Here come the Covid vaxes

By the time you read this, the FDA may have approved this year’s Covid-19 vaccines. These will be targeting the KP.2 variant — one of the FLiRT clan. Pfizer’s and Moderna’s seem to be on track for approval, but Novovax’s non-mRNA shot is still up in the air.

ICYMI, Covid has been … well, “surging” might be a bit strong, but “picking up steam” is a good description, so the sooner the better.

Long Covid clue

Researchers at the University of Colorado think they’ve found another clue to what causes long Covid. The disease leaves behind antigens that can stick around for a year after the infection is cleared. Those antigens, the Coloradoans say, cause cortisol levels in the brain to drop and even stay down.

Their hypothesis, based on a rat study:

Covid antigens lower cortisol, which serves to keep inflammatory responses to stressors in check in the brain. Once a stressor arises—whether it be a bad day at work, a mild infection or a hard workout—the brain’s inflammatory response is unleashed without those limits and serious symptoms come screaming back.

They don’t think cortisol treatment would help (“they would not get at the root cause and come with a host of side effects”), but finding where those antigens are hiding and eliminating them could be an effective treatment.

Measles in Georgia

The Georgia Department of Public Health reports a fifth case of measles this year — this one’s in the Atlanta. In a shock to no one, the patient wasn’t fully vaccinated. “DPH is working to identify anyone who may have had contact with the individual while they were infectious.”

Good news about nothing

Not only can a placebo work, it can work even if the patient knows it’s a placebo.

Not only can a known placebo work, it can even work (to reduce stress, at least) when administered remotely — i.e., when patients’ only interaction with the prescriber is via Zoom.

That’s what Michigan State researchers found when testing the non-drug’s effect during the pandemic to help reduce stress. Half the 64 participants got no treatment, while the other half (“non-deceptive placebo group”) got education about placebos and then the placebos themselves, which they were instructed to take by an online practitioner.

Result: “[T]he non-deceptive group showed a significant decrease in stress, anxiety, and depression in just two weeks compared to the no-treatment control group.”

Naloxone, opioid abuse, and pregnancy

To protect the newborns of people with opioid use disorder, it’s better to treat the pregnant moms with a combo of buprenorphine and naloxone rather than buprenorphine alone. That comes from a study of 8,700 pregnant women over 18 years.

“According to the authors, buprenorphine/naloxone exposure during pregnancy was associated with a lower risk for neonatal abstinence syndrome” as well as NICU admission.

Tirzepatide’s newest trick

Eli Lilly claims “slashed the risk of developing type 2 diabetes by 94% in adults with prediabetes who also are obese or overweight” in a three-year study.

What’s interesting is that once they stopped, although the patients gained back the weight they lost, their risk of developing diabetes was still cut by 88%.

Latest drugs in shortage

Per the American Society of Health-System Pharmacists:

• Buprenorphine hydrochloride injection
• Dihydroergotamine mesylate injection
• Fluconazole injection
• Glipizide tablet, extended release (discontinued)
• Memantine hydrochloride capsule, extended release (discontinued)

Combo shot setback

Several companies are working on a combination flu/Covid-19 vaccine, but now another candidate seems out of the running. The Pfizer/BioNTech shot worked great against Covid and influenza A, but it failed to work against influenza B in a phase-3 trial.

CureVac and GSK had the same problem with their mRNA flu vax, as did Sanofi. Interestingly, though, both Pfizer and Moderna have separate mRNA flu vaccines that do seem to work against influenza B, but for whatever reason they can’t be combined with the Covid shot.

The companies are now back in the lab, thinking about what they’ve done.

Dues are due!

It’s that time of year — GPhA membership dues are up for renewal! Great news: As a part of our 150th anniversary next year, we’re extending membership benefits for an extra three months!

That means when you renew your membership by September 1, 2024, your membership won’t expire until December 31, 2025 — that’s three months of membership FREE. Zilch. Nada. Bupkis.

Not enough? How ’bout this: Dues are the same for 2024–25 — no increase.

Watch your email and snail mail for your renewal information and invoice. Or you can pop over to GPhA.org/renew to renew there.

We’re glad you’re a member, and we’re counting on you to continue being one, and to be a part of all of the celebrations in store to commemorate GPhA’s 150 years as the Voice of Pharmacy in Georgia!

File under: “Huh, that’s interesting”

Some people get Covid or the flu and barely notice, while some end up in hospital or even dying. It feels like a crapshoot, but that might not be the case.

A new Australian study looked at what the sickest people had in common. What they found is high levels of one enzyme called oleoyl-ACP-hydrolase — Olah to its friends — in the sickest patients. As one immunologist put it:

“[I]n some patients who develop life-threatening disease, Olah is produced at substantially higher levels, whereas we find very low levels in healthy individuals and patients with mild disease.”

What can be done with this info isn’t clear yet, but just finding the correlation is worthy of, as always, more research.

What to know about mpox

The current outbreak of mpox might be worth keeping an eye on. This clade (clade I) is a lot more infectious than the one that spread last time (clade II). Perhaps more importantly, it’s already been seen in at least a couple of patients outside of Africa — and authorities in Pakistan lost track of the one guy there.

Forbes has the details.

Syphilis test reality check

You may have seen that the FDA has given approval to the first at-home test for syphilis, but what you may not have caught is the big caveat that comes with it.

The test won’t actually tell you if you have syphilis — it’ll tell you if you (probably) don’t have it. That’s because “positive test results from this test alone are not sufficient to diagnose syphilis infection and should be followed by additional laboratory testing.”

One big reason: “Results of this test will be positive for individuals previously diagnosed with syphilis, even if they were successfully treated.”

So it’s useless if you’ve ever had syphilis before. If it’s negative it means you’re probably okay. And if it’s positive it doesn’t mean you have syphilis, just that you need to get tested for real.

The Long Read: Gabapentin edition

Gabapentin is technically supposed to be used for seizures and diabetic nerve pain, but lately it’s being used for … well, for a lot of conditions, even if there’s hardly any evidence that it works. (And some older patients just keep taking it, even if they don’t remember why.)

Read on, MacDuff.

The X for Y Files

You might think of ustekinumab as a psoriasis treatment, but a new British study found that it might also help children diagnosed with type-1 diabetes by protecting the function of pancreatic beta-cells and slowing the disease’s progression.

The science-y detail: “Ustekinumab was associated with a 49% higher C-peptide AUC at week 52 [vs placebo].”

Do androids dream of electric Band-Aids?

One way to help a chronic wound heal more quickly is to use an electric current, but that’s an expensive proposition. People with diabetes dealing with those are at risk of amputation. If only someone could create a cheap, disposable bandage that produced a small electric current.

Hearing that call were engineers at NC State^*. They created a tiny, flexible, water-powered electrical wound dressing.

The dressing is applied to a patient so that the electrodes come into contact with the wound. A drop of water is then applied to the battery, activating it. Once activated, the bandage produces an electric field for several hours.

Because they’re flexible, they can fit over irregularly shaped wounds, and when tested on mice the bandages healed wounds 30% faster than regular dressings. And the cost? A couple of bucks apiece.

^* As well as Columbia, Beth Israel Deaconess Medical Center, UNC, Georgia Tech, and Korean researchers

GLP-1 drugs hit real estate

So many ripples: Snack food companies were looking at sales losses because of GLP-1 drugs. Medicare/-caid worried about how they were going to afford them. Orthopedic surgeons were looking at fewer patients.

Now those drugs are getting so popular they’re affecting the kinds of buildings healthcare companies are considering building or buying. Health facilities are rethinking bariatric surgery and even cardiology and orthopedic centers and in favor of consumer-friendly “facilities focused more on lifestyle and metabolic health.”

Congrats to UGA’s new coat-wearers!

UGA just onboarded 146 new Doctor of Pharmacy students at its White Coat Ceremony. Here they are, looking all fresh-faced and innocent, not knowing yet what awaits:

Fun fact: The female to male ratio of the class of 2028 is 3:1.

Hacking Mounjaro

People paying out of pocket for Mounjaro found that — because a high-dose pen costs the same as a low-dose pen — breaking one open and splitting the dose can save a lot of money. Sure there are risks, but if you can split a high-dose pen into six doses, as some patients do, you’ve cut the price by [does math] 83%.

As one splitter put it:

“For me, that’s really just a harm-reduction principle. There are so many people this drug could be so life-changing for, but it’s just utterly, ruinously expensive.”

Have you checked your magnesium?

If you have low levels of magnesium, you’re at risk for DNA damage that can make you “more susceptible to Alzheimer’s and Parkinson’s disease, gastrointestinal diseases, a range of cancers, and diabetes.”

That’s according to Aussie molecular biologists who found that when magnesium levels were low, patients had higher levels of homocysteine, an amino acid that happens to damage DNA.

“Our study showed a direct correlation between low magnesium levels in blood (less than 18mg/L) and increased DNA damage, even after adjusting for gender and age.”

Next step: Figure out the optimum levels and dietary intake.

Luckily there’s a vaccine

Getting shingles just once can raise someone’s risk of “long-term confusion and memory loss” — and thus a career as a politician — by 20 percent.

That comes out of a 17-year meta-study of almost 150,000 participants (25 to 75 years old) by researchers from Brigham and Women’s Hospital. They aren’t sure why this is happening, but they speculate it could be because of “neuroinflammation, direct neuron injury, or the activation of other herpesviruses.”

How Medicare saved billions

You’ve obviously heard the news that the Medicare price negotiations will be saving taxpayers something like $6 billion a year (and seniors “should save $1.5 billion in out-of-pocket costs when the price changes take effect in 2026”).

If you’re curious about the nitty-gritty details of the drugs, the prices, and the process, CMS has a 4-page PDF that explains it all.

6 billion forward, 5 billion back

One of the ways the Inflation Reduction Act helps seniors is by capping how much they have to spend on prescription drugs. But that means insurance companies have to spend more, and they aren’t going to take that sitting down. So they’re raising Medicare premiums.

In response, to stick to the original goal (keeping seniors’ costs down), CMS is planning to give those insurers $15 per month for each patient to keep those premiums down, which will cost the government $5 billion the first year.

That said, the numbers from the price negotiations are still in taxpayers’ favor:

The nonpartisan congressional scorekeeper Congressional Budget Office estimated that the drug pricing negotiation provisions in the IRA will reduce Medicare spending by $98.5 billion over 10 years.

Tongue news

If you thought there were only four uses for your tongue, turns out you’re wrong. You can now add “diagnosis” to the list.

If you let the right computer look at your tongue (and get over the “Eew” factor) it can identify a whole bunch of diseases, including “diabetes, stroke, anemia, asthma, liver and gallbladder conditions, Covid-19, and a range of vascular and gastrointestinal issues.”

That’s what engineers in Australia and Iraq found after they trained an AI on tongue images of people with various conditions. Eventually the computer was able to offer a diagnosis just by looking at tongues — and had a 98% accuracy rate.

“The colour, shape and thickness of the tongue can reveal a litany of health conditions.”

Want more tongue?

Even without a computer, you can still tell if someone has some disease just by looking at their tongue. A British neuroscientist explains how in “Black hairy, strawberry and geographic – what the state of your tongue can say about your health”.

Mail-order summer blues

Fun fact: Federal rules for storing meds don’t apply to mail-order delivery. That means that, as summers get hotter, lots of mail-order meds could be having problems.

[T]he temperatures inside the cargo areas of delivery trucks can reach 150 degrees Fahrenheit in the summer, according to drivers — far exceeding the range of 68 to 77 degrees recommended by the national organization that sets standards for drug handling.

The mail-order folks say they use temperature-controlled packaging, but when researchers actually tested that with thermometers, they “found that the packages had spent more than two-thirds of their transit time outside the appropriate temperature range, ‘regardless of the shipping method, carrier, or season’.”

Unexpected diseases

Parvovirus: The CDC has issued an alert after it noticed an uptick in cases of parvovirus in kids 5 to 9 years old.

The biggest concern is for pregnant women and those who are immunocompromised if they haven’t previously had parvovirus B19 infection. In nonimmune pregnant women, 5-10% will develop fetal anemia, severe edema of the fetus (hydrops), or death of the fetus.

“Sloth fever”: Just in case you were bored with all the existing diseases, here comes sloth fever — “Dubbed a ‘mysterious threat’ in the Lancet journal, little is known about the emerging disease.”

It comes from the oropouche virus, and it seems to have started in South America and Cuba before jumping to Germany, Italy, and Spain. And when Germany, Italy, and Spain are involved, there might be trouble.

Oh, and it’s killed at least two people in their 20s.

Another blow to moderate drinking

This time it’s specifically about older adults. “Even light drinking was associated with an increase in cancer deaths among older adults,” according to a team of British, American, and Spanish researchers. They based that on 12 years of data from 135,000 adults aged 60 and older.

The researchers found no reduction in heart disease deaths among light or moderate drinkers, regardless of this health or socioeconomic status, when compared with occasional drinkers.

[…]

On the other hand, alcohol probably raises the risk of cancer “from the first drop.”

Gummies have downsides

Ever wonder about gummy vitamins and supplements and whether they’re bad for your teeth? A dentist from Tufts University weighs in. (Spoiler: Gummies are worse than chewables, both are potentially bad for your teeth, but in some cases the benefits might outweigh the risks.)

Hit me with your best spot

Half of doctors and 58% of civilians say that pharma ads on television are helpful. Maybe you think, “Yeah, that makes sense,” but at the Buzz offices our reaction was, “There’s no accounting for taste.”

The survey from ZoomRx was small (100 people), and …

A “significant majority” of the patients surveyed said they’d spoken to their doctors about medications they’d seen in DTC ads […] while doctors acknowledged that the ads can help facilitate those potentially helpful conversations.

We hate to admit it, but some of the responses make sense. If an ad gets someone to seek help, that’s good — “Doc, can we talk about my moderate to severe plaque psoriasis?” And one patient said an ad alerted them to a new treatment for an autoimmune disease.

Then again…

[W]hile physician viewers hold on to the clinical information provided in an ad, patients’ biggest takeaways often focus on nonclinical elements like the music used or celebrity spokespeople featured.

(sigh)

Obligatory “Only the US and New Zealand allow direct-to-consumer pharma advertising.

The Long(ish) Q&A: Stopping GLP-1s

There are a bunch of reasons someone might want to stop taking semaglutide or tirzepatide, from cost to side effects to “I reached my goal.” But whether cold turkey or tapering off, it’s not easy.

“The most common question is, ‘How long do I have to take it?’ The proper answer is probably forever.”

ICYMI: nasal spray epinephrine

The FDA has approved the first nasal spray alternative to EpiPens: ARS Pharmaceuticals’ neffy. One spritz into a nostril works like an epinephrine injection, but sans needle.

ARS expects neffy to hit shelves in the next couple of months. It’ll cost $199 for two doses for uninsured patients, and $25 for two doses for people with insurance (via a co-pay program).

The X for Y files: Ezetimibe for dementia

Before there were statins, there was ezetimibe. And ezetimibe seems to have an unexpected benefit: It might prevent Alzheimer’s protein tangles.

Researchers at the University of Arkansas for Medical Sciences looked at the ‘glue’ holding those protein clumps together. Using computer modeling, they tested 1,800 FDA-approved medications against that glue. And bingo — ezetimibe was able to disrupt that aggregation.

“We focused on ezetimibe and found that it prevented a key aggregate interaction found only in the brains of people with Alzheimer’s and in lab models of Alzheimer’s-like aggregation.”

But computers aren’t people (yet), so they next went to clinical data. And what d’ya know, out of 950,000 people, “patients taking ezetimibe had a much lower incidence of Alzheimer’s and related forms of dementia than those in the control group.”

But you know the drill, though: More research is needed.

Irony, irony, all is irony

Purdue “Trust us, these opioids aren’t addictive” Pharma has won FDA approval for its opioid overdose-reversing injection, Zurnai (nalmefene).

Which antibiotics are riskiest?

A new study out of the University of Toronto looked at which antibiotics were most likely to cause severe drug rashes. These “serious cutaneous adverse drug reactions” can be dangerous, especially when they spread to internal organs — “Some of these reactions carry mortality rates from 20 to 40 per cent.” Yikes.

The answer, they found, was that sulfonamides and cephalosporins had the highest risk, while macrolides had the lowest. (Penicillins, fluoroquinolones, and nitrofurantoin were in the middle.)

The sky didn’t fall after all

Biden administration: “Welcome to capitalism, pharma companies. We’re going to negotiate the prices of 10 out of the hundreds of drugs you sell to Medicare, like every other country on Earth.”

Pharma companies: “The world will end! The sky will fall! Dogs and cats, living together!”

CMS: [makes rude gesture]

Pharma companies: “We’ll sue! Suckling off the government teat is our God-given right!”

Courts: [rolls eyes]

—NEGOTIATIONS ENSUE—

Public: “So how bad was it, pharma?”

Pharma companies: “Meh. It’s not really going to impact our bottom line after all. But, um, research may suffer or something.”

Brad from finance: “Actually, if we cut dividends, reduce C-suite bonuses a bit, or just focus on late-stage research, it would more than make up fo—”

Pharma companies: “Shut up, Brad.”

(sigh)

There’s another weight-loss hack spreading on TikTok. This one— oh, sheesh, who cares?

(It’s rice water, aka “ricezempic.”)

The Long(ish) Read: Smart Insulin edition

Several groups of researchers have developed versions of insulin that can stay in the bloodstream and by [insert science here] only release when blood sugar is too high. Called glucose-responsive insulins, if they pan out they would mean patients’ injections might be weekly, rather than daily … or more often.

Midnight at the crossroads of happy and healthy

If you know someone who’s graduating from high school but isn’t planning to go on to college, you can suggest they go to work at Walgreens. The company is #3 on the American Opportunity Index list of Best Places for High School Graduates to Start a Career. (If you’re curious, Chipotle and Lowe’s are #1 and #2, respectively.)

The list is based on companies’ willingness to hire people without degrees as well as their opportunities for promotion.

Congrats, Mandy!

PCOM has named Dr. Sara (Mandy) Reece the interim dean of the School of Pharmacy at PCOM Georgia. She’s been a fixture at PCOM, serving as the college’s vice chair of the Department of Pharmacy Practice and director of interprofessional education. Chops-wise, she’s got them: In 2019 she was named PCOM School of Pharmacy Teacher of the Year for Pharmacy Practice, and in 2022 and 2023 was named Faculty Preceptor of the Year.

A big high-five from all of us!

Two-question test for smokers

How can you tell if someone will be able to quit smoking? Turns out all it takes is two simple questions to get a score of how addicted they are, and thus how difficult quitting will be:

1. On the days that you smoke, how soon after you wake up do you have your first cigarette? (four options from ‘5 minutes’ to ‘more than an hour’)

2. How many cigarettes do you typically smoke per day? (four options from ‘10 or fewer’ to ‘more than 30’)

Read the details.

Nasal sprays vs respiratory viruses

The idea of nasal-spray vaccines has been gaining ground since the pandemic, and the latest place with a twist on the concept is the University of Houston.

Two twists, actually: One (NanoSTING) is “complementary to vaccines.” It helps prevent infection by keeping the immune system in the nasal compartment primed to fight whatever comes in through the nose.

Because it kills whatever comes in through the nose, NanoSTING also helps prevent transmission.

The other (NanoSTING-SN) is an actual vaccine delivered through the nose that, the UH folks say, might be a universal coronavirus vaccine; it “eliminates virus replication in both the lungs and the nostrils” … well, in the lab at least.

Both are still in the preclinical stage, so we’ll just file them under “check back in a few years.”

It’s allergy time!

Actually, it’s allergy med time, according to the American College of Allergy Asthma and Immunology. Meaning it’s time to at least start thinking about putting those allergy meds out on the end caps so patients can start taking them a couple of weeks before the allergens (think ragweed) begin to appear.

We can do better

The latest analysis from WalletHub, “Best & Worst States for Health Care (2024)^*,” has bad news for the Peach State. Georgia ranks #48 out of 51 states and DC; only West Virginia, Alabama, and Mississippi are worse.

The rankings are based on a lonnng list of weighted criteria in categories of cost, access, and outcomes, e.g., insurance premiums and coverage, hospital beds, number of healthcare pros, rates of certain diseases, and more.

If you’re curious, Minnesota ranked #1, followed by Rhode Island and South Dakota.

^* aka “States with Best Health Care Systems”

Elsewhere: Razorback edition

Arkansas officials have ordered four PBMs — CVS Caremark, Express Scripts, Magellan, and MedImpact — to pay a total of $1.47 million in fines for paying Arkansas pharmacies less than what they’re required to, which is “at least as much as the national average of what drugstores pay wholesalers for the drugs.”

How much money the PBMs saved by underpaying wasn’t clear, but they were fined $5,000 for each violation the state knows about. And no, the money isn’t going back to the pharmacies.

Lacks estate sues

The estate of the “immortal” Henrietta Lacks is suing both Novartis and Viatris for, they say, profiting off Lacks’s cells, which were harvested at Johns Hopkins in 1951 without her consent while she was being treated for cervical cancer. (You can search for the whole story if you don’t know it.)

While Johns Hopkins never profited from HeLa cells, companies and other research organizations have developed thousands of patents using HeLa cells. Novartis holds “hundreds” of those patents, according to the lawsuit.

GLP-1 reality check

Both Eli Lilly and Novo Nordisk say that they now have supplies of their GLP-1 drugs (Mounjaro and Zepbound for Lilly; Ozempic and Wegovy for Novo). The implication is that they’re out of shortage.

In reality, though, pharmacists are having trouble getting them. Supplies are still limited and can’t meet demand — that’s why the FDA still lists semaglutide and tirzepatide as ‘in shortage.’ That’s particularly important for compounding pharmacies, which are able to dispense both drugs as long as they’re one that shortage list.

When fish oil works

There are claims that fish oil supplements are good not only for the heart, but for the brain as well. That turns out to be true — some of the time.

Oregon Health & Science University researchers found that taking fish oil had “no statistically significant benefit for all older adults in general.” There was an exception, though: If someone carries the APOE4 gene (which indicates a higher risk of Alzheimer’s), taking fish oil put the brakes on the breakdown of nerve cells in the brain.

Of course, the main reason people take omega-3 supplements is for cardiovascular health, but now there’s a (possible) reason for those susceptible to Alzheimer’s to consider it as well.

Unanswered: Would this hold true for other sources of omega-3 fatty acids, like algae, or is it specific to fish oil? ¯\_ (ツ)_/¯

Pharmacists can prevent AFib

Canadian researchers were curious: What would happen if pharmacists were able to prescribe oral anticoagulation therapy for “high-risk older individuals with atrial fibrillation.” Turns out it makes a big difference in how many of those people used the meds.

After three months, 92.3% of people who got prescriptions from pharmacists were sticking with usage guidelines, compared to only 56.1% who got them from a PCP. And a fun fact: More than a quarter of those PCPs contacted pharmacists to ask about dosing.

It’s almost as if you’re medication experts or something.

Why insulin price caps don’t work

The idea seemed good: States set caps on the monthly cost of insulin — usually $25 or $35 — so more people could afford it. But now a study out of the University of Colorado found those policies make little difference to patients on commercial plans.

Why? Because patients on commercial plans those usually have a lower co-pay anyway. The cap doesn’t help.

Instead, the researchers say, insulin-price caps should focus on people without insurance or those with high-deductible commercial plans — those are the folks who need help affording it.

Updating the threat list

The WHO has added several new pathogens to its list of What Could Cause the Next Pandemic, which, like most WHO announcements, we will all ignore until the next pandemic arrives.

New to the list, which numbers more than 30, are the dengue, influenza A, and monkeypox viruses.

The priority pathogens […] were selected for their potential to cause a global public-health emergency in people, such as a pandemic. This was on the basis of evidence showing that the pathogens were highly transmissible and virulent, and that there was limited access to vaccines and treatments.

Lilly’s GLP-1s out of shortage (sort of)

On Saturday we told you that one of Lilly’s two tirzepatide products, Zepbound, was expected to come out of shortage. Now the FDA says that both of them — Zepbound and Mounjaro — are available. They’re both still listed as in shortage, though, because the agency needs to consider the demand and how much of a backlog the company faces.

Look up a shortage

Did you know you can (easily!) search the FDA’s drug-shortages database? Just enter the generic name for a drug and you can see the different formulations and manufacturers, why they’re in shortage, and when they’re expected to be back, if the agency knows. (Sadly, it often doesn’t know.)

Check out the database: https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm.

Interestingly, a drug like lisdexamfetamine might be in shortage, but some manufacturers, like Rhodes Pharmaceuticals, still have some forms available — you just have to scroll down the list.

Aspirin vs colon cancer

Regular aspirin use can reduce your risk of colorectal cancer — something that’s particularly important these days, when the disease is (mysteriously) rising among younger people.

That’s what Harvard researchers found after analyzing “three decades’ worth of data collected from 100,000 health care workers.”

[A]spirin was associated with a one-third drop in colon cancer risk among those with a low “healthy lifestyle score” [which includes] regular tobacco and alcohol use, the lack of a healthy diet, a lack of exercise, and a high body mass index.

Yes, aspirin has some dangers, notably the risk of GI bleeding, so there’s no one-size-fits-all for taking it. But when it comes to whether and how much to take, there are more factors to consider than heart risk.

RSV season is starting

It’s time to encourage your unvaccinated senior patients to get their shots before the season gets into full swing.

Florida, with its humid weather, is the nation’s ground zero for RSV. Each year, infections typically start in Florida and the Southeast before spreading to other parts of the United States, according to the University of Florida’s Emerging Pathogens Institute.

The road to myocardial infarction is paved with good intentions

Last year, the American Heart Association and American College of Cardiology released new guidelines for determining whether someone should start on statin therapy. Called PREVENT (Predicting Risk of cardiovascular disease EVENTs), it’s supposed to calculate whether someone should start on statin or blood pressure therapy based on their risk profile.

But there might be a problem with PREVENT. A study out of Harvard Med calculated that using it instead of older guidelines^* called PCEs would mean a lot fewer people taking statins and a lot fewer taking antihypertensive meds.

And that, they say, would lead to “107,000 additional instances of myocardial infarction (MI) or stroke over 10 years.”

That said, both the AHA and ACC guidelines say that medication is recommended for anyone who shows a high risk based on either PCE or PREVENT scores. I.e., the new guidelines aren’t meant to replace the old ones, just to supplement them.

^* Pooled cohort equations, which date back to 2013

Pharma will survive

Drug companies have claimed, over and over, that if they have to negotiate the price of their drugs, the world will end innovation will end and patients will suffer, yada yada yada. In reality, they spend more on marketing, stockholder dividends, and executive pay than on research.

Two new analyses out of Bentley University found a couple of tidbits that show how wrong these arguments are. First, the researchers found that drug prices don’t influence investment in biotech companies. Second, pharma companies pay for their R&D from their own investments, not from drug sales.

But even in a worst-case scenario, all pharma companies need to do is what they have been doing: Let other companies (or universities) do the initial research, then use their R&D budgets for late-stage product development. In that case, “According to the analysis, even a drastic 10% drop in global revenue would hardly impact the number of drug approvals.”

Fighting flesh-eaters

If you’ve ever gone swimming in a lake or the ocean near Florida, you’ve probably thought about flesh-eating bacteria. It’s out there. Waiting.

Luckily there’s some good news out of Washington University School of Medicine in St. Louis: Scientists there have developed what they say is a compound that can kill the kind of gram-positive bacteria that causes necrotizing soft-tissue infections like the flesh-eating disease that keeps popping up in Florida. (It also kills C. difficile, enterococci, staphylococci, and streptococci.)

You’d think they’d get the message by now

Novo Nordisk is the latest company to have its lawsuit challenging the Inflation Reduction Act’s drug-price negotiation provision thrown out of court. The Danish company argued that having to negotiate violated its free-speech rights (?) and that it was forced to participate in Medicare. The judge was having none of it.

What are we up to? Six of these cases?

Monitor those DOACs

When patients are on direct oral anticoagulants like rivaroxaban, it’s not “fire and forget” — you need to monitor their dosage after that first prescription, especially when it’s being used off label.

The drugs “have their own complicated dosing schemes that can vary based on factors such as kidney function and select interactions between drugs,” and a new study out of Michigan Medicine found that one in eight patients was either under- or over-prescribed a DOAC.

Nearly 70% of the alerts to off-label dosing occurred during a follow up visit compared to the time of the initial prescription […] When prescribers were contacted about the dosing issue, they made changes three-quarters of the time.

FYI

There are eight drugs newly in shortage:

• Basiliximab injection
• Bisoprolol fumarate
• Cyanocobalamin spray
• Disulfiram tablet
• Esmolol injection
• Estradiol cypionate injection
• Indocyanine green
• Orphenadrine citrate injection

Speaking of shortages, there’s Zepbound

Eli Lilly says at least some of its Zepbound-brand tirzepatide will be out of shortage in the coming days. What’s unclear from the Bloomberg article is whether Mounjaro will also be out of shortage. (Both are tirzepatide, but Zepbound is approved for weight loss and Mounjaro is approved for diabetes.)

Tirzepatide itself, the API, hasn’t been in shortage (as compounding pharmacists know), just the delivery systems. If Mounjaro remains in shortage, it means clinicians can still write prescriptions for ‘compounded tirzepatide injections.’ If both are out of shortage, though, it gets problematic.

Don’t peel your own face

The FDA recommends you don’t put acid on your face to peel the skin off — at least not at home. Just because Walmart sells a chemical peel doesn’t mean its safe.

“The agency has not approved any chemical peel products^*, and consumers should only consider using chemical peel products under the supervision of a dermatologist or licensed and trained practitioner.”

^* To be fair, this is disingenuous. The FDA hasn’t approved lipstick either — it doesn’t regulate cosmetics. 

Elsewhere: Peanuts down under

Babies in Australia with peanut allergies will be allowed to take advantage of a free nationwide oral immunotherapy program — the first such program outside a clinical study, available to kids up to 12 months old.

“[It] aims to change the way the most common food allergy in Australian in children is managed, from strictly avoiding peanut in the diet to slowly building tolerance to the allergen and hopefully achieving remission.”

The Long Read: TEFCA and sharing health info

Sharing your medical information in the US is a tough thing. Providers store their info all sorts of ways, which is why there’s still so much paper involved if you change doctors or health systems. Heck, if you get a health app on your phone you still have to type in your info manually.

Clinics, hospitals and health systems can store their information in a variety of formats across dozens of different vendors, and there hasn’t been a trusted nationwide mechanism in place for transporting it securely.

That is changing thanks to TEFCA — the Trusted Exchange Framework and Common Agreement. In broad strokes, it’s a standard for storing and exchanging medical information so participating providers can share it.

Under TEFCA, companies called QHINs (qualified health information networks) are authorized to share health data in different ways. There are six QHINs so far, and they’re like cellphone networks — they connect with other networks. So the SmithCo healthcare network might sign up with one QHIN, and the JonesCo network might sign up with a different QHIN, and they could exchange healthcare data (just like a Verizon customer can call a T-Mobile user).

But QHINs are limited in why they can share that data; they have to be approved for one or more “purposes”:

• Treatment
• Payment
• Health Care Operations
• Public Health
• Government Benefits Determination
• Individual Access Services

Lots of QHINs support the treatment purpose, and they’re all working to support all six purposes.

And now a QHIN called Epic Systems has taken a big step, becoming the first one authorized to exchange healthcare data for individual access services. That’s a big deal for consumers because it means, using Epic, apps on smartphones can accept data from healthcare networks.

For instance, if patients are using a health coaching app or an app that reminds them to take their medicine, they can choose to import their records directly into those platforms. All they need are the credentials they use to sign into Epic.

How those credentials would work — would individuals need an Epic account or would that be up to the app? — isn’t clear.

The point is, this is a big step toward being able to move your data from place to place, provider to provider, and maybe not having to fill out as much paperwork when you switch hospitals.

Dosing errors all along

After all the fuss it kicked up about compounded versions of GLP-1 drugs, you could say the FDA is changing its tune a bit. It seems that the adverse effects of the drugs aren’t about the quality of the compounded versions, but about dosing errors.

Inspired by social media, patients are requesting — and some prescribers are prescribing — higher doses of the drugs than are recommended. In other cases, patients are simply misusing injectors. It’s bad enough that the agency had to make a public announcement.

Mercer: A fond farewell and an enthusiastic welcome

Our best wishes for an amazing retirement to Mercer College of Pharmacy’s Dean Brian Crabtree — after seven years in the position, he’s retiring as of … well, yesterday.

And then welcome to Interim Dean Pamela Moye, a longtime member of the CoP’s faculty and the chair of the Department of Pharmacy Practice. (Notice the “interim”? The college is conducting a nationwide search for a permanent replacement for Dr. Crabtree.)

Sanitizer out, mask on hand

Georgia, like much of the country, is dealing with a summer surge in Covid-19, the Atlanta Journal-Constitution reports. Back in April, the Northeast Georgia Health System was seeing a 2% positivity rate for Covid tests, but now it’s up to 22% positive … and rising.

According to the CDC, in the week that ended July 13, Georgia reported 1.1% of emergency room visits were diagnosed as Covid-19, a 40% increase from the previous week

The good news: It’s still a small number, even with the percentage jumping. The FLiRT variants causing the surge seem to be milder than previous variants — even an 81-year-old can be infected and be back in action after a few days — but it’s also more transmissible.

Happy Valentine’s Day 2027

Indy pharmacies: Are you ready for “Summerween”? After years of the Christmas season starting in September, Halloween wants its due — so “retailers are promoting the spooky holiday earlier than ever.”

ICYMI: Colorectal blood test

The FDA has approved a blood test for colorectal cancer — the first one that can be used as a primary screening option, and the first one that can be covered by Medicare.

It’s not as good as the gold standard colonoscopy, but it’s about on par with pooping in a jar at-home stool tests like ColoGuard. It’s expected to be available within a week or so.

“A simple blood test may be more convenient for some patients while^* colonoscopies can feel invasive, or at-home stool tests can feel awkward.”

^* Implying that at some point colonoscopies might not feel invasive and at-home stool tests might not be awkward.

Lettuce treat that

When your patients are suffering from nettle stings, you probably told them to rub a dock leaf on the skin for relief. But there may be a simpler solution: lettuce.

A “randomised, double blind, active placebo-controlled trial” in Britain found that it’s likely any crushed leaf would work:

The observed discomfort of nettle stings eased rapidly over 15–20 minutes with both dock and lettuce leaf applications, say the researchers. But “the effect was not significantly different between the two interventions.”

[…]

“We conclude that dock leaf may work for nettle stings, [but] lettuce may be just as good, [and] relief comes quickly either way.”

Elsewhere: Danger Shrooms edition

Warm, wet weather in the Midwest has meant a lot of mushrooms sprouting — and a lot of calls to poison control centers. People, it seems, are foraging for mushrooms without knowing the difference between poisonous and safe.

Common ones that typically cause milder symptoms include the little brown mushrooms that grow in yards and the small white mushrooms that can form “fairy rings,” Brown said. But some deadly species also grow in the area, including one popularly known as the “death angel” or “destroying angel.”