August 13, 2024     Andrew Kantor

ICYMI: nasal spray epinephrine

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

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

The X for Y files: Ezetimibe for dementia

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

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

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

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

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

Irony, irony, all is irony

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

Which antibiotics are riskiest?

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

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

The sky didn’t fall after all

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

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

CMS: [makes rude gesture]

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

Courts: [rolls eyes]

—NEGOTIATIONS ENSUE—

Public: “So how bad was it, pharma?”

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

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

Pharma companies: “Shut up, Brad.”

(sigh)

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

(It’s rice water, aka “ricezempic.”)

The Long(ish) Read: Smart Insulin edition

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

August 10, 2024     Andrew Kantor

Midnight at the crossroads of happy and healthy

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

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

Congrats, Mandy!

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

A big high-five from all of us!

Two-question test for smokers

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

  1. On the days that you smoke, how soon after you wake up do you have your first cigarette? (four options from ‘5 minutes’ to ‘more than an hour’)
  1. How many cigarettes do you typically smoke per day? (four options from ‘10 or fewer’ to ‘more than 30’)

Read the details.

Nasal sprays vs respiratory viruses

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

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

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

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

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

It’s allergy time!

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

We can do better

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

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

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

* aka “States with Best Health Care Systems”

Elsewhere: Razorback edition

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

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

August 08, 2024     Andrew Kantor

Lacks estate sues

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

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

GLP-1 reality check

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

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

When fish oil works

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

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

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

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

Pharmacists can prevent AFib

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

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

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

Why insulin price caps don’t work

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

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

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

Updating the threat list

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

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

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

August 06, 2024     Andrew Kantor

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

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

Look up a shortage

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

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

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

Aspirin vs colon cancer

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

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

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

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

RSV season is starting

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

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

The road to myocardial infarction is paved with good intentions

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

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

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

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

* Pooled cohort equations, which date back to 2013

Pharma will survive

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

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

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

Fighting flesh-eaters

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

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

August 03, 2024     Andrew Kantor

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

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

What are we up to? Six of these cases?

Monitor those DOACs

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

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

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

FYI

There are eight drugs newly in shortage:

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

Speaking of shortages, there’s Zepbound

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

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

Don’t peel your own face

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

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

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

Elsewhere: Peanuts down under

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

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

The Long Read: TEFCA and sharing health info

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

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

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

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

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

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

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

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

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

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

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

August 01, 2024     Andrew Kantor

Dosing errors all along

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

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

Mercer: A fond farewell and an enthusiastic welcome

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

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

Sanitizer out, mask on hand

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

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

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

Happy Valentine’s Day 2027

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

ICYMI: Colorectal blood test

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

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

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

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

Lettuce treat that

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

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

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

[…]

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

Elsewhere: Danger Shrooms edition

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

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

July 30, 2024     Andrew Kantor

Antidepressants and alcohol abuse

Taking antidepressants can reduce someone’s risk of alcohol-abuse relapse … except when it increases that risk.

You read that right. When the drugs work against a patient’s depression, they’ll also reduce the risk of relapse. That’s good. But when the antidepressant is ineffective against depression (as many are), patients “may have an increased risk for relapse into problem alcohol use.”

The Swiss authors, though, caution that “findings should not be considered causal relationships.”

New birth control

The FDA has approved Millicent’s Femlyv (norethindrone acetate and ethinyl estradiol) — the first orally disintegrating birth control tablet. That is all.

Another front in the Alzheimer’s war

If you have a mouse with Alzheimer’s, a nasal spray might remove some of the protein tangles that cause it. Not the amyloid plaque — this drug clears up the tau “tangles.” Like amyloids, tau proteins can form those tangles, which in Alzheimer’s patients aren’t cleared as they should be. That eventually leads to the dementia that’s the hallmark of the disease.

The big difference between amyloid plaque and tau tangles is that amyloid accumulates outside neurons, while tau accumulates inside them. That makes those tau tangles harder to tackle because they’re harder to reach.

That’s the problem that University of Texas neurologists say they’ve solved with a nasal spray: They packed nanoscopic lipid bubbles — which are small enough to slip through the blood-brain barrier — with tau-destroying antibodies. “Once in the brain, the outer layer of the bubble dissolved, releasing the antibodies and clearing the build up of tau.”

The results showed that a single dose of this nasal spray in the old Alzheimer’s mice significantly reduced tau accumulation in their brains. The same results were also discovered when applying the spray to human nerve tissue samples.

ICYMI: Alzheimer’s blood test

A blood test for Alzheimer’s is not only as good or better than current invasive testing methods, it doesn’t require a specialized lab; it can be used in a primary care setting. The best part? It’s already commercially available in the US.

The test measures levels of p-tau217 and Aβ42/40* and a Swedish-American team found it can predict the accumulation of amyloid beta in the brain, i.e., it “can determine with 90% accuracy whether a person experiencing memory loss is suffering from Alzheimer’s.” That compares to specialist physicians, whose assessments are right about 73% of the time.

“The next steps include establishing clear clinical guidelines for the blood test’s use in healthcare.” […] “Initially, it will mainly be used in specialist memory clinics, and it may take approximately one to two years to implement guidelines and training in primary care.”

* I’m putting this detail in hoping you’ll know what it means, but I sure don’t. 

FDA’s social crackdown

The FDA is serious about cracking down on social media posts about pharmaceuticals — at least when a pharma company pays for an informercial. In this case, that infomercial came from Brittany “My husband is Patrick” Mahomes. She wrote about Kaléo Auvi-Q — the alternative to Epi-Pens.

Mahomes talked about the benefits of Auvi-Q but didn’t mention the side effects and risk information. It’s one thing for a celebrity to talk about her personal experiences, but once she crossed the line into talking about product benefits (and was paid by the company to do so), the rules come into play.

The FDA told Kaléo to send a response addressing its concerns within 15 working days of receiving the letter, which the agency sent July 17. The link to the Instagram post now returns a result that says “Sorry, this page isn’t available.”

Chemo-damage mystery solved

Doxorubicin is often the first-line chemo treatment for cancer patients, but it has a serious side effect: heart damage. Now scientists at Tufts have figured out why, which could be the first step toward reducing it.

You should know this by now: Everything bad is either caused by gut bacteria or inflammation. In this case it’s inflammation — apparently doxorubicin increases the levels of immune cells called CD8+ cytotoxic T-cells.

Their research showed that in mice the T-cells are releasing molecules that are meant to cause cell death, which are normally intended to combat viruses and other invaders, but these molecules cause fibrosis and stiffen the heart, preventing it from contracting well.

They don’t know how to prevent it … yet. But their finding “suggests that blocking T-cells from going into the heart might be a strategy to make a medication to prevent the cardiac damage associated with the drug.”

The Long Read: Flovent fallout

Since GSK stopped selling Flovent in favor of its identical generic, patients (and their parents) are left scrambling for an alternative, as PBMs aren’t covering the generic.

[T]he generic version costs more, and pharmacy benefit managers did not want to pay more, so they didn’t cover it in many insurance plans. The end result of the negotiation stalemate is that patients lost out.

Next time someone says, “We don’t want the government deciding what drugs I can take!” ask them if it’s better to have insurance companies making that choice….

July 27, 2024     Andrew Kantor

The X for Y files: Shingrix

The Shingrix shingles vaccine might protect against dementia. Weird, right? That conclusion came from British researchers who used American health data, specifically for about 200,000 people, half of whom got the old shingles vaccine (Zostavax) and half who got Shingrix.

The bottom line: “Over the next six years, the risk of dementia was 17% lower in those who received Shingrix compared with Zostavax.”

And just to be sure, they looked at other vaccinations, and they found that only Shingrix had any effect on dementia risk. (“[T]hose given Shingrix had a 23 to 27% lower risk of dementia than people who were vaccinated against flu, tetanus, diphtheria, or pertussis.”)

How does it work? Dunno. Is it correlation without causation? Maybe, although it’s hard to see what else could explain the effect. Still, you know the mantra: More research is needed.

NCPA (and others) sue Change

NCPA, along with a long list of providers — from Agius Psychological Services to Wiemer Family Podiatry — “have filed a class action lawsuit against UnitedHealth Group for losses from the Change Healthcare cyberattack that happened earlier this year.”

“UnitedHealth Group and its subsidiaries need to be held accountable for their lax security measures and for their failure to provide our members with adequate support and assurances to alleviate the financial losses our members suffered.”

They’re also pointing to the fact that independent practices “have received little, if any, reimbursement from insurers for patient visits,” which literally can threaten their existence. They’re demanding not only monetary relief, but that UnitedHealth Group be required to change its security and reporting practices so this doesn’t happen again.

Short Takes: The kids are all right

They’re not getting pregnant

Teen births dropped for 2000 to 2022. In fact, they dropped 69 percent. And it was an even bigger reduction — 79 percent! — among girls aged 15 to 17.

Researchers attributed the decline to teenagers being older when they first start having sex, less sexual activity among teen girls, and greater use of effective contraception among sexually active teenagers.

They’re abusing fewer drugs

Fewer teens are abusing prescription drugs, according to University of Michigan researchers.

The percentage of seniors who say they’ve misused prescription drugs in the past year has dropped to 2% in 2022, down from 11% back in 2009.

Moderate alcohol? Nah

The latest answer to the question “Is moderate drinking good or bad?” is … not good. A glass of wine a day (or beer — these were Canadians) doesn’t extend your life or improve your health.

Why so? Based on an analysis of 107 studies, those Canadian researchers found that 1) the studies that indicated moderate drinking was good turned out to be poor-quality research, and B) the good studies focused on older adults who may have changed their habits after a lifetime of drinking.

In other words, they compared moderate drinkers to abstainers and occasional drinkers — but those latter groups “included some older adults who had quit or cut down on drinking because they’d developed any number of health conditions.” Obviously, they say, a young moderate drinker looked good compared to an older tea-totaller who used to drink heavily.

Elsewhere: Carolina in My Mind edition

North Carolina’s Department of Health and Human Services has said that the state’s Medicaid program will cover GLP-1 drugs. The logic is sound: Reducing obesity will reduce spending to treat the various issues it causes, saving the program money in the long term.

Double-trouble antibiotic

A new antibiotic that kills bacteria two different ways can keep the bugs from evolving resistance. At least that’s the idea from University of Illinois molecular biologists. The drugs are macrolones — a combination of macrolides and fluoroquinolones — that attack bacteria by both blocking the ribosome and by targeting an enzyme (DNA gyrase).

The macrolones actually did better at both jobs than single-target drugs did, the Illini found, but the important part is that …

“If the antibiotic hits both targets at the same concentration, then the bacteria lose their ability to become resistant via acquisition of random mutations in any of the two targets.”

Lyme vax gets closer

Pfizer’s Lyme disease vaccine is in its phase-3 trial, with the participants having gotten all three of the vaccine series. Now we wait; they’ll be monitored until the end of the 2025 tick season (i.e., end of summer). If all goes well, it could be available in 2026.

 

AI statement: GPhA Buzz is 100% human-written; no AI is used to research or write any of the text. We occasionally use AI-created imagery in a non-editorial way; i.e., just for a smile, not to imply a factual illustration.

 

July 25, 2024     Andrew Kantor

Hot seat for PBMs

PBM execs testified before the House Com­mit­tee on Over­sight and Ac­count­abil­i­ty that they’re the good guys — they keep costs down when those evil pharma companies raise prices so high. Plus they rescue bunnies and orphans and they help little old ladies cross the street. Mm hmm.

They blamed “patent abuses” by drug manufacturers that delay launches of cheaper generic and biosimilar medicines for the heightened costs to consumers. The launch price of new drugs was also an issue, they said.

They apparently spent a lot of their testimony talking about the wholesale prices, rather than their role in the process. Regardless, the DC fire department was on hand in case the fire on the execs’ pants spread to the rest of the room.

Fertility — and life — extension

Rapamycin might extend women’s fertility by up to five years and make them healthier to boot. Columbia University researchers are studying that very possibility, and they’ve completed the first step: Proving the drug is safe. (Which isn’t a high bar, as rapamycin has been FDA approved, at least for transplant patients, since the ’90s.)

Rapamycin has gotten press before as a potential anti-aging drug that might reduce a long list of age-related conditions, but it hasn’t been tested on something like fertility. Even though it’s still only approved for transplant patients, rapamycin has been prescribed off-label for other aging issues — this could be a huge new indication for it, on- or off-label.

And counting

There have been six straight quarters (metric: 18 months) of drug shortages in the US according to data from the American Society of Health-System Pharmacists. That is all.

A better morphine than morphine

Opioids, as you know, work by binding to pain-suppressing receptors, and we all know the problems they can cause. So what if there was a drug that also binds to that receptor, but in a slightly different place? That might also relieve pain, but maybe not come with opioids’ baggage.

That was the thinking of researchers at Washington University School of Medicine and Stanford. In fact, they knew of a molecule called C6 guano that binds to just such a different spot. Unfortunately, it was too big to pass the blood-brain barrier.

They needed something smaller … and they found it. It’s called RO76 and it was derived from fentanyl of all things. It binds to the anti-pain receptor in a different way than opioids do, and in tests with mice they found it “appeared to suppress pain as effectively as morphine” but without slowing the mice’s breathing the way opioids do.

Oh, and it also has fewer withdrawal symptoms and works when taken by mouth or by injection. A few decades from now, it could actually be a new medication.

Short takes

Let’s go with vitamin B1

Vitamin B1 can reduce constipation, according to a Chinese study that used five years of survey data from 10,371 adults.

Constipation prevalence was 7.69% in the group with the highest B1 intake, 10.7% in the middle group, and 14.09% in the group with the lowest intake.

Caveat: As is often the case, this showed correlation, not causation.

GLP-1s: A different supply shortage

The battle for the GLP-1 market is heating up not just in the lab or even the market, but on the factory floor. With demand high and supply low, existing and upcoming GLP-1 makers are racing to secure manufacturing facilities — either by buying existing plants or building new ones — and paying a premium for it as demand goes up and up.

Cranberry’s OK

Researchers at University, Bond University have confirmed (they say) that cranberry juice can prevent urinary tract infections*. They base that on “a network meta-analysis that amalgamated the results of 20 studies involving 3,091 participants worldwide.”

* When used orally, not topically

A 100% HIV preventative?

A large clinical trial in Africa found that lenacapavir, an injected fusion capside inhibitor, was 100% effective in preventing HIV in young women. One hundred percent. That compares to 98.5% of women who took Truvada and 98.2% of those who took Descovy.

98.5% and 98.2% might seem like really good numbers, unless you’re one of the 1.5% or so where it wasn’t effective.

While both Truvada and Descovy are daily oral medications, Lenacapavir is injected twice a year. You might think a pill would be a better option, but in fact taking one daily is “challenging to maintain, for a number of social and structural reasons.” A six-month injection will actually be a better option for a lot of those women.

The Long Read/Elsewhere: Drug pricing boards pick up steam

State price-control boards for prescriptions are gaining traction, as more states hear from angry consumers about the cost of drugs. Today, 11 states already have some sort of prescription drug affordability board, and 14 more have bills in the legislature to do so.

The boards won’t simply set lower prices for drugs. Their real power is in forcing transparency in the system by requiring drug makers to justify their prices. As the chair of Minnesota’s board put it:

“We want [these businesses] to be successful, but this marketplace is not transparent enough for people to feel like they’re getting a fair shake. Free market forces really only work when there is equal information on both sides of the equation. When there’s so much that is not transparent, it takes a public actor to bring about transparency.”

July 23, 2024     Andrew Kantor

The only mucus-and-nanobot story you need to read today

Everyone know how much trouble it is to push through a wall of mucus, and it’s even tougher if you’re a drug molecule. That’s why Spanish researchers developed hydrogen peroxide-powered nano-robots that carry drug molecules though that wall.

The peroxide not only propels the ’bots, it also breaks down the mucus barrier long enough for the drugs to slip through “helping them sneak through the mucus defenses like a Trojan horse.”

[In the lab] The bots passed through the model’s mucus layer within 15 minutes, without significantly harming the cells underneath.

Then they tried it on mouse colons, and it worked there as well, with 28% of the nanobots successfully crossing the mucus barrier. That may not seem like a lot, but 1) it’s the first test of this technique, and B) “that 28% is a 60-fold increase over passive diffusion of particles.”

Medicare drug option coming

People with Medicare prescription drug coverage will have a new payment option next year, and CMS wants to be sure they’re aware of it.

Starting in 2025, Medicare patients can opt to be billed monthly by their plan provider rather than pay at the pharmacy counter.

What’s the difference? As part of the Inflation Reduction Act, annual Medicare prescription drug costs will be capped at $2,000 per patient starting in 2025. The new payment option will be good for people who have typically had high out-of-pocket costs — they won’t have to shell out that $2,000 in the first few months of the year; it’ll be a ‘smoother’ payment system for them, as insurers’ monthly charges are also limited by the IRA.

The latest universal flu vaccine

Scientists at Oregon Health & Science University and Pitt may have killed 11 monkeys to make their point, but that point was the latest potential universal flu vaccine. In fact, it could be a universal [insert-virus-name-here] vaccine if their technique works outside the lab.

Their vax uses a mild herpes virus to carry small pieces of the target virus to activate effector memory T cells. The advantage is that this type of T cell will attack a target based on its internal structure, rather than its outer shell. In other words, the virus can mutate all over the place, but the T cells still recognize it.

For an added twist, they tested this not against the current H5N1 virus, but the super-deadly one that caused the 1918 flu pandemic*. And it worked pretty well for a proof of concept: Six of the 11 monkeys exposed to the 1918 flu survived, while all six of the control group died.

* Don’t worry, they worked in a “highly secure biosafety level 3 laboratory” so there’s no chance of a virus escaping and causing a pandemic.

Speaking of H5N1…

Good news: The H5N1 vaccine in the US Strategic National Stockpile, which was designed to work against the variant that circulated in the early 2000s, also seems to work against the current clade. It’s not perfect, but it’s good enough to work as a “bridging vaccine” while a new one is developed.

Birth control with acne meds?

It’s been a while since we’ve written about anything controversial, so here you go: A pediatric dermatologist at Penn State is recommending that her peers prescribe emergency contraception along with isotretinoin (aka Accutane).

Why? Because isotretinoin presents a serious risk to a fetus, and “Not all teens taking isotretinoin can be trusted to be sexually abstinent.” Making sure those teens have Plan B or something similar available can save a lot of heartache later. (And, of course, levonorgestrel and ulipristal acetate are essentially birth control, not abortifacients, so they avoid that thorny issue.)

Home treatment Q&A

Q: Can drinking olive oil prevent a hangover by coating the stomach?

A: No.

If it was a snake, it would’ve bit me … but now I have a better anti-venom

Obviously we all worry about cobra bites, especially because the antivenom is expensive and, while it can save your life, probably won’t save the limb that got bit. (Can you say “necrosis”?)

We can all rest a little easier thanks to some Aussie researchers. They led a team that made a breakthrough — they found that cobra venom targets a human enzyme that produces heparan and heparin. So they gave the venom another target: good ol’ heparin — yep, the blood thinner. By flooding the bite with heparin, it binds to the venom before it can attack the cells.

This means that cheap, plentiful heparin can be added to existing cobra-bite treatments to help prevent the second-worst effect of the bite. (The first being, obviously, death.)

Covid update

Wastewater surveillance shows that SARS-CoV-2 is gaining ground across the country.(Georgia is reporting “High” levels — 7 out of 10 on the CDC’s scale.) The latest data show that almost one percent of all deaths in the country are from Covid-19 — that’s not insignificant.