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”

Little Brother to watch you

Cops wear body cameras to help them do their jobs. So what about doctors and pharmacists in ORs and ICUs? Not to record what they do, but fitted with AI to stop them from making a mistake.

University of Washington researchers have developed just that: “the first wearable camera system that, with the help of artificial intelligence, detects potential errors in medication delivery.”

And, as with a lot of what AI does, it’s creepily good. It can identify what medications are being drawn and administered even while clinicians are moving fast — they’re not holding anything up to the camera.

The video system does not directly read the wording on each vial, but scans for other visual cues: vial and syringe size and shape, vial cap color, label print size.

And the AI is good. It “achieved 99.6% sensitivity and 98.8% specificity at detecting vial-swap errors.”

Insurance merger back on the table

They may have cancelled their wedding last year, but Cigna and Humana might be back at the wedding planner, talking about a merger. Well, it’s more that Cigna would assimilate Humana. Cigna is finalizing the sale of its Medicare Advantage business, so it hopes regulators would allow it to buy its smaller competitor once that sale is complete.

mRNA news

Vomit vaccine

Good news for anyone planning a cruise: An international group of researchers has begun stage-3 trials of an mRNA vaccine against norovirus, aka the “vomiting bug.” The trial is set to run for two years and include 25,000 subjects across Australia, Canada, Japan, and the UK.

Even faster vaccines

Developing mRNA vaccines is (as we’ve learned) a lot quicker than developing traditional ones, but there are still bottlenecks, notably synthesizing the mRNA itself. Doing the synthesis requires both a chemical process (fast) and an enzyme-based process (slow). But now Japanese scientists say they’ve found a method^* “capable of producing high purity, fully chemically synthesized mRNA.” If it pans out, it could mean faster production of existing mRNA vaccines, and even faster development of new ones.

^* As you probably guessed, they “devised a novel phosphorylation reagent with a nitrobenzyl group that serves as a hydrophobic purification tag.”

You’ll like this

The New York Times pulls no punches in its feature on PBMs, “The Powerful Companies Driving Local Drugstores Out of Business.”

[A] New York Times investigation found P.B.M.s, which employers and government programs hire to oversee prescription drug benefits, have been systematically underpaying small pharmacies, helping to drive hundreds out of business.

You knew that already. But take a moment to appreciate the deep dive the Times takes — this was a 3,200-word, front-page story that crosses the country and goes deep into the devastating impact of PBMs on independent pharmacies.

Short takes

Surprising Parkinson’s findings

Rutgers researchers found two unexpected connections between common drugs and the risk of Parkinson’s:

1. “[P]eople who took multiple courses of penicillin antibiotics had a 15% lower risk of developing Parkinson’s disease.”
2. Those who took antifungal meds, though, “had a 16% higher risk of Parkinson’s.”

Both those findings came out of a review of medical records of more than 93,000 Brits.

Preventing delirium after surgery

There might be a simple solution to post-op delirium — a condition that 15% of surgical patients can get, where they experience confusion that can last a week or more after surgery. That solution? Ibuprofen (or other non-salicylate NSAIDs like celecoxib or ketorolac).

Johns Hopkins researchers found that those non-salicylate NSAIDs were better at heading off delirium than acetaminophen, and way better than aspirin.

The Long Reads: Why you might want to worry about the bird flu

The bird flu, which has been spreading to cows and humans (slowly) doesn’t feel like a big deal — more of a “Meh, keep an eye on it, I guess” situation. But there’s more going on behind the scenes, implying the situation might be a lot worse than we all think.

The bottom line: Rather than help stop the spread in dairy cattle, the USDA is actually blockading testing efforts and information sharing to protect short-term profits.

• Vanity Fair: “Inside the Bungled Bird Flu Response, Where Profits Collide With Public Health”
• Reuters: “Exclusive: State and industry input led US farm agency to relax bird flu testing order for cows”

The good news is that we have a lot of experience with flu vaccines, so hopefully even a major human outbreak would be containable … as long as people get vaccinated.

The risk of beta blockers

There’s more evidence that beta blockers given before surgery increase patients’ risk of stroke, according to research out of Montefiore Medical Center.

Looking at the records of almost 206,000 patients over 16 years, they found that using beta blockers for the first time in the month before surgery increased stroke risk by 25%, while patients already using them had a 17% increased risk.

A couple of notes: This doesn’t apply to cardiac surgery (beta-blockers did help protect against myocardial infarction and cardiac revascularizations). And Black and Hispanic patients seemed to be prescribed beta blockers more often, even though they weren’t sicker.

RSV vax works

A big new study (230 hospitals and 245 emergency departments across the country) found that the RSV vaccine works well in the real world — it was “80% effective in protecting against hospitalizations and deaths during the 2023-2024 RSV season.”

You might think “Wait, they’re just now looking at how effective it is?” The idea is that this is a real-world study, as opposed to the study-based ones the approval was based on.

Short Takes

USA Today discovers pharmacy deserts

To be fair, the deserts are growing as more and more independent pharmacies close, and chains start cutting back on their locations.

The X for Y Files

Radicava (aka edaravone), which was approved to treat ALS, seems to stop brain-tumor stem cells from proliferating. That means — Canadian researchers say — “repurposing the drug may prove to be a potent weapon against glioblastoma.”

In a sad irony, despite that approval, edaravone may not even provide a “clinically relevant benefit” to ALS patients.

When seven days is enough

Patients with blood infections only need a 7-day course of antibiotics — not the 14 days that’s often prescribed. Only a week is not only just as good, it actually might be slightly better, according to the study out of the University of Toronto.

Among patients with bloodstream infections who received 7 days of antibiotics, 14.5% had died at 90 days, versus 16.1% of those who received 14 days of antibiotics.

The data held true, they said, regardless of whether patients were in the regular hospital or the ICU, and no matter the severity or type of the infection.

What’s better than GLP-1s?

With all the hubbub about GLP-1 drugs, it turns out they’re not really cost-effective for weight loss — at least not compared to surgery. A Northwestern University study found that bariatric surgery is the way to go if money is an issue (e.g., if you’re an insurance company), “delivering two more healthy years of life and saving patients about $9,000 a year.”

Of course GLP-1s will eventually be less expensive, but they still have to be taken for life while surgery is once-and-done, although you might have to take some extra supplements to make up for the GI changes.

ICYMI: Part D changes

There are big changes afoot for Medicare Part D plans next year, making it important for recipients not to just keep doin’ what they’ve been doin’. Notably, there’s good news — with a caveat. The good news is that, thanks to provisions in the IRA…

• Out-of-pocket costs for beneficiaries are capped at $2,000 per year.
• The deductible is capped at $590.
• Low-income folks may be eligible for subsidies to help pay for it.

The downside is that about 70% of insurers have raised their premiums (although there’s an incentive for insurers to keep that premium increase to $35), and some may reduce coverage of certain drugs in favor of less expensive options. They may also “eliminate pharmacies, doctors, or other services from the provider networks beneficiaries must use.”

Bottom line: Recipients really need to read the details of plans before choosing one — it’s the biggest change in coverage since 2003.

You know it’s 2024 when someone has to write this opinion piece

“Doctors, Not AI, Should Authorize Treatments”

Benzo overprescribing

Stroke survivors may be getting too many benzos, according to a new paper out of Harvard Med.

Giving them drugs like lorazepam to help deal with recovery anxiety is fine. The trouble, the paper suggests, is that…

More than half of the new prescriptions of benzodiazepines were written for a supply of 15 to 30 days, rather than the smaller number of pills for short-term, as-needed use.

That extra, oversupply “would be enough for patients to become long-term users or possibly addicted,” they wrote.

Telehealth rules update

Remember when it was leaked that the DEA was considering reinstating in-person requirements for getting controlleds via telehealth? That didn’t sit well with a lot of people. Most people, in fact, including HHS.

Quick refresher: Telemedicine rules were relaxed during the pandemic to ensure continuity of care, but everyone liked them so much the DEA extended that relaxation twice. The ‘temporary’ rules were set to expire at the end of this year, though.

The latest: A bipartisan group of senators has written to the Biden administration, “calling such restrictions ‘detrimental to patients and a barrier to accessing care’.”

Coincidentally, the very day the letter was sent, DEA submitted a proposal to extend the relaxed requirements for another year, probably grumbling under its breath while it did that.

^* If you want to go down a rabbit hole, note that the senators referred to President Biden as “The Honorable,” but it’s not clear that the title should be given to the president himself.

What, them worry?

The public — that great, teeming mass of rabble — is still a bit worried about Covid-19 and the flu, but not so much about RSV. That’s according to a survey out of Penn’s Annenberg Public Policy Center. It’s unfortunate, because RSV kills 6,000 adults and at least 100 young children die every year, and it’s preventable with a quick vaccine.

Still, most people aren’t concerned:

• Only 26% are worried about getting or having a family member get RSV in the next few months
• 33% are worried about Covid-19
• 37% are worried about the flu

Of note is that the worry about RSV has dropped since last year for no good reason — it’s not as if the disease has waned in any way. (Worry about Covid and the flu have remained steady, though.)

Compounding update

FDA: All compounders can still make tirzepatide

While it sits in the corner and thinks about what it did, the FDA has said that yes, all compounding pharmacies can create and dispense compounded tirzepatide. (Its statement the other day wasn’t clear whether smaller, 503A pharmacies were allowed to renew dispensing it. Now the agency clarified that.)

Novo is still on the attack

Meanwhile, although it’s still unable to supply Ozempic, Novo Nordisk has filed “18 law­suits against GLP-1 com­pounders in 44 days.” That’s despite the fact that compounding semaglutide is perfectly legal while it’s in shortage. (It’s not legal, though, to refer to a compounded product as “Ozempic” — that’s a trademark violation.)

Standing doesn’t deliver

If you stand a lot at work, you might be tempted to silently mock those people who buy standing desks just to get the benefits you enjoy. Well, you might want to keep your mockery silent. A new Aussie study finds that, contrary to anecdotal reports …

… over the long-term, standing more compared with sitting does not improve cardiovascular health (coronary heart disease, stroke and heart failure), and could increase the risk of circulatory issues related to standing, such as varicose veins and deep vein thrombosis.

Not that sitting is any better — it’s still pretty awful for your body to be on your butt more than 10 hours a day —so getting up and getting physical is important. But a standing desk isn’t going to help.

The Long Read

The first ED treatment gel is available over the counter. Forbes’s Bruce “No Relation” Lee ponders “How New OTC Eroxon Gel May Affect Erectile Dysfunction And Sex”.

If it’s a gel, you figure that someone somewhere will smear it on all kinds of things in all kinds of amounts.

Walgreens plans to shrink

After losing another $3 billion, Walgreens says it’s going to close 1,200 retail stores over the next three years to try to become profitable again.

Why the big hit? Well, there was losing billions on VillageMD when the company wanted to get into the primary care business. Then there were the lawsuits for its role in the opioid crisis. And then there was “a non-cash impairment charge related to equity investment in China,” whatever that means.

So now the company is planning to close 14% of its stores under a “transformational cost management program,” starting with 500 stores between now and next August.

Tirzepatide compounding saga continues

Compounding pharmacists, it seems, can continue to make and dispense compounded tirzepatide.

Eli Lilly’s brand-name Mounjaro and Zepbound have officially been in shortage for a couple of years. But there was plenty of the active ingredient, tirzepatide, so compounding pharmacies were able to dispense it to patients, albeit without the fancy injectors. A huge business sprung up filling the need.

On October 3, though, Lilly convinced the FDA that the shortage was over, and the agency removed Mounjaro and Zepbound from its shortage list, meaning compounders could no longer make it. Except that the shortage wasn’t over; wholesalers and pharmacists weren’t actually able to get the drugs.

An organization representing compounders, the Outsourcing Facilities Association, filed suit against the FDA and its decision to remove Mounjaro and Zepbound from the shortage list. It claimed the agency made a “reckless and arbitrary decision — lacking any semblance of lawful process” because it only took Lilly’s word that the drugs were available. In reality, it pointed out, wholesalers barely had any stock.

The latest: Before a federal judge could even make a ruling, the FDA essentially said, “Hold up, we’re going to review our decision.” So the judge put the suit on hold, and tirzepatide is essentially back on the shortage list. Compounders can compound it while the FDA considers what the supply actually looks like, perhaps collecting data from wholesalers and pharmacies, rather than just the manufacturer.

Combo vax trial paused

Novavax was one of several companies working on a combo flu/Covid vaccine. I say “was” because the FDA has paused the company’s trial after one subject reported nerve damage.

Notably, the person got the vaccine in January 2023, and there’s no evidence the vaccine had anything to do with it. Still, the trial was put on hold while Novavax and the FDA look into what happened. (The company’s stock plunged almost 20% by the end of the day.)

Short takes

Covid and flu down

The latest CDC data has good news: Wastewater monitoring shows that both Covid and flu are on the decline. Covid is at “low” levels in the South (and “medium” overall) and continuing to decline, while flu levels remain low and are holding steady.

Whooping cough ‘surging’

On the other hand, the CDC also found that rates of whooping cough (i.e., pertussis) are already four times higher than they were last year, with more than 16,000 cases reported so far this year, including two confirmed deaths. Health officials attribute the rise to missed vaccinations during the pandemic.

Weekly hemophilia treatment

The FDA approved Pfizer’s Hympavzi — the first weekly treatment for hemophilia and “the first antitissue-factor pathway inhibitor.”

Medical stuff:

Pfizer’s new drug is aimed at adult and pediatric patients 12 years of age and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors (neutralizing antibodies). It is administered via a pre-filled, auto-injector pen.

A simple way to save millions

Medicare could save between $133 million and $336 million a year on the Alzheimer’s drug lecanemab with one minor change: smaller vials.

[B]ecause the drug is currently available only in single-use 500 mg and 200 mg vials, substantial amounts of the expensive medication are discarded when the dose a patient is prescribed is lower than the amount contained in the vials.

UCLA researchers calculated how much patients use (based on average age and weight), and did the math to figure how much of those 200-mg and 500-mg vials are thrown out. The answer: about 5.8%. But that could be cut by almost three-quarters “by adding a third, 75-mg vial without significantly harming quality of care.”

Disney didn’t cover this part

Sanofi wants girls and women in Portugal to be comfortable pooping — there’s apparently a stigma about it — so it’s launched a campaign with AI-generated images called “Pooping Princesses” to promote its Dulcolax laxative.

Really, there’s nothing more to say here^*.

^* Actually, that’s not true. If you miss the letter “A” in the tagline at the bottom, it appears to read “Ducolax — Release.”

Acne-med danger is more widespread

Back in March it came to light that benzoyl peroxide products can break down and produce benzene, a carcinogen and thus something you don’t want on your face.

Now some more info: It seems that “can break down” is more aptly “does break down.” The folks at Valisure, an indy lab that tests pharma products, found that acne products taken off local store shelves had “very high levels” of benzene.

Among 111 benzoyl peroxide products purchased from various retailers across the U.S., about a third (34%) had benzene above the “conditionally restricted” FDA limit of 2 ppm.

Then the benzene levels go up at a rate of about 4.36 ppb per hour^*.

What can be done? They found that cold storage stabilizes the benzoyl peroxide, which jibes with the American Acne and Rosacea Society’s guidance that recommends refrigerating products.

^* Note that the first number was parts per million and the second is parts per billion. So it increases, but not by a crazy amount.

Speaking of Valisure…

That’s the lab that first flagged the dangers of Zantac back in 2019. Just this week, GSK “agreed to pay up to $2.2 billion to resolve approximately 80,000 lawsuits brought by users of Zantac who claimed the heartburn drug caused their cancer.”

GSK will also pay Valisure $70 million to resolve Valisure’s whistleblower lawsuit.

A clue to metastasis

One of cancer’s deadliest features is its ability to spread around the body — breast cancer spreading to the lungs is all too common. But now scientists may have found a clue to stopping cancer from metastasizing.

It’s been unclear why, after cancer cells spread, some can lay dormant for years before developing into tumors. Looking into why that happens, researchers at Montefiore Einstein Comprehensive Cancer Center discovered the answer: macrophages. They found that the macrophages in mouse lungs essentially prevent any disseminated cancer cells (DCCs) from metastasizing — at least for a while.

How do they pull that off? It seems the macrophages secrete a protein called TGF-β2 that keeps the cancer cells dormant. Well, that sounds like a helpful bit of information, doesn’t it?

If the finding holds true for every organ (all of which have their own macrophages), this could be a big step on the road to preventing cancer from metastasizing in general.

Baxter IV-drug update

Since Hurricane Helene knocked out the Baxter plant in Marion, NC — the one that supplies 60% of the country’s IV medications — it’s been unclear when the plant may be back in action.

Now the company has at least a little more info. It says it hopes to be able to produce 90% to 100% of what’s allocated to customers of certain IV solutions by the end of the year.

For its “highest demand IV fluids,” Baxter says it’s currently supplying direct customers about 40% to 60% of their normal ordering, with the hope to meet the majority of regular demand by year-end.

Who wants cannabis?

Prescribers are iffy about medical cannabis, but you know who’s a lot less iffy? Patients with chronic pain. A study of “1,600 people with chronic pain and 1,000 physicians in states with medical cannabis programs” by Rutgers researchers found that the majority of both supported medical marijuana, but with a noticeable difference:

Researchers found that 71% of chronic pain patients supported federal legalization of medical cannabis, compared with 59% of physicians.

A couple of other tidbits:

• Federal legalization for recreational use: 55% of chronic pain patients support it, but only 38% of physicians
• Requiring insurance coverage of medical cannabis treatment: 64% of patients support it, and 51% of physicians

A new combo test

The FDA has approved the first another at-home combo test for Covid-19 and the flu. The difference is that this one is outside an Emergency Use Authorization. (What difference that makes, we don’t know. But we’d already started writing this item when we noticed that it wasn’t the first.)

Healgen Rapid Check COVID-19/Flu A&B Antigen Test takes 15 minutes to detect proteins from both COVID-19 and influenza A and B in nasal swabs.

Oh, do they?

“Eating Nothing But Sardines May Help You Lose Weight, But Experts Say It’s a Bad Idea”

Captain Obvious puts his headphones on “Hear Through” mode

“Texting while walking puts pedestrians in danger”

Money savers won’t save much

Lawmakers have come up with all sorts of ways they say will reduce drug prices: allow importation from Canada, reducing or eliminating direct-to-consumer advertising, speeding the process for generics and biosimilars, and increasing pricing transparency, for example.

But when the Congressional Budget Office ran the numbers, it found that those ideas would have negligible impact. The only proposal that made a notable difference would be capping U.S. prices based on what other countries pay — that would result in about a 5% savings. Why so little? “[D]rugmakers could respond to the policy by delaying launches outside of the U.S. or withdrawing their products in smaller countries.”

(Price negotiations can save only 1-3% because the Inflation Reduction Act includes penalties when drug makers raise prices above the rate of inflation.)

Flu vax may be so-so this year

Based on reports from South America, this year’s flu vaccine seems to be about 34.5% effective at preventing hospitalization. That’s not great, but still better than not getting the vaccine.

(Preliminary) $2 drug list released

CMS has released the preliminary list of 101 generic drugs that will cost Medicare recipients only $2 per month. It’s a test of a program that “aims to test whether offering low-cost generics can boost seniors’ medication adherence and health outcomes, while giving them more certainty on out-of-pocket costs.”

The list covers common prescriptions like penicillin, metformin, lithium and albuterol asthma inhalers. Thirty-five of the drugs treat blood pressure and other cardiovascular conditions.

This is a ‘companion’ plan of the Biden administration that complements the $2,000 annual cap on out-of-pocket drug costs for Medicare recipients. As Axios points out, though, “A future administration could decide to change courses or halt the initiative.”

There’s a Swiss cheese joke to be made here

If you want to get a medication through the skin, the only way right now is via a microneedle patch; the epidermis is pretty good at keeping out large molecules, like a lot of drugs.

A patch is effective, but it’s limited to a small, smooth area, making it useless for conditions like psoriasis that covers a lot of skin. What you need is a mechanism as flexible as a cream, but that can send larger drug molecules though the skin.

How about a cream filled with Chinese throwing stars? That’s what researchers in Switzerland came up with. They’re three-pointed, 3D stars made of nanoceramics that, when added to a gel, roll over the skin creating “micro-wounds” that heal quickly, but not before allowing large molecules to enter. (Said one researcher, “It feels like a skin scrub.”)

Next up: making the material biodegradable (or at least disintegrable), and possibly testing it as an alternative for the needle-phobic.

Easy-to-swallow chemo?

Stanford researchers say they’ve found an “embarrassingly simple” method of turning injectable chemo drugs into pill form.

Through early trials in mice, they showed that their version of oral paclitaxel, one of the most prescribed chemotherapy drugs for many common cancers, performed better than the typical IV dose.

Honestly, the science is a bit too much to get into here, so you’ll need to read the article. Essentially, the addition of a “chemical tag” that covers the part of the drug molecule that attaches to the target. The tag only dissolves when the drug is in the right place, making the bioavailability nearly 100%.

Compounding news

Suing the FDA

A group representing outsourcing facilities — the aptly named Outsourcing Facilities Association — is suing the FDA over the agency taking Mounjaro and Zepbound out of shortage. The group points out that the FDA is basically taking Lilly’s word for the availability and should have taken public comments first, as the drugs are still hard to come by for a lot of pharmacies.

Weight Watchers hops on the bandwagon

Weight Watchers — or WW if you prefer the slimmed-down version — is offering compounded semaglutide, joining a bunch of telehealth companies that are dispensing it. WW will sell it for $129 for a month’s supply. (Novo Nordisk expects the shortage of Ozempic/Wegovy pens to last for at least several more months.)

ICYMI: BP and arm position

You probably don’t take your patients’ BP that often, but when you do — and if you counsel them on using home cuffs — be aware that arm position matters. A lot. A new study out of Johns Hopkins found that BP readings can be artificially high unless a patient’s feet are flat on the floor and the arm with the cuff is at heart level and supported (e.g., by a desk or table). No holding their arms, and no putting the arm in their laps.

Researchers found that BP measurements obtained with arm positions frequently used in clinical practice — an arm on the lap or unsupported at the side — were markedly higher than those obtained when the arm was supported on a desk.