April 13, 2023     Andrew Kantor

Probiotic of the dog

Hangover “cures” are as common as hiccup cures, and they’re at best hit or miss. Now Chinese scientists think they’ve got one that actually works thanks to, you know, science.

The idea is simple: “An enzyme called ADH1B accelerates the breakdown of alcohol in the body. Researchers genetically engineered a probiotic to express ADH1B in mice.” When they gave the mice the probiotic, it reduced the amount of alcohol they absorbed and let them recover sooner.

Picture this:

Untreated mice showed signs of drunkenness  20 minutes after exposure to alcohol. When the mice were placed on their backs, for example, they were unable to get back on their feet. But in the group that received a probiotic that expressed human ADH1B, half the mice were still able to turn themselves over 1 hour after alcohol exposure. A quarter never lost their ability to turn themselves over.

Fun fact: That ADH1B enzyme is common in East Asian and Polynesian populations, which is why you never get into a drinking contest with a Samoan.

Shout-out to GPhA’s Lucy

Check it out: GPhA’s marketing and communications manager, Lucy “Yes, I play the ukulele” Haney, was profiled in VoyageATL, where she talked about her role with GPhA, and how her creative background has helped her career in healthcare communications.

Working at GPhA allows me to support the growth and development of the pharmacy profession in Georgia, as well as to contribute to Georgian’s overall access to healthcare (after all, pharmacists are the most accessible healthcare professionals)!

Mean kids need their vitamins

If you’ve spawned a mean kid (we won’t say mean girl because we all know they come in both flavors), you might want to consider vitamins. Really.

A Canadian review study (in the journal Aggression and Violent Behavior) — found that in between “psychosocial interventions” and prescription meds are supplements to help the nervous system develop properly — before Junior can recite the Miranda warning from memory.

Well, maybe. The results of 22 studies that covered macro- and micro-nutrients were mixed, although 14 of them found vitamins and other supplements (e.g,. omega-3 fatty acids) had beneficial effects on aggression. A full 19 studies found they could help depression and even symptoms of ADHD.

The conclusion: A single supplement may not help, but “wide-range vitamin and mineral supplements may have beneficial effects in reducing excessive hetero-aggression in children and adolescents.”

Don’t believe the lies (and live longer)

The US continues to lag the rest of the developed world in life expectancy — Americans average 3 to 5 years less — and it’s getting worse. One reason, says FDA commish Robert Califf, is the spread of misinformation (what we used to call lies).

Our medical system is almost as good as that of Western Europe, for example, but we simply don’t use it as well because too many people believe what they see on social media.

“Why aren’t we using medical products as effectively and efficiently as our peer countries? A lot of it has to do with choices that people make because of the things that influenced their thinking,” Califf said.

Peanut allergy vaccine in the works

These days half of new treatments seem to involve either mRNA or nanotechnology. Now UCLA immunologists are using both, and they think they’ve got essentially a peanut allergy vaccine. It delivers an mRNA payload to the liver, where they “teach the body’s natural defenses to tolerate peanut proteins.”

It works similarly to how mRNA vaccinations prevent Covid-19, but instead of encoding for the SARS-CoV-2 spike protein, it encodes for a peanut protein — one that doesn’t trigger an allergic reaction, but that primes the body to deal with the peanut proteins that do present a problem.

Soon you’ll be able to schedule that Royal Caribbean cruise

How about a vaccine against food poisoning? Specifically, against norovirus? How ’bout if we throw in protection from rotavirus, too?

That’s what Washington University in St. Louis molecular microbiologists think they’ve accomplished. They piggybacked a norovirus protein onto an existing rotavirus vaccine and presto: “Mice that received the experimental vaccine produced neutralizing antibodies against both rotavirus and norovirus.”

So far it’s just in vitro and in mouse-o, but obviously more experiments are underway.

The Long Read: When bacteria play possum

Antibiotic resistance has a cousin: antibiotic tolerance, where bacteria aren’t killed by a drug, but instead slip into a dormant state, waiting for the danger to pass. A microbiologist explains.

Short Takes

Well that’s not good

China reported the first human death from the H3N8 bird flu. It had been found in humans for the first time last year.

Elmo needs his Epi-Pen

Food manufacturers found it’s less expensive to add sesame to food — and add a warning label — than to sterilize the equipment so they can call it “sesame-free” as a new law requires.

The result? Foods that sesame-allergic kids and adults have eaten safely for years are now potentially life-threatening.

ICYMI: STIs on the rise

Sexually transmitted diseases hit a record high in the US in 2021 according to the latest CDC data — up 5.8% from 2020, in fact.

Some STIs such as syphilis saw their highest numbers in more than 70 years. The 176,713 syphilis cases recorded in 2021 were the highest since 217,558 in 1950.

 

April 12, 2023     Andrew Kantor

Insulin lasts longer than you think

Stored at room temperature, insulin may have a shelf life up to four times longer than what’s on the package — that’s according to a new international study led out of Sweden’s University of Gothenburg.

How’d they test? Let’s just say they didn’t use any fancy temperature controls:

Six different families in Nagpur, India, stored the insulin for a period ranging from one to four months in the summer. It was stored either in a box in the coolest room in the home or in clay pots designed to serve as simple cooling systems, with evaporation of water keeping the contents cool.

Larger studies are needed, they say, but “The period when insulin may still be used can potentially […] be extended to three or perhaps even four months.”

High BP now, smaller brain later

Don’t wait to treat high blood pressure. A new study out of UC Davis found that having hypertension in your 30s could mean that, 40 years down the line, your brain isn’t working properly.

The researchers found that the high blood pressure group had significantly lower regional brain volumes and worse white matter integrity. Both factors are associated with dementia.

The research also showed that the negative brain changes in some regions — such as decreased grey matter volume and frontal cortex volume — were stronger in men.

With treatment for dementia so limited, the researchers point out, it’s critical to find ways to reduce the risk as early as possible.

RSV vaxes gets closer still

New stage 3 trials confirm Pfizer’s earlier results: The company’s RSV vaccine “was found to be 82 percent effective in preventing severe cases of RSV in infants when it was given to pregnant mothers in the second half of their pregnancy.”

One downside is that it only prevented severe cases, but didn’t do well to prevent non-severe infections.

Side note: There’s more

The University of Rochester would like you to know that there are three other RSV vaccines in the works (and it’s been involved in the testing of Pfizer’s vax and two of the others, including a candidate from GlaxoSmithKline).

Minty not-so-goodness

There was a lot of hubbub regarding the regulation of mint-flavored e-cigarettes, mostly because they were disproportionately marketed to and used by kids and the Black community.

But a new study out of the University of Pittsburgh finds that …

… e-cigarette liquids containing menthol generated a larger number of toxic microparticles in the lungs compared to menthol-free juice.

And when they looked at patients themselves, they confirmed that yep, there was a “difference in lung function between menthol e-cigarettes and non-menthol smokers.”

New Medicare Advantage rules in place

CMS has finalized a rule for Medicare Advantage providers designed to keep those insurance companies in line. First of all it sets marketing rules (e.g., prohibiting confusing words and imagery) and second, it improves the prior-authorization process.

[It] requires prior authorization approvals to be valid as long as medically necessary and states that coverage denials based on medical necessity must be reviewed by healthcare professionals with relevant expertise before issuing a denial.

It will also make it easier for patients to switch MA plans, and “implements provisions of the Inflation Reduction Act to improve access to affordable prescription drug coverage” by expanding eligibility to individuals with incomes up to 150 percent of the federal poverty level.

Short Takes

Bird Flu Watch

It’s infecting condors in Arizona and — notably — more pet cats.

Gut health goes even more mainstream

Food processing giant Archer Daniels Midland is working with a biotech startup called Brightseed to develop biological products designed to improve that ol’ gut microbiome. As they put it “natural and plant-based solutions that target immune function, metabolic health and mental well-being.”

The companies are expecting to launch their synbiotics as functional ingredients in foods, beverages, dietary supplements and medical foods, by 2025.

Another Lyme vax is in the works

A new vaccine for Lyme disease is still coming down the pike — this one’s from Moderna.

 

April 11, 2023     Andrew Kantor

The conflicting judicial rulings on the legality of mifepristone dominated the pharmacy news over the last few days. Between that and the Easter weekend, it’s been quieter on the pharma front and thus a shorter Buzz than usual.

Strep spreads, meds don’t

Bad news: There’s a particularly nasty version of strep circulating right now — invasive group A strep. (We mentioned this in Saturday’s Buzz). Most notably, it can infect more than just the throat.

Worse news: Pediatric amoxicillin to treat it is still in shortage.

Better news: Not every strength is in shortage. While the popular 400 mg/5mL might be hard to find, you can get the same result by, say, taking more of a lower strength.

“You might need to switch,” [said one drug-shortages expert]. “So you might have to take a little bit more volume… I have given children antibiotics, and I know that that’s not fun, but you can do that.”

What’s behind the shortage? Demand, not supply. Manufacturers based their production on previous years’ needs, but the pandemic ‘bounce-back’ of various infections means this year is seeing a higher than normal demand, and it’s lasting into spring. Said one epidemiologist, “I can’t be confident that April will mark the end of this strep throat season.”

One interesting story about the dueling mifepristone rulings….

Led by Pfizer, hundreds of US drugmakers have called for the reversal of the Texas judge’s ruling (the one that suspended the FDA’s 23-year-old approval). This isn’t because they agree or disagree with how the drug is used, or even because they make mifepristone (most don’t), but because if upheld it throws the entire FDA approval process into chaos.

“If courts can overturn drug approvals without regard for science or evidence, or for the complexity required to fully vet the safety and efficacy of new drugs, any medicine is at risk for the same outcome as mifepristone,” the letter said.

As one exec put it, “This is a nightmare scenario for the industry. It’s the single worst threat to the industry in over 50 years.”

Covid Notes

What, you thought it was all over but for the credits? Ha!

Surfaces tension

Remember at the beginning of the pandemic, when cleaning products were selling out as people disinfected everything? Then we learned that the virus was airborne and masks were more important than Lysol.

Well guess what? A new British study found that yeah, Covid still spreads through household surfaces (and hands).

It’s twice as deadly as the flu

If given a choice to be hospitalized for Covid-19 or the flu, pick the flu. A study of more than 11,000 Veterans Affairs patients found that almost 6% of Covid patients died within 30 days, compared with just over 3% of flu patients. (For what it’s worth, the risk of Covid death declined with the number of vaccinations.)

Hospitalizations are going up some places

Just as the XBB.1.16 variant is spreading, now 16 states (not including Georgia) are seeing hospitalizations rise. Of those 16, seven have the new variant, so it’s not yet clear how much of an effect it’s having.

Don’t leave out the eye of newt

Some stores (not yours, of course) are apparently selling fake “treatments” for prostate problems — capsules that are nothing more than a bunch of supplements and extracts with no evidence that they can help do anything of the sort.

Treatments is in quotes because it’s the kind of word that FDA enforcers are sensitive about. You can’t throw it around willy-nilly.

Forbes writer Steven Salzberg points to one pill, Prostoxalen, that promises to “get rid of the constant pressure on the bladder, unpleasant pain and all other ailments related to prostate enlargement! Once and for all!”

What’s in this miracle drug? The kind of stuff you would normally get from that nice old lady who lives alone in the woods with her one-eyed cat: saw palmetto, pumpkin seeds, cranberries, tomatoes, nettles, and willowherb, plus some vitamins.

 

April 08, 2023     Andrew Kantor

Do they really need levothyroxine?

Maybe not. Prescribing the drug is usually based on a patient’s level of thyroid-stimulating hormone and free thyroxine. But Yale researchers found that those levels vary with the seasons, meaning “an enormous number of unnecessary levothyroxine prescriptions.”

That’s because the levels rise in the winter, when depression (e.g., seasonal affective disorder) is more common. As the lead researcher pointed out, “[I]f many of those same people had gotten the same test a few months later, it would have come back as normal.”

“The emerging evidence is very concerning because we’re actively giving patients a drug that they don’t need that can have potentially severe side effects, especially in elderly individuals over 80.”

Strep A spike

Group A streptococcal infections spiked late last year as masking and distancing faded out, so University of Texas researchers want healthcare folks to be on the lookout for kids with sore throats or skin infections — the signs of strep A.

“[D]uring the last quarter of 2022, the number of infections we saw, including invasive infections, were far greater than what we’d ever seen before.”

Reuters ruminates on ruling ripples

Usual warning: This is a story about mifepristone, so let’s all chill because it’s actually pretty interesting.

Regardless of your opinions on the Texas court case questioning mifepristone’s legality, Reuters has an analysis of what a ruling pulling it from the market would mean to the rest of the industry.

The important thing to remember is that the case isn’t technically about mifepristone itself — it’s about the FDA’s approval process and whether it followed proper procedures 23 years ago.

A ruling against the agency’s approval of a drug over 20 years earlier would be unprecedented and could ripple through drug research and development for years, with implications for public health and access to new treatments.

For example, Reuters explains, it could cause the FDA to adopt much more stringent testing requirements, for better or worse, knowing that a court could review every step 20 years down the line. And the spectre of that kind of court challenge would hang over every product — imagine, for example, a competitor suing to have a medication removed claiming the approval process was flawed.

As we said: Interesting.

Obesity drugs: Well that was fast

The World Health Organization is considering adding anti-obesity drugs to its list of essential medicines. By “essential” it means these are drugs that countries should be sure to provide for citizens, and can often lead to lower costs in low-income nations.

The argument is that obesity leads to so many other health problems, an ounce of prevention spending could lead to a lot of pounds saved in curing. And “At present, there are no medications included in the [list] that specifically target weight loss for the ongoing global burden of obesity.”

On the other hand, GLP-1 receptor agonists are pretty new and do have side effects. Also, “ some public health experts warn against introducing such medicines too broadly as a solution to a complex condition that is still not completely understood.”

From the Broccoli Files

If you want your mice to have a better chance at being healthy, feed ’em broccoli — that’s what a study out of Penn State concluded. (And no, it wasn’t funded by Big Broc.)

The researchers found that “broccoli contains certain molecules that bind to a receptor within mice and help to protect the lining of the small intestine, thereby inhibiting the development of disease.”

The down side for picky eaters: The mice that benefitted from the broccoli were fed a diet that was 15% broccoli — “equivalent to about 3.5 cups per day for humans.”

Captain Obvious mumbles something about “Sherlock”

China holds the key to understanding COVID-19 origins

Short Takes

Peeps of destruction

Consumer Reports warns that some Peeps are made with FD&C Red #3, a known carcinogen. Stick with the yellow ones. (It’s not just a carcinogen in California, either. The FDA has banned Red Dye #3 from cosmetics because of the cancer risk.)

AI comes for medicine

“Everyone whose job is safe from artificial intelligence, step forward.”

Not so fast, pathologists.

April 07, 2023     Andrew Kantor

A different morning-after pill

Not everyone thinks about pregnancy after a night of, you know, listening to Barry White with a friend. There’s also the issue of STIs, which usually are treated after they’re discovered, often with some discomfort involved.

But, just like with tick bites, taking a dose of doxycycline quickly enough can — per UC San Francisco researchers — prevent the infection from ever taking hold. Specifically, “Researchers discovered that taking the antibiotic doxycycline within 72 hours of unprotected sex slashed the risk of gonorrhea, chlamydia and syphilis by two-thirds.”

Pharmacy techs: Immunization training is a week away

The best immunization training you can get comes from the Georgia Pharmacy Association — and it’s the smart move to help your career and your bank account.

GPhA’s Immunization Delivery Training for Pharmacy Technicians is a six hour program (that’s 6.0 hours of CE) — 3 hours in the classroom, 3 hours of home study.

That live training is Saturday, April 15 in Sandy Springs, from 9:00 am till noon .

Space is limited. Don’t wait. Click the button (or go to GPhA.org/techimmunization) for the details and to register:

The best Covid protections, ranked

Covid vaccine, Covid infection, or both — which gives you the best protection against being seriously infected (or infected again)?

We all know this answer will change over time as more data come in (science!), but the latest — courtesy of Stanford research — says that getting infected with SARS-CoV-2 before you’re vaccinated reduces the vaccine’s effectiveness.

Their rankings, based on the results:

  • Most killer T-cells: Vaccinated but never infected
  • Next most: Vaccinated, then a breakthrough infection
  • Third most: Infected, then vaccinated
  • Fewest killer T-cells: Infected but not vaccinated

What’s different about this study is that it looked at the amount and strength of killer T-cells, rather than antibodies. It’s the T-cells that provide the long-term protection, which these days is probably more important.

The common cold and your brain

Here’s a scary thought: Could every time you catch a cold mean your risk of dementia increases? We wouldn’t ask unless someone with a lab asked the same question. And they did.

A Tulane/West Virginia University study found that, in mice at least…

…repeated, intermittent experiences with moderate inflammation, such as that caused by the flu or a seasonal head cold, caused impaired cognition and disrupted communication between neurons in those mice.

The Air You Breathe

A risk of dementia

Air pollution — specifically, the ultra-fine particles — seems to increase the risk of dementia. That’s what Harvard researchers found in a meta-analysis of more than 2,000 studies, 51 of which looked at the pollution-dementia connection.

The researchers found consistent evidence of an association between PM2.5 [fine particulate air pollutants] and dementia, even when annual exposure was less than the current EPA annual standard […] the researchers found a 17% increase in risk for developing dementia for every 2 μg/m3 increase in average annual exposure to PM2.5.

They also found evidence suggesting associations between dementia and nitrogen oxide and nitrogen dioxide “though the data was more limited.”

Pollution hurts vaccination

A new study out of Germany and Spain found that living where there are higher levels of air pollution made Covid vaccinations less effective.

[I]n uninfected individuals, pre-pandemic exposure to the tested pollutant was associated with a 5% to 10% reduction in vaccine-induced spike antibodies.

Interestingly, it had less of an effect on people who had been vaccinated and infected with Covid. On that finding, they suggested, “additional investigations should be done.”

Short Take

Makena is gone

The FDA has officially pulled Covis Pharma’s Makena from the market, following the advice last month of its advisory committee. Makena was given accelerated approval to help with pre-term births, but later studies found it had limited if any benefit.

 

April 06, 2023     Andrew Kantor

An end to the J&J talc suits

The Johnson & Johnson talc lawsuits are over. Well, until they’re not. But they’re over for now, as the company has reached a deal to pay $8.9 billion over 25 years to resolve the thousands of suits that claim that the company’s talcum powder caused cancer.

The company said it had secured the support of the more than 60,000 parties that have filed lawsuits against Johnson & Johnson on the agreement, which will go toward resolving “all current and future talc claims.”

Fun fact: Other companies are being sued for their talcum products, and “Suppliers of talcum powder, as well as retailers including Target, Walmart, CVS and Walgreens, have all been successfully sued.”

FDA wants opioid-return envelopes

Starting next year, the FDA expects to require opioid manufacturers “to make prepaid mail-back envelopes available to outpatient pharmacies and other dispensers as an additional opioid analgesic disposal option for patients.”

When implemented, outpatient pharmacies and other dispensers will have the option to order prepaid mail-back envelopes from opioid analgesic manufacturers, which they may then provide to patients prescribed opioid analgesics.

The agency is also considering requiring manufacturers to provide patients with at-home disposal products, e.g., a bag of used cat litter with every prescription.

Freestyle Libre warning

If you have any patients using FreeStyle Libre diabetes monitors, let them know they need to keep an eye out to make sure their devices don’t swell, catch fire, or explode. (We assume they would notice if this happens.)

The maker, Abbott, isn’t recalling any of the devices, just warning folks to store their monitors properly (i.e., not where it’s really hot) and to charge them “only with the Abbott-provided power adapter and bright yellow USB cable.”

Note: This affects the readers, not the sensors.

Recalled eye drops get scarier

You may have been following the whole saga of contaminated eye drops — at least three people have died and eight more have lost an eye. Now it’s gotten worse. Apparently the infection can spread from person to person.

So the CDC is reiterating “that clinicians and patients stop using EzriCare’s or Delsam Pharma’s Artificial Tears products, both manufactured by India-based Global Pharma Healthcare.”

Statins won’t hurt if you exercise

There are folks who worry that taking statins doesn’t play well with exercise — they’re concerned about muscle pain and fatigue, specifically.

It turns out that “I’m afraid of muscle pain or fatigue during moderate exercise”* isn’t an excuse. Dutch researchers tested 100 patients, including a bunch who were already having muscle issues, and found that not only did the statins not start causing pain, those with existing muscle issues didn’t feel any worse.

So, they figure, it’s okay to start exercising even if you’re taking statins. It certainly won’t hurt.

* Hopefully no one ever actually talks like that.

Early menopause? Don’t wait to start hormone therapy

Here’s a scary fact (based on research out of Mass General Brigham): If a woman has early menopause, the later she starts hormone therapy, the greater her risk of developing Alzheimer’s.

Quoth one of the study’s authors:

“We found that the highest levels of tau, a protein involved in Alzheimer’s disease, were only observed in hormone therapy users who reported a long delay between age at menopause onset and their initiation of hormone therapy.”

Said another, a bit more bluntly, “When it comes to hormone therapy, timing is everything.”

The Long Read: Post-Antibiotic Era edition

It’s been decades since the first warnings were sounded about antibiotic resistance, and now the WHO says we’ve reached the point where it’s getting clear we didn’t do enough.

“The post-antibiotic era” is the phrase, because there are too few new treatments in the pipeline to keep pace with the resistant infections that are showing up — “Just 27 new antibiotics for the most threatening infections are in the clinical trial stage of drug development.”

The problem is that there’s just not enough money to be made for drug companies to invest in creating antibiotics — ironically, that’s in part because the message is to use them less.

Short Takes

An Ozempic-free weight loss future

“Ozempic,” says the Atlantic, “Is About to Be Old News” as a new crop of better, stronger, faster weight-loss drugs come to market.

New knees? Check your sodium

If you have patients who’ve had a joint replacement, you might want to suggest they have their sodium levels checked. Having hyponatremia — low sodium — leads to more complications and adverse outcomes, according to a study out of Philly’s Thomas Jefferson University.

April 05, 2023     Andrew Kantor

Pharmacists are burning out

In what must come as a complete shock to you, it seems that “Growing workloads and stresses lead to well-documented exhaustion, subsequent staffing shortages.”

But while the pandemic slammed pharmacists, as it did many other health-care workers, pharmacy groups say working conditions are generally more stressful and demanding now than they were before the pandemic.

The Washington Post has the story.

Drug takeback (half) day is coming

The next DEA’s National Prescription Drug Take Back Day is coming up: April 22 from 10:00 am to 2:00 pm across the state.

If you don’t have a drop-off box in your pharmacy, your patients have two options: They can use the DEA drive up collection-box locator at DEA.gov/takebackday

=OR=

They can find a pharmacy with a drop box using the locator at prescriptiondrugdisposal.com. Let ’em know!

Georgia Gwinnett College gets fast track to Mercer

Good news for students at Georgia Gwinnett College: 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 GGC, then enroll in Mercer’s PharmD program. Their first year of Mercer credits will transfer back to GGC so they end up earning their bachelor’s degrees a year early. It’s like fuzzy math!

Alcohol doesn’t help

Once again it’s time to answer the question that never gets an answer: Is a bit of alcohol good for you? Today’s answer comes courtesy of Canada’s University of Victoria, and it is … no.

Not that it’s necessarily bad for you — that’s not what the study was about — but rather that studies showing a benefit to a glass of beer or wine were flawed. “[A]fter adjusting for study flaws and biases, ‘the appearance of the benefit from moderate drinking greatly diminishes and, in some cases, vanishes altogether’.”

Again, this study didn’t find any harm, just no benefit.

The combined adjusted data from the [previous] studies showed that neither occasional drinkers (less than 1.3 grams of alcohol, or one drink every two weeks) nor low-volume drinkers (up to 24 grams a day, or nearly two drinks) had a significantly reduced risk of death.

Captain Obvious would rather call a friend

ChatGPT doesn’t have all the answers on cancer screening

The responses were appropriate for 22 questions, or 88%. But one question was answered incorrectly with outdated information, and two others had inconsistent responses that varied significantly each time the same question was posed.

Lithium and autism?

Could lithium in drinking water mean a higher risk of autism? That’s what UCLA researchers, working with a group of those shifty Danes, concluded: “Pregnant women whose household tap water had higher levels of lithium had a moderately higher risk of their offspring being diagnosed with autism spectrum disorder,” they wrote.

Essentially, they compared health records of almost 64,000 Danish kids and cross-referenced autism diagnoses with mom’s address when they were born. The bottom line: “As lithium levels increased, so did the risk of an autism diagnosis.”

Oh, and they note that it could become a bigger issue as more electronic devices — with their lithium batteries — are discarded and leach into the environment.

Elsewhere: OK has had enough

Strange as it may seem, apparently corporations — in this case CVS/Caremark — can only ignore the law* so long before the Powers That Be take action. Over in Oklahoma, Insurance Commissioner Glen Mulready has filed an “administrative action” against the pharmacy/PBM, claiming it repeatedly ignore the state’s law against PBMs steering patients to the pharmacy it owns.

“I am convinced that CVS/Caremark does not want to follow Oklahoma law and wants to find every opportunity to skirt their responsibility,” Mulready said. “I am extremely frustrated with the misinformation and confusion presented to Oklahoma consumers.”

* For people it’s “break the law.”

Short Take

Long acting time-release tech

Time release meds are nothing new, and super-fancy ones using microtechnology isn’t, either. But now Rice University bioengineers say they can do that one better — an injectable payload of medication that can be tweaked to adjust when the drugs are released.

Said one engineer: “With this, you’d give them one shot, and they’d be all set for the next couple of months.”

 

April 04, 2023     Andrew Kantor

It’s not your father’s testosterone patch

For the first time, women prescribed testosterone might have a more convenient and appropriate option at their neighborhood pharmacy: a patch.

Clinical trials of a testosterone patch designed for women — i.e., with a dosage more appropriate for them — are beginning in Britain, and could lead to a better treatment for all those symptoms that go with menopause.

Although testosterone creams and gels are available to help women with loss of sex drive in some countries, they have to apply the correct amount to their skin themselves, and in some cases have to use products originally designed for men.

The article doesn’t mention compounding pharmacies, though, which have been creating this kind of custom-dose, custom-delivery medication for a long time — just on a much smaller scale than the British patch would be.

The other danger with antibiotic overprescribing

That other danger is patient harm — like, direct patient harm, not just the long-term threat of antibiotic resistance.

A big retrospective study out of Intermountain Health and Stanford University — looking at the insurance and medical records of 23 million people — found that getting the wrong antibiotic, or an unnecessary one, often ended up sending people back for help dealing with side effects from a medication that didn’t do them any good anyway.

Researchers found that some of the most dangerous antibiotics were rarely indicated and commonly used, leading to one in 300 of those patients experiencing side effects dire enough to require a follow up doctor’s visit—or even hospitalization.

Addiction, use, or maintenance?

If someone uses a drug therapeutically, is that considered a ‘use disorder’? Probably not — you don’t hear about “insulin-use disorder” or “fiorinal-use disorder.” That means, argues a Rutgers researcher, that we need to start rethinking how we diagnose cannabis-use disorder.

“[T]he manual used to define substance-use disorders was developed before the sharp rise in cannabis use for therapeutic purposes. This means that the diagnostic manual considers cannabis to be an illicit substance, even if a person reports cannabis use only for therapeutic purposes.

Furry cuteness of doom

You might know that having pets from an early age can help kids grow up without food allergies. But there’s one big exception. Hamsters.

According to Japanese researchers, while “exposure to dogs and cats might be beneficial against the development of certain food allergies,” when it comes to hamsters, kids who grew up with them were actually more at risk of developing a nut allergy.

Jumping fungus

I could write a whole bunch about “another thing to worry about” or make a reference to The Last of Us, but I think I’ll just let this stand on its own:

In what researchers suggest is the first reported case of its kind, a 61-year-old Indian mycologist appears to have contracted a rather serious case of silver leaf disease in his own throat.

The Long Read: Everything you need to know about how the feds are tackling PBMs

From the Senate Committee on Commerce to the FTC to bipartisan House groups, the federal government is starting to wake up and see the writing on the wall. (It says, “PBMs are not our friends.”)

 

Short Takes

Carter launches bipartisan pharma group

Meet the Domestic Pharmaceutical Manufacturing Caucus for the 118th Congress. Its goal:

[A]dvancing legislation that incentivizes more domestic production for essential medicines to reduce American reliance on foreign adversaries, head off potential supply chain disruptions, and ensure a steady supply of pharmaceuticals in the event of public health emergencies or natural disasters.

It’s over when it’s over

WHO tracking Omicron XBB.1.16 subvariant, rising cases in some countries”:

“So this is one to watch. It’s been in circulation for a few months. We haven’t seen a change in severity in individuals or in populations, but that’s why we have these systems in place.”

April 01, 2023     Andrew Kantor

One is enough … for now

The CDC says that, at least for now, having a single bivalent booster — e.g., the Omicron booster — is enough, even if you got it more than six months ago. Health officials’ focus, the San Francisco Chronicle explained, “is shifting from preventing new infections to reducing the severity of the disease.”

But doesn’t the shot only last a few months? True, but there hasn’t been a spike in infections lately, so the CDC is cool just chilling for a while.

Hologram of John Pemberton to speak at convention

John Stith Pemberton, the Georgia pharmacist who invented Coca-Cola in 1886, will be a featured speaker at the Georgia Pharmacy Convention thanks to a pair of modern technologies. Sort of.

A hologram of Pemberton will be projected onto the podium at the Thursday general session, using similar technology to what brought Tupac Shakur to the stage in 2012, more than 15 years after the singer’s death.

More interestingly, though, is that Pemberton’s presentation will be generated by a pharmacy-specific version of the ChatGPT AI software that was developed just for GPhA’s convention.

“The technology has matured enough that we’re able bring Pemberton to the stage using a machine about the size of a PC,” said Robert April, CEO of HistoryAlive Technologies, the Augusta-based company that’s providing the technology. “With ChatGPT, we’re able to add a new layer of realism.”

Pemberton will talk about his role as a pharmacist and how it shaped his development of what would become Coca-Cola. The details of his presentation aren’t pre-written, though — they’ll be generated by ChatGPT based on Pemberton’s own writings and biography.

“We’ll have to remember that he was a Confederate army veteran, a Freemason, and a morphine addict,” April cautioned, “So we can’t be entirely sure what will come out of his mouth.”

PS: Happy April Fools Day from GPhA. See you at convention!

Double-duty heart/apnea med

It’s a heart failure med! It’s a sleep apnea treatment! It’s both! A new drug developed in New Zealand can prevent continuing damage after heart failure and also treat sleep apnea. In fact, were it to come to market, it would be the only pharmaceutical treatment for apnea. (More on that in a moment.)

The drug, called AF-130, can do both because “The part of the brain that sends nervous impulses to the heart is also controlling respiration.” So when AF-130 tells the brain to get out of “fight or flight” mode after heart failure, that same signal helps stimulate breathing. Kind of like yelling “Fire!” could cause one person to flee a building and another to launch a torpedo.

As for coming to market, the Kiwis say that AF-130 is about to be approved by the FDA for a different condition (they don’t say what, unfortunately), so they can jump into human trials for these new indications quickly.

Someone thought this was a good idea

What happens when you combine a gut-muscle stimulant with a relaxant? You get Starbucks new olive oil-infused coffee.

Sine Die

By Melissa Reybold, vice president of public policy

’Twas the last night of session,
And all through the House,
The representatives waited their turn,
To speak on bills they espouse.

Speaker Burns at the podium,
With gavel in hand,
His brief breaks were covered,
By the eloquent Speaker Jan.

Lobbyists outside each chamber,
Waiting for their bills to be called,
While lawmakers read pleading texts,
From those “friends in the hall.”

Some bills took quite a while,
So lawmakers checked their cells,
While others delayed the vote,
Speaking down in the well.

Bills got added to others,
Like cannabis and hemp,
Unfortunately, that one got gummed up,
And won’t make its way to Kemp.

White baggin’ was waiting,
After thinking it was dead,
But it wasn’t called for a vote,
So, no votes green or red.

Some passed the time,
Listening for the lingo,
Waiting to cross it off,
On the Sine Die Bingo.

The tech vaccine passed,
Earlier that day,
Now Governor Kemp has to sign it,
Before the 11^th^ of May.

All ACIP vaccines,
For 18 and above?
This is one law passed,
That our pharmacists will love.

Low volume pharmacies,
Will be thrilled to see,
A line item in the budget,
For an increased dispensing fee*.

* $11.50 Medicaid dispensing fee for stores under 65,000 scripts/year

Your pharmacist legislators,
Fought for you under the Dome,
Thank you Butch and Ron,
Now, enjoy your time at home.

Bills that didn’t make it and
not voted on this year,
Are eligible in 2024,
When they can reappear.

For an in-depth discussion on session,
And networking with food and drink,
Register for your spring region meeting,
When we send you the link!

A new kind of weight-loss med

A new drug can help your fat rats become thinner by getting them to stop eating — and without nausea and vomiting. A new weekly injectable peptide treatment out of Syracuse University targets “three different weight-loss and glucoregulatory receptor pathways at the same time,” meaning the rats don’t want to eat.

This is a benefit, the researchers say, because you don’t end up with rats who want to eat but can’t. Rather, they feel full. “[W]e aim to chemically replicate the benefits of surgery without patients having to undergo surgery.” And it works:

The drug caused obese rats to eat up to 80% less than they would typically eat. By the end of one 16-day study, they lost an average of 12% of their weight.

(Sharp-eyed readers may wonder how they can say it doesn’t cause vomiting in rats, when rats can’t vomit. They tested it in shrews, too.)

Opioid abuse: red flags to watch for

So, to keep out of the DEA’s crosshairs you’re on the lookout for “suspicious prescriptions for controlled substances.” Good for you. There are obvious signs, like a handwritten script that spells “Rx” wrong, but what else should you be looking for?

The good folks at Pharmacy Practice News have the answers to that very question, as well as some advice if the feds come a-knockin’.

Bad and good mutations; bad and better flu shots

A single problematic protein in a flu vaccine can make it less effective. That’s what scientists at St. Jude Children’s Research Hospital found, and it could lead to creating annual flu shots that are more effective.

It seems that, while the virus is being grown in chicken eggs to make that year’s vaccine, a mutation in its hemagglutinin can make it less “human like” and thus less effective. And that, they say, could be why many season’s vaccines don’t work very well even when they match the current strain.

Luckily, not every virus has that mutation. In fact, some have a different mutation that not only doesn’t destabilize the hemagglutinin, but also prevents that first mutation from occurring.

Bottom line: Before they start growing virus strains to make a vaccine, pharma companies should test those strains to see if they have the ‘good’ or ‘bad’ versions of hemagglutinin.

 

March 31, 2023     Andrew Kantor

Get the worm!

Today — March 31 — is the last day to get the early-bird rate for the Georgia Pharmacy Convention! The price goes up $50 tomorrow at midnight, and it’s $126 more at the door.

Save some money while you can! Head over to GPhAConvention.com/register before 11:59 pm tonight to grab that early-bird rate, and we’ll see you at the beach!

Antibiotic ups and downs

The good folks at the University of Minnesota’s Center for Infectious Disease Research and Policy have two noteworthy stories about antibiotics:

First, when antibiotics kill: Not only do antibiotics not reduce the chance of death from a viral respiratory infection (obviously), but Norwegian researchers found the opposite: “[P]atients with viral respiratory infections who received antibiotics at any point during their hospitalization were more than twice as likely to die as those who didn’t receive antibiotics.

Second, when antibiotics save: A combination of ceftolozane and tazobactam works a treat in “complicated, multidrug-resistant infections in outpatient settings.” There had been some data about inpatient use, but now it’s confirmed that the combo works for outpatients with a variety of conditions, including bone and joint infection and UTIs.

Georgia transparency FTW

A big Buzz high-five to the state of Georgia for being one of the minority of states promising to be open about how it’s planning to spend the $636 million coming in from the Big Opioid Settlement.

Georgia will share how 75% of that $636 million will be spent — that’s the part controlled by the state. The other 25% is controlled by local municipalities, which may or may not reveal their plans. That makes Georgia one of the 23 states that will report more than half of its spending plans; only 12 (not including Georgia) will report how they’re spending every cent.

Most of the settlements stipulate that states must spend at least 85% of the money on addiction treatment and prevention. But defining those concepts depends on stakeholders’ views — and state politics. To some, it might mean opening more treatment sites. To others, buying police cruisers.

Telehealth helps opioid abusers quit

While the DEA wants to force people to cut back on telehealth services, especially for opioid-abuse treatment, the data say that’s a bad idea.

A new study out of the CDC found that when telehealth visits were available, more people got medication to treat opioid-use disorder — and that saved lives.

“The expansion of telehealth during the Covid-19 pandemic appears to have had positive effects on patients receiving MOUD* [medications for opioid use disorder], improved retention among patients who received MOUD, and lowered risks for both nonfatal and fatal overdose.

Perhaps someone should tell the DEA.

* Does everything have an abbrev. these days?

ICYMI: Insurers can nix preventative coverage (for now)

A conservative Texas judge has ruled that health insurance plans do not have to cover preventative care as required by the Affordable Care Act. That means insurers will be able to sell plans that don’t cover basic care like cancer screenings, pregnancy care, diabetes tests, vision screenings for children, mammograms, and more.

The lawsuit was brought by a Christian group that argued their religion forbids the use of contraceptives and HIV PrEP, and thus they shouldn’t have to pay for health insurance that covers it. But because the ruling affects preventative care across the board, it was opposed by, well, just about every medical organization in the country. (Ironically, the judge upheld the ACA’s contraceptive mandate.)

More than 60 health organizations, led by the American Medical Association, issued a joint statement in July warning about the potential ramifications of a ruling from O’Connor that struck down the preventive services mandate.

The ruling is based on the idea that the U.S. Preventive Services Task Force itself, which develops the list of preventative services insurers must cover, has no power because its members weren’t approved by the Senate. It’s certain to be appealed before most new policies take effect in 2024; this is the same judge who once ruled that the Affordable Care Act was unconstitutional only to have that ruling overturned.

Coffee vs diabetes

And the latest health benefit from coffee is…

[spins wheel]

Reducing your type-2 diabetes risk! Oh, wait. This isn’t new. What’s new is that Dutch and Scottish epidemiologists think they’ve found the mechanism. Keeping in mind the Buzz theory that it’s always either inflammation or gut bacteria, the answer here isn’t surprising — it’s inflammation:

Higher coffee consumption was associated with lower levels of CRP and leptin, pro-inflammatory markers, and higher levels of interleukin-13 and adiponectin concentrations, which have anti-inflammatory effects.

Short Take

The next worry

This year’s tick season has a higher risk of babesiosis (bah-bee-see-OH-sis), as the CDC is warning that there’s a lot more being reported. It comes from good ol’ deer ticks (you know, the super-tiny ones that are all but impossible to spot), and it joins the ranks of anaplasmosis and Lyme disease as reasons to soak your socks in permethrin.