Moderna shot lasts … sort of

If you got a Moderna RSV shot last year and think it’ll last through the next season, you’re half right. The company says its vaccination is 50% effective in its second year. That’s bad news for Moderna, as both GSK’s and Pfizer’s RSV shots were more effective — 78% — after 18 months.

Speaking of RSV vaccines

Two decisions out of the CDC. First, the agency tweaked its guidance for the shots, saying, essentially, that’s its Pretty Darned Important for people 75 and older, and Not Quite as Important for people 60-74 (unless they’re at high risk^*).

Second, despite the FDA’s approval of the shots for people 50 and over, the CDC declined to endorse that, meaning insurance probably won’t cover for younger folks.

^* Those with “chronic heart disease, advanced-stage kidney disease, chronic lung illnesses, [or] severe obesity”

Get your Covid vax this fall

The CDC has officially recommended that everyone eligible get an updated Covid-19 vaccination this fall. This might seem obvious — of course you should get a vaccine — but the official recommendation is important for insurance (especially Medicare/caid) coverage.

Covid is still out there; it killed more than 75,500 Americans last year. Perspective: That’s the equivalent of two 737s crashing every single weekday throughout the year.

ICYMI: Multivitamins

The Flintstones are not going to be happy: Apparently multivitamins don’t help you live longer. That’s the result of a pretty big study — almost 400,000 tracked over 27 years — out of the US National Cancer Institute. In fact, taking them was associated with a slightly higher risk of death.

But … that doesn’t mean vitamins can’t help at all, just that a daily multivitamin doesn’t. People (in case you haven’t noticed) are individuals, and they can be deficient in various vitamins and minerals where a targeted supplement can make a big difference.

It’s possible that people who just pop a convenient multivitamin without considering their actual needs are simply less concerned about their health. Could healthier people be more likely to check for and treat deficiencies?

No hidin’ place down there

I went to the rock to hide my face, but the rock cried out, “No hidin’ place!”

In this case the rock is the US Supreme Court, and the people trying to hide were the Sackler family of Purdue Pharma fame.

SCOTUS voted 5-4 that no, the multi-billion-dollar opioid settlement between the family and the government (for the Sacklers’ role in the opioid crisis) cannot give the Family immunity from civil lawsuits.

Although Purdue filed for bankruptcy, the Sacklers did not. The ruling means the whole mess gets sent back to bankruptcy court where this time the Family can’t dodge liability.

Oops, did we capitalize “Family”?

Fungus news: death in the garden

There are “high levels of multidrug-resistant fungi in commercially available compost, soil, and flower bulbs” — high enough to be dangerous to people with compromised immune systems. That’s what UGA agricultural researchers found, and when they say “dangerous,” they mean those people are “facing a near 100% fatality rate if infected with a multidrug-resistant strain.”

As the lead researcher put it, “People don’t think of tulips as deadly, but they could be.”

The “bargain” of mail-order drugs

Mail-order drugs were supposed to save employers and patients money by providing drugs at a much lower price than those old-fashioned brick-and-mortar pharmacies.

Ha, we say. Ha.

It turns out, reports the Wall Street Journal, that mail-order pharmacies — many of which are owned by PBMs, sometimes charge a lot more. We’re talking 35 times more, based on a study commissioned by the good folks at the Washington State Pharmacy Association.

Branded drugs filled by mail were marked up on average three to six times higher than the cost of medicines dispensed by chain and grocery-store pharmacies, and roughly 35 times higher than those filled by independent pharmacies, according to the analysis, which looked at 2.4 million claims by self-insured employers in Washington state from 2020 to 2023.

What do the PBMs say? “Companies’ home-delivery programs save employers on prescription drugs and their convenience helps ensure patients take their medicines,” according to the article, despite the fact that the data proved the opposite.

Oh, and those 2.4 million claims that were analyzed? The PBMs say that was cherry-picked data. Seems like them’s a lot of cherries.

What if we redefined “shortage”?

Medical doctor and Forbes contributor Robert Pearl has an idea for cutting the price of GLP-1 drugs, which he says are “Overpriced By 400-500%” in the U.S.:

Americans pay over $1,300 for a 28-day supply of Wegovy while patients pay far less in countries like Denmark ($186), Germany ($137) and the UK ($92).

That idea: Amend the Food, Drug, and Cosmetic Act to expand the definition of “in shortage” to take into account a drug’s affordability. If a drug is not affordable, he argues, putting it in the shortage category would allow compounding pharmacies to produce it at a reasonable price. In fact, he says, telehealth company Hims & Hers sells compounded semaglutide for $199 per month right now.

“Once market competition brings the price of these drugs under $200 a month (as it is in other nations),” he says, “the ban on compounded production could be reinstated.”

We’re not agreeing or disagreeing with him, but it’s certainly food for thought.

Speaking of compounded semaglutide

Back in May we poked fun at Axios being excited about the stock price of Hims and Hers when the companies started selling compounded semaglutide for a lot less than the brand-name version.

The problem is that it’s not clear what will happen when semaglutide comes out of shortage. Will compounded versions still be allowed? It seems the Wall Street Journal just realized that’s an issue. Aside from being late, though, it’s an excellent piece, especially in how it covers the nuances of compounding.

A ketamine pill?

Ketamine for depression seems to have a lot going for it, but there’s at least one problem: Injections and nasal sprays “can leave people feeling spaced out, sedated, and increases their blood pressure.” That’s how researchers in New Zealand put it, and they set out to find an alternative. What they came up with was an extended-release tablet that — after testing it on 168 adults — they say “showed significant improvement in depressive symptoms.”

“Because most doses of this tablet formulation can be taken at home, this is potentially a much cheaper and convenient option for these patients compared with weekly clinic visits for ketamine injections or nasal sprays.”

CBD and pregnancy

CBD can treat help deal with a bunch of symptoms, and it’s generally considered safe (although opinions are mixed on how effective it is).

But what about for pregnant women? French researchers were curious if CBD might affect the kids of moms who used it. So they tested it on mice, injecting them a low dose of CBD for about two-thirds of their pregnancy.

The kids … well, the kids were different. That’s the scary-sounding result — in fact, the article is titled, “CBD use during pregnancy produces strange behavior in offspring .” But it’s not like the mice are listening to dubstep or watching Canadian football. There were changes to their insular cortexes, though:

“CBD-exposed females tended to move around their new environment more compared to females that didn’t receive CBD during gestation. Furthermore, compared to control mice, both male and female mice treated with CBD established more physical contacts with each other.”

So it’s not bad behavior, it’s just different. What’s the takeaway? Say it with me: More research is needed.

ICYMI: Gesundheit

The next time you sneeze, take a note of how many people say, “Bless you.” Then count your blessings. You could be like the man who eviscerated his bowels after a forceful sneeze.

Fear not: “The man was rushed to hospital for emergency surgery where his bowels were returned to his abdomen.”

(Yes, yes, he was recovering from abdominal surgery. But he still blew out his bowels by sneezing.)

Elsewhere: The Finnish start

Finland is about to become the first country to vaccinate some people against the H5N1 bird flu. Not everyone — just people at risk because they’re exposed to animals, specifically the country’s fur farms. The Finns purchased about 10,000 doses, some to be offered immediately and some to be on hand in case a human case pops up.

A new talc lawsuit

Could every woman get free cancer screening from Johnson & Johnson? That seems to be the implication from a new lawsuit. It’s asking that the company pay for medical monitoring for any woman who might develop cancer and who used J&J talcum powder.

The lawsuit, filed on Monday, opens new tab in New Jersey federal court, is the first to seek medical monitoring, or regular testing meant to catch cancer early, on behalf of talc users. The proposed class could include thousands of women, but would not include the more than 61,000 people who have already filed personal injury lawsuits over J&J’s talc.

With a huge number of people having used baby powder for, well, forever, that sounds like a class that’ll expand quickly — and all over a cancer connection that’s far from proven.

A leap for HIV PrEP

HIV pre-exposure prophylaxis drugs are pretty good at reducing the chance of getting an HIV infection, but now Gilead may have taken it a step further.

A phase-3 trial of its twice-yearly HIV PrEP drug lenacapavir showed zero infections. None. Nada. That trial was conducted on more than 5,300 girls and women aged 16 to 25, and “no infections happened during the trial period among more than 2,000 women in the lenacapavir group.”

The good thing about lenacapavir is that it’s already FDA approved — it’s Sunlenca, and it’s used to treat some treatment-resistant HIV infections. Now it seems to have found a second calling as a PrEP drug.

Short Takes

Pot makes Covid worse

Using marijuana seems to increase your chances of having severe Covid-19, according to a new study out of Washington University School of Medicine — and that’s after “accounting for cigarette smoking, vaccination status, two or more co-existing diseases, and other risk factors.”

Menthol is back

The FDA has approved the first menthol e-cigarettes for sale: four products from Philip Morris Altria’s NJOY. That means the agency bought the cigarette company’s contention that vaping can help people quit smoking, rather than the alternative view that flavors get more people to start vaping.

Zepbound vs. sleep apnea

According to a year-long study of 469 apnea sufferers, Lilly’s weight loss drug “led to a significant decrease in the number of breathing interruptions during sleep.” What wasn’t clear is whether the drug affected sleep apnea directly, or if the reduction in breathing interruptions was due to weight loss. Either way, it’s another trick in the GLP-1 playbook.

[T]hose on tirzepatide — the active ingredient in Zepbound — improved to the point where CPAP might not be necessary, the researchers said, noting that existing data strongly indicated drug therapy that targets both sleep apnea and obesity delivers greater benefits rather than treating either condition separately.

Teeny correction

The other day we referred to Eli Lilly and Ozempic, but it’s Novo Nordisk that makes Ozempic — Eli Lilly’s lawsuits happen to be the ones getting the bigger media coverage. Sorry about the mixup.

Coffee consumption questions

Is coffee good for you? An international group of researchers aimed to find out by conducting yet another coffee study.

This one was based on information from 23 and Me^* and the ginormous UK Biobank database and after trying to tease out any actual correlations or definitive connections, they found, well, not much: “The answer is not definitive.” (That’s in part, they say, because Americans put of a lot of milk and sugar in their coffee, while the Brits — for unfathomable reasons — drink a lot of instant coffee and use less embellishment.)

But!

The study did find some interesting genetic correlations by using that 23 and Me data, including information on coffee consumption.

“We used this data to identify regions on the genome associated with whether somebody is more or less likely to consume coffee,” the lead author explained. “And then identify the genes and biology that could underlie coffee intake.”

So yes, there literally is a gene that controls how much coffee someone wants to consume.

^* What, you thought your personal info was kept private? You sweet summer child. 

The Long Read: Everything PBMs edition

The New York Times has what might be the definitive explanation and take-down of PBMs so far. Check out “The Opaque Industry Secretly Inflating Prices for Prescription Drugs.”

A big ol’ clarification

The other day we told you about a local TV news story about pharmacy deserts and how independent pharmacies are closing because, WSB said, of high (wholesale) drug prices.

What we should have pointed out was that it’s not exactly high prices that are killing independent pharmacies, it’s the fact that pharmacies are being under-reimbursed. A $1,000 drug is fine^*, as long as PBMs aren’t reimbursing pharmacies $800 for it.

^* There are issues with prices, too, but that’s for another day.

Easing the biosimilar path

The FDA continues to try to make it easier to swap out biosimilar drugs for their brand-name counterparts. Its latest move: Instead of requiring biosimilar makers to conduct a whole new set of studies to prove their drugs are as safe as the original, the agency now says they can “use analy­ses of com­par­a­tive an­a­lyt­i­cal and clin­i­cal da­ta” instead.

If it looks like a duck, quacks like a duck, and swims like a duck, they don’t need to test whether it also tastes like a duck^*.

This comes after the FDA actually looked at whether there was a safety difference among par­tic­i­pants who switched be­tween biosim­i­lars and brand-name prod­ucts. There wasn’t, and the change will save biosimilar makers millions — not to mention patients and insurers.

^* Not the best analogy, but you get the drift.

The X for Y Files: Tz/Dz/Az

Three drugs for treating enlarged prostate — terazosin, alfuzosin, and doxazosin — might also be able to treat neurodegenerative diseases like Lewy body dementia, Parkinson’s, and even Alzheimer’s.

It seems, found University of Iowa researchers, that those drugs boost energy production in brain cells, which can slow or even prevent those diseases.

“Overall, men taking terazosin-type medications had about a 40% lower risk of developing a DLB diagnosis compared to men taking tamsulosin, and about a 37% reduction in risk compared to men taking five alpha reductase inhibitors.”

This is based on a “large observational study” of 643,000 men over three years, so even though it’s big it’s still only showing correlation, but it’s still an interesting finding that, as always, calls for more research.

Speaking of Parkinson’s….

A new blood test might be able to detect it seven years before symptoms occur. It was developed at University College London and uses artificial intelligence, of course. The good news:

The AI could diagnose Parkinson’s with 100% accuracy, researchers found. They then tested the program’s ability to predict whether a person would go on to develop Parkinson’s later in their lives.

The study involved only 72 patients, 16 of whom went on to develop Parkinson’s, but now they have eight blood markers they believe can be used to diagnose the disease years in advance — after more study, of course.

Short Takes

Skyrizi expands

The FDA has approved Abbvie’s Skyrizi for treating active ulcerative colitis in adults; it was previously used for Crohn’s disease, psoriatic arthritis, and plaque psoriasis — in case you missed the TV ads.

Five more drugs in shortage

Per the FDA and the American Society of Health-System Pharmacists:

• Calcium chloride, dextrose, magnesium chloride, sodium chloride, sodium lactate solution
• Dantrolene sodium injection (“The shortage is predicted to resolve between late June and mid-July.”)
• Furosemide injection (“No resupply dates are available.”)
• Levofloxacin injection in 5% dextrose (“The drugmakers said they expect supply to rebound between late summer 2024 and December 2026.”)
• Sodium acetate injection (“Recovery is expected to happen between June and December.”)

“Micro” makes it worse

So, gentlemen, are you worried now?

Forbes falls for pharma fallacy

Oh, Forbes, you’re usually so good in your reporting, but you dropped the ball on “What To Know About Fake Weight Loss Drugs.”

See, there are (at least) three different kinds of alternative Ozempic, and the article doesn’t differentiate — and the distinction is crucial.

First, there’s the kind that’s sold as “Ozempic,” which clearly violates Lilly’s trademark. Never trust that stuff. Then there’s the semaglutide that’s cooked up in basement labs and sold by pop-up online shops and may or may not be real^*. And then there’s the compounded semaglutide that’s made by legit compounding pharmacies.

Drug makers are deliberately trying to confuse people by lumping those together, and then they toss out misleading statements like ‘We don’t sell a generic version, so this is clearly fake.’ (The reality is that legit compounders get their ingredients — in this case semaglutide — from sources other than Lilly.)

Unfortunately, Forbes fell for the tricks and made it sound like anything other than the brand name is suspect, and it’s not.

^* It’s not.

Got wood?

Wooden cutting boards have anti-bacterial properties — that’s not news. But now Finnish researchers have looked at whether and how well different wood surfaces kill viruses.

Turns out they do a darned good job.

Your best bet: oak, which “was notably effective against non-enveloped enteroviruses,”

But pine or spruce were also excellent — they started working to kill enveloped coronaviruses the fastest, “significantly reducing viral infectivity within just 10 to 15 minutes” and rendering them totally ineffective in an hour.

Track and trace delayed … again

Enforcement of the Drug Supply Chain Security Act — at least for smaller pharmacies — has been postponed until November 2026, according to the FDA. The delay is “to offer small dispensers more time ‘to stabilize their operations and fully implement the enhanced drug distribution security requirements’ of the law.”

The law was passed in 2013 and was supposed to go into effect in 2023, but pharma organizations argued that 10 years wasn’t enough time to implement it, so enforcement was postponed until 2024, and now again (for pharmacies with 25 or fewer full-time employees) for another couple of years.

A pneumococcal vaccine

The FDA has approved the first pneumococcal vaccine for adults — Merck’s Capvaxive.

While the nod applies to people at least 18 years of age, Capvaxive is specifically adapted for patients age 50 and older as the 21 serotypes it covers account for 84% of the pneumococcal disease of people in the age group.

Next up: The CDC’s Advisory Committee on Immunization Practices will decide what uses of Capvaxive to officially sanction.

Attention pharmacy grad students!

The Southern Pharmacy Administration Conference is being held on UGA’s campus this year, August 8–10, and of course all grad students are invited to attend and to submit abstracts.

The goal of the conference is “offering enriching learning opportunities for graduate students” and giving them a chance to interact with faculty and peers. (There’s even “Dinner & Fun/Games” scheduled for Friday night.)

An allergy twist

Conventional wisdom these days says that early exposure to a bunch of bacteria is good for kids’ immune systems (the “hygiene hypothesis” v.2). And that seems to be true … but.

A group of Canadian researchers found a downside: Early exposure to weed pollen in urban areas actually increases the risk of kids developing asthma. So you’ve got competing effects, with the green spaces being good for the kids’ allergies and immune systems, but the pollen they’re exposed to reducing the benefit.

Good news for the lazy

People who sit all day and drink coffee have a lower risk of death than sedentary people who don’t drink coffee. (Well, we all have 100% risk of death. This was over the course of the study — 13 years for about 10,600 adults.)

Often stories about coffee are really about caffeine, but in this case it was actually coffee that made the difference. “[G]iven that coffee is a complex compound, further research is needed to explore this miracle compound.”

Fool me once….

With the huge success and popularity of pharmacy benefits managers, here comes their cousin to add to the complexity and cost of the US healthcare system: specialty benefit managers or SBMs.

Just as PBMs “help” companies manage their pharmacy benefits, SBMs …

… help payers manage high-cost, high-complexity disease states by leveraging provider networks and making coverage recommendations intended to improve outcomes and lower cost.

Ah, yes, “improve outcomes and lower cost.”

Typically, they drive volume to less expensive cost-of-care settings and high-performing specialists within their network, often contracting at lower rates.

What could possibly go wrong?

Healthcare is growing big-time

The US economy is booming (sorry, rest of the world), and healthcare is benefitting from that, too. The latest data show that there were more than 68,000 healthcare jobs created in May, with the biggest gains in ambulatory services, physician’s offices, and home healthcare.

In fact, healthcare accounted for a quarter of May’s job creation, even beating out government; leisure and hospitality; and professional, scientific, and technical services.

Thanks for … not much

We were happy to see a local news story about pharmacy deserts in Georgia (well, not happy about the deserts, but happy about the local coverage). Sadly, the story ended up not saying all that much, at least nothing new other than a pharmacy is opening in Tabbleton with a bit of government help.

The gist: Pharmacies, especially independents, are getting screwed like an Ikea bookshelf by the high cost of drugs. Patients are unhappy. U.S. Rep. Buddy Carter wants it to change. And … that’s about it. As you were.

The Long Read: Obesity First? edition

The conventional wisdom is that you treat each condition with a medication designed for it, but GLP-1 drugs are changing that thinking. For many prescribers, drugs like Ozempic make them want to treat obesity first and see how well those drugs also affect other issues like arthritis, high blood pressure, sleep apnea, and more.

Check out “Doctors Test the Limits of What Obesity Drugs Can Fix.”

Flu foreshadowing

While health officials are tracking the spread of bird flu, a different strain of everyone’s favorite virus — H1N1 — has been mutating into not one but two variants that resist Tamiflu. Oh, and both are already in the US (and, in fact, on every continent (except Antarctica)).

The good news is that “These mutated viruses retained sensitivity to other anti-influenza medications, including a newer one, baloxavir marboxil.”

The other good news is that this has happened before, and those nasty strains tend to get outcompeted, so this is probably just hair-trigger panic about the flu.

Probably.

Beeting heart issues

If you’re a post-menopausal woman, you might want to choke down some beetroot juice. A study out of Penn State found that “daily consumption of beetroot juice […] may improve blood vessel function enough to reduce future heart disease risk.”

Beetroot juice has lots of nitrate, which the body converts to nitric oxide. And nitric oxide can dilate blood vessels — a useful feature especially if you do have a heart attack (or just an episode of limited blood flow).

Bees sniff cancer

Oh, Mother Nature, how she likes to play. Her latest trick: Giving bees the ability to smell lung cancer. Mm hmm.

Not only did Michigan State University researchers find that honeybees can smell lung cancer, they can actually differentiate different kinds of tumors.

Wait, it gets cooler. How did they know the bees could detect it? They created a harness to hold a single bee in place while they stuck an electrode into its brain.

“We pass those odors on to the antenna of the honeybees and recorded the neural signals from their brain. We see a change in the honeybee’s neural firing response.”

The obvious plan would be to use swarms of honeybees as an alternative to biopsies, but that’s probably a bad idea. (If nothing else, putting it in the form of a take-home test would be difficult.) Instead the MSU folks hope to use what they’ve learned to create an artificial ‘nose’ of sorts.

“Plant” doesn’t mean “healthy”

If you thought that eating plant-based burgers was a healthy option (looking at you, Impossible Whopper), bad news: They’re so over-processed that it negates any health benefit.

New research has found that eating plant-based ultra-processed foods may increase your risk of heart disease and early death,” according to an international group of researchers.

Why? They may not have meat, but they have plenty of fat and sodium and they’re a bit lax on the nutrients. Turkey burgers for the win!

And it gets worse

Eating ultra-processed foods can keep you up at night. A three-year French study found “a statistically significant association between consumption of ultra-processed foods and chronic insomnia independent of sociodemographic, lifestyle, diet quality, and mental health status characteristics.”

There is the usual caveat here: The Frenchies found an association but can’t determine causation, so it’s possible that the opposite is true — people with insomnia are more likely to hit the kitchen at 2:00 am for some Slim Jims.

The Long Read: Behind the curtain

A pair of researchers — one Canadian, one Dutch — went through the documents opioid maker Mallinckrodt was forced to release in its settlement with the US government. (Mallinckrodt actually sold a heck of a lot more opioids than Purdue Pharma.)

The records showed all the tactics Mallinckrodt used to increase sales, addiction be damned.

The documents outline a smorgasbord of tactics to achieve greater sales — from shaping the language of medicine through designing continuing medical education (CME) courses and recruiting physicians to serve as influencers, to planting articles in scientific journals. And all of this against the backdrop of an epidemic of addiction.

Welcome to the future

Want to deliver drugs to metastatic lung tumors? How about using — and we’re not kidding — cyborg nano-robots?

UC San Diego engineers wrapped doxorubicin in nanoparticles, coated them with the membranes of red blood cells, then attached them to green algae cells that can swim. They injected that the lungs of mice, where the red-blood-cell camouflage helped ensure they weren’t attacked by the immune system.

If that isn’t a 21st century paragraph, I don’t know what is.

Oh, and “Treated mice experienced a median survival time of 37 days, an improvement over the 27-day median survival time observed in untreated mice.”

Bird flu news

Testing? What testing?

So we know the bird flu is spreading, and — let’s be real — it’s probably only a matter of time before it’s a human problem. Good thing we’re able to test for it to get ahead of another pandemic! Oh, wait.

Right now there’s only one authorized test (the CDC’s), and it’s only for people who work with livestock. A single authorized test? Sound familiar? As Donald Trump’s coronavirus response coordinator put it, “We’re making the same mistakes today that we made with Covid.”

This time, though, some people — farmers — may not want to know if they or their livestock are sick because of the economic impact. The lack of testing means someone could have, say, pink eye, a runny nose, or a fever and no one would know if it was the flu.

The usual suspects … and more

If you’re keeping track, besides birds and livestock, H5N1 has been detected in bears, big cats (fishers, mountain lions, bobcats), domestic cats, coyotes, dolphins, foxes, martins, mice, minks, opossums, otters, raccoons, seals, skunks, and squirrels.

Vaccine development

There are two dozen companies (literally 24) working to find a bird flu vaccine for cows, in addition to the USDA. That agency is also looking at the possibility of respiratory spread, which we really, really don’t want to happen.

Don’t hold your breath for a cow vaccine, though. “That could happen tomorrow, or it could take six months, or it could take a year,” said Agriculture Secretary Tom Vilsack.

Great idea (not)

If you’re thinking, “Why not vaccinate the chickens and turkeys? Isn’t this the bird flu?” the Des Moines Register explains why it’s not that simple:

Because the vaccine can mask symptoms in infected birds, other countries would likely ban U.S. poultry imports, costing producers an estimated $24 billion and axing 215,000 poultry jobs, an export council analysis shows. In addition, vaccinating hundreds of millions of chickens, turkeys and other poultry — potentially more than once — is a costly and practical challenge. Plus, researchers still are trying to determine how effective vaccines would be.

So yeah … no.

Are you kidding?

Pasteurizing milk kills the flu virus, so the milk supply is safe, unless you’re foolish enough to drink raw milk, which obviously people aren’t going to do.

Oh, wait. “Interest in raw milk is soaring, and some states are moving to legalize its sale.”

The latest definition of “long Covid”

The folks at the National Academies of Sciences, Engineering, and Medicine have come up with what they hope to be the definitive description of long Covid — at least until someone else comes up with one.

They’ve also started capitalizing the “L” and referring to it as “LC” so they’ve definitely gotten serious.

Long COVID (LC) is an infection-associated chronic condition that occurs after SARS-CoV-2 infection and is present for at least three months as a continuous, relapsing and remitting, or progressive disease state that affects one or more organ systems.

There’s a bunch more to it than that, but a big disclaimer: “The definition does not list any symptoms or conditions as being required or any as being exclusionary.” In fact, it’s a pretty broad definition (“LC can follow asymptomatic, mild, or severe SARS-CoV-2 infection”) that boils down to “Still feeling sick after recovering from Covid.”

Compounders: Beware sulfites

Some patients are having allergic reactions to sulfite-containing compounded drugs, and the FDA wants healthcare folks to be aware of them. It’s received reports of a bunch of reactions, from conjunctivitis and swollen eyelids to asthmatic episodes, all of which it thinks might be related to sulfides including sodium bisulfite, sodium metabisulfite, sodium sulfite, potassium bisulfite, potassium metabisulfite.

If you compound, your takeaway is: “Indicate the presence of sulfites on product labels or include a sulfite warning statement.”

Bowel cancer annihilator

A new immunotherapy called pembrolizumab, developed in Britain, destroys bowel-cancer tumors — like totally destroys them. The downside is that it only works for the 15% of people who have a particular genetic makeup. Still, it’s a huge breakthrough (yes, someone called it a “game-changer”).

Results show 59% of patients had no signs of cancer after treatment with pembrolizumab, with any cancer in the remaining 41% of patients removed during surgery. All of the patients in the trial were cancer-free after treatment.

Bonus: None of them required chemo, either.

Arachnophobes can relax

Every kid knows that when it comes to dangers lurking in the world, black widow spider bites top the list^*. Good news: German researchers think they’ve found an antidote.

Today, the only antivenom (or antivenin, if you’re that sort) comes from horses; it can trigger all sorts of allergic reactions. If the Germans’ human-specific antibody pans out — so far it’s only been tested in the lab — it could finally end the scourge that has taken so many lives on late-night TV movies.

Bad news: So far they’ve only created an antibody for two of the three varieties of black widows in the US. But they’re working on it.

^* Followed by quicksand and being trapped in a refrigerator

Statin overuse?

Do too many people take statins? Maybe. A new analysis from the University of Pittsburgh, based on the American Heart Association’s new risk calculator, suggests as many as 40% fewer people need statins that then current model suggests.

Essentially the Pittsburghians compared the 2013 calculator’s results with the 2023 version when applied to the records of 3,785 adults.

Overall, 4% of people had a 10-year risk of developing cardiovascular disease, compared to the 8% previously predicted by the [equations]. The number of adults recommended for statins could drop from 45.4 million to 28.3 million.

Medicare rule clobbers pharmacies

Biden administration: New rule! Medicare and Medicaid patients are gonna pay less for their meds. We’ll make price adjustments first, at the pharmacy counter, rather than later.

PBMs: Ah, so essentially our clawbacks will happen immediately.

Administration: Um, yeah. But it will save patients and the government money.

Independent pharmacists: Wait a second! That cuts my reimbursement from the PBM — sometimes it’s less than what I pay for the drug!

CMS: “We cannot interfere in the negotiations that occur between the plans and pharmacy benefits managers. We cannot tell a plan how much to pay a pharmacy or a PBM.”

Independent pharmacists: [expletive deleted]

The X for Y files: melatonin

Sleep, shleep — taking melatonin supplements might reduce the risk of age-related macular degeneration. That’s what researchers at Case Western Reserve University found when they parsed the medical records of almost 190,000 people aged 60 and older.

In fact, they found that melatonin use both reduced the risk of developing macular degeneration (in patients didn’t have it) and reduced the chance of it worsening (in patients who did).

CVS faces store-brand recalls

Even the big guys can have serious manufacturing problems. Several factories that make CVS-branded products have had conditions bad enough to force product recalls, according to a Bloomberg investigation.

One factory making CVS-branded pain and fever medications for children used contaminated water. Another made drugs for kids that were too potent. And a third made nasal sprays for babies on the same machines it used to produce pesticides.

Bloomberg focused on CVS, but the company isn’t alone. One of the issues for large chains that contract with manufacturers is that the FDA considers them “private-label distributors,” who are themselves responsible for the quality of the drugs, rather than the FDA.

Elsewhere: Baltimore edition

The city of Baltimore opted not to participate in the Big Opioid Settlement, and it seems to have been the right choice. The city just won a $45 million settlement from Allergan for its role in the opioid epidemic — $38 million more than it would have received if it had joined the big settlement.

The Allergan victory is just the beginning.

The city is still suing Johnson & Johnson, McKesson, Cardinal Health, AmerisourceBergen, Walgreens, CVS, Teva, former Insys CEO John Kapoor, members of the Sackler family and others.

People are still researching this

Researchers at the University of Chicago have just reported a shocker: You can’t get good health information on TikTok.

The research group’s next study will question whether it’s safe to tug on Superman’s cape or spit into the wind.

The Long Read: Could Covid cause weird cancers?

During the height of the pandemic, oncologists began noticing “an uptick in aggressive, late-stage cancers” — anecdotes later borne out by data.

Could it simply be caused by disruptions to care? If so, how would that explain the emergence of unusual cancers? Or could it be that Covid can cause a chain reaction — “an inflammatory cascade and other responses that, in theory, could exacerbate the growth of cancer cells”?

RSV shot coming to the 50s set

Good news for people aged 50–59 at high risk from RSV: The FDA gave its stamp of approval to giving them GlaxoSmithKline’s vaccine. Right now you have to be at least 60 to get it, but GSK says that ‘More than 13 million Americans ages 50 to 59 have a medical condition that increases their risk of having a severe RSV outcome.’

That doesn’t mean those folks can get it immediately. The CDC hasn’t blessed the vax yet, and it won’t until July at the earliest. And insurers, including Medicaid, won’t cover it without the CDC’s thumbs-up.

Coming soon: Moderna’s combo vax?

The idea of a combo Covid/flu shot has been floated ever since we realized we’ll probably need annual updates for both. Now good news from (and for) Moderna: The company says its combo mRNA vaccine elicited…

…‘significantly higher immune responses’ against a number of influenza strains, as well as against SARSs-CoV-2, the virus that causes Covid-19, after a single dose.

That’s compared to Moderna’s existing Covid vaccine and the Fluzone HD flu shot, so yeah — it’s better than what’s out there, and faster to produce, too.

Danger of a stronger nicotine

Vape makers are getting around nicotine regulations by creating nicotine variants — e.g., 6-methyl nicotine — that are more addictive than nicotine. That lets them skip FDA approval while still getting kids hooked on e-cigs.

Twist: That was brought to the FDA’s attention by legit e-cig companies including Altria (née Philip Morris) and British American Tobacco.

[Altria] urged the agency to evaluate the compounds and establish what authority it had over them, warning they posed a “new threat” to regulation of the sector.

In related news

The feds, it seems, are going to crack down on illegal e-cigarettes.

There are only 23 approved tobacco-flavored vapes, but you wouldn’t know that looking at what’s for sale in some places. So the FDA and the Justice Department have launched a new task force — it includes the ATF, US Marshals Service, and even the US Postal Inspection Service and the FTC — to ensure “vigorous enforcement of the tobacco laws” including “criminal and civil prosecutions, seizures, and forfeitures.”

Short Takes

Paxlovid fails against long Covid

Paxlovid might help shorten Covid symptoms, but it doesn’t help relieve long Covid. That’s the result of a study out of Stanford University, where they were hoping to find a treatment for the brain fog and exhaustion that affects a lot of people (10%?) who have recovered from the disease.

Another needle-free insulin candidate

This one consists of drops placed under the tongue. The trick is a “unique cell-penetrating peptide” developed at the University of British Columbia that allows the insulin to squeeze through the lining of the mouth and into the bloodstream. Still, it’s only in pre-clinical trials.

FDA committee backs Lilly’s Alzheimer’s drug

After a delay earlier this year, an FDA ad­vi­so­ry com­mit­tee gave an 11-0 thumbs-up to Eli Lil­ly’s Alzheimer’s drug do­nanemab. (That’s just the adcomm, though. The FDA still has to make the formal approval decision.)

When ferrets are canaries

Give ferrets the (human) seasonal flu, and they get sick. Give them the bird flu that infected a Texas dairy worker and they die. That’s not a good sign.

Ferrets are considered the best small mammal for studying influenza virus infection and transmission and are commonly used as a tool to inform public health risk assessments of emerging influenza viruses, according to the CDC.

The good news is that “The virus was less efficient than other influenza strains at spreading by respiratory droplets,” meaning it “would need to undergo changes to spread efficiently by droplets through the air.”

And really, what are the chances of a virus mutating like that?

News shocker: Pharmacies are closing

The Associated Press has just realized that a heck of a lot of pharmacies are closing, and that’s not good for anyone (especially rural areas and Black and Latino neighborhoods). Chains have shareholders to cater to, so they close less-profitable locations, while independents having fight tooth-and-nail to get fair reimbursements from PBMs.

Across the U.S., more than 7,000 pharmacies have closed since 2019, according to data from University of Pittsburgh researcher Lucas Berenbrok, who considers that estimate conservative. Of those pharmacies, 54% were independent drugstores.

Blame the closings on problems like sliding revenue and rising expenses. For years, the reimbursement that drugstores receive for filling most prescriptions has shrunk while things like utilities and employee pay continue to climb.

Eventually we’ll need to worry

The first human has died from bird flu — a man in Mexico. What’s notable is that he died from the H5N2 strain, not the H5N1 variant that’s sickened at least three people in the US of A. It’s also the first documented human case of H5N2.

If you’re the worrying type, here are a couple of other tidbits to feed your unease:

1. The gentleman in question had significant underlying health issues, but he didn’t have contact with poultry or livestock.
2. “Twelve additional people the patient came into contact with — seven with symptoms and five without — were identified near the patient’s residence.” Those could be the first human-to-human transmission of bird flu.

Fear not, though! “The Ministry of Health informs that there is no risk of contagion for the population with the detection of the first human case of low pathogenic avian influenza A (H5N2) in Mexico, since there is no identified source of infection.”

Yep: Since they don’t know where it came from, there’s no risk!

Good news from two studies

Melanoma vax leads to long-term survival

Moderna and Merck’s cancer vaccine — combined with Keytruda — worked incredibly well against melanoma.

[A]fter two and a half years, melanoma patients that had received the cancer vaccine combination showed an overall survival rate of 96%, compared with 90.2% with Keytruda alone.

Multiple myeloma breakthrough

GSK’s multiple myeloma drug Blenrep “nearly halved the risk of disease progression or death compared to standard-of-care treatments” according to a phase-3 study.

In the trial of 302 patients with relapsed or difficult-to-treat multiple myeloma, 71% of those who received Blenrep in combination with the steroid dexamethasone and pomalidomide were alive without their disease worsening at the end of a year.

Even better, Blenrep is an outpatient drug that’s (relatively) easy to produce.

A spoonful of AF-353 helps the medicine go down

Some medication is so bitter — and some people are so sensitive to tastes — that a spoonful of sugar ain’t gonna help it go down. Adults can (usually) buck up and swallow, but try convincing a five-year-old how important it is to take his Augmentin.

To the rescue are the researchers at the Monell Chemical Senses Center in Philly. Despite living in Eagles territory, they actually have something useful to contribute to society: They’ve identified “the first temporary, universal taste blocker.”

“Remarkably, and unlike our experience with blockers of bitter taste receptors, the taste-nerve blocker we tested worked for every subject and every bitter compound we tested.”

That’s a breakthrough because the tongue has several kinds of bitter taste buds, and blocking one didn’t mean blocking the others; you would need a different “bitter blocker” for each yucky med.

The only downsides to their new compound, called AF-353, is that once you put it on the tongue it lasts 60-90 minutes and it also affects other tastes. That means you couldn’t give Junior some ice cream as a treat for taking his meds.

Four scary words

“Drug-resistant jock itch.”

Cases of highly contagious and tough-to-treat cases of ringworm are appearing across the country from two different strains of fungus.

One outbreak is caused by Trichophyton mentagrophytes type VII (TMVII), which, while it seems to respond to terbinafine, can take months to clear up.

The other comes from Trichophyton indotineae — and that is resistant to terbinafine. (Even 42 days of treatment didn’t help.) It’s a new mutation that has “several variations in the genetic code that prevent terbinafine from hooking onto fungal cells and poking holes in their protective membranes.”

The good(ish) news is that Trichophyton indotineae can be treated with itraconazole. The bad news is that itraconazole has a long list of side effects.

Oh, and compounding the issue is that both “may instead be confused for lesions caused by eczema and can therefore go without proper treatment for months,” and that’s coupled with the fact that folks don’t always want to talk about issues down there.

Inhaler prices drop (probably)

The price of asthma inhalers from AstraZeneca and Boehringer Ingelheim has dropped (at least it’s supposed to have dropped) to $35 per month out of pocket. GlaxoSmithKline said it’ll be following suit in January.

The price drops come as the government has turned its attention to the fact that inhalers cost Americans a heck of a lot more than they do people in other countries. (“AstraZeneca charges $645 in the U.S. for the same inhaler it charges $49 for in the U.K. Teva Pharmaceuticals […] charges $286 in the U.S. for an inhaler that costs $9 in Germany.”)

Manufacturers are afraid that they’ll be forced to lower prices, and this way they can do it on their terms and reap the PR value. How easy it’ll be for patients remains to be seen

A spokesperson for Boehringer Ingelheim said the $35 cap will be automatically applied at the pharmacy counter for the majority of eligible patients with commercial insurance. For those without insurance or whose pharmacies aren’t participating, they’ll be able to visit the company’s website starting Saturday, where they can enroll in a copay card that will reduce the out-of-pocket cost to $35.

As one immunologist put it, “I think what you’ll find is most doctors saying, ‘I’ll believe it when it happens’.”

Short Takes

Pharma pollution

We’re drugging a heck of a lot of animals and plants. And by “we” I mean pharmaceutical manufacturers.

Swedish and British researchers have found that “discharges to the environment during drug production, use, and disposal have resulted in ecosystems around the globe being polluted with mixtures of pharmaceuticals, posing a growing danger to wildlife and human health.”

Any day now

The next next candidate for male birth control comes from YourChoice Therapeutics, which just completed a phase-1 study on 16 men “showing that doses of their drug YCT-529 are safe for men.”

What’s interesting is that the drug might be able to be taken every two weeks, making compliance less of an issue.

The Long Read

“Pharmacies are in shambles.”

The gathering tsunami of pharmacy shutdowns highlights a worsening national crisis for the United States, where health care is the most expensive in the world. As U.S. health care companies continue getting bigger and more consolidated, while the number of primary care doctors shrinks, pharmacies could have filled in some of the gaps. Instead, they’re becoming dystopian nightmares—or vanishing entirely.