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.

When antidepressants cause mania

Antidepressants are often prescribed for people with bipolar disorder, but some of them may do more harm than good (the drugs, not the people) (although it’s true for the people, too, I suppose).

Certain antidepressants can increase “mitochondrial energetics,” says a research team from the Mayo Clinic, and when given to a bipolar person, “may elevate the risk of treatment-emergent mania.”

In other words, if we were still calling it “manic depression” these meds would turn that manic part up to 11.

The increased energy expenditure of mania associated with impulsivity, poor judgment, psychosis, and loss of insight can drive high-risk behaviors, often resulting in hospitalization or incarceration.

But which drugs might cause that? There’s the rub — they aren’t sorted that way. “These data suggest categorizing antidepressants based on mitochondrial energetics may be of value.”

Would you recognize the signs of mental illness or substance abuse if they weren’t incredibly obvious? Face it: probably not. But catching those signs early is critical to getting patients on the right path.

That’s why the Georgia Pharmacy Foundation is offering an important CE course: Mental Health First Aid. It’ll teach you to identify and respond to signs of mental illnesses and substance abuse sooner rather than later.

The course: 5½ hours live training, plus 2 hours self study — a total of 7.5 hours of CPE credit for pharmacists and technicians. (You’re expected to complete the home study portion first.)

The next date: Saturday, March 18, from 9:00 am – 3:30 pm on the UGA CoP campus in Savannah.

GPhF is making this training available to pharmacists, pharmacy techs, and student pharmacists for just $49.00. (It’s normally $170.00.)

Be ready to recognize and help the people who need it.

Click here for details!

A different PrEP delivery

An experimental form of HIV PrEP is being tested at the University of Pittsburgh — a combination of tenofovir alafenamide and elvitegravir that’s not a pill. If it entered the market, it would be a form of on-demand protection, rather than the daily dose of oral drugs like Truvada and Descovy. (To be fair, those are often taken on-demand as well, although that’s still off-label.)

So far the tests have been small-scale (21 people) and in the lab, but they’ve been promising. That’s not surprising, considering that oral antivirals have been shown to be 99% effective in reducing HIV risk.

The ultimate goal, say investigators, is to add yet another PrEP delivery method to the growing menu of oral and injectable options that at-risk men and women can use.

Playing with patents could mean pending penalties

Has Merck been playing games with the patent system to protect Keytruda from generic competition? The Senate, led by Senator Elizabeth “Don’t Mess With Consumers” Warren, thinks so, and it wants the U.S. Patent and Trademark Office to look into it.

In short, Merck keeps tweaking Keytruda without actually changing the basic drug. As the company put it, it’s creating “innovations around composition of matter, method of use, formulation, dosing and combinations with other agents.”

Which is fine, except when (Warren et al. say) it’s trying to use minor tweaks — e.g., a subcutaneous injection formula — to extend its patent on drug itself. In fact, they pointed out, 74% of Merck’s new patents on Keytruda cover “different indications and formulations of the drug, not the key antibody.”

“These efforts by Merck appear to be part of a long-standing pattern of drug manufacturers’ abuse of the patent system,” they wrote, adding that Merck’s use of patents is “an example of anti-competitive business practices.”

ICYMI: Moderately confusing

Big news! The Energy Department apparently has low confidence that the SARS-CoV-2 virus likely originated in a lab leak. Why yes, the words “likely” and “low confidence” make the entire conclusion confusing, but it makes for headlines. (The Wall Street Journal breathlessly reported “Lab Leak Most Likely Origin of Covid-19 Pandemic, Energy Department Now Says,” not mentioning the “low confidence” part till later.)

Other agencies had similarly low confidence the virus spread naturally, although the FBI said it had moderate confidence it came from a lab leak.

The one thing everyone seems to agree on is that, even if it was a lab leak, it was accidental. Still, it’s critical that we spend more time and money arguing over its origins. Once we’re confident we know how it happened, we can … I dunno. Write a strongly worded letter, perhaps.

Today’s non-pharma, cool science story

Swedish materials scientists have grown electrodes in living flesh (of a fish, for starters), but by using the fish’s own sugars to build the electrodes inside itself without damaging tissues.

The result, published in the journal Science, paves the way for the formation of fully integrated electronic circuits in living organisms.

What they hope: These might be used for brain therapies to treat conditions like Parkinson’s or even to advance prosthetics.

What the reality will be:

Short Takes

Double-duty OTC test

The FDA has authorized Lucira Health’s combo flu and Covid test. It takes about 30 minutes, uses a shallow nasal swap (thank you!) and is about 90% accurate for both. Note: It’s been describe as a “major milestone,” but not a game-changer.

One booster will do the trick

One booster a year will (probably) be enough, even for the immunocompromised, according to the CDC’s Advisory Committee For Immunization Practices. The current CDC recommendation is that at-risk folks get more frequent boosters, so this would be a change … although the ACIP did say some flexibility is important, especially as we see what new variants might be in store.

Whew! Nothing can go wrong now.

The viruses that killed one person and sickened another in Cambodia are from an endemic clade of bird flu — i.e., it’s not some new variant that will soon sweep the globe and lead to a new crop of post-apocalyptic video games. It’s one that’s been “among birds and poultry for many years and has sporadically caused infections in people.”

The best drugs for back pain

Did you ever look out your window, daydreaming about what’s the best treatment for acute lower-back pain? Of course you have. Now there’s an answer: If it’s not caused by something specific (e.g., cancer, kidney stones, YouTube comments) the best pharmaceutical treatment seems to be a combination of NSAIDs, acetaminophen, and myorelaxants.

So say a group of German and Italian researchers in a systemic review of lots of literature, looking for the best non-opioid solutions.

What they found: NSAIDs alone work great, and myorelaxants alone work to some extent, but acetaminophen doesn’t do much unless it’s combined with NSAIDs.

And there you have it. Back to daydreaming.

Looking for superbug stories

Have you had any run-ins with superbugs outside of Kafka novellas? If you’ve dealt with antibiotic-resistant infections, the Partnership to Fight Infectious Disease (PFID) wants to hear from you. It’s collecting stories from healthcare providers for its Squash SuperBugs Day in March, and so far doesn’t have anything from pharmacists.

If you or someone you know is willing to share your story of dealing with — professionally or personally — drug-resistance, please share! Just click here for the handy-dandy (and short) form. (If they use it, you’ll be able to approve it before it appears on the site.)

Our insulin mistake

Could we be wrong about insulin’s chemistry? Those shifty Danes think so. They’ve discovered that “we’ve gotten things wrong by 200 percent” when it comes to the distribution of molecules in an insulin shot.

Insulin divides itself into either single molecules (which work quickly) or clumps of six (which are long-acting). That’s why a dose does double duty, and the ratio is taken into account by manufacturers.

Oopsie, said the Danes. “There are only half as many single molecules in insulin compared to what we thought. Conversely, there are far more six-molecule clusters than we assumed.” That means it might not be working the way we expect. That isn’t necessarily dangerous, but it does mean we can do better.

“[O]ur results may mean that when we believe to be administering a certain dose, it may mean that insulin behaves in a different way than expected and that even better insulin therapeutics can be developed.”

States aim to detox makeup

Cosmetics fall into a loophole of regulation — they aren’t covered by either the FDA or the EPA, so manufacturers are free to put all sorts of unhealthy stuff into them. With the feds not being willing to regulate them, states are stepping in.

Washington, for example, “…found lead, arsenic, and formaldehyde in makeup, lotion, and hair-straightening products made by CoverGirl and other brands.” The state legislature is considering a bill that would ban toxic ingredients in cosmetics.

Of course, once enough states start banning those ingredients (they’re already banned in Europe), the cosmetic companies will likely remove the chemicals across the country … and make a big deal about how safe they’re making their products.

A pharma social media guide

Ogilvy Health has rated 10 pharma companies’ social media efforts using its own six-category scale. Whoopdie-do, you say.

Fair enough. But what’s worth noting is how Ogilvy rated each of those six areas. The report is effectively a primer in making social media work for you, including branding, response time, mobile design, and more. Check out the full report here — it’s 10 pages of content squeezed into a 36-page PDF.

Unfriendly skies?

Should you be worried about bird flu (other than because you have chickens)? Maybe? Some recent headlines:

1. “Cambodia tests more people for bird flu after death of 11-year-old girl”
2. “Analysis: Why public health officials are not panicked about bird flu”
3. “Experts say bird flu threat small despite Cambodian fatality”
4. “Bird flu situation ‘worrying’; WHO working with Cambodia”
5. “Flu experts gather with H5N1 risk on the agenda”

Choosing the most expensive drugs

CMS is beginning the process of choosing Medicare’s 10 most expensive drugs — the medications it now has the power to negotiate the prices of*.

It’s not entirely simple; the agency first has to decide whether it will use gross or net spending (the latter considers discounts). Then it will look at total spending over a year and determine the top 10.

CMS said in January it would announce the list of 10 drugs in September. The agency will make its initial offers in February 2024 and the negotiation period will end that Aug. 1.

Capitalism at work: The buyer and seller will come to an agreement on pricing, which will take effect on January 1, 2026, saving taxpayers billions.

^* “… the prices of which it now has the power to negotiate” if you’re a Latin speaker

So many bad-pun headlines to choose from

Who would have thought that taking laxatives regularly could raise your risk of dementia? Yet here we are. In fact, found researchers in China and Boston, using them “most days of the week” increased dementia risk by 50 percent.

And those who used multiple types of laxative had an even greater risk — 90% higher than non-users.

The big disclaimer: “The study does not prove that laxatives cause dementia. It only shows an association.”

So what can you do?

Afraid of the Ex-Lax now? No worries — gastroenterologists at the Medical College of Georgia have the solution.

CMS rejects paying for Aduhelm or Leqembi — again

CMS said no, it’s not changing its stance on Alzheimer’s drugs. Medicare will only pay for drugs that have been approved through the FDA’s standard process, not the accelerated process. Specifically, it’s not going to pay for Aduhelm or Leqembi.

The Alzheimer’s Association immediately made it political, of course, but the reason behind the decision is simple: Neither drug has shown it makes a huge difference in the real world, which CMS said it requires to determine that a medication is “reasonable and necessary.”

Per the agency:

CMS will expeditiously review any new evidence that becomes available that could lead to a reconsideration and change in the [national coverage determination].

When remdesivir works

In the beginning, remdesivir was the go-to treatment for Covid-19, but it didn’t always work, and now we’ve got better stuff. (“Stuff” being nirmatrelvir/ritonavir, aka Paxlovid.)

But we never figured out why it only worked part of the time.

Enter the Swiss. University of Basel researchers wanted to know when remdesivir worked and when it didn’t. What they found was that “a specific group of patients benefits the most from the drug.”

What group? People who got, at most, conventional oxygen therapy. If they needed intensive ventilation support, it didn’t seem to help because the infection was too serious.

Will this make a difference? Probably not, with Paxlovid the go-to these days, but it does mean that remdesivir is worthwhile in milder cases.

FDA on the attack (kinda)

The FDA warned vape makers not to sell illegal products because, you know, they’re illegal. Most of the time the industry just ignores the law, but now the agency is showing how tough it is … by fining four smaller companies (of the 120 it warned more than a year ago) for ignoring the rules.

Non-pharma interesting medical story of the week

It kinda makes sense when you think about it: Wearable fitness devices like smartwatches that use electrical impedance (i.e., tiny electrical currents) to measure things like heart rate can interfere with pacemakers and other implanted cardiac devices.

“Bioimpedance sensing generated an electrical interference that exceeded Food and Drug Administration-accepted guidelines and interfered with proper CIED [cardiac implantable electronic devices] functioning.”

We’ll say it again: You really don’t want Covid

The bad news: 59% of Covid patients experience organ damage in their heart, kidneys, liver, lungs, pancreas, and spleen, and it continues up to a year after infection according to a new British study.

The good news: It’s typically mild. The organ damage, that is. But…

While 59% of them experienced impairment in a single organ, 29% were found to have multi-organ impairment one year after a Covid infection.

The other good news — sort of — is that between six months to a year later, the number of patients suffering from various Covid-related ailments dropped a bit. (A bit. We’re talking 10 to 12 percent.) So … yay?

Vegetarian Enfamil recall

ICYMI, Reckitt has recalled two batches of its Enfamil ProSobee Simply Plant-Based Infant Formula “because of possible cross-contamination with Cronobacter sakazakii bacteria.”

These are 12.9 oz. containers of powder.

Per the Georgia DPH:

Recalled product batches are ZL2HZF and ZL2HZZ, both with a UPC code of 300871214415 and a “Use by Date” of “1 Mar 2024.”

Skin pill’s surprising other use

So you know the psoriasis drug apremilast (aka Otezla)? Turns out it can also treat — wait for it — alcohol use disorder.

Yep. People taking it “reduced their alcohol intake by more than half — from five drinks per day to two,” according to Oregon Health & Science University neuroscientists.

They found the connection by looking for compounds that might “counteract the expression of genes known to be linked to heavy alcohol use.” Apremilast, oddly enough, was one of those compounds. They tested it in mice, then in humans.

They found that apremilast triggered an increase in activity in the nucleus accumbens, the region of the brain involved in controlling alcohol intake.

Of course, you know the drill by now: More research is needed, including seeing its effect on people who want help vs. those who don’t.

Statins, diabetes, and hip fractures

Diabetics are more likely to suffer hip fractures thanks to osteoporosis, but Taiwanese researchers found a surprising preventative: statins.

They looked at the health records of more than 188,000 people with type 2 diabetes and divided them into a statin group and a non-users group. They found …

… 1.48% of the statin group and 3.17% of the nonusers sustained a hip fracture. Adults who used statins had a lower risk for hip fractures than nonusers. Men were less likely to sustain a fracture than women.

So there weren’t a lot of hip fractures, but statin users were still half as likely to suffer one. (And get this: They also found that the higher the dose, the lower the risk of hip fracture.)

Another HIV patient cured

A fifth person has been cured of HIV. A 52-year-old German man — “the Dusseldorf patient” — was treated with stem cells a decade ago and hasn’t taken HIV meds for four years. The virus is gone from his body, and now the people treating him have declared him cured.

“It’s really cure, and not just, you know, long term remission.”

Howzit work, you ask? In brief, the stem-cell donors had a particular mutation that happens to delete the CCR5 protein, which HIV needs to enter cells, making them effectively HIV-proof.

Short Takes

Our short influencer nightmare is over

Lilly’s diabetes weight-loss drug Mounjaro is back in stock.

Vape to quit

It’s official, at least for the next 20 minutes: “[T]here is enough evidence to support e-cigarettes’ use as a first-line aid for smoking cessation in adults.”

Merck slinks back into its corner

Did you know Merck was a player in the Covid-treatment game? It isn’t, really, but not for lack of trying. The company’s latest setback: Its version of molnupiravir, called Lagevrio, “was not effective at cutting the risk of coronavirus infections in people living with someone infected with the virus.”

If I’ve told you once, I’ve told you a thousand times

Francisco Franco is still dead, and ivermectin still doesn’t help treat Covid — even at higher doses and with longer duration. But you keep testing it, Duke researchers. (In fact, there are at least 10 ivermectin studies in the pipeline around the world!)