GLP-1 cage match winner

“Mounjaro is more effective than Ozempic for weight loss” —in other words, tirzepatide is better than semaglutide.

Patients taking Eli Lilly’s Mounjaro were significantly more likely to lose 5%, 10% and 15% of their body weight overall and saw larger reductions in body weight after three months, six months and a year compared with those on Novo Nordisk’s Ozempic.

What makes this story different is that it’s based on a large, real-world study, and that it found a significant difference between the two; previous (small) studies found just a slight difference.

Gov’t declares shortages to be a national security issue, invokes Cold War law

We’ve said before that the federal government can’t force companies to make drugs, but it can encourage them with taxpayer dollars — as it’s taxpayers who are dealing with drug shortages.

Invoking a 1950s law — the Defense Production Act — the Biden administration is essentially declaring those shortages to be a national security issue.

Doing so means the government will be able to invest money “in domestic manufacturing of essential medicines, medical countermeasures, and critical inputs that have been deemed by the president as essential to the national defense.” It’s not waiting, either; HHS has already identified $35 million worth of investments “in domestic production of key starting materials for sterile injectable medicines.”

Other plans announced:

• A new HHS supply chain resilience and shortage coordinator “to strengthen the resilience of medical product and critical food supply chains, and to address related shortages.”
• The Defense Department will also be looking at ways of “reducing reliance on high-risk foreign suppliers.”
• Better monitoring of all aspects of the supply chain, including “supply chain risk assessment tools” out of the Commerce Department that will hopefully “address foreign dependency vulnerabilities and points of failure.”
• A public-private partnership headed by the Department of Transportation to monitor logistics so companies can “avoid bottlenecks, shorten lead times for customers, and enable a more resilient and globally competitive freight network.”

In short, the government will be able to pay to increase production, and to use its gigantic resources to provide information to help reduce disruptions. But there’s only so much it can do in a market-driven economy — at the moment, American companies can simply reap more profits by having foreign manufacturers make their drugs on the cheap.

Trigger warning: The link goes to the White House website, which is a bit … let’s call it rah-rah. It has more detail than a lot of the news stories, though.

A recall you can snicker about

Miami-based Noah Wholesale has recalled its sexual enhancement pill, “The Rock,” because 1) it turns out not to be FDA-approved and 2) it may or may not work. It contains good ol’ sildenafil, but that’s not listed on the package.

Each red 1200 mg capsule was sold solo in a blister pack with red and black lettering on a white piece of cardboard. The recalled lot is No. 03032021, expiration 12/2007 with UPC No. 6 61799 95052 7.

And in the final bad pun, it was distributed by a company called Steele Products.

Long-term use issues

Of ADHD meds

Taking methylphenidate or lisdexamfetamine for three years or more raises a patient’s risk of cardiovascular issues. That’s according to a meta-analysis by Swedish researchers, who found that “each 1-year increase in use of ADHD drugs was tied to a 4% increased risk of CVD,” and this applied to both children and adults.

In particular, hypertension and arterial disease were the big issues. The good news was that they didn’t find a connection to arrhythmias, cerebrovascular disease, heart failure, ischemic heart disease, or thromboembolic disease. So there’s that.

Marketing opportunity: Recommend sphygmomanometers to your patients taking ADHD meds.

Of aspirin

Taking low-dose aspirin used to be a gimme for older people to cut the risk of heart issues. Then it got dialed back because of GI problems. Now there’s a new twist: cancer.

Based on 20 years’ of data, a group of those shifty Danes found that continuous use of low-dose aspirin was associated with…

• Increased risk of lung, bladder, brain, and renal pelvis or ureter cancers

BUT

• Decreased risk of melanoma, as well as non-Hodgkin lymphoma and cancers of the small intestine and liver

And then, to add yet another twist, “The researchers also looked at high-dose aspirin (500 mg) use and found that consistent use was associated with a lower risk of cancer overall.”

The takeaway? “It’s complicated.”

Are you coming to Asheville?

The early-bird deadline for the 2024 Southeastern Pharmacy Leadership Weekend is fast approaching — you only have until this Friday, December 1 if you want the discounted rate for the conference and the hotel.

The former “Women of Pharmacy Leadership Weekend” is now open to everyone — it’s January 12-14 at the Omni Grove Park Inn in Asheville, North Carolina.

Great speakers, tons of CE, and “plenty of time for spa appointments.”

GPhA members get a $100 discount: The early-bird rate till December 1 is just $379 for the weekend; after that it jumps to $479. Use discount code GAMEMBER24.

Full registration includes participation in all events, event materials, Friday night networking reception, and dinner and two breakfasts. It does not include the hotel, which is $259 per night, which includes the resort fee.

Click here for all the details.

Bird flu comes to Georgia

The bird flu (H5N1) has hit a Georgia duck-breeder in Sumter, affecting 30,000 birds. This is the first time avian influenza has hit Georgia.

Used coffee grounds can help treat neurodegenerative diseases

That’s not exactly true, but it makes for a good headline.

What University of Texas chemists found was that chemicals called “caffeic-acid based carbon quantum dots” (CACQDs) can protect brain cells from damage by Alzheimer’s, Parkinson’s, and other neurodegenerative diseases. That’s because caffeic acid has an important property: It can penetrate the blood-brain barrier. Once there, it goes to work.

The CACQDs, the team observed, were able to remove free radicals or prevent them from causing damage and inhibited the aggregation of amyloid protein fragments without causing any significant side effects.

And then there’s the headline. The CACQDs can be easily cooked from used coffee grounds, which are obviously pretty common. So the process is simple, cheap, and green.

The downside: This was only done in the lab, so a lot of further testing is needed.

Meanwhile, in caffeine news…

People who consume caffeine regularly might be giving up brain plasticity in the bargain. Specifically, researchers found, because caffeine is an adenosine receptor antagonist, it can interfere with neurons’ long-term potentiation. That’s kind of important, because long-term potentiation means ‘forming long-lasting connections’ — something you need for learning and memory.

(Note: This is yet another story that confuses coffee and caffeine. The story is about caffeine, although the article’s headline speaks of coffee.)

The bad amino acid

You’re used to hearing about how amino acids can do a body good, but there’s at least one case where cutting down on one helps mice live longer and happier.

The acid is isoleucine, and University of Wisconsin researchers found that cutting it out of mice’s diets helped them live longer and better, even when they ate more.

Mice on the low-isoleucine diet lived longer — on average 33% longer for males and 7% longer for females. And, based on 26 measures of health, including assessments ranging from muscle strength and endurance to tail use and even hair loss, the low-isoleucine mice were in much better shape during their extended lives.

Good luck cutting isoleucine from your diet, though. First of all, you need some of it to live. Secondly, it’s in a lot of foods — you can’t switch to a diet of isoleucine-free mouse chow. But learning the effect of this one amino acid “gets us closer to understanding the biological processes and maybe potential interventions for humans, like an isoleucine-blocking drug.”

Cancer hates lidocaine

Lidocaine, besides numbing skin, activates a person’s bitter-taste receptors. So what? I hear you ask. It turns out that the receptor, called T2R14, is pretty popular with cancer cells, especially oral and throat cancers.

The fun part: When lidocaine hits those cancer cells, it kills them. That’s what UPenn researchers found, and it surprised them: “Lidocaine targets the one receptor that happened to be most highly expressed across cancers.”

“While we’re not suggesting the lidocaine could cure cancer, we’re galvanized by the possibility that it could get an edge on head and neck cancer treatment and move the dial forward.

Simpler, cheaper chemo ingredients

Making cancer drugs is expensive — we’re talking more than the price of gold for just one component. (That’s partly because the manufacturing process requires platinum and gold.)

But now UCLA chemists have made a breakthrough that uses oxygen and copper instead of that platinum or gold to create amines, a building block of a lot of pharmaceuticals. Their process, called aminodealkenylation^*, not only uses cheaper materials, it takes fewer steps — three instead of more than a dozen.

And the final bit of good news is that the technique works for more than just cancer drugs:

“We have used this unconventional transformation for late-stage modification of hormones, pharmaceutical reagents, peptides, and nucleosides.”

That means once it’s out of the lab it could knock down a lot of drug prices.

^* Coincidentally, that’s also the name of one of UCLA’s backup linebackers.

The Long(ish) Read: Stopping Ozempic edition

Can people stop taking GLP-1 inhibitors? Well, they do stop — many people give up after a year or two for various reasons (side effects, insurance coverage). The question is whether people can stop taking them and keep off the weight, and how to help them do that.

Still nothing to see here

While there is absolutely nothing to worry about with the new respiratory illness spreading in China, the Chinese ministry of health has “urged local authorities to increase the number of fever clinics.”

“Efforts should be made to increase the number of relevant clinics and treatment areas, appropriately extend service hours and strengthen guarantees of drug supplies.”

(For its part, the WHO says that this spike in illnesses ‘isn’t as high as it was before the pandemic.’ This makes no sense at all — at some point there were only a handful of Covid cases, just like with the current outbreak.)

The cause of itching

Harvard researchers might have figured out what causes itching — at least some of it. The answer: Staphylococcus aureus, or rather an enzyme it generates (protease V8, if you’re interested). They knew that people with eczema often had more S. aureus on their skin, but didn’t know what the connection was. Now they do.

Normally conditions like eczema and atopic dermatitis are treated by treating the inflammation — the result. But this new research means they might be able to tackle the cause instead using an FDA-approved PAR1 blocker.

Of course, the researchers have already filed for a patent based on this.

Turkey vs. ulcerative colitis

If you have turkey leftovers, good for you — they might help relieve the symptoms of ulcerative colitis.

You might think of tryptophans as what people argue about every Thanksgiving. Do they make you sleepy, or is that a myth?

Who cares? The news out of Jefferson University is that — now follow along — tryptophan can make T-reg immune cells produce more of a receptor called GPR15. The more GPR15 receptors they have, the more strongly they’re attracted to the colon. And when they get to the colon, those T-reg cells reduce inflammation.

They tested this on mice and …

They saw a doubling in the amount of inflammation-suppressing T-reg cells in the colon tissue compared to mice that weren’t fed extra tryptophan [… as well as] a reduction in colitis symptoms. What’s more, the effects seemed to last for at least a week after tryptophan was removed from the diet.

The only downside is that it seems to prevent colitis flare-ups, but do little to treat them when they occur. Still, it’s a new twist on the annual tryptophan story.

Lower cholesterol, better breast cancer outcome

Statins, it seems, might help women with breast cancer stay alive. Well, it’s more accurate to say that lowering cholesterol was good for women with breast cancer.

Finnish researchers looked at the data for more than 13,000 women with breast cancer. They found that women had a lower risk of death from that cancer if, after diagnosis, they lowered their cholesterol level.

Read that carefully. It wasn’t just that lower cholesterol was good. It was that they lowered their cholesterol after they were diagnosed. I.e., they were looking at the change in levels, not the absolute levels.

Covid’s holiday rebound

Covid cases are on the rise again, and hospitalizations jumped 8.6% in mid-November, according to CDC data.

The good news is that it’s easy to get a high percentage jump when numbers are low, which is the case. The news to watch is that cases and hospitalizations are going up.

The bad news lurking in the background is that the CDC figures are probably low; there’s no longer any kind of national tracking in place. It’s not time to buy toilet paper, or probably even to mask up … but it might be time to think about avoiding crowded indoor spaces with strangers.

Nothing to see here

There’s a Mysterious Respiratory illness spreading in China, but don’t you worry says the WHO. It’s probably nothing to worry about.

This report brought to you by Charmin bathroom tissue. Do you have enough?

New med to keep Mr. Fluffikins chill

The FDA has just approved a new drug designed to relax your feline friend so you can safely take Mittens to the vet.

Best of all is the name: Bonqat — pronounced “bonk-cat.”

The drug is administered orally approximately 1.5 hours before the start of the transportation or veterinary visit and can be given on two consecutive days.

Good news for both Snuggles and her owner.

Our number two story

Probiotics are hit-and-miss — we know they can do good stuff in general, but teasing out which bacteria have the effect we want is a lot tougher. You can’t just load up on your favorite yogurt.

But now Chinese researchers think they’ve found one cause and effect: Strains of the gut bacteria Bifidobacteria longum can “kickstart gut motility.” That is, B. longum can relieve constipation.

The catch is that it has to be a strain that contains the abfA gene cluster, which helps gut bacteria process some plant-based nutrients. So now they know not only which bacteria can help, but also why — and that can lead to finding other probiotics that do the same thing.

You know the headline writer was giggling

“Nuts may enhance fertility for men: study” The gist is — per Aussie researchers — that eating about two handfuls^* of nuts per day improved the quality, although not quantity, of sperm.

That’s based on a review of four published studied that looked at walnuts, hazelnuts, and almonds, raw and roasted, although they think any nut combo would have the same effects.

Hypothesis: “[T]he high concentration of omega-3 polyunsaturated fats, dietary fibres, vitamins, minerals and polyphenols found in nuts could improve reproductive health.”

Bonus: No, it was not funded by Big Nut. This was legit.

^* (snicker)

Things that make you go “Hmmm”

What is a drug?

↑ That’s the question an Australian medical philosopher asks. And he couldn’t find a good answer, only lists of what’s officially considered a drug.

Despite their centrality to medicine, we have no idea what medical drugs are. We can’t even tell the difference between drugs and food, let alone drugs and so-called “natural” alternatives.

That makes it hard to write regulation or even decide what can be prescribed. It’s not about chemistry, or origin, or function, or outcome. In fact, he says, “there is nothing, chemically speaking, all drugs have in common.”

Why not 12 months?

How can you reduce pharmacist workload and maybe even increase adherence? Why not stop making patients pick up their meds every month? So argues one drug supply chain expert.

[I]nstead of dispensing 30- or 90-day prescriptions, convert patients to receive six or twelve months of medication in a single prescription pick-up. I’m not talking about new prescriptions a patient is trying for the first time, where titration is still occurring, or controlled substances. I’m talking about the long-term chronic medications on which a patient is stable on therapy.

Teamwork makes the dream work (if the dream is lower blood pressure)

Researchers at Tulane University have found a new way to tackle high blood pressure, especially in low-income folks: Have a small team spend a little more time with them.

They ran a trial^* of a new hands-on approach, where nurses, pharmacists, and medical assistants got down to business, coaching patients on lifestyle changes and sticking to their meds. Plus, patients learned to check their blood pressure at home.

The results? Those in this more involved group saw their systolic blood pressure drop by a solid 16 mmHg, compared to a 9 mmHg drop in the usual-care group. That ‘involved’ group was also better at taking care of themselves at home over the long term.

^* 18 months long, with more than 1,200 low-income patients in Louisiana and Mississippi 

Legal, schmegal — what’s the fam doing?

The latest twist to the effects of marijuana legalization comes out of the University of Massachusetts. Researchers’ finding: High school students are more likely to try pot if their family or friends use it, but — and this is the news part — legalization had no effect on that.

When comparing data from 2016, before legalization [in Massachusetts], and 2018, after legalization but before retail cannabis stores had opened, the researchers found no statistically significant differences in the prevalence of past 30-day marijuana use.

FDA’s big new rules for pharma TV ads

The FDA has released new rules for prescription-drug ads that run on television and other video streaming media — collectively called “TV format^*.”

The gist is that companies can no longer play fast and loose with the side effects they list.

Like six-year-olds saying “I’m not touching!” in the back seat, pharma has gotten around the rules about listing side effects by using tricks like rattling them off at 20x normal speed while music plays in the background.

The FDA has had enough. Now those side effects have to be understandable. And just like six-year-olds who need the nuance explained, the agency took 87 pages to do just that.

There are five new standards that “help ensure that the major statement is presented in a clear, conspicuous, and neutral manner.”

1. No jargon: [T]he information must be presented in consumer-friendly language and terminology that is readily understandable.
2. No mumbling or speed talking: The audio information in the major statement must be at least as understandable as the audio information presented in the rest of the ad.
3. Put it in writing: The information presented in the audio portion of the major statement must also be presented concurrently in text for a sufficient duration to allow it to be read easily.
4. No tiny text: The information in text must be formatted such that the information can be read easily.
5. No distractions: The ad must not include audio or visual elements during the presentation of the major statement that are likely to interfere with comprehension of the major statement.

^* “TV format,” because you know companies would try to skirt the rules if the FDA got too specific — although advertisers on TikTok will probably claim that vertical ads aren’t “TV format.”

How dare you call yourself “Doctor”

Physicians are getting their stethoscopes in a wad because nurse practitioners can earn doctorates and thus be entitled to be called “Dr.” Oh no no no, say the physicians, only medical doctors should be able to use the term “Doctor” in the healthcare world.

Florida, in fact, was considering barring non-physicians from using “Doctor” in clinical practice. Similar “not-a-doctor” bills are under consideration in California, Connecticut, Florida, Massachusetts, North Carolina, Texas, and Wisconsin.

Nurse practitioners and physician assistants^* argue they deserve to be able to practice to the fullest extent allowed by their education and credentials, and that — like anyone who’s earned a doctorate — they should be able to use the title conferred on them.

“It has nothing to do with ego or wanting to be something I’m not,” [one doctor of nursing practice] said. “If I worked hard and earned a doctorate, I can use the title of ‘Dr.’”

If only there was some other designation an MD could use to indicate that he or she was an MD. Perhaps MDs could use some other letters to indicate that they’re MDs. Surely MDs can come up with something to differentiate themselves from people who aren’t MDs. Maybe they can ask the DDSs.

^* Yes, we’re aware the article left off a rather significant group of doctorate holders.

Flu ‘soars’ in Georgia

Georgia is one of seven states where the latest CDC data shows flu cases are at the highest. (The others are Alabama, Florida, Louisiana, Mississippi, New Mexico, and South Carolina as well as Puerto Rico.)

The flu season is a little early this year — typically it starts big-time in December, but last year October was kickoff, so November isn’t too unusual.

The good news is that “the version that’s been spreading the most so far this year usually leads to a lesser amount of hospitalizations and deaths in the elderly.”

Another benefit of the flu vax

It can reduce your risk of heart attack. Mm hmm. That’s what an analysis of five studies and more than 9,000 patients by Iranian researchers found; it was published in Nature’s Scientific Reports.

Participants who received the flu vaccine saw a notable reduction in the occurrence of major cardiovascular events, with 517 cases compared to 621 cases in the placebo group.

There was a decreased risk of heart attacks in vaccinated patients and a significant reduction in cardiovascular death events.

Why? Their hypothesis is that vaccination might reduce inflammation, or possibly “ensuring the stability of atherosclerotic plaque, which can become destabilized during the flu.”

Health-system pharmacists, take note

The FDA is reminding/warning you not to use Cardinal’s new (since June) Monoject syringes with patient-controlled pumps. Cardinal recalled those “due to incompatibility concerns with syringe pumps.”

The older version — called Covidien — are still okay to use. The problem is with the new Monoject syringes.

Red wine headaches explained

As Thanksgiving approaches, we see the usual lineup of food-related news stories. Here’s a different one, though: an answer to the question, “Why do some people get headaches from red wine?”

The answer (per UC Davis researchers) is that red wine contains quercetin, a flavanol in grapes that’s even available as a supplement. But when quercetin mixes with alcohol it becomes quercetin glucuronide, which happens to block alcohol metabolism.

As a result, people can end up accumulating the toxin acetaldehyde […] a well-known toxin, irritant and inflammatory substance.”

And there you have it.

Migraine meds: Cheaper is better

When it comes to migraines, the first-line meds aren’t the best ones — at least according to a new study out of Norway that looked at a decade’s worth of health data of more than 100,000 people.

The top line: amitriptyline, CGRP inhibitors, and simvastatin work better than beta blockers to prevent migraines. But the bottom line is also worth noting: amitriptyline and simvastatin are darned cheap compared to beta blockers or CGRP inhibitors.

With that simvastatin finding, their next step will be “to measure the effect of established cholesterol-lowering medicines as a preventive measure against chronic and episodic migraine.”

More free Covid tests

The federal government is once again offering free Covid-19 tests — four per household, beginning yesterday (November 20). This is in addition to the free tests it offered in September.

Just head over to Covid.gov/tests and order ’em.

Don’t forget to nominate someone

Do you know a great student pharmacist? An amazing technician? Or a pharmacist who goes above above and beyond?

It’s time to tell us about it — to nominate someone for one, two, or more 2024 GPhA awards. They’ll be presented at the 2024 Georgia Pharmacy Convention on Amelia Island, but first we need to know who deserves them.

Head over to GPhA.org/awards to see the list of awards, the criteria, and how to nominate someone. The deadline for nominations is January 19, 2024, so don’t wait too long!

Food allergies: when silent is deadly

Researchers at the University of Virginia Health System have stumbled upon a curious link: Common food allergy antibodies, known as IgEs, might increase the risk of heart problems.

Important twist: Even people with a low-level immune response to foods like peanuts or cow’s milk — not even an allergy — could be affected.

The researchers analyzed data from around 5,400 individuals and found that those with IgE antibodies to any food had a higher chance of cardiovascular death. (Milk allergies had the strongest connection, but peanut and shrimp allergies were pretty high.)

And people without obvious food allergy symptoms? They were most at risk.

Hypothesis: These antibodies might activate mast cells, which are not only involved in allergic reactions but are also found in heart tissue. As usual, of course, more research is needed.

Drug makers try to shift blame

Makers of ADHD drugs are trying to blame the federal government for their shortages, claiming government production limits are at least partially to blame.

This isn’t true. As we covered earlier this month, drug makers are actually not reaching those production limits, and the feds have resorted to pressuring them to do so and make more meds.

Nice try, though.

Faster drugs, more addiction

When drugs are taken intravenously, they work faster. (You are permitted to say “Duh” at this point.)

Interestingly, people are also more likely to become addicted to a drug if they take it intravenously (or by smoking) rather than by mouth (or nose). [T]he faster a drug enters the brain, the more addictive it is.”

Why this is true wasn’t clear — until NIH researchers looked into it. First of all, they found, there’s the quicker dopamine hit. But it’s more complex than that. Get this: Taking the same drug intravenously will have different effects than taking it orally.

Apparently taking a drug intravenously activates a part of the brain called the salience network, while taking the same drug orally does not. The salience network lets the brain monitor sensations like the effect of drugs, so it’s as if the brain is telling itself, “This is good stuff.” It’s so powerful that people who sustain damage to the salience network “can have a complete remission of their addiction.”

This means, the scientists says, that targeting parts of the salience network might be a way to treat addiction.

Elsewhere: Weight-loss coverage?

Medicaid directors in five states — Illinois, Massachusetts, New Mexico, Utah, and Vermont — have said they’re considering adding GLP-1 inhibitors for weight loss to their state’s coverage. The idea is that helping people lose weight will pay off in the broad health benefits it provides, saving money in the long run.

Feds release more RSV vaccines

Apparently there was a secret stockpile of RSV vaccinations, and the CDC has just released more than 77,000 doses to ease the shortage. It seems demand for infant RSV vaccines was higher than expected and people are having trouble getting the shots.

The agencies are also working with manufacturers (to get more doses out there) and with Ob/Gyns (to encourage more women to get the maternal vaccine to protect the kids before they’re even born).

Congress tackles PBMs (again)

Two bills targeting PBMs have passed the House health subcommittee of Energy and Commerce, and both have bipartisan support.

The first, introduced by Georgia’s own Buddy Carter, would fight retroactive DIR fees by having CMS create standards for those fees. I.e., PBMs wouldn’t be able to demand clawbacks later because they dreamed about a talking chicken (or whatever method they currently use).

The second…

… would delink PBM compensation from cost of medications, ban spread pricing and require PBMs to reimburse network pharmacies the same as affiliated pharmacies.

As similar bills are in the Senate, also with wide support, this might actually happen.

A hormone path to liver treatment

Hormone treatment may be about more than just menopause, mood, and fertility. How about adding liver fibrosis to the list?

Those shifty Danes have figured out that a certain type of liver cell, called a stellate cell, is activated in cases of fibrosis, i.e., scar tissue caused by various diseases. Then they found that those stellate cells can be deactivated by vasoactive intestinal polypeptide (VIP) — an intestinal hormone.

So … like making Kardashians famous, you might create a synthetic VIP. This one would actually be useful, though, keeping those stellate cells at bay and treating the fibrosis without serious side effects. But that, they say, is still years away.

Ecstasy may be coming

Two studies have found that MDMA, when combined with human therapy, can ease the symptoms of PTSD. That in mind, the FDA might approve it for treatment next year.

Interesting notes: 1) If that happens, that would be the first new PTSD medication in more than two decades. B) MDMA has been shown (again, along with therapy) to help with treatment-resistant depression as well, so once the door is open, who knows? iii) Despite all the science showing otherwise, the DEA still considers MDMA to have no medical use. Go figure.

Vitamin D mystery mystery solved

Whether vitamin D supplements can help prevent heart attacks is still unclear. Now, though, researchers from Intermountain Health in Utah say there might be a reason for this uncertainly: Study patients aren’t getting enough to overcome their deficiencies.

Specifically, while the USRDA is 600 to 800 IU of vitamin D as a supplement, “In some cases, patients needed more than 10,000 IU” to reach a level of 40 ng/mL.

“Our findings here show that just giving patients some Vitamin D does not help them achieve optimal levels. If researchers are going to further look at Vitamin D dosing as a possible way to improve heart health, patients need to be given the right doses to reach those ideal levels.”

Cause and effect

Measles vaccination rates have been declining, and what d’ya know, measles cases are skyrocketing around the world. In many places it’s because of a shortage of the vaccine, but in the US, “I don’t wanna^*” exemptions are increasing in kindergartens.

^* “Philosophical objections.” The only large religious sect that doesn’t believe in vaccination is the Christian Science Church, and even it recommends obeying public-health authorities when it comes to vaccination. 

Shocking finding about air travel

University of Texas researchers have concluded — after carefully studying 21 years’ worth of data from more than 915 on-board incidents — that misconduct on airplanes is “predominantly caused by passenger intoxication.”

Automated statin scripts

Statins can be life-saving, but for reasons, they aren’t always prescribed for patients who could use them. How can you get them to more people who could benefit?

Have a computer nudge the prescriber. Or, to sound less creepy, “use automated referral” to get a message to a pharmacist: This patient could use statins. The pharmacist calls the patient, gets the important info, and works with the doctor to get a prescription.

This comes from a UPenn experiment with a group of primary care practices. The goal was to see if they could increase statin use by bringing pharmacists into the loop^*. And it worked:

Patients in the intervention-arm practices saw a significant increase in statin prescription rates, with 31.6 percent prescribed a statin, compared with 15.2 percent in usual care practices.

Not content with “This is cool,” they had to take the next step and call it — you guessed it — a game-changer.

^* Technically “loupe” but that’s a losing argument

Taurine and depression

Taurine is commonly known an ingredient in energy drinks or as a supplement to ease the jitters from caffeine. But there might be more to it: Korean researchers found that women with depression have lower taurine levels in their hippocampus.

They actually measured levels of choline, creatine, glutamine, glutamate, myo-inositol, N-acetyl aspartate, and taurine in various brain regions of women with major depressive disorder, but only found the depression-taurine link.

Of course this doesn’t imply causation, but it’s interesting to note — a “novel characteristic of MDD,” as they put it. So, of course, more research is needed.

Express Scripts to offer fixed-price option

Seeing the success of Mark Cuban’s Cost Plus mail-order pharmacy (cash only with a markup of 15% + $5.00 above wholesale), Express Scripts (ESI) is jumping on that bandwagon.

Next year, ESI customers will have the option to either pay the standard co-pay, or “15% above [the pharmacy’s] wholesale costs, plus an extra fee for dispensing the medicines.” That 15% will be shared between ESI and the pharmacy. And unlike Cost Plus, the ESI pricing will be available for both brand name and generic drugs.

What’s not clear:

• How will that 15% be divided?
• Will it also cover controlled meds? (Cost Plus does not.)
• Will patients be able to use on a per-script basis, or will they have to choose this plan for all their meds?

CBD vs dental pain

CBD, it seems, “alleviates acute dental pain,” according to Rutgers researchers.

This first-of-its-kind result appears in the Journal of Dental Research and indicates that CBD, which produces no “high” among users, may be an equally effective but far safer alternative to addictive opioid painkillers.

Not enough? How about “the compound improved tooth function and thus may prove particularly beneficial for those with dental pain that affects their ability to chew”?

The more you know.

An mRNA vax for Lyme?

Research out of UPenn and Yale has developed another candidate for a human^* Lyme disease vaccine. This one is based on mRNA technology^†, in contrast to the ‘standard’ Lyme vax currently in phase 3 trials.

The researchers who developed the mRNA shot say theirs is better — it induces more memory B cells and more “antibody-producing, long-lived plasma cells within their bone marrow.”

Sounds good to us.

All that said, this vaccine is still in the mouse-testing phase, so it’ll be a while before anything comes of it, while other Lyme vaccines are much closer to market.

^* Dogs already have one.
^† “a lipid nanoparticle (LNP)-encapsulated, nucleoside-modified mRNA vaccine that encodes the outer surface protein A (OspA) from B. burgdorferi”

Another new weight loss drug

This one has its own twist: It seems to combat fatty liver disease.

Eli Lilly’s upcoming entry into the GLP-1 wars, retatrutide, not only helped people lose weight, but “also culled excessive fat from around the livers of obese people,” according to a study out of VCU — in other words, it cures fatty liver disease.

[P]eople given the smaller 8 milligram (mg) dose of retatrutide experienced an average 81.7% reduction in their liver fat, the team reported. Those given the 12 mg dose experienced an average 86% reduction in liver fat.

It’s still in the testing phase, of course, giving other companies a chance to see if their drugs also have that effect.

First home STD test a-comin’

The FDA has approved the first home test for chlamydia and gonorrhea. LetsGetChecked’s Simple 2 Test won’t give results at home — the samples need to be sent to a lab — but it’s the first such test that doesn’t need to be done in a clinicians office. Pricing hasn’t been set, but you’ll probably see them on your shelves soon enough.

No good deed goes unpunished … by PBMs

The Biden administration enacted a policy to limit PBM “performance fees” to the time of filling — no more clawbacks. Pharmacist groups applauded. Angels got their wings.

Then the PBMs hit back.

Pharmacist groups […] didn’t anticipate the PBMs’ response, which has been to demand they accept new contracts with draconian cuts to their payments for dispensing medicines.

[…]

If pharmacies refuse the contracts, they risk losing Medicare customers — likely to the same giant PBM conglomerates, which have absorbed a growing share of the pharmacy business in recent years.

(Technically this would be considered a Long Read, but the PBM blowback is at the beginning of the story — the rest is an explanation of how clawbacks work and how they’re affecting independent pharmacies.)

We added a tech-immunization session!

We got caught off-guard by the flood of interest in our immunization program for pharmacy techs (a good problem to have, if we’re honest).

The live session — half of the six-hour program — filled up fast. So we’re holding a second live session that same day to accommodate the interest.

Technicians: If you couldn’t register for the live session of Immunization Delivery Training, there’s room in the afternoon now, in the 2:00 – 5:00 pm session. (At least there is as we write this.)

Get more info and sign up at GPhA.org/techimmunization.

And if you weren’t interested, take note: A lot of techs are about to have an immunization certificate — are you sure you want to be left behind?

Melatonin concerns

Melatonin has replaced Benadryl as the go-to med that parents give their kids to get them out of their hair help them fall asleep. But there isn’t a ton of data on what giving kids a hormone regularly will actually do. After all, supplements like melatonin aren’t FDA-regulated.

Before you say, “Yeah, but that doesn’t mean they’re bad” note a few things:

1. Calls to poison-control centers for melatonin have skyrocketed over the last decade.
2. In other countries melatonin is prescription-only, for what that tells you.
3. Tests show that the dosage on the bottle doesn’t always reflect the dosage of the gummy.
4. There’s no standard dosage, so parents just wing it.

Paxlovid giveth, and Paxlovid taketh away

Sure Paxlovid can help make sure serious Covid doesn’t become deadly Covid, but it might be a “two steps forward, one step back” situation. It seems — according to researchers at a group of big-name Boston institutions — that Paxlovid increases your chance of “Covid rebound,” i.e., having symptoms recur after getting better.

[T]here is no question that Paxlovid is a useful drug that can help keep patients infected with the SARS-CoV-2 virus from being hospitalized. But some also wondered if the results might be an indicator that the current dosing duration of Paxlovid — daily, for five days — is not long enough.

More BP news from the American Heart Association

No, it isn’t paying us (sadly). AHA’s annual conference is just chock full of pharma news.

Good for the brain

Lowering blood pressure isn’t just good for the heart (found a four-year study from rural China), it also reduced risk of dementia. Keeping a target BP of 130/80 cut all-cause dementia by 15% — and we suspect a lot of that is from reducing the vascular kind.

One and done (for a while)

A new drug called zilebesiran reduced blood pressure (in adults with mild-to-moderate hypertension) with just a single injection — and it lasted six months.

It’s currently in a phase 2 study, so it’s well out of the lab. And if you’re curious, “Zilebesiran is an investigational RNA interference agent targeting angiotensinogen (AGT), a hormone produced predominantly in the liver that contributes to blood pressure regulation.”

Research news that gets you to raise an eyebrow

“Men experience less pain when a woman is in charge” —Lund University

(Trying to find an illustration has skewed Google’s opinion of me.)

D is for “Dropping childhood asthma”

Pregnant women should take vitamin D supplements. That’s the conclusion of Brigham and Women’s Hospital researchers who reviewed 15 years’ of data. Of course it can’t prevent all cases of asthma, but they found it cut asthma rates by half compared to just a standard multivitamin.

That’s not to say that more vitamin D is better. Rather, mom’s deficiency can raise the child’s asthma risk, so it’s important to make sure she’s got enough.

“Based on our findings, we would recommend that all pregnant women consider a daily intake of at least 4400 IU vitamin D3 throughout their pregnancy, starting at the time of conception.”

And, they say, rather than their review, someone should follow up with a clinical trial “and supplement with 6000 IU vitamin D and seek a very high enrollment of women of color.”

Broccoli vs IBD

If you give a mouse some broccoli, that will feed its gut bacteria. If the gut bacteria eat broccoli, they’ll convert it into an anti-inflammatory compound. If a mouse has more anti-inflammatory compounds in its gut, it can deal better with inflammatory bowel diseases.

Put simply, University of Maine researchers found that if you give younger mice broccoli sprouts in their diet, it builds up the right mix of gut bacteria to make IBD milder when it occurs.

First, we show that the mice that ate the broccoli sprout diet had a greater concentration of an anti-inflammatory metabolite called sulforaphane in their blood. Even though our mice were immunocompromised and had colitis, this increase in sulforaphane protected them from severe disease symptoms like weight loss, fecal blood and diarrhea.”

The younger part is important, too. The earlier the diet was started, the milder the disease. So teach Junior to like broccoli while he’s still in the high chair.

Life expectancy gap widens

ICYMI: A disturbing bit of information came out of the latest US life expectancy data. The gap between women’s and men’s life expectancy jumped to a whopping 5.8 years. That’s a full year wider than in 2010. (It’s because more men died from Covid “influenced by a higher burden of comorbidities, differences in health behaviors, and employment in higher-risk industries.”)

The latest data show that US life expectancy, which had been increasing slowly, has dropped because of disproportionate Covid deaths here. We already trail the rest of the developed world^*, and now it’s just gotten worse.

^* The average for high-income countries was 80.3 in 2021, while in the US it was 76.4 years.

Flu rising, Covid stable

The latest CDC data shows that cases of flu are rising, especially in the South. “Outpatient visits are rising for all age-groups but are highest in children ages 4 and younger.” Currently Georgia is experiencing moderate activity, but Florida has high activity and an anti-vaccine government, which doesn’t bode well.

Meanwhile, Covid numbers are trending down (deaths and hospitalizations) or holding steady (test positivity).

Fighting high cholesterol

The American Heart Association’s Scientific Sessions are going on, so lots of heart-related stories are hitting the news.

Four times a year

A new PCSK9 inhibitor called recaticimab can, it seems, be given to patients just four times a year and still significantly lower LDL cholesterol. That, say the Chinese researchers conducting the study, could help overcome adherence issues.

The more often you give recaticimab the better, but even a dose every 12 weeks had a major effect:

• Monthly injections: 62% LDL reduction vs placebo
• Bi-monthly injections: 59% LDL reduction
• 12-week injections: 51% LDL reduction

It also helped reduce Lp(a) cholesterol and other lipoproteins you don’t want circulating. More studies are already in progress.

Once a year

There aren’t any treatments for people with genetically high levels of lipoprotein(a) — Lp(a) — so most doctors don’t even test for it. But that could change thanks to a new drug out of Ohio’s Cleveland Clinic.

Called lepodisiran, a single injection reduced Lp(a) levels “to undetectable levels.” And here’s the kicker: It worked for nearly a full year.

Considering that the only treatment available to Lp(a) patients is apheresis (“a dialysis-like treatment to remove harmful cholesterol from their blood”), this could be a … dare we say it? Game changer.

A phase 2 human study is already underway.

PharmPAC in action

David Stanley, owner of McElveen’s Pharmacy in Gainesville, presented a PharmPAC check to Georgia State Representative Lee Hawkins, chairman of the House Health Committee — that’s where a lot of our bills are presented during the legislative process. Oh, and Hawkins sits on a bunch of other committees that are important to use, including the House Insurance Committee and the Public Health Committee.

Hawkins is a dentist, so understands the issues affecting pharmacists and other healthcare providers. Most importantly, he’s always been a huge ally for GPhA and the pharmacy profession.