberine was “associated with modest reductions in body mass index, waist circumference, and body weight (around 6½ lbs).” But there’s no information about side effects, long-term use, drug interactions, or how it will work for people who aren’t obese.

And, because the people taking it are likely to be influenced by TikTok, there’s zero reason to believe they’ll take safe or reasonable doses.

* Don’t.

Did you vote yet?

GPhA members — don’t forget that you have only until Thursday, June 15 at 11:59:59 pm to cast your vote for members of the 2023–24 board of directors.

You should have received your electronic ballot from AssociationVoting to the email address GPhA has on file for you. Can’t find your ballot or have a question? Reach out to Lia Andros, GPhA’s governance manager, at (404) 419-8173 or landros@gpha.org.

FDA relaxes import rules

To help ease the shortage of cancer drugs, the FDA will be allowing imports from foreign manufacturers that aren’t approved to distribute to the US.

It’s one of the few things the government can do to ease the shortages of cisplatin and carboplatin. The drugs are privately made, and one of the major manufacturers has temporarily shut down with no clear start-up date. Still, despite the fact that the FDA doesn’t have a big red “Ease Drug Shortage” button to press, and that medication doesn’t just magically appear, people are demanding that Someone Do Something, sometimes with amusing analogies:

Philip Schwieterman, director of oncology and infusion services at the University of Kentucky health system, said, “If I go in the grocery store and I want a kiwi, there are usually kiwis there. It boggles my mind that if I want some cisplatin, I can’t get cisplatin even though it saves lives.”

What could be done, though, is to create a national stockpile of medications — but first we need to get through the current shortage.

Sorry, there is no Medication Fairy

Anti-steering law is back (and not everyone is happy)

With the end of the pandemic’s public health emergency, a law that had been set aside is back in play. It says that prescribers can’t steer Medicare and Medicaid patients ‘to facilities and services in which they have a financial interest.’

That makes sense on the surface, but, as always, there are broad strokes and there is nuance. In this case the issue is specialty drugs that aren’t available at community pharmacies. CMS’s interpretation says that those can’t be provided by, say, oncologists. The oncologists for their part say that sending scripts out to mail-order pharmacies causes delays and can even mean patients don’t get their meds because the drug is in shortage.

As one oncology-practice manager put it:

“I know my inventory level. I know how many weeks on hand I’ve got and I can work with the providers proactively before I run out. When you go to a mail-order facility, you’re just sending a prescription out. You don’t know.”

Of course both sides are making huge, definitive statements — ‘there won’t be any problem’ vs. ‘patients will be dropping like flies.’ (“They have ripped seamless medical care out of the hands of providers,” said one. Yet the law has been in place since 2001; enforcement was simply waived during the pandemic.)

A group of US representatives, including several from Georgia, is asking CMS to retract the guidance that’s causing the kerfuffle, and one patient-advocacy group is considering a lawsuit. Whatever happens, knowing the rulemaking process it’s unlikely to happen quickly.

Big cancer breakthroughs

A new drug against glioma

For patients with treatment-resistant glioma, there’s great news. A phase 3 trial of a new drug dubbed vorasidenib didn’t just work, it worked gangbusters.

The team found the drug vorasidenib more than doubled progression-free survival in people with recurrent grade 2 glioma with IDH1 and IDH2 mutations. Compared with people who received a placebo, those who took vorasidenib went for nearly 17 more months without their cancer worsening, delaying the time before they needed to begin chemotherapy and radiation.

Because glioma often strikes younger people, and the treatment for it can do nasty things to their brains, being able to delay or reduce traditional chemo/radiation treatment can make a huge difference. And vorasidenib is targeted only at cancer cells, so it doesn’t damage healthy ones.

With the phase 3 trial complete, FDA approval could (should?) be coming soon.

For some patients, huge lung cancer news

About a quarter of people diagnosed with lung cancer have a mutation in their EGFR gene. For those people, great news: “Taking the drug osimertinib after surgery dramatically reduced the risk of patients dying by 51%.

The survival benefit “was observed consistently” in an analysis across all study subgroups, including those with stage one, stage two, and stage three lung cancer. Chemotherapy had been given to 60% of those in the study, and the survival benefit of osimertinib was seen regardless of whether prior chemotherapy was received.

That’s a big enough deal that one researcher said osimertinib — aka Tagrisso — should become the standard of care for those patients.

Short Takes

Send in the bot

Endoscopy, schmendoscopy. Why stick a tube into someone when you can not just send in a tiny camera robot, but (now, thanks to George Washington University engineers) one that can be steered to the right location?

Think about this one for a bit

Intelligent minds take longer to solve difficult problems”.

[B]rains with less synchrony among various regions were prone to making hasty decisions without waiting for upstream brain regions to process the necessary information for solving the problem. However, for those with higher intelligence, their brain simulations took longer to solve the tougher tasks but committed fewer errors.

June 03, 2023     Andrew Kantor

Fentanyl as a weapon

With fentanyl overdoses killing people to the point that the drug is “already the number one killer of Americans under 50,” Rutgers University researchers wondered Can fentanyl be weaponized?

Why yes, they concluded. Yes it can. It would just have to be in really high concentrations, like a lot of powder being dumped into a building’s air handler. At least until someone comes up with an even more powerful analog.

(The good news is that currently (despite what some police are claiming) “There has never been an overdose through skin contact or accidentally inhaling fentanyl.”)

Alumni receptions at the convention

Three of Georgia’s four pharmacy schools are planning alumni receptions at the Georgia Pharmacy Convention. Be sure to sign up for yours!

  • Mercer University: Thursday, June 15 from 6:00–7:30 pm in the Oceanview Room & Terrace. (Click here to register; questions go to Genice Johnson)
  • South University: Thursday, June 15 from 6:00–9:00 pm in the Sunrise Café. (Registration info to come; questions go to Ajay Singh.)
  • UGA: Thursday, June 15 from 6:00–7:00 pm in the Magnolia Garden. (Click here to register; questions go to Kim Hamby.)

PCOM shout-out!

Congrats to the 76 pharmacists who just graduated from PCOM Georgia, now set to embark on what’s sure to be an exciting, lucrative, confusing, important, stressful, and fun career. Welcome to the PharmD world, everyone!

A better atropine for kids’ myopia

Atropine has uses in fighting some poisonings and in some surgeries, but off-label (as eye drops) it can treat myopia in kids. That’s good, but the eye drops are only available from compounding pharmacies — that’s not bad, but it means it’s harder to get and includes preservatives, which aren’t the first choice of what you want to put into your kid’s eyes.

But researchers at an Ohio State University have tested a preservative-free version of low-dose atropine eye drops that “led to significant improvements in several markers of myopia in children” with no serious side effects. In fact, the lower dose they tested (0.01%) did better than the higher dose (0.02%).

Cool fact: Atropine slows the growth of the eyeball, which is why it needs to be used on kids. And it’s not a lifelong treatment — it’s just used during the formative years. A second study is looking at what happens when treatment is over, and it’s hoped the drug can eventually get on-label FDA approval as a myopia treatment.

Basic research: how brown fat works

You probably know that there’s good fat (brown, which burns calories) and bad fat (white, which stores calories).

Now researchers from the US, Britain, and even Belgium have teased out the molecular structure of a protein called UCP1, which is the found the big difference between the two fats; it’s what gives brown fat its calorie-burning abilities.

And, as we all know, once the scientists get into this level of detailed understanding the possibilities of (in this case) either turning white fat brown or making brown fat more effective increase yugely.

The Long Read: Brother vs Brother edition

More and more weapons are being brought to bear in the fight against antibiotic-resistant bacteria. The latest: Engineering one strain of E. coli to kill another strain of E. coli.

In fact, different strains of the bacteria will already try to kill each other off so they can colonize the same space, kind of like the British when they discover a new continent. They use some interesting techniques, like intercepting chemical signals sent by the ‘other side.’ By harnessing this information-processing skill, biologists can create E. coli that releases toxins at just the right time.

Read more about the promise of synthetic biology from Leaps.org.

Short Takes

A new buprenorphine

The FDA has approved two formulations of Braeburn’s Brixadi transmucosal buprenorphine for treating opioid use disorder.

Brixadi is approved in both weekly and monthly subcutaneous injectable formulations at varying doses, including lower doses that may be appropriate for those who do not tolerate higher doses of extended-release buprenorphine that are currently available.

The next CDC head

Mandy Cohen is (almost certainly) President Biden’s pick to take over at the CDC. Who is she? What’s her experience. Newsweek has the deets.

June 02, 2023     Andrew Kantor

Surprising C diff risk factor

Is there a link between antidepressants and C. diff infection (CDI) in the hospital? Maybe, according to some scattered studies, but Cleveland Clinic researchers wanted to find out for sure. They looked at the data from more than 55 million patients (!) and found that “As it turns out, there is a link between antidepressants and hospital-acquired CDI.”

  1. The percentage difference is big: Almost 33% more of the patients on antidepressants got C. diff infections.
  2. The number difference is small: 0.8% of antidepressant users got infections compared to only 0.6% of non-users.
  3. This just shows a connection, not a cause and effect.

What exactly is the connection? You know the drill: More research is needed.

Go go, GPh Go!

The official Georgia Pharmacy Convention app will be available June 2 — that’s this afternoon! [insert new-app dance here]

If you’re coming to the convention — or just want to attend vicariously through those who are — grab it today. It’s free, of course, and it’ll let you see what’s happening and keep up with what attendees, exhibitors, and speakers are doing. So search your favorite app store for GPh Go or use a link:

Fight GLP-1, fight nicotine?

First diabetes, then weight loss, then cancer — what’s next for GLP-1 inhibitors? How about curing nicotine addiction?

Looking at how liraglutide affects weight gain, a group of those shifty Danes…

“ … discovered, more or less by accident, that a well-known drug, liraglutide, used to treat diabetes and overweight, affects the impact of nicotine on the brain. Liraglutide inhibits the effect that nicotine has on the brain’s reward system.”

Both GLP-1 and nicotine can control appetite, so it’s not entirely surprising that drugs that inhibit GLP-1 can also hinder nicotine’s effects. But, of course, this was just the “That’s odd” moment — more work is needed to see if it’s got true clinical benefit.

FDA’s hands are tied

Hospitals and oncology practices are facing a critical shortage of cisplatin and carboplatin and people are turning to the government — in particular the FDA — to solve the problem. But it’s a private-industry issue, explained Richard Pazdur, director of the FDA’s Oncology Center of Excellence. It’s because “manufacturers failed to invest in enhancing production capacity.”

Said he:

“Based on current laws, FDA cannot require a manufacturer to report an increase in demand that may lead to a drug shortage. Appropriately, we cannot require a company to manufacture a drug.

“We cannot require a company to make greater quantities of the drug — specifically, to step-up production. We cannot require a distributor to report on the quantities that are distributed and specific purchasers who may be given priority.”

In theory, Congress could give the FDA more power to control the pharmaceutical industry, but smacks of a Soviet-style* planned economy, and we know how that turned out. The FDA is doing what it can, including “exploring temporary importation to help meet patients’ needs during the shortage.”

* Kids, ask your parents.

Elsewhere: Cutting off their noses

Some states (not Georgia!) are more concerned about saving money than making sure people can afford healthcare. They’re cutting residents from Medicaid rolls now that the pandemic is over, but they’re so enthusiastic that most of the people being cut are seeing it done for paperwork reasons, not eligibility reasons.

The overwhelming majority of people who have lost coverage in most states were dropped because of technicalities, not because state officials determined they no longer meet Medicaid income limits. Four out of every five people dropped so far either never returned the paperwork or omitted required documents.

New medication … or asteroid?

It’s been a while, but it’s time to play everyone’s favorite pharmaceutical quiz!

Five of these are novel drugs approved by the FDA in 2022 or early 2023. Five are minor asteroids in the solar system. Do you know which is which?

Jaypirca

Egeria

Zynyz

Diotima

Bamberga

Vonjo

Camzyos

Patientia

Cybele

Orserdu

Find the answers here.

You can play previous versions of the game!

Short Take

Now there are two (RSV vaxes)

The FDA has approved Pfizer’s Abrysvo RSV vaccine for people 60 and over; this follows on the heels of the agency’s approval of GSK’s RSV vax Arexvy. It’s expected to be available before the fall RSV season.

June 01, 2023     Andrew Kantor

Board considers allowing pharmacies to dispense cannabis products

The Georgia Board of Pharmacy is considering allowing medical cannabis products to be sold at independent pharmacies.

The logic is that there are only two dispensaries — one each in Macon and Marietta — and four more might open in places including Newnan and Pooler. That leaves a lot of the state uncovered and only half of the 12 allowed dispensary licenses in use. Independent pharmacies could fill the gap.

Next stop: The June 14 Board of Pharmacy meeting.

Stop the poppers

The FDA would really like it if you didn’t use or sell “poppers”. They’re packaged like energy drinks, sold as solvents or other household chemicals (wink, wink), might work like vasodilators, and they can really — to use the scientific phrase — mess you up.

“These chemicals can be caustic and damage the skin or other tissues they come in contact with, cause difficulty breathing, extreme drops in blood pressure, decreases in blood oxygen levels, seizures, heart arrhythmia, coma, and death. Do not ingest or inhale under any circumstances.”

They might have names like “Super Rush” and “Jungle Juice,” but they’re more drain cleaner than drug.

Simpler info sheets

The patient-information sheets that come with medications are full of information, but they’re not particularly useful to the people who are supposed to make sense of them. So the FDA is proposing a change: new, easier-to-read guides for patients.

“Studies have found that the current system for written information for prescription drugs and certain biological products can be confusing, conflicting, incomplete, or repetitive,” the agency wrote. (Apparently they needed studies to figure this out.)

The new proposal, called Patient Medication Information sheets, would be single-page documents (presumably not in 6-point type) that would include the drug name, a “Concise summary of the indications and uses” and safety information, the most common side effects, and of course directions for use.

They would replace and simplify the two types of prescription drug information currently in use. Well, mostly. It’s not as if the sheets won’t be overwhelming to a lot of folks — just a bit less overwhelming. (Click to expandify.)

Diabetics at risk

If you have patients with type 2 diabetes, take note: A new study out of Johns Hopkins finds that 1 in 3 of them are likely to have biomarkers for cardiovascular disease without having any signs of heart trouble … yet.

“What we are seeing is that many people with Type 2 diabetes who have not had a heart attack or a history of cardiovascular disease are at high risk for cardiovascular complications.”

Better to deal with that now than later, doncha think?

A faster way to classify narcotics

New synthetic drugs, especially cannabinoids, hit the streets faster than regulations can keep up: Restrict 1,3,4-polydichloric euthimal and someone develops 1,3,5-polydichloric euthimal. You can’t just ban “any related substance” without causing a huge headache.

It’s not just a US problem — Europe is grappling with it too. Now, though, a group of Swedish biomed researchers have developed what they say is a standard method to classify new drugs that’s all about measuring the chemical’s effect on the appropriate cell receptor.

It’s actually pretty simple: They expose cultured cells that have (for example) the cannabinoid receptor on their surfaces, then measure how much the receptor is activated, if at all. That measurement tells them immediately whether the drug is akin to a street drug, how strong its effect is, and whether it’s dangerous. Then, in theory, public health officials could ban, say, “Any drug that has this much of an effect on this receptor.”

The researchers have further developed the method so as to also measure effects on the cellular systems affected by substances similar to for example amphetamine, cocaine, heroin, morphine and fentanyl.

Going postbiotic

The benefits of pre- and probiotics aren’t just in the bacteria themselves, they’re in what those bacteria produce: metabolites.

It’s those metabolites, Aussie researchers explain, “like short-chain fatty acids, certain vitamins (Vitamin B and K), amino acids and antimicrobial peptides” that give the -biotics their good reputation.

So why not skip the pre- and pro- and go right to the postbiotics?

[T]he beauty of postbiotics is they can provide these benefits even without any side effects that probiotics and prebiotics may have. For example, some people might experience discomfort because of a temporary increase in gas and bloating after intake of probiotics and prebiotics.

And as a bonus it seems that there’s a feedback loop — having those good postbiotics can help the growth of the bacteria that produce them. The benefits are widespread, too, from boosting the immune system to helping prevent cancer, and even to improving mental health.

The big downside: Postbiotics have only been played with in the lab, so “there will be a lot more to discover in the coming years.”

Now we know who to blame

40% of US foodborne restaurant outbreaks traced to sick workers

This item has very little useful information about ketamine and migraines

It seems that, based on a retrospective look at a clinical trial, ketamine nasal spray might help relieve chronic migraines.

Ah, but the caveats: The study considered was small. Eighty percent of the participants were female and most were white, with an average age of 44. The women also took other meds. Still, among that narrow cohort it seemed to work:

Overall, the patients said they used the nasal spray six times over an average of 10 days a month. Nearly half (49%) said the spray was “very effective,” while 39.5% found it “somewhat effective.” More than one-third (35.5%) said their quality of life was “much better.”

But there are downsides, most notably the chance for dependency. And even the researchers who did the study said it didn’t necessarily show ketamine was a useful treatment.

Short (non-pharma) Takes

When no one gives up

That social media is bad for health — mental and even physical — is kind of obvious at this point. But what about quitting it? How much will that improve your health? Researchers don’t know because “Almost nobody can log off long enough to find out.”

A night to remember

Gentlemen between about 56 and 68: If you’re not satisfied with your, um, personal life, you might want to write it down: “Low sexual satisfaction linked to memory decline later in life, study finds.”

May 31, 2023     Andrew Kantor

J&J joins in the blame game

Why does Johnson & Johnson keep raising the prices of its medication above the rate of inflation? According to the company, it’s not because of R&D costs, it’s because it has to pay more in rebates, discounts, and fees. It’s the latest in the finger-pointing game that healthcare companies play, each blaming the others for high prices.

In J&J’s case, it says that while the list prices of its drugs went up, the net prices (i.e., after discounts) dropped 3.5%. (It wouldn’t provide data on those list prices, though.) It claimed that more than half of its list prices — 58% — were given back.

J&J’s rebates, discounts and fees added up to $39 billion last year, according to the report, with $11.2 billion going to commercial payers and pharmacy benefit managers, while $8.9 billion went to Medicare and Medicaid programs.

New virus in the news

While Covid and RSV get all the attention when it comes to respiratory viruses, healthcare officials are quietly sounding the alarm* about another bug: human metapneumovirus, or HMPV. Often HMPV goes unnoticed unless someone is specifically tested for it, but it can send you to hospital. This spring it “filled hospital intensive care units with young children and seniors who are the most vulnerable to these infections.”

In fact, only RSV causes more respiratory infections in kids. And older folks can end up in the ICU. There’s no cure or vaccine; it’s just a matter of treating symptoms.

Here’s a not-so-fun fact: HMPV was only discovered in 2001 — there are a lot of unknown respiratory viruses out there.

Respiratory infections are the leading cause of death for children around the world and the No. 1 reason kids are hospitalized in the United States, but scientists don’t know what causes a good chunk of them.

And another: Once you get HMPV, you aren’t immune. “The infection generates weak or incomplete immune protection, however, and humans get reinfected throughout their lives.”

* Yeah, that’s an oxymoron, but it’s pretty accurate.

The latest long Covid list

The latest semi-official catalog of long Covid symptoms comes out of NYU and is based on examinations of 10,000 people. Unfortunately, several of them are so generic (thirst?) that their usefulness seems limited (abnormal movements?), but the point is more to create a catalog of what you might expect rather than a diagnostic tool.

Ready?

  • Post-exertional malaise, or worsening of symptoms after mild activity
  • Fatigue
  • Brain fog
  • Dizziness
  • Gastrointestinal symptoms
  • Heart palpitations
  • Issues with sexual desire or capacity
  • Loss of smell or taste
  • Thirst
  • Chronic cough
  • Chest pain
  • Abnormal movements

The 10-cent BP tester

Who needs one of those old-fashioned sphygmomanometers when you can just use a smartphone and a 10-cent device instead, without the hassle of looking up the spelling?

UC San Diego engineers have developed a 3-D printable blood pressure measurement system that clips to a smartphone camera and flash. An app to walk users through the process, which involves simply pressing on the device. That’s it. It doesn’t require calibration, and the clip-on doohickey — which essentially uses a pinhole camera — costs a dime to create.

“A blood pressure monitoring clip could be given to you at your checkup, much like how you get a pack of floss and toothbrush at your dental visit.”

Not only would it be good for lower-income patients, the device could be printed on site anywhere in the world to help healthcare efforts in poor countries.

AI helps fight hospital bug

Acinetobacter baumannii is a nasty little bug that likes to hang out in hospitals, and — you guessed it — it’s resistant to a lot of antibiotics. So McMaster University and MIT researchers asked a computer for help. They gave it a library of 7,000 compounds to consider and asked it which ones might, based on their molecular shape, work against A. baumannii.

Dutifully, the AI complied and spit out (metaphorically) a compound that’s since been named “abaucin.” That doesn’t mean it’s found a new drug — rather, it’s cut down the trial-and-error time for drug discovery by identifying a molecule more likely to work as one.

Abaucin is especially promising, the researchers report, because it only targets A. baumannii, a crucial finding which means the pathogen is less likely to rapidly develop drug resistance, and which could lead to more precise and effective treatments.

Short Takes

Another (potential) Lyme treatment

A Northeastern University biologist claims than an old antibiotic, hygromycin A, is effective against Lyme disease — and it can even prevent its chronic form. The big deal: It does this, he says, without harming gut bacteria the way broad-spectrum drugs do.

Get off your butt (so you don’t die)

Just a bit of aerobic exercise — even if it’s not enough to register on a FitBit — can reduce your risk from dying from pneumonia and the flu.

Flu vax effectiveness

The first data of the 2022–23 flu vaccine effectiveness is out, based on several European studies, so there’s a range of effectiveness rather than a single number. The gist:

  • Overall the vaccine was 28% to 46.0% for preventing influenza A infection.
    • Children had better protection: 49% to 77%.
  • Overall the vaccine was greater than 50% effective against influenza B.
    • Again, it was more effective for children — between 87% and 95%.

May 27, 2023     Andrew Kantor

GPhA Buzz will not publish on Tuesday, May 30, as we’ll be recovering from the Memorial Day festivities (and because Buzz is written the day before you see it).

Did you take home ec?

Hey, recent grads! Do you know how to cook? No, stirring a microwave meal doesn’t count. It seems that college grads don’t know how to prepare healthy meals, and that — per Brazilian nutritionists — might make them, er, larger than life, shall we say.

As they put it, “[O]ur findings showed that overweight and obesity were associated with lower cooking skills.”

Their tips: Learn to cook with healthy ingredients and, if you live with others (especially a spouse or children), learn to share the cooking (with those healthy ingredients). Otherwise “Living with other people and eating out of the home were associated with higher chances for overweight and obesity.”

Having a properly multi-ethnic and -cultural group makes your cooking even better!

High-five to Mercer’s Angela Shogbon Nwaesei

A big GPhA Buzz congrats to Mercer’s Dr. Angela Shogbon Nwaesei, who was named the recipient of the American College of Clinical Pharmacy’s 2023 ACCP Education Award.

This award recognizes a college member who has made substantial and outstanding contributions to clinical pharmacy education at either the professional or postgraduate level.

Way to go, Dr. Nwaesei!

Scent of a migraine

What do perfume, tobacco, fabric softener, body odor, garbage, hairdressing products, cars, and sweat* have in common, besides a hot date behind a 7-Eleven? According to Japanese researchers, they’re the most common odors associated with triggering a migraine attack.

Of course that doesn’t discount all the other possible triggers, like stress, weather, hormones, etc. But it does suggest that there might be an olfactory component to migraines. You know the mantra: More research is necessary.

* Those are just the top eight. Apparently there’s a lot that can trigger a migraine; other scents reported in more than 10% of cases were garlic, rice, grilled fish, alcohol, excrement, machine oil, vomit, “chemicals,” propane gas, and “animals.”

When the pond grows larger, even the big fish feel smaller

As healthcare organizations get bigger from consolidation, acquisition, expansion, or just too many French fries, that’s usually pretty good for the company, and may even be good for the workers it employs … at least on paper. But when companies get super-sized, they often start to standardize procedures and eliminate wiggle room.

That means employees start to feel smaller and smaller as their professional judgement takes a back seat to the three-ring binder of corporate policy.

Inside their workplaces, standardization becomes a burden. When an employee tries to do things differently or to tailor care to an individual patient’s needs, they’re told, “The policy is the policy.” Bigger does not feel better. The are transformed from highly trained professionals into invisible line workers. There is a loss of agency that can be painfully numbing.

A cause found for SIDS?

Researchers at Boston Children’s Hospital have made what appears to be a breakthrough in understanding Sudden Infant Death Syndrome — a biological cause. It’s not a simple one, though.

[T]hey hold the belief that sudden infant death syndrome occurs when three factors coincide. Firstly, it happens during a crucial stage of cardiorespiratory development in the infant’s first year. Secondly, the child experiences an external stressor, such as sleeping in a face-down position or sharing a bed. Finally, the child possesses a biological abnormality that renders them susceptible to respiratory difficulties while sleeping. It is the convergence of these three elements that is thought to contribute to cases of sudden infant death syndrome.

A pathway to nerve regeneration

British molecular biologists have found a way to promote the regeneration of nerve cells. That’s kind of a big deal.

There’s a signalling pathway in cells that works via an enzyme called PI3K that helps cells grow. Scientists have been looking for ways to reliably activate PI3K as a potential cancer-treatment target (as you might expect with an enzyme that helps cells grow).

It seems that a newly discovered compounded that they dubbed “1938” (thus making it really difficult to google), does just that — and that’s potentially a big deal, because they found something interesting. When activated with 1938, PI3K not only promotes cell growth in general, but specifically helps nerve cells regenerate.

What this means — after the necessary further studies, natch — is that “PI3K activators” could someday be a class of drugs used to treat nerve damage.

Short Takes

Paxlovid is official

The FDA has given Pfizer’s Paxlovid full approval for the treatment of Covid-19 in adults, moving it up from just an emergency use authorization. (It’s still under an EUA for teens.)

This is your brain on Musk

Elon Musk’s Neuralink says it has FDA approval to begin human trials for its brain implant that aims to allow humans to control computers with their minds. (It’s meant for paralysis patients, but we all know what it’ll really be used for … wink wink.)

May 26, 2023     Andrew Kantor

High-five to PCOM’s new PharmDs!

Congrats to the 76 newly minted PharmDs* who just graduated from PCOM Georgia! Let’s give them all virtual hugs as they’re about to commence their lives as pharmacists in the cold, cruel world. Also for having to endure bagpipes and a snare drum at the ceremony. (Could have been worse. Could have been an accordion.)

* And other medical disciplines
Kidding! We love “Scotland The Brave” as much as anyone!

Vitamin D: Give it to ’em early

A Finnish study…

…found that “higher than standard vitamin D3 supplementation up to age 2 years decreased the risk for internalizing problems in later childhood.” In other words, hit ’em with the D early so when they’re older the kids have a lower risk of mental disorders including autism and ADHD.

An Australian study…

…found that low maternal vitamin D levels raises a child’s risk of schizophrenia. How? Having enough vitamin D, it seems, is essential for the growth of neurons that process dopamine. If mom’s levels are too low, the neurons don’t differentiate the way they should.

They showed that dopamine release was enhanced in cells grown in the presence of the [vitamin D] hormone compared to a control.

And while the details of schizophrenia are still being worked out, “what is known is that schizophrenia is associated with a pronounced change in the way the brain uses dopamine.”

Monday Night Brewing — less than a week!

It’s back, better than ever, and barely a week away!

Do you like craft beer? Soda or soft drinks? A chance to network with the friendliest pharmacists, technicians, and students in the nation? Of course you do!

So come have a drink of your choice with us* at Monday Night Brewing! Mark your calendars for this coming Thursday, June 1, from 4:00–7:00 pm.

Click here for the details and to sign up, and don’t miss out on a night of fun! (If you feel guilty, tell yourself it’s good for your career. It is.)

* “Us” being the Academy of Employee Pharmacists, their friends and relations — including students!

First Medicare, now Medicaid

CMS is proposing new rules that aim to help states reduce Medicaid spending. They’re simple, really: They’d require true transparency from drug makers and -sellers, so pharma companies couldn’t hide their costs and pricing.

“For example, transparency into a manufacturer’s costs and process for establishing a drug price via the survey, along with other factors, would give states the ability to better negotiate supplemental rebates, and better understand the impact of the drug on its budget as supplemental rebates are negotiated.”

Expect pharma to, as usual, claim the sky will fall and life as we know it will end if they don’t get their way and be able to hide their costs and pricing.

Proving the pain

How does someone with chronic pain — which doesn’t leave a mark — prove they’re in pain? There isn’t a way, but UC San Francisco scientists have taken an important step. No, it won’t be something patients can show their friends, but it could convince medical pros that someone really is hurting.

It’s just on the border of being a true biomarker, and it shows there’s a path to a kind of official ‘test’ for chronic pain. They were able to see that certain parts of the brain ‘lit up’ when the patient experienced chronic pain.

The team implanted electrodes into areas of the brain responsible for planning, expectation and emotion, which are important in the genesis of the experience of pain. They then correlated the brain activity in these areas using machine learning[…] The research enabled them to objectively demonstrate that the information-processing areas of the brain in chronic pain are distinct from that of acute pain.

Not only could this mean confirmation of pain, but — as pain is all in the brain anyway — it could open the door to new treatments now that we know what to target.

Elsewhere: Colorado

Slowly but surely, Colorado is fleshing out its plan to handle the sky-high prices of medications. A panel of medical and pharmacy experts will choose 18 drugs “for review over the next three years to determine if the medications are unaffordable and whether to cap what health plans and consumers pay for them.”

Of course, choosing which 18 to target isn’t simple.

Do they tackle drugs with extremely high costs taken by only a handful of patients, or drugs with merely very high costs taken by a larger group? Should they consider only out-of-pocket costs paid by consumers, such as for insulin, whose copays Colorado caps at $50 a month, or the total cost of the drug to the health system? Will they weigh only drug prices, or will they try to right social wrongs with their choices?

Short take

Afternoon chaser for diabetes

If you have patients come in with type 2 diabetes, check the clock. If it’s after noon, consider chasing them around the pharmacy for a bit. Why? “Afternoon exercise linked with greater improvements in blood sugar levels for patients with type 2 diabetes.”

May 25, 2023     Andrew Kantor

A new kind of pain treatment

If you have a rat suffering from neurological pain — perhaps from chemotherapy or diabetes — there’s good news out of Duke.

Autologous conditioned serum (ACS), which athletes apparently swear by to treat sports injuries because of its anti-inflammatory effects, seems to help with rodents’ pain — and the effects are long-lasting, as in several weeks.

What’s weird is that the mechanism by which ACS is thought to work shouldn’t last long, so something else is going on. That something else is exosomes:

Instead, the Duke researchers found that exosomes appear to be the component that gives ACS its durability. These tiny vesicles contain a host of molecules that fight inflammation, including micro-RNAs, and they become highly activated through the conditioning and incubation process of ACS.

Now that they’ve discovered this unexpected mechanism, the Dukians say, “we can explore a number of additional therapeutic uses.”

Short take: better buprenorphine

The FDA has approved Braeburn’s Brixadi — a long-acting injectable form of buprenorphine — “for use in patients with moderate to severe opioid use disorder.”

Change the delivery, change the dose

After a particular type of stroke, patients are often given nimodipine to prevent complications — specifically, delayed cerebral ischemia. But not every patient can swallow a pill, and, found University of Alberta pharmacy researchers, when other delivery methods are used the outcomes can be completely different.

Part of that is because nimodipine is light-sensitive, part because there’s no standard for mixing it into an injection. But the overall point goes beyond just one drug: There are often mitigating factors when changing how a medication is administered, and that can have a profound impact.

Of the patients involved in the study, 31 per cent experienced delayed cerebral ischemia. However, the prevalence was 59.1 per cent among the patients who received crushed tablets and 45.8 per cent among those who received liquid drawn from capsules at the bedside.

Nutrition news

Multivitamins for memory

Older folks who took a multivitamin for a year had a mild improvement to their memory, according to a new study out of Columbia and Harvard universities.

[T]he study found people who continued to take a daily multivitamin were able to remember, on average, nearly one extra word compared with those who took a placebo. While the effect was small, it was statistically significant.

Of course, a little perspective helps. As one researcher put it, ‘While the less-than-a-word improvement was statistically significant, it would be hard to tell if such a small change would improve a person’s life.’

Also, multivitamins have a lot of ingredients, so figuring out which of them (or which combos) makes the difference will have to be on the agenda.

Flavonoids for frailty

Eating foods with lots of the flavonoid quercetin might help stave off frailty, at least according to a new study out of Harvard’s Beth Israel Deaconess Medical Center.

“Our findings suggest that for every 10 mg higher intake of flavonols per day, the odds of frailty were reduced by 20%. Individuals can easily consume 10 mg of flavonols intake per day since one medium-sized apple has about 10 mg of flavonols.”

It was quercetin in particular that did the heavy lifting, suggesting “that there may be particular subclasses of flavonoids that have the most potential as a dietary strategy for frailty prevention.” (Also, if our math is right, having 50 mg of flavonoids would reduce your frailty risk to zero!)

Captain Obvious thinks, “When vaping is outlawed….”

Full ban on the sale of flavored tobacco products associated with lower use”.

Sex and anesthesia drugs

Anesthesia drugs including diazepam, midazolam, nitrous oxide, and propofol can cause patients to have sexual hallucinations, according to a literature review by pharmacology researchers at the University of Connecticut.

That sounds embarrassing, but in fact it’s much worse. Some patients can hallucinate being sexually assaulted, while some patients may actually be sexually assaulted. If that’s not bad enough, the repercussions last long beyond the procedure, whether for patients or their surgeons.

The emotional turmoil a patient undergoes is likely the same whether actually experiencing sexual assault under anesthesia or having vivid hallucinations of the event. And practitioners too can experience distress: Some medical professionals accused of real or perceived sexual assault have been brought before regulatory boards or the courts and lose their license to practice.