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….

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.

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.”

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.

ICYMI: Rite Aid hacked

Rite Aid reported that 2.2 million of its customers’ personal information was stolen in June in a data breach … sorry, a “data security incident.” The theft occurred this year, but the data is a few years old:

“This data included purchaser name, address, date of birth, and driver’s license number or other form of government-issued ID presented at the time of a purchase between June 6, 2017, and July 30, 2018.”

The company halted ransom negotiations, and the hackers — a group called RansomHub — said they’ll leak the information by the end of the month if they aren’t paid.

Telemed works for opioid treatment

If you want patients to stick with their treatment for opioid addiction, it’s better for them to use telehealth visits than go to the ER.

That’s what University of Buffalo researchers found when they looked at the records of people referred to a local opioid treatment network. Those who came from the ER didn’t stick with the program nearly as well as telemedicine referrals.

65.1% of those referred via a telemedicine call showed up at their first clinic appointment versus 32.3% of those referred via an in-person emergency department visit.
And 53.2% of telemedicine patients were still in treatment at the 30-day mark versus 22.2% of those referred from an emergency department visit.

High-five to Buddy

Buddy Carter, the Georgia pharmacist — who also happens to be a US congressman — takes it to PBMs in an editorial in the Atlanta Journal-Constitution: “It’s time to bust it up the PBM cartel.” (Bonus: GPhA member Nikki Bryant is featured in the photo.)

Short takes: Long Covid

The 7 percent

A new report from the US Agency for Healthcare Research and Quality concludes that about 7% of the US population (18 million people) has had long Covid. That’s based on a survey of 17,000 adults across the county.

Vaccines cut risk

A different study out of the VA Saint Louis Health Care System found even more detail. Long-Covid rates have been declining to the point that only 3.5% of people vaccinated “during the Omicron era” — i.e., later in the pandemic — have long Covid, compared to 7.8% for unvaccinated patients. (That’s based on data from more than 5 million veterans.)

The conclusion: “Vaccines Significantly Reduce the Risk of Long Covid”.

… and so does repeat infection

Looking at longer-term trends, German researchers found that later variants of the virus were less likely to result in long Covid; “An Omicron infection was substantially less frequently associated with post-Covid-19 condition than earlier virus variants.”

Interesting: The more times someone was infected, and the more boosters they had, the lower their risk of long Covid.

Conclusion: Expect rates of long Covid to decrease over time.

Elsewhere: PBMs under fire

Vermont’s attorney general is suing CVS Caremark and Express Scripts, alleging they “pushed patients toward more expensive drugs even when cheaper ones were available, and pocketed the extra cost through an opaque system of fees^*,” which violates Vermont law.

Pennsylvania’s governor signed a bill that requires PBMs to reimburse all pharmacies equally and gives the Pennsylvania Insurance Department more oversight over those PBMs. Critically it reads:

A PBM registered with the department and conducting business on behalf of a health insurer client in this commonwealth may not:
(1) reimburse a retail pharmacy an amount less than the amount that the PBM reimburses a PBM-affiliated retail pharmacy located in this commonwealth for providing the same pharmacist services. (Emphasis ours.)

^* We’re shocked. Just shocked.

Another HIV cure

A seventh person has been cleared entirely of HIV. (We say “cleared” because we’re talking about the virus being removed from his system, even though the news says “cured.”)

In this case, a German man who developed acute myeloid leukemia after an HIV diagnosis needed a stem cell transplant. His treatment team found a donor with a rare mutation (“homozygous delta-32 CCR5”) that provides natural resistance to HIV. The transplant not only treated his cancer but also cleared the HIV from his body — it’s been almost six years now.

The detailed science is interesting: The donor was heterozygous with that mutation, meaning they had one copy of the gene … but the treatment still worked. People with heterozygosity for that delta-32 mutation are a lot more common than those with two copies of the gene, meaning there is more hope for a broad treatment.

Hormone therapy can reduce dementia risk — sometimes

Senior women who had hormone therapy as part of breast cancer treatment had “a 7% lower risk of developing Alzheimer’s disease and related dementias later in life,” according to a study out of the universities of South Carolina and Pittsburgh.

The effect is particularly strong in younger women— ages 65 to 69, and even more so in Black women; those aged 65 to 74 had a whopping 24% reduction in relative risk of developing dementia. (White women in that age group had an 11% reduction.)

“The benefits of HMT [hormone therapy] decreased for women aged 75 and older, particularly in those who identified as white^*. This suggests that the timing of HMT initiation is crucial and treatment plans should be tailored to a patient’s age.”

In fact, once a woman is over 80 the risk of dementia increases with hormone therapy, meaning care needs to be taken to weigh benefits and risks.

There are other nuances, including that different types of hormone therapy have different risk profiles, and the mechanism at work isn’t understood. So, as always, more research is needed.

^* I admit I’m getting old — I didn’t realize you could ‘identify as white.’ Maybe it just means they checked the box marked “White,” but it still sounds odd. Can how you identify affect how a treatment works? By the way, thanks for reading this long footnote.

Our number 2 story

How often you poop is a pretty good indicator of your overall health. There’s a Goldilocks zone between too often and not often enough, according to Institute for Systems Biology researchers.

In one sense, frequency reflects health: “Specifically, younger people, women, and those with a lower BMI tended to have less frequent bowel movements.” But too infrequent isn’t good either, as gut microbes will start to ferment proteins rather than fiber, producing toxins.

Pooping once or twice a day is that Goldilocks zone (they left that out of the fairy tale) — that’s where the good gut bacteria thrive, which both helps with and indicates good health.

Pharma tax break under fire — again

Did you know that drug companies get a tax deduction for their direct-to-consumer ads? That’s right — they’re rewarded by the government for running those interminable commercials. That’s because the law considers ad spending to be a deductible business expense just like research and development.

“In 2022, the total pharma ad spend topped $8 billion,” meaning that’s $8 billion that wasn’t taxed^* and $8 billion worth of ads we all had to watch.

Lawmakers have been trying to close that loophole, but fierce lobbying by the pharma industry has meant that there are never enough votes. Still, they’re trying yet again.

^* Math! The US corporate tax rate is 21%. So that’s almost $1.7 billion per year we could’ve had to spend on, oh, fixing roads, buying school books, cutting taxes on small business….

Short Takes

Just what we need

Healthcare pros don’t think pharma companies are using social media enough … according to a survey by a company called Medfluencers that supplies social media marketing.

CBD blocks UV-A

CBD cream reduced damage from UV-A rays according to a small study out of George Washington University. Big caveat: This didn’t compare CBD creams to other sunscreens — it just showed that CBD creams can help.

Obesity, mood, and risk taking

Santa might not be as jolly as the news reports suggest. It seems that people who are overweight or obese not only tend to have more depressed moods, they’re also more likely to engage in risky behavior.

German researchers investigated how metabolic factors, including glucose metabolism, affect both mood and risk-taking. They hypothesized that when glucose metabolism is impaired, so is mood — and then the brain doesn’t get all the signals it needs to control risk-taking.

To test this, they put 62 people with severe obesity on an intense 10-week diet and measured their mood and willingness to take risks. After the diet…

… there was a significant reduction in the body mass index and the HbA1c level as a marker for glucose metabolism, as well as a significant improvement in mood. In addition, the scientists were able to demonstrate a positive change in behavior, as the weight loss led to risk-avoiding decisions.

USP launches product finder

Choosing supplements can be tough for consumers — not just which ingredients to take, but also which brands they can trust. Because they’re not FDA-regulated, you never know how good Prol-E-Fine™ brand will be. (And if it’s something for long-term health, you might never know.)

The closest thing to regulation is USP verification, which is a pretty good indicator that the supplement contains what it says it contains. So now USP has created a product finder at quality-supplements.org/usp_verified_products that lets you look up a supplement or brand to see what’s got the seal.

Use it yourself to see what to stock or what to recommend, or point your patients to it to help them shop.

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Of course, the lack of a USP seal doesn’t mean a supplement isn’t good, just that it hasn’t been tested (and for some supplements there are no USP Verified products).

Patent pruning shears

The US Senate unanimously passed a bill that will limit drugmakers’ ability to create patent thickets — a “complex web of intellectual property that’s hard for generic or biosimilars developers to navigate.”

That’s right, unanimously. The US Senate. I know, right?

How do they do it? By literally limiting to 20 the number of patents that can be used to defend a product from competition — not more than 10 of which were issued after another company filed to make a generic. (In other words, when they see generic competition coming pharma companies can’t suddenly file for 50 new patents.)

Weekly insulin nixed … for now

We’ve reported a couple of times about Novo Nordisk’s weekly insulin icodec candidate, Awiqli. Not surprisingly, though, the FDA has declined to approve it — at least not without getting more info from the company.

(We wrote back in May how an FDA committee recommended against approval because it thought “the weekly insulin icodec’s benefits do not outweigh the risks.” Novo hoped to get around the criticism with better labeling, but that didn’t fly.)

ICYMI: Ounces of prevention

About 40% of cancer cases — and almost half of all cancer deaths — are attributable to “modifiable risk factors” like smoking, obesity, smoking, poor diet, smoking, over exposure to the sun, alcohol consumption, and smoking, according to a study by the American Cancer Society.

In order of risk:

• Cigarette smoking (attributable to 19.3% of cancer cases)
• Excess body weight (7.6% of all cases)
• Alcohol consumption (5.4%)
• UV radiation exposure (4.6%)
• Physical inactivity (3.1%)

Short takes

Weight loss in a pill

Here’s everything you want to know about the status of oral versions of GLP-1 drugs, courtesy of CNBC.

A little more H5N1

Colorado has reported three new (presumptive) cases of H5N1 bird flu in humans. They were all poultry workers and all had mild symptoms, so nothing to worry about. No sirree.

Found: the cause of lupus

A group of researchers say they’ve found the root cause of lupus: Too much of a particular type of interferon that leads to a “fundamental imbalance in the types of T cells that patients with lupus make.”

Looking at the blood of 19 people (i.e., this was a small sample), they found that those with lupus have too much type I interferon. That ends up blocking the aryl hydrocarbon receptor — “which helps regulate the body’s response to bacteria or environmental pollutants.”

Because that receptor is blocked, two bad things happen. First, the body can’t make enough wound-healing T cells. Second, it “stimulates the production of T cells involved in creating autoantibodies, which attack healthy cells and are a hallmark of lupus.” There’s that “fundamental imbalance.”

The researchers (from Northwestern Medicine and Brigham and Women’s Hospital) think this is going to hold true for all lupus patients, but others aren’t so sure — “Until they study 100 patients prospectively, how are we going to know?”

Captain Obvious thinks you throw like a girl

“Adolescent Boys Show Aggression When Masculinity is Threatened”

Easy infection prevention

A couple of simple, over-the-counter products can prevent colds, chest infections, and even the flu from taking hold.

We won’t bury the lede. The products are Vicks First Defence^* gel-based nasal spray or — get this — a simple saline nasal spray. According to British researchers…

[B]oth sprays were shown to reduce the overall illness duration participants experienced by around 20 per cent, and resulted in a 20-30 per cent reduction in the days lost of work or normal activity.

That’s based on a study of 13,800 adults who either got one of the two sprays, or “an online resource promoting physical activity and stress management.”

Tidbits:

• Most of the patients didn’t use the sprays as often as they were asked to, but they still worked well.
• Even that online resource helped a bit, reducing infections by about 5 percent.

^* Bad news: As you might guess from the misspelling, Vicks First Defence is a British product, but we did find it on Amazon in the US as “Vicks Prèmiere Défense” — at $28 a bottle.

Sauce for the (insurance) gander

Insurers: We’re using AI to automatically deny treatment claims and prior authorizations.

Doctors: Fine. We’ve got AI too, and we’re going to use it to draft requests and appeals with a heck of a lot of detail.

With the help of ChatGPT, [one doctor] now types in a couple of sentences describing the purpose of the letter and the types of scientific studies he wants referenced, and a draft is produced in seconds.

Then he can tell the chatbot to make it four times longer. “If you’re going to put all kinds of barriers up for my patients, then when I fire back, I’m going to make it very time consuming,” he said.

They’re actually using a product called Doximity GPT (based on ChatGPT), which is HIPAA-compliant. It uses not only scientific studies to make its case, but also patient medical records and the insurer’s coverage requirements. And it works.

GLP-1 v2?

Side effects are a big downside to GLP-1 agonists, and nausea is a big one. It’s kind of a “you take the good, you take the bad” situation.

But researchers at Philly’s Monell Center found something interesting. It seems that GLP-1 inhibitors affect two types of neurons. Some neurons affect satiety, i.e., feeling full, while some affect nausea. (Want more Latin? The GLP-receptive neurons that affect satiety tend to be in the hindbrain’s nucleus tractus solitarius, while the ones that are more “aversive” are in the area postrema.)

All this means, the Monellites figure, that it might be possible to target just one set of neurons, so people felt full without the side effect of nausea.

This is all in the early stages, but they’re really into the idea of “separating therapeutic and side effects at the level of neural circuits.”

Natural killers: the sequel

CAR-T cancer treatment works by taking a patient’s own T cells, modifying them to attack cancer, and reintroducing them to do their killing. But there are serious side effects — including death.

Enter CAR-NK therapy, which uses natural killer cells instead of T cells. Those don’t need to be taken from the patient’s own body (making them easier to get) and they don’t have CAR-T’s side effects. The downside is that while they work well against leukemia, they can’t work against solid tumors like breast cancer.

Yale researchers, though, might have a way around that. They were able to disable some of the CAR-NK cells’ “brakes” — the cellular-checkpoint genes that keep them from becoming too active, notably a gene called CALHM2 that, when knocked out, “made natural killer cells more potent in terms of cancer-killing, more efficient in terms of infiltrating the tumor, and more efficient in producing anti-tumor cytokines.”

Now they’re looking at the details of why this works, with a plan to develop a treatment for clinical trial.

Elsewhere: Penn’s PDMP

How well do prescription drug monitoring programs work? In Pennsylvania at least, really, really well.

Researchers there looked at a simple metric: opioid prescription rates. They found that prescriptions for opioids dropped 38% from 2017 to 2020; the PDMP took effect January 1, 2017.

Side note: The biggest percentage drops were in meperidine (Demerol; down 89%) and fentanyl (down 51%).

The big limitation/missed opportunity is that they didn’t look at records before the PDMP was required, to see if opioid prescribing was already decreasing.

Phage breakthrough

Here at Buzz we’re big fans of bacteriophages and their potential to treat infections when antibiotics fail. Phages have a few problems, though. They have to be matched to specific bacteria, for one. And to be transported they need to be suspended in liquid and refrigerated or frozen, so labs around the world don’t share as much as they could.

Now Canadian researchers have developed a way to help solve those problems — they can store the phages at room temperature in trays that also serve as a testing medium to match phages to bacteria.

That means, in principle, that a hospital looking to fight an infection could receive a tray of candidate phages and know within an hour or two if any of them could fight the bacteria they’re facing. It also means they could save those phages in their own library for the future.

“If everything moves forward to commercial application as we anticipate, this could revolutionize the way we use phages for different purposes.”

After report, FTC to sue PBMs

On Tuesday, the Federal Trade Commission released a scathing, two-years-in-the-making report about PBMs — a report that concluded, “This vertically integrated and concentrated market structure has allowed PBMs to profit at the expense of patients and independent pharmacists.”

Then on Wednesday, the agency followed up, saying it’s going to sue the biggest PBMs (Caremark, Express Scripts, and OptumRx) over their tactics for negotiating prices for drugs including insulin.”

In case you missed it, that report didn’t pull punches:

[PBMs’ power] can have dire consequences, with nearly 30 percent of Americans surveyed reporting rationing or even skipping doses of their prescribed medicines due to high costs.

The interim report also finds that PBMs hold substantial influence over independent pharmacies by imposing unfair, arbitrary, and harmful contractual terms that can impact independent pharmacies’ ability to stay in business and serve their communities.

The lawsuit news was breaking at press time, so there isn’t much detail. Still, you’re allowed a big smile knowing that it’s happening.

Side note: Georgia’s Buddy Carter weighed in, too:

I’m proud that the FTC launched a bipartisan investigation into these shadowy middlemen, and its preliminary findings prove yet again that it’s time to bust up the PBM monopoly.

Mounjaro beats Ozempic

People taking Mounjaro lost more weight than people taking Ozempic, according to a new study from data-analytics company Truveta.

Based on the health records of more than 18,000 overweight or obese adults, it found that…

• 82% of people on tirzepatide lost 5% of their body weight, compared to only 67% of those taking semaglutide.
• 42% of people on tirzepatide lost at least 15% of their body weight within a year, compared to only 18% of those taking semaglutide.
• “At six months, average weight loss was 10% on tirzepatide and about 6% on semaglutide.”

Side note: More than three-quarters of GLP-1 drug users quit within two years, according to the latest study of pharmacy claims data.

Pharma allowed to combat online misinformation

When some chucklehead influencer on TikTok says something stupid about a drug (“Adderall makes your earlobes shrink!”) drug companies have trouble refuting it because of the regulations about what they can say online.

Now the FDA has released draft guidance that loosens the leash on those companies when they want to combat misinformation^*.

Essentially, the companies will be allowed to refute specific claims that are “false, inaccurate, and/or misleading” (but not statements that are someone’s “own experience, opinion, and value judgments”). As long as the companies’ responses target a specific claim, they don’t need to meet all the usual labeling and advertising requirements.

The guidance itself is full of boring legalese, but you can skip to the more interesting stuff — the FDA’s examples — on page 13 of the PDF by clicking here.

^*  We used to call it “lies.”

Short takes

Losartan boosts chemo (in mice)

Giving losartan to mice with acute myeloid leukemia makes the cancer more sensitive to chemotherapy. The science: Losartan inhibits the AGTR1 receptor in blood cells, which is critical for cell reproduction — and it’s overabundant in leukemia patients. “This disrupted cancer growth, slowing the development of leukemia and led to longer survival.”

Fighting acne with omega-3s

A lot of people with severe acne (98.3%!) are deficient in omega-3 fatty acids, found German researchers. So … what if you fixed that? It makes a big difference.

Over 16 weeks, a Mediterranean diet and algae-derived omega-3 supplements led to sizable reductions in inflammatory and non-inflammatory skin lesions in 60 people with mild to moderate acne.

This was a small study, of course, but the Germans hope it will lead to a larger, more comprehensive one.

A simple autism test?

People with autism have different gut microbes^* than people without, and that fact has led Chinese researchers to develop an autism test using biomarkers from stool samples. Their test was 82% accurate in identifying autistic children, which could be incredibly useful for earlier diagnosis.

(They don’t know if the changed microbiome is the cause of the autism or the result of it — either way, it serves as a useful tool.)

^* “In all, 51 types of bacteria, 18 viruses, 14 archaea, seven fungi, and a dozen metabolic pathways, were altered in autistic children.”

Covid is still FLiRTing

Like Kardashians, Covid-19 still lurks in the shadows. Just when you think it might be gone for good, it reminds you that it’s still out there … and still mutating. Right now it seems that the new FLiRT variants (KP.2 and KP.3 mostly) are surging.

[E]mergency room visits due to Covid-19 from June 16 through June 22 […] were up 23.3% from the previous week.

Also, Covid-19-related hospitalizations during the week of June 9 through 15 were 13.3% higher than they were than the week before.

“Surging” might be a strong word, as the numbers are still low. But keep in mind that Covid surveillance has pretty much shut down, so there’s probably a lot circulating that health officials don’t know of. “I’ve got a cough, so I’ll stay home today.”