The seven annoying symptoms of long Covid

We’re at the point where just about any chronic health issue after a Covid infection is considered “long Covid” — the reported list has 47 symptoms.

But Missouri University data scientists weren’t convinced. They wanted actual data, so they looked at the health records of more than 52,000 people, considering whether they had Covid, another respiratory infection, or neither. After cross-referencing the symptoms, they discovered not 47 but only seven symptoms that were consistently associated with long Covid.

As we know you’re curious, they are: fast-beating heart, hair loss, fatigue, chest pain, shortness of breath, joint pain, and obesity.

Technicians: Know your new CPE requirements

Starting on June 30, 2025, pharmacy technicians in Georgia will need to meet new CPE requirements to renew their biennial registrations.

You’ll be required to have at least 20 CPE hours to renew your license — but you’ll need to have at least 10 hours per year; i.e., you can’t cram it in all at once.

The first time you’ll need CPE is for your June 30, 2025 renewal.

• You’ll need to get 10 hours between July 1, 2023 and June 30, 2024.
• You’ll need another 10 hours between July 1, 2024 and renewal on June 30, 2025.

Awesome sauce: If you get more than 20 hours, you can roll over those extra hours into the next year!

(New technicians will have CPE requirements of zero, 10, or 20 hours based on their first registration month. It’s complicated.)

Of course, all existing requirements for pharmacy technicians — i.e., board approval — remain in place.

What to do, what to do

Start by creating an NABP eProfile if you don’t have one already, so you can track your CE credits using CPE Monitor (and print transcripts).

Look for CPE courses that are accredited by either ACPE or the Georgia Board of Pharmacy. (All GPhA’s CPEasy courses are accredited.) There are also PowerPak and other Web-based services that offer free or low-cost CPE.

Pay attention to GPhA announcements of new CPE courses. Most of them are available as webinars, many are on-demand, and there are new courses being offered all the time. (Did you know you can get a hour of CPE by learning the history of Coca-Cola?)

Just remember: No cramming — you need to spread your hours out over the two-year period!

Questions? Reach out to J. Ross Hays, CPhT, the chair of GPhA’s Academy of Pharmacy Technicians. He’s at apt@gpha.org.

ICYMI: Emergency to end in May

The Biden administration will finally end the Covid-19 public health emergency on May 11.

(What happens then? That’s a long read, but here you go.)

Café au lait keeps the inflammation away

Coffee is good for you, but now those shifty Danes say that coffee with milk might be even better.

It’s all about coffee’s polyphenols — the antioxidants that are part of what makes coffee healthy. But when you combine polyphenols with proteins like the ones found in milk, the result is really, really good for immune cells.

[A]s a polyphenol reacts with an amino acid, its inhibitory effect on inflammation in immune cells is enhanced.

And they mean significantly enhanced:

[I]mmune cells treated with the combination of polyphenols and amino acids were twice as effective at fighting inflammation as the cells to which only polyphenols were added.

Of course this is all in the lab, so, as always, further research (first in animals, then humans) is needed.

Court: J&J can’t two-step

Johnson & Johnson tried to limit the pain of those talcum powder lawsuits by spinning off those liabilities into a new company, then having that company declare bankruptcy — the “Texas Two-Step.” (Named because Texas law allows it.)

But now a federal appeals court has reversed a lower-court decision and told J&J it’s going to have to face the music sans spinoff.

Feds target Medicare Advantage fraud

A new CMS rule gets aggressive with Medicare Advantage audits. In short, it allows the agency to review a subset of a Medicare Advantage provider’s records, determine how much fraud it committed, and extrapolate that to all the provider’s billing since 2018.

In other words, if the subset showed the company overcharged by an average of 1 percent, the government would assume that it was overbilled by 1 percent on every patient since 2018.

Providers — for which Medicare Advantage is the most profitable product — aren’t happy, and they’re doing the “World Will End if This Happens” dance.

But supporters of the rule point out that it was originally planned to go back to 2011, so insurers should count their blessings … which include hundreds of millions of dollars taxpayers overpaid them.

If you’re overweight, at least get your vitamin A

The paper: “Vitamin A preserves cardiac energetic gene expression in a murine model of diet-induced obesity”

The news: “Vitamin A May Protect Heart from Some Effects of Obesity”

The finding: Mice who are both obese and vitamin-A deficient have “greater disruption to genes involved in heart function,” according to German researchers.

‘[T]the vitamin-deficient obese mice had repression of genes in the heart that are associated with extracting energy from fat, extracting energy from glucose, and the production of [ATP].’

Chains cut pharmacy hours

Pharmacists are getting closer to being on the endangered species list, and that means both CVS and Walmart have announced they’re “adjusting” their pharmacy hours as a result of the shortage of pharmacists.

CVS will start its “adjustment” in March, which will include cutting some hours in some stores. Walmart will adjust its pharmacy hours in most stores by closing at 7:00 pm — two hours early.

Per Walmart: “[W]e are making this change to not only enhance their [pharmacists’] work-life balance but also to maintain the best level of service for our customers.”

What’s with the antibiotic shortage?

The entire world is facing shortages of antibiotics — including amoxicillin, ceftolozane, and penicillin — to one degree or another, but what’s behind it?

Demand tops the list, as PharmaPhorum explains, but it’s hardly the only issue.

“Recently, shortages have been exacerbated by geopolitical events or trends, such as the war in Ukraine, the energy crisis, high inflation rates, as well as the recent surge of Covid-19 cases in China.”

Introducing the Jeff Lurey Independent Community Pharmacy scholarship

GPhA is proud to announce the Jeff Lurey Independent Community Pharmacy Scholarship — a $5,000 award presented annually to a P3 student pharmacist at one of Georgia’s four pharmacy schools.

Who is eligible

• P3 students who are current GPhA members and enrolled at either Mercer, PCOM, South, or UGA’s school/college of pharmacy
• A person who has expressed an interest in owning an independent pharmacy after graduation

What judges will consider

• Have you worked in or completed a rotation in an independent pharmacy?
• Have you attended a GPhA region meeting or the Georgia Pharmacy Convention?
• Have you taken business or entrepreneurial classes?
• Do you have a family member who owns or operates an independent pharmacy?
• Are you able to attend the Georgia Pharmacy Convention to receive the award?

Applications will be judged by the AIP Executive Committee, and the AIP Board of Directors will decide the final recipient.

Applications for the Jeff Lurey Independent Community Pharmacy Scholarship are due by March 1, 2023. (The winner will be notified by May 1 so he or she can make plans to attend the convention.)

Don’t wait! Apply today!

Update your address book

AmerisourceBergen now identifies as Cencora. That is all.

Oxytocin: Who needs it?

Ah, the love hormone — necessary for … well, if not love, at least for forming social attachments that lead to love, kids, and all that fun stuff. Or so we thought.

Neuroscientists in California tested the theory on prairie voles not only because they’re adorable (the voles, not necessarily the researchers), but because they form life-long pairs, share parenting duties, and even “show signs of preferring their partner over strangers of the opposite sex, and actively reject new partners.”

But when the voles were genetically engineered to completely lack oxytocin receptors, they still bonded. We’re talking not only the metaphorical snogging behind the bleachers, but all the normal bonded-pair behaviors, up to and including rearing their pups to weaning age.

“We were all shocked that no matter how many different ways we tried to test this, the voles demonstrated a very robust social attachment with their sexual partner, as strong as their normal counterparts.”

And that is how what we “know” becomes “what we used to think.”

Once more, with numbness

The WHO has extended the Covid-19 public health emergency, but “signaled strongly that it believes it may be able to lift that designation in coming months.”

Soybeans vs cholesterol

When we first saw the story that soybean protein might be as good as statins for lowering cholesterol, we assumed it had been sponsored by Big Soybean. But it wasn’t.

In fact, the University of Illinois researchers found that it isn’t simply soybeans, but a particular protein: B-conglycinin. Soybeans with higher levels of B-conglycinin block metabolism of triglycerides and LDL cholesterol and — via [insert science here] — “were able to reduce lipid accumulation by 50%-70% […] That was comparable to the statin, which reduced it by 60%.”

Of course, this was just in the lab, but it shows a potentially different path to regulating lipid metabolism.

Scary man to target pharma companies

When you consider politicians, who would be a fun neighbor to have? In the Buzz offices, both George W. Bush and Joe Biden come to mind as cool dudes.

But (regardless of your politics) who would be an absolutely terrifying neighbor?

Now Bernie is chairman of the Senate health committee^*, and that makes pharma companies his metaphorical neighbors — neighbors who’ve let their lawns get a little too tall.

Money quote: “However scared they are, they’re not scared enough.”

^* Technically the U.S. Senate Committee on Health, Education, Labor & Pensions.

Today’s grain-of-salt story

Eating grapes could reduce your chances of getting surnburnt … according to a small study (partially) funded by the California Table Grape Commission. (They think it might have something to do with — you guessed it — the gut biome.)

FDA a step closer to changing Covid vaxes

The other day, the FDA’s vaccine advisory committee^* met to decide what to recommend when it came to new, Omicron-specific vaccines and boosters.

In a surprise to no one, the committee recommended that the original, circa-2020 vaccines be replaced by the combo Omicron shots — and that’s for all doses, from the primary series to any boosters. Everything’s bivalent now!

(Well … that’s assuming the FDA follows the committee’s recommendation. Once upon a time that was a given. These days, who knows?)

^* Technically the Vaccines and Related Biological Products Advisory Committee

Speaking of new vaccinations…

Do NOT wait to get your APhA vaccination certificate!

February 12 is your last chance until the end of May to take the Big Kahuna of immunization certificate courses: APhA’s Pharmacy-Based Immunization Delivery Certificate Training Program.

It’s a total of 23 hours of CE, and it’s the nationwide immunization training you want.

The live portion (8 hours) is being held at GPhA’s North American headquarters in Sandy Springs from 8:00am to 5:00pm on Sunday, February 12.

Space is limited and time is running out.

After you take the live portion, the rest is self study — easy peasy. At the end you get the certificate for your wall and the important line on your CV.

Et tu, antidepressants?

Just because they’re an entirely different type of drug doesn’t mean antidepressants can’t do their part to increase antimicrobial resistance.

Apparently, found Aussie biotechnologists, when bacteria in the lab are exposed to antidepressants for a few days, they “develop drug resistance, not only against one but multiple antibiotics.” As the senior author put it, “This is both interesting and scary.”

You want a bit more science? Here you go:

In bacteria grown in well-oxygenated laboratory conditions, the antidepressants caused the cells to generate reactive oxygen species: toxic molecules that activated the microbe’s defence mechanisms. Most prominently, this activated the bacteria’s efflux pump systems, a general expulsion system that many bacteria use to eliminate various molecules, including antibiotics. This probably explains how the bacteria could withstand the antibiotics without having specific resistance genes.

FDA punts on CBD regulation

When it comes to regulating CBD, the FDA admits it doesn’t know what to do. So it’s punting the question to Congress.

The FDA has strict regs for drugs but not for supplements, so it doesn’t think it has the (clear) authority to regulate CBD products, which, if you believe the hype, can treat anything from mood disorders to itchy toenails.

It’s a legal mess out there: Cannabis is illegal federally, but hemp is legal. CBD isn’t psychoactive, but there haven’t been many good studies about what it can do.

So now it’s in Congress’s lap.

Who’s using sleep meds?

More than 1 in 12 Americans takes some kind of medication to help fall asleep, either prescription or over the counter. That’s the latest data from the CDC’s National Center for Health Statistics.

Some notable takeaways:

• The older people were, the more likely they were to use sleep aids — almost 12% of those over 65 used them most days, compared to only 5.6% of adults under 45.
• Women used them more than men — 10.2% compared to 6.6%. (So yes, women over 65 used them the most: 13.5%.
• The lower the household income, the more likely people were to use sleep meds — by an noticeable but not huge amount.
• White, non-Hispanic people use them the most — a lot more than Black, Hispanic, or Asian folks.

Link above goes to the CDC/NCHS brief; click here for the news story.

Cross Evusheld off the list

The FDA has revoked it’s emergency use authorization for AstraZeneca’s Evusheld Covid treatment saying that it no longer works thanks to Omicron.

It (and AZ) will keep an eye on which strains are circulating in case Evusheld turns out to be effective again. But it seems the days of monoclonal antibodies vs. Covid are over and ritonavir/nirmatrelvir rules the roost.

For now.

Elsewhere: Big Sky edition

Out in Montana, where “rural” takes on a whole new meaning, the state might expand pharmacists’ ability to prescribe certain meds as long as the pharmacist has some added training (and is working with a physician).

Under the bill, pharmacists could prescribe for patients who do not require a new diagnosis, for minor conditions, or in emergencies. They could not prescribe controlled substances.

Naturally, the Montana Medical Association opposes the idea.

The kids are sickening

We all know kids are walking, coughing Petri dishes, but how big a Petri dish are we talking? University of Utah infectious disease specialists decided to find out.

The answer is — yes, we see you nodding in the back, Captain Obvious — very big. Especially the youngest ones, who, they found, “were infected with some kind of respiratory virus a full 50% of the year.” (Keep in mind that infected doesn’t necessarily mean sick.)

Still…

For families with two, three or four kids, someone at home had an infection a little more than half the year. Families with six kids had a viral detection a whopping 87% of the year. Childless households, on the other hand, only had a viral detection 7% of the year.

Covid notes

The vaccines work against Kraken

The CDC finally has data on how well the Omicron booster (mRNA shot #4, if you’re keeping track) works against the latest Kraken variant, aka BA.5 and XBB.

The answer is: pretty well, but not amazing. We’re talking about 52% effective against symptomatic infection in people 18 to 49 years of age, 43% effective for the 50-64 group, and 37% effective for seniors.

The better news is that the efficacy seemed to remain for at least three months (in people who also had the initial mRNA shots).

This jibes with previous studies of the second booster’s effectiveness against older Omicron variants, meaning anyone who says “Almost every study now has said with these new boosters, you’re more likely to get infected with the bivalent booster” is clueless.

Get sick and get vaccinated

That’s how you get the most protection from future Covid infections according to University of Calgary/WHO research. Being fully vaccinated and a prior infection (in any order) is, they say, 95 percent effective against severe disease over a year.

So even if you’ve had your shots, go stand in front of someone^* with a cough and a Flat-Earther T-shirt — just for that extra oomph.

^* Don’t do this.

The drug-advertising loophole

You know that drug companies are prohibited from stretching the truth about their products in television advertising. But thanks to the age of the law, there’s a huge loophole: It only applies to companies “that manufacture, distribute, or pack” prescription drugs.

But now, with online advertising a Big Deal, other companies are making misleading or unproven claims about products. The FDA can’t stop them (per the law) and neither can the Federal Trade Commission (because only the FDA has jurisdiction over prescription-drug ads).

An amino acid for neuropathy

Could a simple amino acid supplement help diabetics with peripheral neuropathy? We wouldn’t ask if it was a possibility.

Salk scientists were studying peripheral neuropathy in mice when they found an interesting connection: “diabetic mice with low levels of two related amino acids, serine and glycine, are at higher risk for peripheral neuropathy.”

Is it cause and effect? Apparently so: “[T]he researchers were able to alleviate neuropathy symptoms in diabetic mice by supplementing their diets with serine.”

So much for serine being a “non-essential” amino acid.

The researchers were surprised to find that low serine, in combination with a high-fat diet, accelerated the onset of peripheral neuropathy in the mice. In contrast, serine supplementation in diabetic mice slowed the progression of peripheral neuropathy, and the mice fared better.

You know the drill, of course: More studies are needed.

A suit with long-term repercussions

Standard warning: This is a story about mifepristone. Remain calm.

A complaint filed in federal court is challenging West Virginia and North Carolina’s ban/restriction on the drug, saying the state doesn’t have the right to override FDA approval.

No matter which side of the question you’re on (if any), the question has much broader implications. If a federal court rules that individual states can regulate drugs separately from the FDA, it would obviously apply to every drug … and wouldn’t that be interesting?

Standard disclaimer: GPhA does not have a position on the dispensing of mifepristone.

The Long Read: The Other Side of Ketamine edition

“Ketamine is being sold as a depression wonder drug. For some, it’s making everything worse.”

For real this time

A new technique can measure thousands of molecules from a single drop of blood, and potentially use that to detect health issues.

This time, though, it’s a real thing. Stanford Med researchers use a technique called “multi-omic microsampling” that’s based on good ol’ mass spectrometry. And there’s no mysterious black box involved (looking at you, Theranos) — the pin-pricked sample needs to be sent to a lab.

In a pilot study of two test subjects, the researchers were able to measure the levels of 128 proteins, 1,461 metabolites and 776 lipids from each microsample.

Next up: Testing the approach on more patients. As the lead researcher said, “The bottom line is that we can get a really deep profile of a person’s metabolic and immune health, all through the convenience of a home test.”

What d’ya know about OTC hearing aids?

Over-the-counter hearing aids are out in the wild now, and chances are consumers are already dabbling.

You, dear pharmacist, need to be ready to answer their questions!

How lucky for you that GPhA is offering a one-hour lunchtime CPE webinar with UGA professor and audiologist Alison Morrison on this very subject!

Sit in for “OTC Hearing Aids: How Pharmacists Can Support Safe Self-Care,” ask all your questions, get an hour of CE credit, and be ready to help your patients know what’s likely to work best, cut through the marketing chatter, and understand the differences between hearing aid types.

Deets:

Tuesday, February 28, 2023 Noon – 1:00 pm via Zoom

It’s a mere $20 for GPhA members (non-members are $42).

Click here for all the rest of the details and sign up today!

Lilly prepares to cash in on Mounjaro

The company is investing an additional $450 million into its North Carolina tirzepatide production facility, bringing the total to $1.7 billion for that plant alone. Sounds like confidence. Let’s hope the next story doesn’t get too much traction:

“Ozempic face”?

Apparently people are learning that weight loss has side effects, especially when it’s unnecessary. They call it “Ozempic face” — when your face starts to look gaunt and older.

“When it comes to facial aging, fat is typically more friend than foe. Weight loss may turn back your biological age, but it tends to turn your facial clock forward.”

The solution: Off to the dermatologist for filler, of course.

15-second flu update

Flu cases are dropping worldwide, but a bit slower in the north. Still, it looks like the worst of the season is over.

Of note: The 2009 H1N1 variant is now the most prevalent, pushing H3N2 into second place.

Chemo’s afternoon delight

Here’s an unexpected finding: Women with lymphoma do much better when they have their chemo in the afternoon, rather than in the morning. And by “much better” we’re talking about a huge difference in both mortality and side effects.

According to Korean researchers…

It was found that female patients who received afternoon treatment had 12.5 times reduced mortality rate (25% to 2%), while the cancer recurrence after 60 months was decreased by 2.8 times (37% to 13%). In addition, chemotherapy side effects such as neutropenia were more common in female patients who received morning treatment.

And yes, this only applies to female patients; there was no difference in efficacy for men. Go figure.

Get ready to talk to your Medicaid patients

They might need your help when continuous enrollment ends on March 31. That’s when Medicaid patients in Georgia (and other non-expansion states) will need to re-verify their eligibility or be removed from the program.

[HHS] expects 6.8 million people to lose their coverage even though they are still eligible, based on historical trends looking at paperwork and other administrative hurdles. Pre-pandemic, some states made signing up for and re-enrolling in Medicaid very difficult to keep people off the rolls.

The Long Read: Viruses and Neurodegenerative Diseases edition

Could viruses like the flu be a cause of diseases like Alzheimer’s and Parkinson’s? It’s not that simple — there’s a connection, but causation is a lot tougher to prove: “Study links viral infections to Alzheimer’s, Parkinson’s—with many caveats.”

A pill for diabetic cats

If you have (or know) a diabetic cat, great news — seriously. A new daily pill can replace insulin shots … but only in cats that haven’t been taking injectable insulin.

Elanco’s Bexacat was approved in December and it’s expected to hit the (metaphorical) counters in the next few weeks.

In studies involving more than 300 diabetic cats, Bexacat improved glucose control and decreased at least one symptom of diabetes in more than 80% of newly diagnosed, healthy animals.

Big ol’ caveats: It only works for otherwise-healthy cats; some animals in the studies died, so it’s got a black-box warning. The wholesale price is about $53 a month.

While we’re talking about cats and diabetes…

The FDA has approved bexaflilozin for adult (human!) type 2 diabetes. The feline connection: Bexaflilozin was originally developed to treat cats.

The pharma deets:

The phase 3 trials showed significant HbA1c and fasting glucose reductions by the 24th week when used as a monotherapy, in combination with metformin, or as an additional treatment for those already being treated with sulfonylureas, metformin, insulin and DPP-4 inhibitors.

Amazon adds $5 all-you-can-fill prescription service

Amazon has jumped into the ultra-cheap-generics game with a new program for its Prime members: RxPass. The gist: For $5 a month, customers can fill as many prescriptions as they need … but only from a list of about 50 generic meds, and the program doesn’t take insurance. (Click here to see the list.)

This is, of course, Amazon’s way of joining Mark Cuban’s Cost Plus Drugs in the “cheap generics without insurance” game, although in Amazon’s case it also requires a $15 monthly Prime membership.

When the sun sets on the PREP Act

So the PREP Act — which allows pharmacists and technicians to provide Covid-19 and other vaccinations nationwide — is going to sunset in 2024. What happens then? Chaos. Forty years of darkness, earthquakes, volcanoes, the dead rising from the grave, human sacrifice, dogs and cats living together….

Georgia (yes, thanks to GPhA advocacy) already allowed pharmacists to administer most vaccinations, but still, count on patient confusion if and when it happens — and many GPhA emails and press releases.

Lookin’ good with fish oil

Fish oil supplements might not only protect against cardiovascular and kidney issues, they might make men sexier — if you’re a mouse, at least.

It seems that those omega-3 fatty acids that are so important to health can also cause hair loss via an autoimmune reaction. So found a University of Iowa immunologist who was studying obesity.

The mice fed the omega-3–rich fish oil lost a considerable amount of hair along their shoulders. Meanwhile, the mice fed cocoa butter (which contains saturated fats) and the low-fat diet control mice exhibited no hair loss at all.

What’s going on? The science in a nutshell: The omega-3s cause the skin to generate two inflammatory cytokines — IL-36 and TNF-a — which end up killing hair follicle stem cells.

The next question: In what other areas of the body might these fatty acids might accumulate, and what could they do there?

Today’s anti-aging drug

Do you want to live longer? Start taking rilmenidine. If you’re a roundworm, anyway.

British longevity researchers found that …

… animals treated with rilmenidine, currently used to treat hypertension, at young and older ages increases lifespan and improves health markers, mimicking the effects of caloric restriction.

How will it translate to humans? Wait and see.

Yeah, whatever: Antidepressant blunting explained

Why do some people taking SSRIs feel emotionally “blunted” — not getting excited when their team makes the playoffs for the first time in six years, or simply having trouble even finding pleasure at all?

British researchers, with help from some of those shifty Danes, found that long-term use of an SSRI (escitalopram in this case) caused “reduced reinforcement sensitivity” — trouble learning from feedback.

In other words, both punishments and rewards didn’t mean as much to them. As one team member explained:

“[Antidepressants] take away some of the emotional pain that people who experience depression feel, but, unfortunately, it seems that they also take away some of the enjoyment […] we can now see that this is because they become less sensitive to rewards, which provide important feedback.”

The Long Read: Alternate Reality edition

It’s gone beyond anti-vaxxers touting bogus ideas and debunked papers. A column in Forbes explain how “In The U.S., Conspiracy Theories And Alternate Facts Undermine Public Health And Cause Death” (and features at least one Georgia legislator).

Don’t get too excited

The headline: “Men who use Viagra are 25% less likely to suffer early death.”

The reality: The USC study was based on insurance claim data and death records, and it found that men who had filled at least one prescription for PDE-5is had a lower death rate and were less likely to suffer a major heart issue.

It showed correlation but nothing close to causation. As Forbes’s Bruce Lee (no relation) points out, the men who took ED drugs were the ones having sex — “typically you don’t take ED medications just for the heck of it”.

“[W]hen you are regularly having sex, there’s a good chance that you are already reasonably healthy. Sex is probably not the first thing that may come to mind when you are experiencing symptoms like chest pain or shortness of breath.”

FDA proposes annual Covid shots

The FDA is proposing (to its own advisory panel) that Covid shots become an annual affair — each year, people would get a combo shot that included the original, OG Covid strain, plus whatever Omicron variant is currently in circulation.

[B]arring development of a significantly improved vaccine, periodic future updates […] will likely be needed to induce and maintain vaccine effectiveness.

The advisory committee will decide whether to recommend that shot-a-year plan (two shots for the immunocompromised) and also whether to update the first shot for unvaccinated people to include Omicron protection.

ICYMI: Another good reason to keep boosted

Getting Covid while pregnant increases the mother’s risk of death sevenfold. Or, if you want to sound scary, “…by 700%”.

And yet another

There’s evidence (out of Britain) of fetal brain hemorrhages linked to mom having Covid-19. The culprit is “a reduction in blood vessel integrity,” but it’s not clear whether it’s the virus acting directly, or because of the mother’s immune response to the infection.

Oh, and this applies to cases of “severe viral infection,” not the mother’s response to a vaccine.

Beauty and pre-term birth

Chemicals from beauty products can accumulate in the vagina and lead to pre-term birth. Yeah, let that sink in.

Researchers from Columbia and Penn “found that a handful of non-biological chemicals previously found in cosmetics and hygiene products are strongly associated with preterm birth.”

Originally they thought the clue to unexplained pre-term births (i.e., just about all of them) was in the microbiome, but then they looked at external sources as well. They found that strong association with a set of chemicals “that were significantly higher in women who had delivered early” including diethanolamine, ethyl-beta glucoside, tartrate, and ethylenediaminetetraacetic acid.

None of them are produced by humans or the microbiome — but they’re all found in cosmetics and hygiene products.

“The good news is that if these chemicals are to blame, it may be possible to limit these potentially harmful exposures.”

New STI arrives

America’s first cases of a “novel strain” of antibiotic-resistant gonorrhea has been reported in Massachusetts. Luckily it was treatable with ceftriaxone, but how long that will remain true is anyone’s guess.

This strain had previously been reported in the Asia-Pacific region and the UK, but these two unrelated cases in New England are the first in the US.

Overall, these cases are an important reminder that strains of gonorrhea in the US are becoming less responsive to a limited arsenal of antibiotics.

Nursing homes get anti-psychotic scrutiny

Are nursing homes giving residents unnecessary anti-psychotics, perhaps to keep them docile? CMS is going to start checking.

Beginning this month, CMS will conduct targeted, off-site audits to determine whether nursing homes are accurately assessing and coding individuals with a schizophrenia diagnosis.

Perhaps more notably, if a “deficiency” is found, HHS will post that information to its Care Compare website immediately, even if the facility disputes it. “Displaying this information while it is under dispute can help consumers make more informed choices when it comes to evaluating a facility.”

Fighting infection with bacteria

Instead of attacking an infection with boring ol’ chemicals, why not train a different bacteria to be your army? That’s what researchers in Spain did, creating a “living medicine” from a genetically modified version of the Mycoplasma pneumoniae bacteria. (Yes, the one that causes a form of pneumonia.)

To treat a Pseudomonas aeruginosa lung infection, they used a combo of low-dose antibiotics and the pneumonia bacteria. The bacteria attack the P. aeruginosa, the antibiotics clean up any stragglers, and the body clears out the soldiers when they’re done.

Clinical trials are next.

FDA keeps Lilly in the slow lane

Looks like the FDA is slowing down on accelerated approvals for Alzheimer’s meds. It denied the approval for Eli Lilly’s donanemab, the latest anti-amyloid drug to attempt to enter the market.

It’s not clear whether that’s because previous drugs were only partially effective despite gushing headlines (looking at you, lecanemab), the fact that drugmakers were pricing those drugs sky-high (looking at you, Aduhelm), or because Lilly’s phase-2 results were only so-so.

The company expects to seek normal approval later this year when its phase 3 study is done.

Stroke treatment through the nose

If you have a rat that’s had a stroke, getting drugs to its brain isn’t easy thanks to the ol’ blood-brain barrier. But now — working with the idea that smell-detecting cells might have an easier path to the brain — Swiss scientists are testing a stroke treatment delivered by nasal spray.

The drug is actually antibodies that (in theory) would get to the brain and block a compound called Nogo-A, which inhibits the growth of brain cells. Turns out the theory is right.

[They] found that the treated rats had sprouted more new nerve fibres. “It shows there’s a natural regenerative power within the brain and you just have to take the brakes off to let it happen.”

RSV vax could be coming soon

Moderna’s RSV vaccine just passed its phase 3 trial with flying colors, demonstrating an efficacy of 83.7% for people 60 and older. The trial included 37,000 people from 22 countries, so it would seem to have ticked all the boxes.

The vaccine was also found to be safe and well tolerated, with a few mild or moderate adverse reactions reported. The most common side effects were injection site pain, fatigue, headache, myalgia and arthralgia.

It’s not the crime, it’s the coverup

Pro tip: If you’re going to try to deceive FDA inspectors, don’t leave piles of shredded documents around — certainly not “inside a ‘large black plastic bag that was hid under the staircase’” — or douse them with acid. Eagle-eyed inspectors are likely to notice.

The Indian plant in question received an FDA forms 483, but “the regulatory wrist slap could escalate to a Warning Letter.” Ooh, scary.

Easier continuous monitoring

If you want to monitor someone’s health continuously, there’s not that much you can use. Sweat is easy, but doesn’t provide a lot of info. Blood gives more data, but that would mean wearing a needle in a vein all day.

What about something in between?

That’s what University of Cincinnati bioengineers think as they look to create a way to monitor interstitial fluid — the liquid surrounding cells — which could (soon?) be done using microneedle patches.

Those patches only need to pierce the skin by less than a millimeter to sample that interstitial fluid, and “contains many of the same chemicals in the same proportions as blood, offering a potential alternative to costly and time-consuming lab work.”

At the moment it’s just an idea, but the technology is available to start a proof of concept.

I mean, it makes sense

In places where you can get marijuana over the counter, there’s less use of prescription codeine.

What’s different about this study is that it used data from the DEA that tracks shipments of controlled substances (e.g., codeine). Thus it found, among other things…

A 26% reduction in pharmacy-based distribution of codeine and as much as a 37% reduction after recreational cannabis laws have been in effect for four years.

Cannabis comes with its own set of issues, of course, but they’re a lot milder than, say, opioid addiction.

It’s safe to give out safety drugs

One of the arguments against making buprenorphine easier to get is that having a treatment for opioid abuse would make opioid abuse more common. Not surprisingly, that’s just not true.

An NIH/CDC study confirmed for buprenorphine what was already known about methadone. Despite the hand-wringing…

The proportion of opioid overdose deaths involving buprenorphine, a medication used to treat opioid use disorder, did not increase in the months after prescribing flexibilities were put in place during the Covid-19 pandemic.

Now that we know this, it should open the door to more buprenorphine availability — unless, of course, people ignore the data.

Controlled chaos coming

Eventually the Covid public health emergency will end, and you know what happens then? Telehealth providers won’t be able to prescribe controlleds. Unlike other pandemic waivers that Congress has extended, when it comes to drugs, those restrictions pop into place.

That could leave patients scrambling to find providers who can see them, forcing some to travel long distances or endure extended wait times for an office visit.

Fun fact: The DEA was required to create rules for those telehealth prescriptions by 2019 … and never did.

Take two aspirin

Heparin, schmeparin. If a patient is hospitalized with a bone fracture, you don’t need those fancy-schmancy blood thinners. Good ol’ aspirin works just as well, according to a University of Maryland study — a clinical trial involving “more than 12,000 patients at 21 trauma centers in the U.S. and Canada.”

There was barely any difference in death overall from using aspirin, and…

…the researchers also found no differences between the two groups in clots in the lungs (pulmonary embolisms). The incidence of bleeding complications, infection, wound problems, and other adverse events from the treatments was also similar in both groups.

“Game changer”: Light that kills superbugs

Two skin-based bugs — golden staph and pseudomonas aeruginosa — are resistant to most antibiotics, and that’s a problem for people with skin wounds, catheters, or even those on ventilators. But now Aussie researchers have a way to kill ’em en masse.

They’ve created a lotion filled with nanotech — a compound that, when exposed to a UV laser, “generate[s] highly reactive oxygen molecules that eradicate microbial cells and kill deadly bacteria, without harming human cells.”

The goal is to use the tech to clean existing wounds and protect patients at risk during a procedure. But first, of course, more research is needed.

01010011 01100001 01111001 00100000 01100001 01101000 01101000 01101000

An artificial intelligence — ChatGPT, which some of you may have heard of — has passed all three parts of the U.S. Medical Licensing Examination.

“[W]e were pretty amazed at the results. Not only at what it was getting right, but at how it was explaining itself.”

(You can read more about ChatGPT here. It’s causing schools fits because it can write students’ papers for them.)

Walgreens writes a check

Walgreens has agreed to pay West Virginia more $83 million over eight years for its role in the opioid crisis. (You may remember that other chains — CVS, Rite Aid, and Walmart — already reached settlements with the state of $82.5 million, $30 million, and $65 million, respectively.)

Contraceptive 3.0?

Boston University researchers are working on the pieces of what they hope will form a new kind of non-hormonal contraceptive that also prevents STDs including herpes simplex and HIV.

They’re testing two films that dissolve inside the vagina: Using monoclonal antibodies, one makes sperm immobile to prevent pregnancy, while the other contains antibodies against HSV and HIV…

… with the goal of combining them to make an effective reversible birth control […] The research team is also working to make birth control applicable to people who don’t have vaginas^*.

It’s particularly important, they say, because all three of the 95-plus-percent-effective birth control methods available today (implant, IUD, shot) require a doctor’s visit and don’t protect against STIs.

^* Someday we’ll come up with a simple three-letter word for “people who don’t have vaginas.”

Complex guidance on simplification

Irony, irony, all is irony. The FDA has issued “a wholesale rewrite” of its 2010 guidance on making sure drug labels are “pertinent and understandable” to health care practitioners.

It’s triple the length of the previous guidance.

TV ads don’t really help

In what must come as a total shock, it turns out that the drugs advertised on television are no better than — and may not be as good as — existing medication. Even if they are “As Seen on TV.”

Researchers from Harvard, Yale, and Dartmouth “examined independent therapeutic value ratings for 73 of the most advertised drugs from 2015 to 2021.” Despite the $22 billion the pharma companies pumped into the economy…

Most drugs advertised on television don’t work better than existing alternatives, a new analysis shows. And manufacturers spend more on advertising for those less beneficial drugs than for ones that work better.

But let’s not forget, those high drug prices are needed to fund research and development.

Apparently this used to mean something

The “Drugs to Watch” this year

Research and analysis company Clarivate has released its 2023 list of Drugs to Watch — what it calls “Blockbusters on the cusp and those with the potential to transform treatment paradigms.”

Click here to fill out the form, give away your info, and download a copy.

Please don’t read further where you’ll see the list of drugs and a link to download the report because we at Buzz have taken a hit for the team.

The drugs:

• Bimekizumab
• Capivasertib
• Daprodustat
• Deucravacitinib
• Foscarbidopa/foslevodopa
• Lecanemab and donanemab
• Lenacapavir
• Mirikizumab
• Pegcetacoplan
• Ritlecitinib
• Sparsentan
• Teclistamab
• Teplizumab
• Valoctocogene roxaparvovec

Do not click here to download the 87-page PDF from GPhA Buzz, no questions asked.

Spraying away the tonsillectomy

Want to reduce the risk of kids needing their tonsils removed? There might be a simple answer: saline spray.

Aussie researchers found that either steroids or plain ol’ saline nasal spray cleared up the kind of “sleep disordered breathing” that often results in a tonsillectomy — 40 percent of the time.

“[T]he study found a substantial number of children with sleep disordered breathing could initially be managed by their GP and may not require referral to specialist services.

Vitamin D and body weight

We know that good levels of vitamin D are important for staving off cancer, heart disease, and stroke (and rickets, of course), but it seems that the size of the benefit is related to the size of the patient.

Researchers from Brigham and Women’s Hospital found that yep, vitamin D supplements were generally a Good Thing, but “There seems to be something different happening with vitamin D metabolism at higher body weights.”

It turns out that for people with a low BMI, they found “30-40 percent reductions in cancer deaths, autoimmune diseases, and other outcomes with vitamin D supplementation.” But for people with a high BMI, the vitamin D wasn’t being metabolized as well — what they called “a blunted response to vitamin D supplementation.”

They need more research (of course), but at the moment the takeaway is that larger folks might need to have their vitamin D levels checked more often to find the right supplement dose.

Peds meds coming back

Walgreens has removed limits on pediatric fever meds from over-the-counter sales. That is all.

Hormones can fight Alzheimer’s

Bioidentical hormone therapy (BHT, aka hormone replacement therapy; HRT) isn’t just for mood issues or sexual health — it can also help prevent women from contracting Alzheimer’s.

The British study that found this is preliminary, but it seems to be related to the APOE4 gene — “the strongest risk factor gene for Alzheimer’s disease.”

“We found that HRT use is associated with better memory and larger brain volumes among at-risk APOE4 gene carriers. The associations were particularly evident when HRT was introduced early — during the transition to menopause, known as perimenopause.

Pro tip: Off-the-shelf BHT doesn’t work for everyone, so — if you’re not a compounding pharmacist yourself — this could be a good reason to strike up a relationship with one. Adding the “c” to BHT is kinda their jam.

Don’t wait

Tomorrow we’ll tell you how procrastination is linked to poor mental and physical health.

How chemo can help cancer

New cancer cells often die from “isolation stress” — not having enough oxygen or nutrients. But some overcome it by creating a receptor protein called LPAR4. Then they can start to form tumors.

Here’s the rub: UC San Diego pathologists found that “isolation stress is not the only way to trigger LPAR4.” What else can do it? Chemotherapy drugs — they cause the same stress that isolation does, meaning some of the cells it attacks develop drug resistance.

If you’re expecting a big breakthrough in this paragraph, unfortunately that’s not the case. But the finding — why tumors become chemo-resistant and how chemo can cause that — could itself be a big deal.

You’re a compounder! You’re a compounder! Everyone’s a compounder!

Can’t get hold of Wegovy — either because you don’t have a script or it’s just out of stock? Fear not! You can just order semaglutide or tirzepatide online and make your own injection! What could possibly go wrong?^*

At least a dozen websites that specialize in a class of protein-related products called peptides now list semaglutide and tirzepatide. Though they say their chemicals should only be used for lab research purposes and not for human use, individuals have been ordering from the websites to make their own injections at home.

But wait, there’s more! What are these people actually getting? Novo Nordisk (semaglutide) and Eli Lilly (tirzepatide) only their drugs except as pre-packaged products; they don’t make the ingredients available for compounding — and certainly not for DIY at-home use. “[I]t’s unclear what exactly is inside the alternative products.”

^* Sarcasm. This is sarcasm.

Only 27.4 million to go!

Not only has Obamacare enrollment set a record this year, but we’ve hit another good mark: Only 8.3 percent of Americans are now without health insurance. (At one point it was an embarrassing 20+ percent!)

The drop in uninsured is largely a result of changes to the Affordable Care Act as part of the pandemic response, followed by those changes being extended in the Inflation Reduction Act.