Migraine spray gets thumbs-up

As expected, the FDA has approved Pfizer’s Zavzpret (aka zavegepant) — an anti-migraine nasal spray that works in minutes and can last for up to 48 hours … in trials, at least.

Of course there’s a downside: price.

A Pfizer spokesperson said Zavzpret “is expected to be comparable in price to other FDA approved CGRP migraine medications.” As an example, eight doses of Nurtec, another CGRP-inhibiting tablet taken daily to prevent and treat migraines, can cost over $1,000.

A Crystal congrats

A big ol’ GPhA shout-out to Crystal Pharmacy in Moultrie, named business of the month of March by the Moultrie-Colquitt County Chamber of Commerce!

Treatment for one dementia symptom

Some Alzheimer’s patients experience trichotillomania — the irresistible urge to pull at skin and hair. Now there appears to be a treatment beyond cognitive behavioral therapy: memantine.

University of Chicago researchers found in a small study that it works extremely well — “26 of the 43 study participants taking memantine had much improvement or very much improvement, compared to three of the 36 taking a placebo.”

They think it has to do with blocking the neurotransmitter glutamate (already seen as a culprit in some OCD cases), but as always, more research is needed.

The good news is that memantine is already FDA approved, so people suffering from trichotillomania might be able to convince their physicians to prescribe it off label.

Spring Region Meetings — mark your calendar!

Save your date for your local spring Region Meeting, coming next month. We’re still finalizing the locations, but there’s a good chance they’re in the same awesome eatery as the fall meeting. Stay tuned.

• Thursday, April 13: region 5
• Tuesday, April 18: regions 7/9 and region 11
• Wednesday, April 19: regions 1 and 10
• Thursday, April 20: regions 4 and 8
• Tuesday, April 25: regions 2/3 and region 12
• Wednesday, April 26: region 6

What’s your region? Click here for the map.

The law, the wholesalers, and the patients who can’t get meds

Controls implemented by pharmacy wholesalers are keeping patients from getting their medication — pharmacies are finding their supplies limited with wholesaler’s explanations kept secret by law.

It’s all fallout from the Big Opioid Settlement, but rather than simply hindering pill mills and drug abuse, it’s coming between legitimate patients and their pharmacies. Secret “triggers” limiting pharmacy orders for controlleds are at best confusing and frustrating, and at worst mean patients can’t get their treatment.

This one graf from the New York Times article explains it best:

The distributors use algorithms that cap the quantities of controlled substances a pharmacy can sell in a month. Before the settlement, pharmacists said, they could explain to a distributor the reason for a surge in demand and still receive medications past their limits. Now the caps appear to be more rigid: Drugs are cut off with no advance notice or rapid recourse. As a condition of the settlement, distributors cannot tell pharmacies what the thresholds are.

The 15 big guns

Adam “Drug Channels” Fein has released his annual list of the 15 biggest pharmacies in the country. There are zero surprises, but feel free to check it out.

New hep-B guidelines

[insert news-ticker sound here] The CDC has made a “significant update” to its hep B recommendations. It now says everyone should be screened at least once in their life, and pregnant women should be tested with the extra-fancy triple panel screening. Those at risk — incarcerated, multiple sex partners, history of STIs — “should be tested periodically if they remain unvaccinated.”

Of course, if you weren’t vaccinated as a child, it’s a good idea to get a shot, especially if you’re in (or plan to be in) one of those risk groups.

“I’m not sleeping, boss, I’m making sure my vaccination works better”

Guys: Be sure to sleep before you get your shots. It seems that poor sleep the night before getting a vaccination could mean it doesn’t work as well — but only for men.

That’s what University of Chicago researchers discovered when they did a meta-analysis of studies on flu and hepatitis vaccines, but it applies to any vaccine.

[I]f a person arrived for a Covid-19 vaccination without adequate sleep, their antibody response to the vaccine would be weakened by the equivalent of two months […] “You would have already lost two months of immunity, so to speak, even though you just got the shot.”

Why does this only affect men? They just don’t know.

Short Takes

Short visits, wrong drugs

A study in JAMA Health Forum finds that the shorter a primary care visit, the greater the likelihood that a patient will get an unnecessary antibiotic for a respiratory infection. “The authors say that finding suggests that when clinicians have more time to discuss a diagnosis with patients, they are less likely to reach for a quick fix.”

Shades of thalidomide

If, back in the ’60s and ’70s, your mother used dicyclomine (part of Bendectin) for nausea while she was pregnant with you, you might have a higher risk of colorectal cancer. That’s based on patient records, though, so the University of Texas researchers who discovered this say that — you know it — more studies are needed to figure out the cause and effect.

Nifty implanted drug delivery system

Implanted drug-delivery isn’t new, but it has drawbacks: A passive system just does its thing and eventually is absorbed by the body — but patients can’t control the dosage. And active systems give control, but include electronics that eventually have to be surgically removed.

But now Northwestern bioengineers have created the best of both worlds: an implantable drug-delivery device that can be controlled biologically using external lights of different colors, rather than with electronics.

They implanted test devices containing lidocaine into rats.

Then, three LEDs were placed over the implantation sites to trigger release of the drug. Subsequent testing showed marked pain relief among the rats. Moreover, researchers were able to achieve different patterns of pain relief depending on the LED color-light sequencing.

Science-fiction authors, take note: In future, DJs at wild raves could change the lighting to deliver different drug combos to dancers….

Embrace the darkness

How can a pregnant woman reduce her risk of diabetes? By turning the lights out sooner.

British researchers found that “pregnant women who are exposed to greater levels of light in the three hours before sleep appear to be more likely to develop diabetes during their pregnancy.”

This might sound odd … until you realize that previous studies have found that nighttime shift workers also have a higher risk thanks to that artificial light. Could it be due to melatonin suppression? You know the answer: More research is needed.

Drinks are on Wellstar!

Congrats to the pharmacist-led team at Wellstar that saved the hospital system a whopping $21 million by developing a system-wide opioid-stewardship program.

It started, as these things do, with committees. Those developed ideas that were taught in a “pharmacy opioid stewardship bootcamp” for training ambassadors who spread the ideas to individual hospitals.

Paying particular attention to the highest risk drugs, the team conducted more (and more formal) safety assessments to alert nurses of issues before they got out of hand.

The team developed pharmacist practice changes, such as a therapeutic interchange for morphine for patients with renal dysfunction. They also made it a requirement for pharmacists and prescribers to register for the state prescription drug monitoring program (PDMP), and worked with the information technology department to implement one-click access to the program to make it easier to verify patients’ medication regimens upon admission.

Results included opioid dosage decreases (and increases in acetaminophen and ketorolac), better PDMP use, “discontinuation of inappropriate therapies,” and more — all adding up to that $21 million savings.

Next up: brining AI into the mix to get an even bigger jump on potential problems.

The Long Read: Cancer “Vaccines” edition

There’s been news about vaccines for cancer, but aside from the HPV vax against cervical cancer, these “vaccines” are really treatments, and they could be poised to make a huge difference. An Aussie cancer expert explains.

mRNA bacterial-vaccine breakthrough

Researchers at Tel Aviv University have created an mRNA vaccine against bacteria. Why is this a big deal? Because it was assumed that mRNA vaccines could only work against viruses.

mRNA works, in part, by getting human cells to create the bacterial proteins that will trigger an immune response. But for [insert science here] reasons, when it comes to bacteria, human cells can’t secrete those proteins without changing them too much.

But the TAU folks were able to create bacterial proteins that human cells could produce. Those proteins were then used to create the appropriate mRNA for a vaccines.

According to the researchers, their new technology can enable rapid development of effective vaccines for bacterial diseases, including diseases caused by antibiotic-resistant bacteria — in case of a new fast-spreading pandemic, for example.

Gettin ’em vaccinated

…against the flu

One way to get those shifty Danes to get their flu shots is sending the right message. A study out of Brigham and Women’s Hospital (cautiously working with their Danish counterparts) tested nine kinds of message to see which got the best response.

None made a huge difference, but one strategy stood out.

In particular, the trial found that emphasizing the potential cardiovascular benefits of vaccination and a repeat-letter strategy with a 14-day follow-up letter resulted in 0.89 percent and 0.73 percent increases in vaccinations, respectively.

Of course, with flu having an R0 value of 0.9 to 2.0, each vaccinated person sorta-kinda protects 1.9 to 3.0 people.

…against Covid-19

Emphasize the dangers of Covid and how it can affect lifestyle. Even with a mild infection, the specter of brain fog, long-term organ damage, and long Covid is there — and no one wants to deal with that.

That’s what an NC State study found when looking at the reasons people chose to be vaccinated. Those who planned ahead (like for a cough-free vacation) were more likely to get jabbed. Those whose retirement plans were “Win lottery” … not so much.

Short Takes

Closing the door to SARS

Yale researchers have found a way, via turning off certain genes, to disrupt cells’ ability to produce the ACE-2 receptor. Without that receptor, viruses like SARS-CoV-2 can’t infect cells, so if their research pans out, it could mean a treatment for existing and future Covid-19 variants.

The best acne antibiotic

“Antibiotics for Acne,” reads the headline from Yale Medicine, “Groundbreaking Study Shows Why One Works Best.”

Saving you a click: It’s sarecycline.

It’s specific rather than broad spectrum, which makes resistance less likely to develop, and it targets Cutibacterium acnes, “the bacterium most doctors believe is behind acne and promotes skin inflammation.”

If you want the full 1,300 words about sarecycline and acne treatment, click here.

A (possible) major breakthrough in bone cancer treatment

Bone cancer is one of the most horrific forms of the disease, with a lot of pain, a low survival rate, and grueling treatment. But now researchers at the UK’s University of East Anglia have made what they think is a huge step toward treating it.

They found that bone cancer’s spread is helped by a gene called RUNX2, and were able to develop a drug that “blocks the RUNX2 protein from having an effect.” They tested it on mice, and … wow.

The breakthrough drug increases survival rates by 50 per cent without the need for surgery or chemotherapy. And unlike chemotherapy, it doesn’t cause toxic side effects like hair loss, tiredness and sickness.

It gets better: The drug, called CADD522, works against all the main forms of bone cancer, showed no toxicity, and is not usually required by normal cells, so it doesn’t have chemo’s side effects.

They’ve started the process leading to human trials.

Mercer: Check it out

If you happen to be at the 2023 Atlanta Science Festival show — March 25 at Piedmont Park — be sure to stop by the Mercer exhibit, where the College of Pharmacy (and other schools) will be giving demos.

A visitor at the 2022 festival examines a Braves fan still in its larval stage

Cancer drugs in shortage

Hospital pharmacists are worried about shortages of some important cancer drugs, including cisplatin, fluorouracil, and methotrexate.

It’s not critical … yet. But those are the kinds of meds where “the most likely predictor of success is getting that regimen on time at the full dose.”

The problem is the same as it ever was: Increased demand in some cases, product shortfalls in others (caused by plant delays, supply chain issues, Mercury in retrograde, and so on). And, of course, until the dawn of 3D printing of medication, there are only so many manufacturers.

Note: If you can’t read the story with the above link, here’s a PDF.

Nasal Narcan alternative

The FDA has approved a naloxone hydrochloride nasal spray from Amphastar Pharmaceuticals.

Like other naloxone products, it’s currently available only by prescription (including standing orders, as in Georgia’s case; PDF tip sheet here). That may change, though, as the push continues to allow it to be dispensed OTC.

Well, we tried

With Congressional hearings starting on the cause of the Covid-19 pandemic, we’ll finally reach an informed consensus on where (experts think) the virus actually came from. Unless, of course, the hearings just turn into partisan bickering.

Short Takes

“White-Collar Drug Dealer”

The first pharmacy executive is going to prison for his role in the opioid crisis. Laurence Doud III, 79, former CEO of Rochester Drug Cooperative will be spending 2 years and 3 months in prison “for selling addictive opioids to pharmacies that were suspected of dispensing them to addicts and street dealers.”

James Cagney would like a word

Rats can carry Covid.

Russian roulette

Scientists have not only found and revived a 48,500-year-old virus from permafrost, they’ve now infected modern amoebas (amoebae?) with it to prove it’s still infectious.

Okay, we get it. Old viruses in melting “perma” frost are dangerous. Now would you please destroy them and go research something safe, like fungi?

Who needs coffee … or a cold shower?

Nobody likes to deal with drunk mice. They annoy the cat and spend too much time trying to take over the world. But now there’s a potential solution: a dose of the hormone FGF21.

Researchers led by the University of Texas were looking at how to treat drunk mice, when they realized that FGF21, produced by the liver, is one of the ways the body deals with being drunk. (And when we say “drunk,” we mean really drunk: “defined as the loss of the ‘righting reflex,’ or the mouse’s ability to get upright after being placed on their back.”)

So what if they used artificial FGF21 on those blotto mice?

[W]hen the researchers gave the conked-out mice extra FGF21, they sobered up an average hour-and-a-half faster than the control drunk mice.

By augmenting the FGF21 naturally produced by the liver, the injection “activates a specific part of the brain that controls alertness, known as the noradrenergic nervous system.” (It also makes you want to drink more water.)

Not surprisingly, “More research will need to be done, but the team believes that FGF21 could someday be used to treat acute episodes of alcohol poisoning.”

More eye drop recalls

Two more companies are recalling some of their eye drops due to, obviously, health dangers.

Pharmedica is recalling its over-the-counter Purely Soothing 15% MSM Drops “due to problems ‘that could result in blindness’.”

= AND =

Apotex is recalling six lots of its prescription brimonidine tartrate ophthalmic solution 0.15% because it found cracks in some of the bottle caps.

These drops were made in the US and Canada, respectively, and aren’t related to last month’s eye-drop recall of drops made in India.

The Board of Public Health is meeting

Mark thy calendars: The Georgia Board of Public Health is holding its next public meeting on Tuesday, March 14 from 1:00 – 3:00 pm via Zoom.

Topics include Georgia’s dementia/Alzheimer’s program, environmental health updates, vaccinations for those over 50, and more.

Testing anxiety

There soon could be a simple blood test for anxiety. Not the spur of the moment, “Was that mole there yesterday?” kind, but the longer-term psychological condition.

The test, developed at Indiana University, is based on research that identified certain biomarkers for anxiety.

By examining the RNA biomarkers in their blood, researchers could identify a participant’s current state of anxiety and match them with medications and nutraceuticals, showing how effective different options could be for them based on their biology.

It can also predict someone’s risk of developing anxiety in the future, which, ironically, could end up causing that very anxiety….

AI finds a Parkinson’s drug

One of the contributors to Parkinson’s is that the body has trouble clearing out defective mitochondria*. So one treatment would be, say, a drug that helps with that process, called mitophagy.

But how to find that drug? If you’re a Canadian researcher (and it’s 2023), you turn to IBM’s Watson AI.

First you show it the kinds of words and phrases and clauses that are related to mitophagy (it called semantic similarity). Then you sic it on existing studies of more than 3,000 drugs.

In this case, Watson was able to narrow the drug possibilities down to 79, which was a small enough number to test in the lab. Then the humans took over.

Lo and behold, one of them — probucol — turned out to be “the compound with the best combination of effectiveness and likely safety.” It “was also found to improve motor function, survival, and neuron loss in two different animal models of Parkinson’s disease,” so clearly this was a win.

This is still in vitro, but it’s a better AI story than yet another “Will you lose your job to a robot?” piece.

^* Tradition requires us to include the phrase “the powerhouse of the cell.”

Makena is off the market

Under pressure from the FDA, Covis Pharma has pulled Makena, its hormonal injection to prevent pre-term labor, from the market.

Makena was granted an accelerated approval for Makena under the stipulation that it conduct more tests. But the company — now owned by a private equity firm — didn’t bother to run those tests for almost a decade. Why bother, when the drug was turning a profit?

When it was finally pressured into running those trials, it turned out Makena doesn’t work. And the side effects include miscarriages and stillbirths. With the FDA breathing down its neck (the FDA’s CDER said two and a half years ago it should be pulled from the market), Covis formally withdrew Makena.

Still, as one specialist put it, “We’ve basically been injecting pregnant women for 20 years with a synthetic hormone that doesn’t work, and carries risks to the moms and babies.”

Short Takes

The bright future of testing

What’s better than an at-home Covid test? An at-home Covid test that glows in the dark. It’s not just a gimmick, either. The same technology that causes the glow also makes the test more sensitive.

Biden’s plan to save Medicare

President Biden is joining Republicans in looking for ways to preserve the Medicare trust fund and keep the program funded. His proposal: Increase the number of drugs for which Medicare can negotiate the price. Paying what a drug is worth, rather than whatever drugmakers dream up, could save the program (i.e., taxpayers) billions.

More post-Covid blues

People who have survived Covid may have an unwelcome surprise waiting for them: a higher risk of gastrointestinal issues at least a year after infection. (That’s what Veterans Affairs researchers found looking at the health records of 11.6 million people.) And the worse your Covid infection, the greater the likelihood of GI problems, “with the greatest risk among those who were hospitalized or admitted to an intensive care unit.”

All-weather TB vaccine

In a major breakthrough for health around the world, we may finally have an effective and temperature-stable tuberculosis vaccine. It’s only passed its phase 1 trial, but the freeze-dried vaccine “stimulated both antibodies and responses from the cellular arm of the immune system.” It only needs to be mixed with sterile water before injection.

The good news: This is a freeze-dried version of a vaccine that was already tested, so there’s a good chance it’ll pass it’s phase 2/3 studies.

Meanwhile, in Washington State….

After more than a year of back-and-forth with state health officials (16 separate court visits), a woman who has violated multiple court orders to isolate and treat her tuberculosis is being arrested, “and officials plan to treat her at a nearby detention facility.”

What’s really in the mail

Pharma industry claim: We need to spend millions to search incoming mail for prescription medication because it could contain fentanyl.

Reality: “only a tiny fraction of the drugs inspected contained opioids.”

The FDA said it found 33 packages of opioids and no fentanyl sent by mail in 2022 out of nearly 53,000 drug shipments its inspectors examined at international mail facilities. That’s about 0.06% of examined packages.

What’s actually intercepted? Viagra and other prescription meds that are too expensive in the US.

Ozempic follies continue

Some pharmacies, it seems, are no longer stocking Ozempic — not because it’s in shortage, but because PBMs aren’t reimbursing them enough. And by “enough” we mean they aren’t paid enough to cover the wholesale cost.

The average wholesale price of Ozempic that pharmacies pay is about $900 for a 30-day supply, he said. But [pharmacy owner Nate] Hux said for each prescription, he was typically reimbursed just $860.

The Long Read: Will physicians prescribe buprenorphine?

The roadblocks to prescribing buprenorphine — the “X-waiver requirement” for treating opioid abuse — have been removed. But now comes the real test.

Was the X-waiver and the burdens that came with it the real reason only about 7% of clinicians in the U.S. were cleared to prescribe buprenorphine? Or was it an excuse that masked hesitation about treating addiction, if not outright disdain for these patients?

Required DST story

By rule, at this time of year every news and health organization is required to run a story about the benefits and drawbacks of switching between standard time and daylight saving* time.

Ours: a neurologist explains why the shift is bad, and why standard time is better for us than DST. (Spoiler: It’s because standard time puts the sun in the right place in the sky.)

^* Did you know that it’s officially singular — daylight saving time? Me either. It should probably take a hyphen, too: daylight-saving time.

Short Takes

Another reminder to quit

Today is No Smoking Day, and the folks at Alzheimer’s Research UK would like to remind people that, among all the other health issues that smoking can cause, people often forget it can lead to dementia.

[J]ust 18% of people who smoke know that smoking increases the risk of dementia, compared to more than 70% who know that smoking causes lung diseases or cancers.

Wait — almost 30% of people don’t know that smoking causes lung disease and cancer?

Elsewhere: The World Turned Upside-Down edition

New York City Mayor Eric Adams is now telling stores not only do they not have to require masks, they should specifically ask customers to remove them so they (the customers) don’t look like criminals.

Georgia families lose in lawsuit

A group of Georgia families hurt by opioid addiction lost their lawsuit against drug distributors Cardinal Health, McKesson Corp, and JM Smith. They had tried to use Georgia’s law designed to fight street-drug dealers against the drug distributors.

This was the first opioid lawsuit brought by individuals as opposed to municipalities.

Unlike those lawsuits, which accused companies of creating a public nuisance by failing to stem the flow of illegal opioids, the Georgia plaintiffs brought their claims under the state’s Drug Dealer Liability Act, which allows people injured by illegal drug use to sue dealers.

Farmer sworn in

A big GPhA congratulations to our past president Michael Farmer on his recent appointment to the Georgia Board of Pharmacy. Here’s a picture taken at the swearing-in ceremony:

A statin alternative

Patients who can’t take statins might have an option: bempedoic acid. It’s already used along with statins to reduce LDL cholesterol, but a new study out of the Cleveland Clinic found that, like Hamburger Helper, it works pretty well on its own.

Patients who received the bempedoic acid saw their LDL cholesterol drop by an average of 29.2 points by the end of the six-month trial.

After a 40-month follow up period, patients who had received the bempedoic acid saw a 19% reduction in the risk of needing cardiac revascularization and saw a 23% reduction in the risk of heart attack.

Most importantly, the patients didn’t have the muscle-pain issues that some statin users had.

It still doesn’t work

Why is phenylephrine still on the market? It was supposed to be a substitution for pseudoephedrine — one that could be bought without the ‘please don’t make meth’ hassle. Problem: As far back as 2006 it was found to be ineffective. (We wrote about that a year ago, in fact.)

But now it’s going beyond scientific papers; the FDA’s Nonprescription Drugs Advisory Committee “will weigh whether the agency should revoke oral phenylephrine’s classification as ‘Generally Recognized as Safe and Effective’ because it may be ineffective.”

Said one of the professors petitioning the FDA to un-approve phenylephrine:

“Let me be clear, oral phenylephrine is not a safety risk. It just doesn’t work.”

Or, as one 2022 article in Science put it, “The only reason it’s sold is to have some alternative to offer consumers, even if it’s a worthless one.”

But wait. There is a form of phenylephrine that might work: a nasal spray. That’s because it’s not destroyed by the digestive system the way the oral version is.

Med groups become misinfo warriors

A whole heck of a lot of medical groups — we won’t bother to list all 50, but it includes the AMA, the American Association of Colleges of Pharmacy, and the National Pharmaceutical Association — is tired of all the health misinformation out there (“gargle bleach,” “use dewormer,” “vaccines are dangerous,” and so on). They’ve banded together as the Coalition for Trust in Health & Science to fight that fake health news.

[A]ll member organizations will work towards ensuring that all patients can “have equitable access to and confidence in the accurate, understandable and relevant information necessary to make personally appropriate health decisions.”

First steps: “developing practical ways the coalition’s member organizations can work together to better disseminate reliable medical information and educate the public.”

Antipsychotics to boost antidepressants

Adding Abilify to an antidepressant for older people — those who aren’t responding to treatment — might be a good idea, at least according to Washington University psychiatric researchers.

When an antidepressant doesn’t work, the typical response is to try another … and another, hoping to find one that works. But the WU folks found…

Augmenting an antidepressant with aripiprazole helped 30% of patients with treatment-resistant depression, compared to only 20% who were switched to another solo antidepressant, results of the study show.

Caveats: Aripiprazole has behavioral side effects to watch for, like compulsive shopping.

And there may be some risk. A 2020 study found that, for adults diagnosed with depression who augment with a newer antipsychotic medication instead of a second antidepressant are at increased risk of dying — “augmentation with a newer antipsychotic was associated with a 45% relative increase in mortality risk,” the authors wrote.

Covid rebound is common

People who catch Covid sometimes rebound — i.e., get a repeat of symptoms a few days or weeks after they’re cured. A small study out of the Scripps Research Institute found that it happens whether or not they’re treated with Paxlovid (although it happens a little more often in those who were treated).

[T]he disappearance and then return of evidence of the virus on antigen tests and in self-reported COVID-19 symptoms occurred in 9.3% and 7.0% of patients who opted not to take antiviral treatment, and in 14.2% and 18.9% of those who opted for Paxlovid.

(While 9.3% vs 14.2% might seem like a big difference, they pointed out that in such a small study it was statistically insignificant.)

Short Takes

ICYMI: 20,000 exposed to measles

An unvaccinated person caught measles overseas and then attended a religious gathering — one with more than 20,000 people from around the world — in Kentucky. Hopefully everyone there was vaccinated. If not, we’ll probably be hearing about an outbreak soon enough.

Covid cases, deaths continue to decline

The US is down to an average of about 32,374 cases per week (i.e., 4,600 per day); Georgia is seeing an average of about 567 new cases a day (more than 600 are currently hospitalized), and the numbers continue to drop.

That said, 95 Georgians a week are still dying from Covid — more than 42,000 have died since the pandemic began.

DEA gets an earful

The other day we told you about the DEA’s plan to go back to pre-pandemic rules for telehealth prescriptions of controlled drugs.

“Throwing a regulatory wrench back into the works is likely to get some serious pushback,” we wrote. Lo and behold: That pushback has started in a big way.

It seems that making it easier for people to get help with mental health issues is pretty popular, and — at least from patients’ and providers’ points of view — outweighs DEA’s concerns about overprescribing. (And it’s especially true for people looking for help with opioid abuse.)

Oh, and pharmacists are also concerned: Will they (i.e., you) have to act as the prescription police^*? Stay tuned.

^* I.e., …proactively police prescriptions to prove a provider processed a patient in person?

Eye-drop warning

The CDC and FDA are warning everyone to stop using EzriCare or Delsam Pharma’s Artificial Tears products — there’s a good chance they’re contaminated with a drug-resistant bacteria that can be particularly dangerous and just about untreatable: So far eight people have lost vision and one person has died. (There hasn’t been a case in Georgia, but there has been one in Florida.)

OTC hearing aids: Now available as home study

The same CE, the same important info, but now available on demand: GPhA’s one-hour webinar on everything you need to know about OTC hearing aids: “OTC Hearing Aids: How Pharmacists Can Support Safe Self-Care.”

When patients ask questions, be ready with the answers thanks to UGA professor and audiologist Alison Morrison (and, of course, GPhA).

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!

For $32 billion, we’ll get a discount

Something to keep in mind as we watch Pfizer and Moderna reap the profits from their mRNA vaccines — and when drug companies in general roll out the tired old line about the cost of drug development. From the BMJ:

The US government invested at least $31.9bn to develop, produce, and purchase mRNA Covid-19 vaccines, including sizeable investments in the three decades before the pandemic.

As the accompanying editorial points out, it’s another case of “public risk, private reward”:

[T]heir development also serves as a cautionary tale of a system in which the risks of pursuing innovation were socialized, while the lion’s share of rewards became privatized to corporate shareholders — financial actors who risked little of their capital in the development process.

How’s your diet’s footprint?

If you help your patients with weight loss programs, here’s something to consider. Tulane researchers looked at how well various diets worked, and also their carbon footprints.

Bad news for keto and paleo diet fans: Those had the lowest nutrition scores and the highest carbon footprint.

What’s best? For carbon footprint, that would be the vegan diet (not surprisingly), with vegetarian and pescatarian close behind.

As for nutrition, fish lovers will be happy to know that “The pescatarian diet scored highest on nutritional quality of the diets analyzed,” although vegetarian and vegan diets weren’t far behind.

An the good ol’ omnivore diet? Squarely in the middle of both nutrition and carbon footprint.

Aieeeeeeeeee

If you sell neti pots (and here at Buzz we’re fans, especially during allergy season), you should also sell your customers distilled water to go along with them. Why? Because of this:

A man in southwest Florida died after becoming infected with a rare brain-eating amoeba, which state health officials say was “possibly as a result of sinus rinse practices utilizing tap water.”

ICYMI

Walgreens said it won’t allow its pharmacists to dispense mifepristone — even for treating miscarriages and even where abortion is legal — in 20 states, including Georgia.

Short Takes

Three UGA kudos

Congrats to…

• Michelle Worst, PharmD, named UGA’s 2022 Outstanding New Alumna
• Chris McCurdy, PharmD, UGA’s 2022 Distinguished Alumnus
• Calita Richards, PharmD, winner of UGA’s 2022 Distinguished Service Award

What, you worry?

The Brazilian government would like you to know that the case of Mad Cow Disease found there wasn’t typical. Move along, citizen. Nothing to see here.

House to investigate PBMs

One of the many investigations the US House of Reps is launching is actually useful: As NCPA cheers it on, the House Committee on Oversight and Accountability is launching an investigation into PBMs.

Kicking off the probe, Chairman James Comer (R-Ky.) is calling on the three largest PBMs — CVS Caremark, Express Scripts, and OptumRx — to provide documents, communications, and information related to their practices that are distorting the pharmaceutical market and limiting high quality care for patients.

All we can say: Good hunting!

Fun pharmacy tech stats

The Pharmacy Technician Certification Board surveyed technicians, and now Becker’s Hospital Review is sharing some of the results. Did you know …

• 4 percent of technicians have a master’s degree, and 2 percent have a doctorate?
• Almost 30 percent got a pay increase for becoming certified, but 34 percent said they got bupkis?
• 85 percent are very or at least somewhat satisfied with their jobs?

Check out the story for the details. And more stats are coming your way soon — look for the Numbers Issue of Georgia Pharmacy magazine in your mailbox!

More humans getting bird flu

You might want to quietly stock up on toilet paper again. China has reported three more cases of bird flu jumping to humans — one of H5N6 (often fatal) and two of H9N2 (usually mild).

Human cases are rare because the virus can only attach to receptors deep in our lungs; they have to pass through a gauntlet of defenses first. But if one mutates to infect differently….

This year’s flu vax was pretty good

This season’s flu vaccine was 54% effective at protecting adults under 65 against disease, according to the CDC — that’s about average. It was 71% effective for people under 18, which is pretty darned good.

Still…

[T]here were an estimated 25 million illnesses, 280,000 hospitalizations, and 18,000 flu-related deaths caused by this flu season as of February 24, 2023.

Sell eye masks, make patients smarter

An international group of researchers found that wearing an eye mask while you sleep not only keeps you from seeing your high school crush dancing with your English teacher while you sit naked taking a final exam you aren’t prepared for^*, it can also improve “episodic learning and alertness” by reducing the ambient light that’s in most people’s bedrooms.

[T]he participants performed better on a word-pair association task, which measures the ability to recall events and experiences, after having their eyes covered while sleeping. They also performed better on a test that measures reaction times.

Also, as any child under 10 will tell you, if you can’t see the Thing in the Closet, it can’t see you.

^* I mean, just as an example.

Captain Obvious is a little tired of singing this song

“Medically accurate asthma information sparse on TikTok”

While the researchers classified 13.7% of the videos as medically accurate, another 13.7% were medically inaccurate. Also, 7.8% were about pet asthma, 5.9% offered helpful advice […], 3.9% mocked asthma, and 2% shared improper inhaler techniques.

Short Takes

ICYMI: RSV vaxes get closer

An FDA panel — not the FDA itself, yet — has recommended approval of both Pfizer’s and GSK’s RSV vaccines for people over 60. Now, like twins in the womb, the race is on to see who’s out first.

Shigella watch

The CDC is warning about an increase in drug-resistant shigella infections. In 2015, no cases were of the resistant variety (called XDR); today that’s 5%. Not a huge jump, but shigellosis can be deadly, and it can spread its antimicrobial resistance to other bugs.

One in 5 refuse statins

A big study — we’re talking more than 24,000 people over almost eight years — found that “roughly 20% of high-risk patients don’t take statins, even when their doctor recommends them.”

Yep, they refuse them, even when their lives are at risk. Women are more likely than men to skip statins — 20% more likely at first, but as men tend to change their minds, eventually women are 50% more likely to refuse to take statins. Not surprisingly, their cholesterol levels went up.

The big question: Why?

“I can only speculate,” said one of the co-authors (out of Brigham and Women’s Hospital), but the answer seems to be — wait for it — misinformation.

“So, for example, if you go to Amazon and you put the word ‘statins’ in the search box, the first things that come back are books with titles like: A Statin-Free Life, The Dark Side of Statins, The Truth About Statins: Risks and Alternatives to Cholesterol Lowering Drugs. I’m not picking these out. These are the top things that come back in my search.

“Then you go to Facebook — and, of course, everyone gets slightly different results — but what I get when I put the word ‘statins’ in the search box is lists of groups with titles like: Stopped Our Statins or No More Statins.”

Why pharma’s rep matters

We sometimes run stories about which pharmaceutical companies have the best reputation. It turns out that’s more than newsletter filler: When it comes to prescribers, reputation matters. (If you can’t read that online, click here to view a PDF copy.)

“Corporate brand matters — a lot,” wrote the folks at We, a branding consultancy, based on their survey of 1,000+ prescribers in six countries.

Two-thirds of HCPs are reluctant to prescribe or recommend a medication from a biotech/pharmaceutical company that does not have a good reputation.

Verapamil vs diabetes?

Patients given the calcium channel blocker within a month of being diagnosed with type 1 diabetes saw their insulin-producing pancreatic beta cells survive longer for up to a year.

To put it another way, verapamil delayed the expected decline in C-peptide production from 3 months after diagnosis of type 1 diabetes to 6 months after diagnosis.

Said one endocrinologist, considering its low cost and high safety, “verapamil should be a consideration for newly diagnosed patients with type 1 diabetes.”

Lawmakers know how to fight drug shortages

Six House Democrats have written a Strongly Worded Letter to the chair of the FDA asking him “to further its efforts to address the shortage of over-the-counter flu and cold medicines.”

Of course, the FDA doesn’t have the power to compel manufacturers to make products or speed up the pipeline. But the reps did have some, er … helpful suggestions:

1. Provide pharmacists with guidance on alternatives to pediatric ibuprofen and acetaminophen^*.
2. Encourage “heightened transparency from manufacturers regarding supply locations and demand”.
3. Proactively communicate with healthcare providers about the shortages.

Well those should solve the global manufacturing and distribution problem in days^†. Get on it, FDA!

^* “Temporarily loosen restrictions on pharmacy compounding” might actually have been a good suggestion.
^† This is sarcasm.

D is for “Don’t get dementia”

People who aren’t at high risk for dementia might reduce their risk even more by taking a vitamin D supplement.

Canadian and British researchers, looking at data on more than 12,000 US patients, found that those without dementia had a better chance of holding it off by taking vitamin D supplements.

It worked better for some people than others. Women, people not (yet) cognitively impaired, and those without the APOEe4 gene (which indicates a higher risk of Alzheimer’s) had the greatest benefit.

Don’t cut salt too much

There’s enough evidence out there to suggest that too much salt might be bad for your heart, so cutting down isn’t the worst idea.

Unless it is. It seems that heart failure patients who lower their salt intake too much can be risking death in a big way, as Creighton University researchers found.

Those who had a target of less than 2.5 grams of salt a day were 80% more likely to die during the study than those whose target was 2.5 grams a day or higher.

They did a meta-analysis of nine randomized, controlled trials from 2008–2022 totalling about 3,500 people with heart failure, in case you were wondering.

The Buddha was right: All things in moderation.

Short Takes

Elsewhere: Rocky Mountains edition

Colorado put a cap on insulin four years ago, and now it’s looking to make sure epinephrine is also affordable. “A proposed state law would cap out-of-pocket copays at $60 for a two-pack of epinephrine autoinjectors.”

Sour sweetener

Check your protein bars, lo-cal baking mixes, and anything sweet and sugar-free. If it’s got erythritol as an ingredient, you might want to think twice. According to the good folks at the Cleveland Clinic, too much in your blood leads to “an increased chance of cardiovascular events, like heart attack or stroke.”

All right, maybe worry a little

Granted, the Atlantic is the World’s Most Depressing Magazine™, but it does have a point. With bird flu spreading to mammals, it could be only a matter of time before it picks up a mutation that makes humans susceptible. In other words, “We Have a Mink Problem.”

DEA wants to slash tele-health prescriptions

The DEA wants to go back to pre-pandemic rules that severely limited telehealth visits where controlleds were prescribed.

After three years of getting comfy with telehealth, the change, if approved, would require more in-person visits in order for physicians to prescribe C-II drugs like Adderall or OxyContin. Some drugs would only require an initial in-person visit, while others would require one every 30 days.

That could mean people who may seeking treatment from a doctor who is hundreds of miles away need to start developing plans for in-person visits with their doctors now. […] Patients will have six months to visit their doctor in person when the regulation is enacted.

After three years, though, telehealth has boomed, and it gets high marks from both patients and prescribers. Throwing a regulatory wrench back into the works is likely to get some serious pushback.

Convention registration is open!

That’s right! Today’s the day — register now to grab that early-bird rate for the 2023 Georgia Pharmacy Convention, June 14–18 at the Omni Amelia Island Resort!

Visit gphaconvention.com for all the details (the site is being updated as you read this, in fact) — and we’ll see you on the beach!

Who’s blocking the generics?

Once upon a time, generic drugs were quick to grab 80% of the market — within a few months, in fact. But today, according to a report from the Association for Accessible Medicine, “many generics are experiencing slower than expected adoption.” Even the top 10 generics only had a 70% market share.

That means patients end up with higher co-pays when a less-expensive alternative is right there in front of them. So, who is stalling the move to generics?

The answer starts with “P” and ends with “armacy benefits managers.” As the AAM put it, “These delays are driven by the perverse incentives of PBMs to prefer high-priced drugs with high rebates over drugs with lower list price.”

It’s not just patients; it’s taxpayers, too. Fewer than two-thirds of Medicare Advantage and Part D plans cover the new generics that debuted in 2016. (Commercial plans did a bit better, covering almost half of those new-in-2016 generics.)

And PBMs go to great lengths to keep generics down. CVS, the report explains, used a “do not substitute” strategy “that allegedly prevented consumers from obtaining low-cost generics if the company profited through rebate agreements from the brand drug.”

To compound matters, the company allegedly trained call center representatives to mislead patients on pricing for the generic options and to discourage beneficiaries from filing formulary exceptions. And the company executed the scheme by refusing to stock the generic versions in its pharmacy, even for patients willing to pay cash.

More ivermectin follies

The same doctors who pushed ivermectin as a Covid cure (hint: it’s not) are now saying the horse dewormer can — miracle of miracles! — treat flu and RSV, too*. Apparently there’s a huge worldwide conspiracy to keep this fact from the masses.

Or maybe there’s simply no evidence at all, and the docs doing this are making bank charging gullible people hundreds of bucks to write them prescriptions.

^* It’s also a floor wax and tasty dessert topping.

New tests for cancers could be coming

From Penn State: Researchers have developed a blood-plasma test that can detect and track glioblastoma tumors by measuring levels of an antigen receptor called IL13Rα2. They found that IL13Rα2 can serve as a biomarker for glioblastoma because it’s “significantly overexpressed in tumor tissue.”

The test is meant to give physicians more information about the progress of a tumor than can be had with an MRI or CT scan, or even from a needle-sized biopsy.

From Australia’s University of Technology Sydney: Instead of a biopsy, Aussie biomed engineers have developed a “static droplet microfluidic device” that can “rapidly detect circulating tumour cells that have broken away from a primary tumour and entered the bloodstream.”

It’s based on the idea that tumor cells produce more lactate than healthy ones, but this device is crazy sensitive — “38,400 chambers capable of isolating and classifying the number of metabolically active tumour cells” in a single, small device.

The Long Read: Breakthrough Drugs, Break-bank Pricing edition

When a breakthrough cure enters the market — a cure, not just a treatment — it can cost … well, a lot. Insurance companies will often (reluctantly) pay for high-priced treatments, but that’s becoming an issue with cures.

Cures cost more, but over 10 or 15 years they’re cost-efficient for insurers … but only if the patient stays with the same payor. (Otherwise the cost savings goes to the new insurer, which doesn’t have to pay for treatment.)

Read more from Leaps.org.

Everything you need to know about the Covid-19 lab-leak vs natural-origin theories

1. Don’t listen to non-scientists. They tend to conveniently leave out important details.
2. No one thinks the SARS-CoV-2 virus was developed in a lab or as a weapon. The options are accidental lab leak or jumped naturally to humans.
3. Fifteen (!) government agencies have weighed in on what they sorta-kinda believe is the virus’s origin; the Energy Department is just the latest.
   • Seven (CDC, NIAID, the National Intelligence Council, and four unnamed intelligence organizations) lean toward the virus originating naturally, probably jumping to humans from bats.
   • Four (FBI, DoE, and two unnamed intelligence organizations) lean toward the virus leaking from a lab that was studying a natural virus. The FBI is the only one to say it has “moderate confidence” in that assessment; the other have “low confidence.”
   • Four (CIA, and three unnamed intelligence organizations*) are undecided and think both theories are possible.
4. Two peer-reviewed studies say the virus emerged in the Huanan Market, not a lab.
5. The WHO is undecided.

Will we ever know for sure? Probably not. An unclassified intelligence briefing gets to the heart of the matter:

China’s cooperation most likely would be needed to reach a conclusive assessment of the origins of Covid-19. Beijing, however, continues to hinder the global investigation, resist sharing information and blame other countries, including the United States.

Sources: A Forbes overview of who thinks what. The Atlantic’s coverage of the debate. An unclassified intelligence briefing for the president. Also helpful: a Forbes timeline of the theories.

^* Dang, we have a lot of those.

Captain Obvious tastes the rainbow

“Personal Psychedelic Use May Be Common Among Psychedelic Therapists”

Short Takes

Pharma puts its money in digital

For the first time, pharmaceutical companies are spending more than half their ad budgets on digital advertising, relegating traditional “linear TV” to second place.

Med shortages, Peach State perspective

Georgia pharmacies — and a UGA professor — are featured in a WSB news story about the medication shortages facing patients, some of whom have to pharmacy hop to find their meds.