February 08, 2023     Andrew Kantor

Suit claims pharma paid terrorists

Did big pharma companies sponsor terrorism? We may soon know, as a lawsuit accusing them of just that is going forward. A federal appeals court has given the go-ahead to the suit, brought by staff sergeant Joshua Atchley and more than 100 other plaintiffs who “alleged that several massive pharmaceutical companies were making ‘corrupt payments’ to Iraq’s Ministry of Health in order to gain contracts.”

The gist: After Saddam Hussein’s government fell, a terrorist group a called Jaysh al-Mahdi took over the ministry charged with drug imports, and companies including AstraZeneca, J&J, Pfizer, and Roche paid that group to allow it to import drugs.

“Those payments [reads the complaint] aided and abetted terrorism in Iraq by directly financing an Iran-backed, Hezbollah-trained militia that killed or injured thousands of Americans.”

Bring a student to dinner (on us)

Pharmacists: We need you to share your experience with student pharmacists, and we’ll take you to dinner so you can do it in style.

Dinner With a Pharmacist is a food and networking evening, brought to you by GPhA’s Student Leadership Board — it’s at the 1818 Club in Duluth on March 11 from 5:30 – to 8:30 pm.

Dinner is free, your knowledge is priceless — but space is limited.

Inspire a student pharmacist and make a difference. Click here to sign up while there are still seats left!

Kiss kiss, bang bang

Sometimes a news story just screams, “Put this in Buzz!” In this case, British researchers have found that injections of the hormone kisspeptin (discovered in Hershey, Penn. (seriously)) can “boost sexual desire in men and women.”

When folks with low sexual desire received kisspeptin shots, areas of their brains charged with feeling sexual desire lit up on scans when they watched erotic videos.

The paper was published in JAMA Network Open. And you can bet that studies will be ongoing.

From the vitamin D files

…vs prediabetes

An analysis out of Tufts Medical Center of about 4,000 patients found that those who took vitamin D supplements (4,000 IU daily) had a 15 percent lower risk being newly diagnosed with diabetes.

There are some caveats. They didn’t consider the safety of taking that much vitamin D, and it was conducted on people already at high risk for diabetes. And “After the trial ended, approximately 30% of the participants’ glucose levels returned to their levels before the study.”

…and birth

Taking extra vitamin D during pregnancy — we’re talking 1,000 IU daily — seems like it might increase your chance of a natural delivery. And by “natural delivery,” the British researchers who did the study mean that it didn’t require assistance, e.g., a suction cup or forceps are to help deliver the baby. (There was no difference in the number of women who had C-sections.) They also had less blood loss.

What wasn’t taken into account was whether any of the women were vitamin D deficient.

…and asthma

For all the good vitamin D seems to do, one thing it can’t do is reduce the risk of asthma attacks. That’s the conclusion of healthcare data-review company* Cochrane, in which British researchers who once thought supplementation could help, looked at newer data and now concluded the opposite.

When they compared patients who were assigned to take a vitamin D supplement with patients who were assigned to take a placebo, the researchers found no statistically significant difference in the number of people who experienced an asthma attack.

* I can’t really come up with a better way to describe it.

The lymphatic system does what?

Apparently, it can make blood. Yep, that’s not just up to bone-marrow stem cells. An Aussie-led team of biologists was investigating the causes of lymphoedema when it found that “the same gene that controls the development of lymphatic vessels also controls the production of blood cells.”

What does this mean? Just hold your wallabies — I mean, they just discovered this, so give ’em a chance to do some more research.

Everyone’s getting into healthcare

Amazon, Mark Cuban, Dollar General — they’re all jumping on the money train that is healthcare. Now you can add Daniel Ek, the founder of Spotify. He’s launching Neko Health in Europe.

Neko Health will offer advanced full-body scanning to help doctors find and prevent disease. It’s launching after four years of research and development — and hopes to be a gamechanger for Europe’s beleaguered* healthcare systems.

* Aside from Britain’s mess, it’s not clear how the rest of Europe is “beleaguered,” but we wish him well regardless.

Elsewhere: Mushrooms Down Under edition

Australia has become the first country — heck, the first continentto approve the medicinal use of both MDMA and psilocybin for some mental health conditions.

Starting July 1, Australia’s FDA-equivalent Therapeutic Goods Administration “will permit specifically-authorised psychiatrists to prescribe MDMA […] for PTSD and psilocybin, the active ingredient in psychedelic mushrooms, for treatment-resistant depression.”

(And no, not everyone is thrilled about it.)

February 07, 2023     Andrew Kantor

PhRMA loses another one

The fallout from the PhRMA’s failure to stop the Medicare-can-negotiate provisions of the Inflation Reduction Act continues to plague the trade group.

Now that they’re being reminded that capitalism is about buyers and sellers, member companies are apparently not happy with the Pharmaceutical Research and Manufacturers of America (PhRMA). The latest to quit the association is Teva, following in Abbvie’s December footsteps.

Of course, Teva doesn’t give a particular reason for leaving the group, but considering the move (like Abbvie’s) was made soon after PhRMA’s big defeat, one might draw a conclusion….

Drugs by contact lens

Forget about using those old-fashioned eye drops to treat glaucoma. How about a contact lens that monitors inter-ocular pressure and releases drugs as needed?

That’s what South Korean researchers have developed, although to be fair they’ve only tested it on rabbits so far.

The contact lens […] is fitted with hollow nanowires made of gold, which serve as sensors that constantly track intraocular pressure. It’s powered by an integrated circuit chip, which allows the lens to release amounts of a drug on demand.

FDA news

EUAs will keep a-goin’

A lot will happen when the Covid-19 emergency ends in May, but one thing that won’t, says the FDA, is its ability to approve tests, treatments, and even vaccines on the fast track if necessary.

That’s because (it reminds us) the FDA’s emergency powers aren’t tied to the official declaration of a health emergency; they’re simply part of it’s bailiwick under the good ol’ Food, Drug, and Cosmetic Act.

FDA feeling more heat over Aduhelm

The agency is coming under yet more pressure over it’s controversial approval of Biogen’s Aduhelm treatment for Alzheimer’s. (You might remember that the FDA granted an accelerated approval even when its own advisory panel gave the drug a thumbs-down. And Aduhelm’s high price is one of the biggest reasons for Medicare’s 2023 premium hikes.)

Now, experts and pointing to new data — and several deaths (unexplained by the company) — and asking the agency to do a better job when considering final approval.

For starters, they want experts to address safety concerns. But they also want the issue of Aduhelm’s lack of effectiveness put on the table.

[T]he underlying concern is the FDA’s decisions could undermine medical standards and give millions of patients false hope, because greenlighting more drugs just because they might work could unleash perverse incentives.

Long Covid declines

Slowly but surely, the number of people with long Covid — the symptoms of Covid-19 after having been infected — is declining.

Previous studies have found that those symptoms can last more than a year in some unlucky folks, so the number of long Covid cases will track Covid itself — just with several months’ lag.

Elsewhere: South of the Equator edition

Next time a “mysterious virus” starts spreading, it could well be the Global South — countries below the equator — that identify it to give the rest of us a head start on containing it.

“One good example was how long it took the United States to have an effective genomic surveillance network. It took years.” By contrast South Africa set up its surveillance network to look for Covid variants within months.

Flu updates

Influenza B has disappeared

The last time anyone in the world was infected with the influenza B virus (IBV), it was 2020. That means — because it doesn’t have an animal reservoir — that IBV could potentially be gone for good.

Dealing with just the ‘A’ variants would be good news, as it would open the door to making annual vaccines more quickly, and in theory more effective. But don’t write off B too quickly; experts point out that “IBV lineages have been known to periodically enter a state of ‘dormancy’ for long time intervals.”

The waning continues, but…

So far this season, 45 Georgians have died from the flu, with the vast majority being over 65. That’s true across the country: Cases continue to drop, and now 90 percent of those being hospitalized also have a chronic condition “such as heart disease, history of stroke, diabetes, obesity, and chronic lung diseases.”

The end of the season is the good news. The bad news is that “Compared to last year’s mild flu season, the U.S. has already seen more than three times the number of flu-related deaths.”

The Long Read: Late-Stage Capitalism edition

CVS isn’t making enough money on parenteral nutrition, so it’s firing pharmacists, nurses, and dieticians — and leaving patients in the lurch — so it can focus on more-profitable sectors.

CVS abandoned most of its less lucrative market in home parenteral nutrition, or HPN, and “acute care” drugs such as IV antibiotics. Instead, it would focus on high-dollar, specialty intravenous medications such as Remicade.

CVS “pivots when necessary,” spokesperson Mike DeAngelis said.

Optum, too, decided to pivot away from patients and toward the higher-profit market.

 

 

February 04, 2023     Andrew Kantor

CVS, Walmart sued over fake meds (and yes, it could affect you)

The DC Court of Appeals has ruled that a consumer-protection group’s lawsuit against CVS and Walmart “for selling FDA-approved, over-the-counter medications alongside homeopathic products” can continue. The group, the Center for Inquiry, is suing the retailers over a “continuing pattern of fraudulent, deceptive, and otherwise improper marketing practice […] regarding the marketing and sale of homeopathic products.”

The DC Court of Appeals agreed that the group had legal standing, and also that “the placement of [homeopathic] products on a store shelf does, in fact, communicate information to consumers that can potentially deceive them.”

The lawsuit will now continue with the discovery phase.

A tale of two GLP-1 agonists

Mounjaro: Eli Lilly is tightening its marketing — and its discount program — to ensure that only people with diabetes are getting rebates or other discounts. (The price difference for consumers is something like $975 per month.) The company realizes it might cut sales, but with the “robust demand” supplies are short anyway. “

Wegovy: Novo Nordisk said it’s increasing production to meet the demand of both Wegovy and its identical cousin, Ozempic.

No test needed for Paxlovid

The FDA has revised its emergency use authorization for both Paxlovid and molnupiravir, now saying that prescribers — including pharmacists — can order it for patients even without a positive Covid test.

The update was made to cover instances where a health care provider might deem it appropriate to prescribe oral antiviral treatment to an individual with a recent known exposure who develops signs and symptoms consistent with COVID-19 and is at high risk for progression, but tests negative for the virus.

Eye drop follow-up

Yesterday we told you that the CDC suspected that preservative-free EzriCare Artificial Tears was contaminated, and to pull it from your shelves. Today it’s official: The manufacturer, Global Pharma, has issued a voluntary recall of all lots of the drops.

Bird-based pain treatment

Everyone’s looking for an alternative to opioid painkillers. The latest candidate comes out of a simple observation: Birds aren’t bothered by capsaicin. Jimmy-Joe’s Atomic Sauce will keep squirrels out of birdseed, but it won’t bother the birds.

That’s thanks to a pain receptor called TRPV1. Birds have a variant of that receptor that’s resistant to pain, and pain researchers at Stanford Medicine found a (rare) analog in mammals.

So they did a little gene editing on mice, and they found that the edited mice were much less bothered by capsaicin. Next they created a drug that had the same effect — altering the function of TRPV1.

When they gave the drug, a peptide named V1-cal, to mice by injection or infusion, it reduced their sensitivity to capsaicin and lessened chronic pain from nerve injury.

Next up: Making the drug last longer before they even consider human trials.

Today’s non-pharma somewhat-disturbing science story

Researchers at the University of California (with help from Boston U) have transplanted human brain tissue into mice and seen that tissue respond to stimuli.

 

February 03, 2023     Andrew Kantor

Vitamin D cuts suicide risk

Way back in 2011, researchers thought they found a link between vitamin D levels and the risk of suicide. In 2014, other researchers also found that low levels of vitamin D ‘appears to be associated with’ suicide attempts.

Now Veterans Affairs researchers have found it works the the opposite way, too: People who take vitamin D supplements are less likely to try to hurt themselves. And they mean a lot less likely:

Overall, vitamin D3 use was linked to a 45% lower risk of suicide attempts and self-harm, and vitamin D2 was linked to a 48% lower risk.

That’s based on the records of more than 600,000 vets over eight years.) Based on this, they suggest that depression is a good reason to screen patients for low vitamin D.

Two notes: First, not surprisingly, the lower someone’s vitamin D level before supplements, the greater the effect. Second, the effect was greater with D3 than with D2.

Warning: The eyes shouldn’t have it

It’s not a recall, but the CDC is warning people not to use preservative-free EzriCare Artificial Tears. It seems that people using them have been infected with the drug-resistant Pseudomonas aeruginosa bacteria — and at least three were blinded in an eye and one person has died.

North Georgia OD cluster

The DPH is warning about what it thinks is a cluster of overdoses in Catoosa and Walker counties, including some that were fatal, from street drugs possibly laced with fentanyl.

It is critical that persons who use drugs understand there is a risk of overdose when using stimulants or other drugs that may be mixed with fentanyl or other synthetic opioids.

Covid’s killing kids

Covid-19 is now the eighth most common cause of death among people under 18 in the US. That’s kind of a big deal, because kids typically don’t die from any cause. It knocks flu and pneumonia down the list, meaning Covid now causes “substantially” more deaths than any vaccine-preventable disease, and is the most deadly respiratory disease.

The top seven: perinatal conditions, unintentional injuries (often gunshots), congenital malformations, assault (ditto), suicide, malignant neoplasms, and heart disease.

Don’t worry, be happy pharmacy workers!

For International Day of Happiness, GPhA is offering a free CPE webinar: From Work to Play.

Happy workers (including you!) are less stressed, more motivated, and generally more pleasant to be around. So From Work to Play will show you how to be that happy person using Positive Psychology and Positive Reinforcement.

It’s free — thanks to the Georgia Pharmacy Foundation’s PharmWell program — and it gives an hour of CPE credit.

Who’s the speaker? That’d be Theodore Rosen, PhD.

When’s it at? Live via Zoom, Monday, March 20 from 7:00 – 8:00 pm.

Click here for the details and to register!

(If, however, you choose to celebrate March 20 as National Alien Abduction Day, when you return you’ll be able to take the webinar on-demand. You just won’t be able to ask questions.)

Reservoir deer

Like the discount rack of DVDs in the back corner of Best Buy, all those old Covid variants haven’t disappeared — they’re just tucked away. Tucked away in white-tailed deer.

Scientists analyzing samples collected from white-tailed deer in New York state have identified the Alpha, Gamma, and Delta SARS-CoV-2 variants well after they caused widespread Covid-19 in people, representing a reservoir for the strains and a potential future risk to humans.

It’s not just New York, by the way — the viruses ware found in deer in six other states.

Antidepressants and pain

More and more, doctors are prescribing antidepressants for some kinds of chronic pain. It seems to work in some cases, but Aussie researchers caution that there’s not a lot of evidence that they work, and the evidence that does exist doesn’t jibe with common prescribing.

Meaning: Tricyclic antidepressants (e.g., amitriptyline) are the type most often prescribed for pain, but “but the review showed that it is unclear how well they work, or whether they work at all for most pain conditions.” In contrast, SSNIs like duloxetine seem to be the most effective.

They caution that prescribers shouldn’t be lumping all antidepressants together when it comes to treating pain, and that more research is needed to determine which work best.

Georgia opioid lawsuit resumes

There’s been lots of press about the Big Opioid Lawsuit (and various Big Opioid Settlements), but let’s not forget the smaller ones.

Here in Georgia, a Covid-delayed trial has resumed that pits families of people hurt by opioids against Cardinal Health, McKesson, and JM Smith Corp, which they say acted as illegal drug dealers — and Georgia law allows people to sue drug dealers.

[The plaintiffs’ attorney] said the distributors fueled illegal opioid use by filling illegitimate pharmacy orders and failing to report suspicious opioid purchases to law enforcement.

Not named are pharmacies or prescribers, though. “A pharmacy can’t fill a prescription if these distributors are not breaking the law, which they did over and over and over again.”

For their part, the distributors say they can’t be held responsible, as they were just following the orders.

 

February 02, 2023     Andrew Kantor

UGA targets fungus

Fungal infections are becoming a much bigger deal these days as they become resistant to drugs — they’re literally killing people because of it.

UGA researchers, though, have developed a vaccine against the three most deadly fungal infections — Aspergillus, Candida, and Pneumocystis — which together are responsible for more than 80% of fatal fungal infections. Candida in particular has been getting a lot of press as it keeps being found in hospitals.

So far it’s been tested on animals (it showed “broad, cross-protective antifungal immunity”), so human trials are on the horizon.

Apnea and brittle bones

If one of your patients mentions snoring a lot, direct ’em to the supplements aisle for some calcium. It seems that — per research out of the University of Buffalo — “Obstructive sleep apnea may be linked to low bone mineral density in adults.”

(Why and how? That “has yet to be fully explored.”)

Beta-blocking the violence

Being on beta blockers reduces someone’s tendency for violent behavior. Yep, that’s what British and Swedish researchers found when examining the medical and criminal records of 1.4 million Swedes over eight years.

Periods on β-blocker treatment were associated with a 13% lower risk of being charged with a violent crime by the police […] Additionally, an 8% lower risk of hospitalization due to a psychiatric disorder was reported as well as an 8% increased association of being treated for suicidal behavior.

There were some caveats, though, notably “past psychiatric problems, as well as the severity and type of the cardiac condition the β-blockers were being used to treat.”

Good news for some

Monkey(pox) done

The mpox Public Health Emergency has expired. That is all.

GoodRx wasn’t being good

The FTC has charged GoodRx with providing users’ personal health information — medications and health conditions — to the likes of Facebook, Google, and Twilio so those companies could better target their advertising.

In 2019, the company gathered a list of users who bought specific medications like blood pressure or heart disease drugs, and shared email addresses, phone numbers, and mobile advertising IDs with Facebook so their profiles could be tagged for health-related advertisements.

The cost of doing business: The company will pay a $1.5 million penalty … although it would not admit it did anything wrong.

In other news, companies including Facebook, Google, and Twilio see nothing wrong with buying individuals’ personal health information so they can better target their advertising.

The oddest medical test you’re likely to hear about today

Ants, it seems, can detect cancer in urine.

Really, what more is there to say? French researchers trained ants — total

… exposed 35 Formica fusca ants to the scent of urine from the cancerous mice and trained them to associate it with a sugary reward. Later, when presented with urine from both sick and healthy mice, the ants spent 20 percent more time around the urine from the sick mice, without the sugar present.

Total training time? About 10 minutes. Their paper was published in Proceedings of the Royal Society B.

Early testing had some issues

A law that does what it’s supposed to

Allowing Medicare to negotiate the price of a handful of drugs is supposed to save the program — and thus taxpayers — a lot of money.

And now a new study out of Harvard and Brigham and Women’s Hospital finds that those provisions of the Inflation Reduction Act will actually … save Americans billions of dollars.

The IRA will allow price negotiations on 10 drugs in 2026, 15 more in 2027, and 15 more in 2028. (After that it adds 20 drugs a year.) If it took effect in 2018 instead of 2026, the researchers found, “it would have saved the U.S. $26.5 billion, about 5% of all drug spending.”

End of a juggernaut

The Humira monopoly is over, as AbbVie’s most popular drug now has biosimilar competition in the form of Amgen’s Amjevita.

To make sure the market remains confusing, Amgen has two list prices:

  • $1,558 for a two-week supply — 5% less than Humira’s list price, for payers using discounts, kickbacks, coupons, rebates, and the like
  • $3,288 for a two-week supply — 55% less than Humira, for insurers that don’t take advantage of those discounts and rebates

Amjevita is just the first; there are seven other Humira biosimilars expected to debut this year: Idacio, Cyltezo, Abrilada, Yusimry, Hadlima, Hulio, and Hyrimoz. Yes, that will be on the final exam.

A different kind of mile-high club

If you’re going to track how Covid (or other diseases) travel, why not take a page from the wastewater-surveillance playbook?

That’s what the CDC is thinking as it looks at testing airplane wastewater for Covid-19. It’s an anonymous early-warning system for finding infections before they become widespread — and knowing where they came from.

Unlike sewer-wide surveillance, which shows us how diseases are spreading among large communities, airplane surveillance is precisely targeted to catch new variants entering the country from abroad.

And yes, if you’re thinking that China’s “No Covid here, no sir!” stance might be a reason for the interest, you’re spot on.

February 02, 2023     Andrew Kantor

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].’

 

 

January 31, 2023     Andrew Kantor

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.)

January 28, 2023     Andrew Kantor

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.

 

 

January 27, 2023     Andrew Kantor

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.”

 

January 26, 2023     Andrew Kantor

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.”