ICYMI: Telehealth prescribing extended

Patients who use telehealth to get controlleds will still be able to do that without an in-person visit, thanks to an agreement between the DEA and HHS. These “telemedicine prescribing flexibilities,” which started during the pandemic, will be in place at least through the end of 2025.

Our number 2 story

Background: Fecal microbiota transplants (FMTs) have been shown to be a disturbingly useful tool for fighting bacterial infections (looking at you, C. diff). It may even help with other conditions, from obesity to depression.

These are done, as Prince might say, ‘in through the out door’ via various techniques, none of which are appropriate for a family newsletter. And it comes with risk, notably that there might be pathogens in the donor stool.

But now a group of those shifty Danes think they’ve found a better way to do an FMT. They’ve managed to use fermentation to cultivate bacteria from feces — and the technique allows them to control which bacteria are grown.

Twist: They’re growing “bad” gastrointestinal bacteria; their plan is to kill those bacteria and leave only the bacteriophages that attack them. Then they’ll put those phages in a pill, which would kill the unwanted bacteria in a patient’s gut.

The long-term goal is for the treatment to evolve into a simple pill that can be prescribed by a doctor or found on a pharmacy shelf — tailored to individuals, but accessible to all.

Three bits of good news

… about drug overdose deaths

They look like they’ll end the year at the lowest level since the pandemic — and this year they’ve dropped for the first time in 5 years (for 12 straight months!), according to CDC data, thanks in large part to federal law enforcement intercepting the drugs. Fun fact: Despite what you might have heard, those drugs aren’t smuggled across the border — they’re shipped in through ports.

… about drug shortages

After hitting an all-time high of 323 meds in shortage, the number dropped to just 277 in the second quarter of this year, according to the American Society of Health-System Pharmacists and the University of Utah. That marks the second quarter in a row where active shortages have decreased.

… about STDs

The nationwide STD epidemic might finally be slowing. The number of sexually transmitted infections is down about 2% from 2022 to 2023. Hopefully it’s the start of a trend, rather than a single downward blip.

More than 2.4 million STIs were reported last year, compared to more than 2.5 million in 2022, with nearly half occurring in adolescents and young adults aged 15–24, according to a report by the [CDC].

Now it’s the carrots

Just as the nation is recovering from the deadly E. coli outbreak from McDonald’s, the CDC is reporting “a multistate outbreak of E. coli O121 infections linked to multiple brands of recalled organic whole bagged carrots and baby carrots sold by Grimmway Farms.”

Brands: 365, Bunny Luv, Cal-Organic, Compliments, Full Circle, Good & Gather, GreenWise, Grimmway Farms, Marketside, Nature’s Promise, O-Organic, President’s Choice, Raley’s, Simple Truth, Sprouts, Trader Joe’s, Wegmans, Wholesome Pantry

How ketamine works

It’s not news that ketamine can treat depression quickly — within hours in many cases. What’s eluded researchers is exactly how that happens. What’s ketamine doing in the brain?

Now biochemists at the University of Buffalo say they know.

Ketamine, they found, works on particular neurotransmitter cells called NMDA receptors. There are several kinds of these, but what the Buffaloians found is that ketamine works on some of them — only the ones that are active for longer periods. (Some are just intermittently active.) Drugs that target all the NMDA receptors, on the other hand, have all sorts of negative side effects.

“[Activating those receptors] results in an immediate increase in excitatory transmission, which in turn lifts depressive symptoms. Moreover, the increase in excitation initiates the formation of new or stronger synapses, which serve to maintain higher excitatory levels even after ketamine has cleared from the body, thus accounting for the long-term relief observed in patients.”

Figuring out ketamine’s mechanism, they think, might lead to even better quick-acting antidepressants.

Elsewhere: Baltimore does it again

Back in September, we told you how Baltimore scored big by opting out of the nationwide opioid settlement and suing drugmakers and distributors on its own. Welp, it did it again, this time scoring a $274 million jury verdict against AmerisourceBergen and McKesson.

But there could be more:

Circuit Judge Lawrence P. Fletcher-Hill scheduled an “abatement” trial in December. That proceeding determines how much the companies must pay to help Baltimore mitigate the ongoing crisis a jury has now ruled that they fueled.

The city will ask for up to $11 billion in abatement.

How does obesity lead to type 2 diabetes?

Current thinking: Obesity impairs the signaling between the liver and fat cells.

New idea out of Rutgers: It’s actually caused by norepinephrine and epinephrine — those stress hormones counteract insulin’s effects, rather than blocking any signals.

How’d they figure it? First researchers created mice without stress hormones (catecholamines) outside of their central nervous systems^*. Then they overfed those mice, as well as normal mice. The genetically engineered mice didn’t develop diabetes.

So why not use catecholamine-blocking drugs? Interestingly, those don’t affect diabetes, so a next step is figuring out why. (It might be that those drugs “don’t block the relevant receptors or because they affect the brain and body in complex ways.”

You know the mantra: More research is needed.

^* Take a moment to appreciate how genetically engineering those mice was a minor step in the process and barely worth a mention. Welcome to the future.

ICYMI

Novavax continues combo-shot trial

Last month the FDA stopped Novavax’s trial of a combo flu-Covid vaccine because of a serious adverse effect on one patient. But the trial can now continue; it turns out that the patient has ALS, and his symptoms weren’t related to the vaccine.

Serious bird flu case in Canada

A Canadian teenager is in critical condition with a case of H5N1 bird flu. As of this writing, health officials in British Columbia don’t know how he or she contracted it. They assume it was contact with an animal, but the province hasn’t had any cases in dairy cattle, the usual animal culprit. The teen had no other health issues.

No heart failure? No beta blockers

People who have heart attacks are often given beta blockers as a matter of course, but a new Swedish study found that not only is that unnecessary, it can raise the risk of depression.

If a patient isn’t suffering from heart failure, the Swedes found, beta blockers don’t help. On the other hand, the side effects can be considerable: “[B]eta blockers are linked to negative side effects such as depression, difficulty sleeping, and nightmares.”

Vitamin D and BP

Overweight older people might be able to lower their blood pressure with vitamin D and calcium supplements. That’s the conclusion of a new study out of American University in Beirut, but it’s got caveats.

First, the participants had low vitamin D levels in their blood. Second, “[M]ore is not necessarily better when it comes to lowering blood pressure. The effect was independent of the dose administered.”

That implies something found in other studies: Getting vitamin D levels to 30 ng/mL or above can have a range of good health effects, but supplements won’t do much for people who aren’t vitamin D deficient.

Captain Obvious sells laetrile on the side

In a shock to absolutely no one, British researchers found that 81% of cancer “cures” promoted on TikTok were fake, and most were designed to sell those products to gullible people.

Worse, the fact that people buy into this tripe can also lead them down the road to other conspiracy theories (e.g., ‘the government is covering up a cancer cure’) and even radicalization.

[T]he cancer misinformation videos can become a gateway to more extreme, conspiratorial content. In the attention economy, content creators are encouraged to post increasingly salacious content, as this is incentivised by the algorithm and the creators stand to gain financially.

Gosh, I wonder why people have trust issues

A UNC professor’s research found that state medical boards rarely discipline physicians who spread health misinformation. Based on his analysis of “[more than] 3,100 medical board disciplinary proceedings across the nation’s five most populous states,” he found that “spreading misinformation to the public was the least common reason for physician discipline, accounting for just 0.1% of all disciplinary offenses.”

“There’s a striking disconnect between medical boards’ statements about the dangers of physician misinformation, as well as increasing public attention to the problem, and the actual enforcement actions.”

Non-pharma medical story of the week:
It has the utmost confidence in this surgery

An AI-powered robot has been trained to perform surgery by watching videos of human surgeons at work. And in then “executed the same surgical procedures as skillfully as the human doctors.”

Said one member of the team of Johns Hopkins and Stanford engineers who built the thing, “It’s really magical to have this model and all we do is feed it camera input and it can predict the robotic movements needed for surgery.”

CVS won’t be getting a Taylor Swift song just yet

Back in October, Bloomberg and Reuters reported that CVS was considering breaking up, splitting the pharmacy business and the insurance business. Welp, that may have been premature. Per Forbes, CVS CEO David Joyner gave investors “no indication any company breakup was in the cards” in the latest earnings call.

In fact, Joyner committed to forging ahead to improve the diversified portfolio of businesses CVS has that include drugstores and an array of outpatient services and primary care clinics; the Caremark pharmacy benefit management company, and Aetna.

Phrase of the day: Joyner referred to the company’s “omnichannel capabilities.”

… and neither will Cigna

Cigna says that no, it’s not planning to hook up with Humana, saying it’s “focused on acquisitions that are ‘strategically aligned, financially attractive, and have a high probability to close’.”

PPIs seem heart-safe

Proton pump inhibitors have been linked — at least anecdotally — with cardiovascular events. But is there data to back that up? Nope, according to a new meta-analysis out of an FDA lab.

The researchers looked at 52 placebo-controlled trials totalling almost 15,000 patients, and what they found was “no significant association between PPI and cardiovascular events.”

They also looked at 61 other trials that compared PPIs with other treatments (e.g., histamine-2 receptor antagonists) and found the same — “no association between PPI treatment and the risk for cardiovascular events.”

Pharmacies sue GoodRx, PBMs

Could GoodRx be in cahoots with PBMs? That’s what at least three class-action lawsuits by independent pharmacies contend.

Essentially, they say that PBMs — plural — entered into agreements with GoodRx so that GoodRx would steer the purchase to the PBM with the lowest price.

The fee the pharmacies pay to be part of GoodRx is then split between the patient’s PBM and the PBM that handles the purchase.

The PBMs do not reimburse pharmacies for these transactions, meaning the patients’ cash payment represents the pharmacies’ only revenue, and PBMs’ profits increase, the lawsuits say.

Money quote: “CVS Caremark generally reimburses independent pharmacies at higher levels than chain drugstores, including CVS pharmacies.” —CVS Caremark spokesman Mike DeAngelis.

A lupus … cure?

When you think of CAR-T therapy, you think of cancer treatment. Now, though, British and European researchers found that it can treat lupus.

In the UK, three patients have received CAR T-cell therapy for the most serious form of lupus, which can be life-threatening and cause damage to the heart, lungs, brain and kidneys. In Germany, patients who have had the new treatment are now in remission and do not need to take lupus drugs.

A lot more long Covid than we thought

When humans estimated how many people have long Covid, they came up with about 7%. But when AI was given access to the health records of almost 300,000 people in Massachusetts, it found the number was more like 23%. That would be almost 79 million Americans.

The AI looked for people who had Covid-19 and then later reported symptoms associated with long Covid — symptoms that couldn’t be explained by their other diagnoses. (E.g., shortness of breath in someone who had asthma wouldn’t count. “Only when every other possibility was exhausted would the tool flag the patient as having long Covid.”)

Interesting side note: This jibes with a 2-year-old CDC study that suggested “More than 1 in 5 adult Covid survivors in the U.S. may develop long Covid.”

Ignorance is bliss

A new report from the National Center for Health Statistics, based on a detailed 2-year survey of more than 6,000 people, found that 40% of Americans who have hypertension aren’t aware of it. Men were both more likely to have it and to be unaware of it.

Please remember

Tomorrow, Nov. 13, is Tailbone Pain Awareness Day.

Finally, it’s over

After literally years of knowing it doesn’t do a bleepin’ thing, the FDA is finally proposing to revoke its approval of oral phenylephrine — the ingredient that replaced pseudoephedrine in cold and flu products when pseudoephedrine went behind the counter. (It used to be used in meth production.)

Thing is, phenylephrine doesn’t work. We’ve written about it several times, and it’s not a secret that it’s a placebo with a fancy name. There have even been lawsuits about its marketing.

Annnnnnyway, the agency is seeking comments, and in the meantime it’s still legal to include it. Oh, and if phenylephrine is pulled, it will still be allowed in nasal sprays for people who enjoy deluding themselves.

The drugs we’re buying

What drugs do Americans spend the most on? Glad you asked. In a shocker, the number one in 2023, in terms of dollars spent, was … brand-name semaglutide (Ozempic and Wegovy). That’s according to data from the AARP, and it found Americans spent about $38.6 billion on that alone.

Semaglutide bumped adalimumab (aka Humira) from the top spot; we spent a mere $35.3 billion on adalimumab. The rest of the top 5 are apixaban (Eliquis), dulaglutide (Trulicity), and empagliflozin (Jardiance). Tirzepatide comes in at number 8, if you’re curious.

Overall drug spending jumped 14% from 2022 to 2023, driven by greater use of drugs, expensive new meds, and of course drug company’s raising prices.

Flovent fallout

Earlier this year, GSK pulled its Flovent inhaler from the market and replaced it with an identical generic version. You wouldn’t think this is a big deal … unless you live in a country where access to medications is controlled by profit-driven pharmacy benefits managers.

The result of the Flovent change “was that the generic alternative was actually more expensive than the previous brand,” as one pediatrician put it. PBMs pushed patients to other, branded inhalers that made them more money, but that weren’t as effective for kids.

Result: More kids are ending up in the hospital because they can’t get their asthma under control.

“The combination of Flovent going off the market and the increasingly restrictive formularies from payers has just made caring for asthma in 2024 much more of a challenge than in previous years.”

Next time someone says, “Do you want a health system where the government decides what drugs you can get?” ask them, “Do you want one where insurers and PBMs do?”

Short Takes

Expanding bird flu testing

Despite pushback from the dairy industry, the USDA is starting to take bird flu more seriously. It’s now expanding human testing to anyone exposed to sick animals, not just people with symptoms.

The change to the agency’s testing recommendation comes as the U.S. Department of Agriculture is also expanding its testing of milk for bird flu, signaling concern by both agencies about the ongoing spread of the virus on dairy and poultry farms.

ICYMI: Diabetes is everywhere

The latest CDC figures show that almost 16% of Americans have diabetes — 1 in 6. (The vast majority have type 2.) And those are the diagnosed cases; there are probably a lot more out there.

Contrast the previous figures from 2000, when only about 9.7% had diabetes, so something is pushing the numbers up. (Age is certainly a factor, though.)

Isn’t this how a horror film starts?

“Police hunt 43 monkeys that escaped from a South Carolina research facility”

The Long Read: Detective work

It didn’t take long for health officials to figure out that it was tainted onions making McDonald’s customers sick. How’d they find the answer so quickly? Let’s just say these people — the CDC and state health departments — really know what they’re doing. Enjoy “How disease detectives’ quick work traced deadly E. coli outbreak to McDonald’s Quarter Pounders.”

Fatty acids’ new trick

A new study out of UGA found that omega-3 and -6 fatty acids don’t just lower cholesterol and protect brain health. They also seem to reduce the risk of cancer.

That conclusion is based on health records from a UK database of more than 250,000 people over more than a decade.

Omega-3s protected against colon, stomach and lung, and digestive tract cancers, while omega-6s “led to lower rates of 14 different cancers, including brain, malignant melanoma, bladder, and more.”

One twist: “[H]igh omega-3 levels could be associated with a slightly higher risk of prostate cancer.”

Fall Region Meetings are coming!

Big news! We’ve scheduled the first three of our 2024 Fall Region Meetings! If you’re in regions 1, 4, or 10, you can register today.

• Region 1: Tuesday, November 19 @ 6:30 pm — District Square Foodhall in Springfield
  → Register here! ←

• Region 4: Tuesday, November 19 @ 6:30 pm — Piedmont Brewery in Griffin
  → Register here! ←

• Region 10: Wednesday, December 11 @ 6:00 pm — Athenic Brewing in Athens
  → Register here! ←

Not sure of your region? Click here.

Want to know more about region meetings? Click here.

We’ll be announcing meeting dates for the other regions as soon as we’ve finalized the locations. Stay tuned!

Short Takes

New envelope mandate

The FDA is now requiring opioid manufacturers to provide pharmacies and dispensaries with mail-back envelopes so patients can return unused opioids.

The FDA said the goal of the change is to provide patients and caregivers with a free method to return unused or leftover opioids provided by the outlet that dispensed the medication.

Prescribers who give a lot

Doctors who prescribe a lot of antibiotics also prescribe a lot of opioids — or at least noticeably more than average — according to researchers from the Washington State Department of Health.

AZ enters GLP-1 fray

Not to be left off the cash-generating monster that is modern weight-loss drugs, AstraZeneca says its pill (which it licenses from Chinese company Eccogene) just passed its phase 1 “is it safe and tolerable?” trials.

It’s yet another GLP-1 agonist, but it’s a once-daily pill instead of an injection. It has similar side effects to injectables, but it has another advantage. Because it’s a small-molecule drug, it…

… can be combined with other small molecule drugs, which is important because more than 60% of obese and overweight people have one or more other medical conditions.

Speaking of GLP-1s, though…

Patients aren’t just quitting GLP-1 drugs — they’re dealing with some serious side effects, and now they’re suing the drug companies.

Thousands of people who have developed health problems including intestinal blockages, gallbladder damage, and especially gastroparesis after taking GLP-1s have filed, or are expected to file, lawsuits against Novo Nordisk and Eli Lilly, arguing they were not adequately informed about the risks of using these medications

The Long Read: hormone therapy and dementia

There’s been a connection — some kind of connection — between women’s hormone replacement therapy (with estrogen and/or progestin) and the risk of dementia. But as in a lot of cases, it’s not a black and white issue.

The timing of the therapy seems to make a big difference, but beyond that it’s just nuance on top of nuance. Medscape gives the latest overview of the science — including what we don’t know.

New drug … or Turkish soccer player?

It’s that time again — time to play the latest version of everyone’s favorite pharmaceutical game!

This time, five of these are new drugs approved by the FDA in 2024, and five are the surnames of players on the Turkey National Football Team.

Difficulty: We’ve anglicized the spellings of their names, removing all the diacriticals.

Do you know which is which?

• Anktiva
• Aqneursa
• Demiral
• Elmali
• Imdelltra
• Karazor
• Sengezer
• Vyloy
• Yildirim
• Zelsuvmi

Check your answers here.

The Flu Index is back

Walgreens’s annual Flu Index is back for the 2024–25 season, and so far it’s showing low activity in most of the country. Mississippi is in the worst shape; it’s in the middle of the index at yellow, while Alabama, Florida, Louisiana, Tennessee, and Texas are all slightly above “low.” Georgia is ranked #10 of all states, but we’re surrounded by the sick, so that might not last.

Canadian resiliency

Even after drug supply chains were disrupted, Canadians saw fewer shortages than we did down here in the States. That’s what a joint study from the universities of Toronto and Pittsburgh found after looking at supply chain issues in both countries between 2017 and 2021.

The countries have similar regulatory structures, and the researchers only considered the effect of similar shortages. They found that supply chain issues caused a shortage in the US about 49% of the time, but the same issues only caused a Canadian shortage 34% of the time.

So what’s the difference?

The biggest factor, they found, is that Health Canada has better relationships not only with drug makers, but with other stakeholders such as wholesalers. That gives the Canadians more information about impending shortages, and the government the ability to react more quickly. (In the US, for example, manufacturers don’t have to give a reason for their shortages, which the researchers called “suboptimal” as it doesn’t provide useful information to health authorities.)

Also, while the US has an emergency national stockpile for “acute events,” Canada’s stockpile is available to alleviate shortages caused by supply chain issues. The result:

Although both countries were affected by drug-related supply chain issues during this period, reports were 40% less likely to result in meaningful drug shortages in Canada.

TB takes the #1 spot

Tuberculosis has taken Covid-19’s place as the world’s number one infectious disease. In 2023, according to the WHO, 8.2 million people were newly diagnosed with TB around the world — the highest total ever recorded, and a 9% increase from the previous year.

The good(ish) news is that, while infections were up, TB deaths were down in 2023 to about 1.25 million. In contrast, Covid-19 ‘only’ killed about 320,000 people that year.

Microscopic targeted tumor killer

MIT researchers have found a way to deliver a double-whammy of therapy to fast-growing tumors, which they say was more effective and has fewer side effects than current chemo options.

The one-two punch: a chemo drug and heat, both delivered via an implantable microparticle. Implantable in the tumor, that is. Once in place, an infrared laser is used on it. That both releases a drug encased in the particle and causes the particle to heat up. And tumors hate heat.

The result is on-demand, localized treatment — no broad chemo necessary. And it works; in early tests on mice, this dual therapy wiped out aggressive tumors and significantly improved survival rates compared to single treatments.

The X for Y files: a tau-tangle buster

The glaucoma drug methazolamide (a carbonic anhydrase inhibitor) reduced the buildup of the tau protein that’s a hallmark of dementia … in zebrafish. British researchers took advantage of the fishes’ short lifespan and quick breeding to test 1,437 drug compounds against “tauopathy” and found that methazolamide seemed to work. Then they tested it on mice, and discovered “that those treated with the drug performed better at memory tasks and showed improved cognitive performance compared with untreated mice.”

Next up: Testing methazolamide against other diseases such as Huntington’s and Parkinson’s, and possibly moving along to human trials.

What, them worry?

Workers in healthcare facilities are taking precautions against the flu, but Covid-19? Not so much. New CDC data found that 81% of personnel in acute care hospitals got this year’s flu vax, but only 15.3% of them got the updated Covid shot.

In nursing homes it was a lot worse: Only 45.4% of personnel there got flu shots, and only 10% of employees got the latest Covid shots.

In both cases, the South lagged the rest of the nation with notably lower vaccination rates, as did independent contractors (i.e., non-staff). Perhaps they figure their patients are more resilient to respiratory illness.

Treat the person, not the test

You’ve got an ICU patient with hospital-acquired pneumonia. You’ve got two choices when choosing an antibiotic: You can do tests for common pathogens to decide which drug will likely be more effective, or you can consider some patient-specific risk factors.

Researchers at the universities of Michigan and Kansas studied ICU patients, then they did a lot of fancy math to figure out which method (if either) was better.

The answer: Forget testing and go with a ‘risk factor–based regimen.’ Not only did that turn out to be more appropriate more often (89.9% vs 83.7%), it also cut down on the unnecessary use of combination therapy — something that occurred almost 70% of the time when a pathogen test was used.

Baxter is back

Baxter’s IV-fluid-producing plant in North Carolina is back online after having been damaged by Hurricane Helene. It’ll take a little bit to get up to speed, and in the meantime the FDA has allowed temporary imports of IV solution from overseas.

Aspirin and anemia

You may have heard that a potential side effect of daily low-dose aspirin is anemia, probably because of GI tract bleeding. Well it might be a little more complicated than that.

A new, real-world study out of the University of Copenhagen found that yes, anemia is certainly a possible side effect. It looked at the health records of 60,000 of those shifty Danes and found that the incidence of anemia (either mild or severe) was more than doubled in the group taking low-dose aspirin.

The twist:

[O]nly 21.5% of adults who experienced anemia also experienced bleeding […] most anemia events were independent of major bleeding.

So there’s another mechanism at work here, underscoring “the significance of continuous, long-term monitoring for individuals prescribed low-dose aspirin.”

(Side note: The good news is that even with aspirin, the rate of anemia was low — just 3.9% were diagnosed with it.)

A supplement for leg cramps

Got a patient who gets nighttime leg cramps? There could be a simple solution: vitamin K₂. It’s usually in the shadow of its alphabetical predecessors, but for people who get charley horses — that might be more than half of adults — Chinese researchers found that vitamin K₂ supplementation cut the frequency of those cramps by more than half. They also found it reduced the duration and severity of cramps — and it happened within a week.

The other K2

Short Takes

Consumption junction

A student at Walton High School in Marietta brought tuberculosis to class. “The student with the bacterial disease had contact with about 200 students and faculty, prompting public health officials in Cobb and Douglas counties to conduct tuberculin skin tests Tuesday.” Health authorities won’t say how the student contracted it.

This headline doesn’t have a “snot” joke

Everything you wanted to know about mucus — the Times has you covered.

Three more cases

Now there’s a total of 39 known cases of humans infected with bird flu, after 3 more people in Washington State were just added to the list. These latest folks worked at a poultry plant.

Stopping tumors’ immune suppression

Cancer cells have a way of preventing immune cells from attacking them, and interrupting that mechanism is the subject of a lot of research. Now Israeli scientists say they’ve made a breakthrough.

The clue was in UV radiation. When skin is exposed to UV light, the immune system comes to life to limit damage — but the body also activates a ‘brake’ on that response to keep it from being overwhelming. That brake, the Israelis found, is a protein called Ly6a.

The breakthrough: They found that Ly6a is not only expressed by tumors (at least melanoma and colon cancer), but in fact overexpressed. That means it might be the key to removing the tumors’ ability to suppress immune cells.

Next step: Seeing if they can use this finding to create a drug that can be tested.

The Long Read: ingredients and products

Reuters writes about “How Asian pharma suppliers cash in on Ozempic copies,” but makes a common mistake: It doesn’t differentiate between making the ingredient and making a final product.

• Not interesting: There are companies in Asia making semaglutide.
• Interesting: There are companies making illegal finished products (“Fitaro”) and shipping them around the world.

In short: Semaglutide manufacturing is perfectly legal and done around the world, although I wouldn’t trust facilities that didn’t get the FDA’s blessing. But selling copies of the final, injectable product — unless you’re a licensed compounding pharmacy — isn’t legal (at least in the US).

Wegovy available?

The FDA has listed both of Novo Nordisk’s versions of semaglutide — Ozempic and Wegovy — as “available” on its shortage site. But it’s still officially in shortage.

That last part is kind of important, because you know the company will be saying “Ozempic is available now.” It might even take a page from Lilly’s playbook and threaten compounding pharmacists. And news media will be confused, making the whole thing more complicated.

But, once again: Ozempic and Wegovy are still officially in shortage, although the FDA now lists them as “available.” (Yes, it’s a weird system the FDA has, where a drug can be both “Available” and “Currently in shortage.”) But the fact that semaglutide injections are still in shortage means that compounding pharmacists can still compound it.

But are Novo’s drugs safe?

The FDA cited Novo Nordisk for “quality lapses” at the second of the company’s two Ozempic manufacturing plants. This facility, in Denmark, was dinged for potential contamination issues — the other is in North Carolina, which got a similar rebuke from the FDA earlier this year. The Denmark issue is bad enough that the company doesn’t expect it to be resolved in 2024.

More meds, more apps

In case you don’t have enough apps on your phone, drug makers are starting to roll out more of them to go with prescriptions.

The idea is that the apps will “prod patients to take pills as directed, manage side effects, or track how well a treatment works.” They couldn’t possibly be used to collect more information on patients or share that data with third parties. No sirree^*.

This adds a headache for the FDA because the whole app-with-drugs marketplace (they’re called PDURS, or prescription drug use-related software) is still evolving. The agency is working on guidance that will update its 7-year-old “Digital Health Innovation Action Plan.” One question it will grapple with is when an app is promotional and when it’s therapeutic.

^* If you want a shock, download the DuckDuckGo Private Browser for your phone (Android)(iPhone). You don’t need to use the browser, but it includes a feature that blocks apps from sending your data to third parties — and shows you what it blocked. It’s frankly terrifying. Click the pic below to enlarge it to see some of mine.

Congrats to Raquibul!

Mercer pharma prof Raquibul Hasan has received his third grant from the American Heart Association for studying how statins might also relax blood vessels and thus lower blood pressure.

That idea isn’t new, but there’s been conflicting evidence as to whether the effect is real. Hasan’s research is focused on how some statins affect a particular (newly discovered) target, which might explain their effects — and could lead to better-targeted therapies.

FDA wants interactions flagged

The FDA wants to make drug interactions clearer on labels, so it’s issued some draft guidance with the changes it wants to see. Essentially, it’s suggesting, the label…

… must document clinically significant observed or predicted drug interactions in the Drug Interactions section, including interactions with over-the-counter drugs, prescription drugs, drug classes, and foods as well as interference with laboratory tests.

It also needs to give “specific practical instructions” to prevent and manage those interactions, and all in language that’s clear to healthcare practitioners who aren’t pharmacists.

Short Takes

Georgia lacks healthcare access

A new survey out of Forbes Advisor looked at how accessible healthcare is across the country, and Georgia … well, Georgia didn’t do so well, ranking #45 out of the 50 states.

Georgia’s population has the second highest percentage of people who don’t have health insurance, accompanied by a high number of residents who cannot afford a visit to the doctor.

The pigs have it

The USDA has detected the first case of the H5N1 flu virus in a pig — it’s in Oregon, and it lived with poultry that had become infected. This is a little worrying because pigs are one of those animals particularly good at mixing human and animal viruses. The good news: It was a small, non-commercial farm so the risk of further spread is limited.

More drugs in shortage

Here are the latest additions to the list compiled by the FDA and the American Society of Health-System Pharmacists:

• Linezolid injection. Shortages primarily due to manufacturing delays; Piramal Critical Care and Sun Pharma have the injection available.
• Droperidol injection. Only limited supplies available
• 0.9% sodium chloride small-volume bags. Baxter is facing supply issues due to damage at its North Carolina plant.
• 23.4% sodium chloride injection. Estimated release dates for Fresenius Kabi’s products range from early November to mid-December. No word on Pfizer versions.
• Technetium Tc-99m sodium pertechnetate generator. Shortages of both active and inactive ingredient components.
• Micardis (brand name). Discontinued for business reasons; no longer available.
• Strattera (brand name). Discontinued for business reasons; no longer available.
• Byetta (brand name). Discontinued for business reasons; no longer available.

Mifepristone vs aging

Well this is interesting. Mifepristone might have an interesting new indication — it might help extend lifespan.

You might know that rapamycin has been shown to help animals live longer. Well it seems, according to USC researchers, that mifepristone works the same way. Both drugs increase mitophagy — the cellular cleanup process that tends to break down as we age. By keeping mitophagy working properly, poorly functioning mitochondria continue to be removed so they can be replaced by working versions.

As the lead researcher points out, because the drug is already FDA approved, clinical trials of its anti-aging effect will be easier.

The best BP managers

When it comes to helping patients lower and control their blood pressure, which kind of healthcare provider do you think does best?

If you said anything other than “pharmacist,” you’re reading the wrong newsletter. A meta-analysis out of Tulane University (that included data on 90,000 patients) found that …

while all the groups studied who led BP control efforts were successful in reducing BP, pharmacist- and community health worker–led teams saw the biggest reductions.

Actually, pharmacists were #1 — their efforts resulted in an average systolic BP drop of 7.3 mm Hg. Physicians and nurses? They got less that half that.

Antibiotic-resistance twist

This is not good: Australian researchers have documented the first case of one antibiotic (rifaximin) resulting in bacteria resistant to a different antibiotic (daptomycin).

The study — published in Nature — found that rifaximin, an antibiotic used to treat liver disease, causes resistance to another antibiotic, daptomycin.

Worse, this means that antibiotics considered “low-risk,” like rifaximin, might not be — as well as suggesting that other antibiotics might be resulting in resistance outside their class.

Microscopic medicine

4-in-1 robot

We’ve written about microscopic robots before, but here’s a new one: The size of a grain of rice, it can actually carry “four types of drugs with reprogrammable drug-dispensing sequence and dosage.”

So yeah, it can not only carry multiple drugs and be steered (via magnetic fields) to where it’s needed, it can be programmed to release those drugs in the right sequence and at the right dosage — kind of like the UPS driver making deliveries to one location after another.

Goldilocks medication

Check this out: Imagine an antibiotic you could take that would only be activated when a specific bacteria was present. That would ensure that the bare minimum of drug was used, reducing the risk of antibiotic resistance.

Imagine no more! Canadian pharmacy engineers have developed just such a … pill?

This new technology consists of fatty compounds invisible to the eye that are tailored to only release a drug in the presence of toxins produced by specific types of bacteria.

Once the target bacteria is eliminated, any excess medication is broken up and excreted so “the patient doesn’t take too much medication and the body is not constantly exposed to the drug.”

A slightly better OUD treatment

When dealing with opioid use disorder, giving patients methadone — rather than either buprenorphine or naloxone — results in them being less likely to quit treatment.

Based on 10 years’ worth of records of almost 31,000 people, Canadian researchers found that more patients stayed in treatment if they were given methadone. To be fair, despite the headline (“Methadone much more effective…”) neither treatment was amazingly effective, but methadone was less ineffective:

• Patients taking buprenorphine/naloxone were 88.8% likely to stop treatment within 24 months.
• Patients taking methadone were only 81.5% likely to stop.

The Long Read: Pharmacists as Police edition

“What We Lose When Pharmacists Are Forced to Act Like Cops”

Pharmacists are trained to think in terms of medicine, but the opioid crisis pushed them to think in terms of crime.

[…]

Today, however, pharmacists regularly police patients by reframing enforcement practices as care. One pharmacist told me that he now views his role as that of a gatekeeper, tasked with making sure patients are not misusing or selling drugs.

Some pharmacies are just more equal than others

PBMs keep saying they pay all pharmacies equally — that they don’t show a preference for the chains they happen to own. No sirree. So I guess there’s no need for a KFF Health News article, focused on Georgia, titled, “PBM Math: Big Chains Are Paid $23.55 To Fill a Blood Pressure Rx. Small Drugstores? $1.51.”

For example, the chains received an average of nearly $54 for the antidepressant bupropion, while Bell’s Family Pharmacy in Tate, Georgia, got $5.54, the analysis said. For a drug used to treat blood pressure, amlodipine, chain pharmacies received an average of $23.55, while Bell’s got $1.51.

Bell’s Family Pharmacy closed earlier this year.

Stroke? Don’t wait on anticoagulants

Old recommendation: When someone with an irregular heartbeat has a stroke, wait 5 days before starting them on anticoagulants to reduce the risk of a brain bleed.

New study’s conclusion: Starting those anticoagulants earlier (within 4 days) not only reduces the risk of a second stroke even more, the patients “have no increased risk of a brain bleed than those who take them later.”

States ponder GLP-1 benefits

Only 13 state Medicaid programs cover GLP-1 drugs for weight loss, but that might be changing as more states are either considering coverage or outright planning it.

What’s interesting is that the states that don’t cover them cite cost as the reason — the drugs are expensive, after all. But at least half the states that do cover them also cite costs — reducing obesity, they figure, will pay benefits by reducing other health issues. (But see “Where are the GLP-1 savings?” below.)

There’s plenty more in the mix, though: Overall Medicaid costs. The (possible) need for legislative approval. Obesity requirements. Federal aid. So it’s all up in the air.

Where are the GLP-1 savings?

The idea is that by combating obesity, GLP-1 drugs will reduce the cost of healthcare for both individuals and insurers. Losing weight helps across the board, and there’s also evidence that the drugs can directly affect other conditions.

But an analysis by PBM Prime Therapeutics of 3,000 people taking either semaglutide or liraglutide for obesity found that, after 2 years, their cost of care went up 46%. (To be fair, the cost of care of people not on GLP-1s went up 14%.)

And that wasn’t just because of those meds — overall medical costs went up.

Over the two-year period, the analysis found “no reduction in obesity-related medical events,” such as heart attacks, strokes and diagnoses of type 2 diabetes, or use of prescription drugs for hypertension and high cholesterol, compared to the control group.

This adds a bit of complexity to the calculus, doesn’t it?

Vaccine-rec updates

Second Covid shot for 65+

The CDC is recommending that people who are 65 or older, or who are immunocompromised, get a second shot of this year’s Covid vaccine. And for those who are severely immunocompromised? Three or more shots are okay in consultation with their health care provider.

More people should get pneumonia vax

The CDC is recommending that all adults 50 and over (not just 65 and older) get the pneumococcal conjugate vaccine. That comes after a 14-1 recommendation from its Advisory Committee on Immunization Practices. Interesting note: ACIP made the recommendation based on age rather than risk because panel members thought that would increase vaccine uptake.

Speaking of pneumonia…

A lot of kids seem to be getting walking pneumonia — infection from Mycoplasma pneumoniae. The surge in cases (all right, maybe “surge” is a bit strong) started in the spring, the CDC reported, and “has been increasing over the past six months, peaking in late August.”

What’s notable, the agency said, is that a lot of 2- to 4-year-olds are getting M. pneumoniae infections, which is unusual.

Cases have been dropping a bit nationwide since August, but there are still localized hot spots, mostly in the middle of the country.

Captain Obvious will remember it for you wholesale

“Reminders Reduce Age-Related Memory Decline”