Helene: What Georgia pharmacists need to know

As you recover from Hurricane Helene, remember that the Georgia Board of Pharmacy has activated Policy 14, which covers emergency situations like this one. Here’s the gist:

Emergency refills

You may give patients up to a 30-day supply of their medication.

Caveats:

• This does not apply to controlled substances.
• In your professional judgment, the prescription drug must be essential to the maintenance of the patient’s life or to the continuation of therapy.
• You must make a “good faith effort” to record all pertinent information as required by law, indicate that it is an “emergency refill prescription,” and keep those records.
• You must inform the patient that the prescription drug “is being provided without the practitioner’s authorization and that authorization of the practitioner is required for future refills.”
• As soon as possible, as conditions permit, you must notify the patient’s prescriber.

Click here for the official statement from the Board of Pharmacy (PDF).

Out of state pharmacy staff

During the state of emergency, pharmacists and pharmacy technicians not licensed in Georgia (but licensed in other states) may do their jobs in Georgia.

Such a pharmacist “may obtain a temporary license to dispense prescription drugs in areas affected by the declared disaster during the time that the state of emergency exists.”

Such a technician or intern “may assist the pharmacist in dispensing prescription drugs in affected disaster areas” during the emergency. There are important caveats — read that official statement — and most important, stay safe!

No drugs, no viruses

We’ve written before how using a simple saline nasal spray can go a long way toward preventing respiratory diseases, including Covid-19. Now researchers at Harvard think they can go one better. They’ve created a “drug-free nasal spray that forms a gel-like matrix that captures and neutralizes germs.”

It’s called PCANS, and it uses a bunch of ingredients that are in the FDA’s Inactive Ingredient Database. As a co-author explained:

“We developed a drug-free formulation using these compounds to block germs in three ways — PCANS forms a gel-like matrix that traps respiratory droplets, immobilizes the germs, and effectively neutralizes them, preventing infection.”

Caveat: It hasn’t been tested on humans, just “a 3D-printed replica of a human nose.”

CMS hit with data breach … in 2023

More than a year ago, the MOVEit data breach came to light, with a huge list of victims including banks, law firms, and even the University System of Georgia.

And now you can add CMS to the list.

The agency has now confirmed suffering a data breach incident as a result of the MOVEit vulnerability that saw sensitive data belonging to 3,112,815 people stolen. Many of those are either deceased, or not Medicare beneficiaries, since CMS only notified roughly 950,000 people.

New schizophrenia drug

The FDA has approved the first new drug for schizophrenia in decades. Bristol Myers Squibb’s Cobenfy is different because it targets the brain’s cholinergic receptors (instead of dopamine receptors) by affecting acetylcholine. It shouldn’t cause the common antipsychotic side effects like weight gain or tiredness.

But … the studies of Cobenfy have been pretty small and short term.

Only three controlled studies of the drug’s efficacy have been published, and all three lasted for only five weeks. So it is not clear how effective Cobenfy will be over longer periods, or whether it has long-term neurological side effects.

Alzheimer’s/cancer connection

People with Alzheimer’s seem to have a lower risk of contracting certain types of cancer, notable the colorectal variety — sometimes that risk is actually cut in half. Now Chinese scientists think they’ve found the reason.

And what d’ya know, it’s all about gut microbes. Specifically, mice that had more Prevotella bacteria in their intestines were more likely to develop Alzheimer’s but less likely to develop GI cancers.

When mice were treated with Prevotella-derived compounds, the animals showed cognitive dysfunction and resistance to tumor development in their rectum and colon.

They think that Prevotella suppresses gut inflammation (and thus suppresses tumor formation), but at the same time makes the gut “leakier,” allowing more microbial byproducts to enter the bloodstream, where they “may create a toxic environment that damages dopamine neurons.”

The Long Read: GLP-1

You might have noticed that GLP-1 agonists seem to treat a lot of issues, from the obvious (diabetes, obesity) to less obvious (alcoholism, sleep apnea). What’s up with that? Nature explains in “Why do obesity drugs seem to treat so many other ailments?”

Saving you a click

“This Many Crosswords Each Week Could Benefit Our Brains as We Age” — more than three times a week.

Americans aren’t iron-y enough

Something like 1 in 6 Americans are iron deficient, at least according to a new US/Egyptian/Saudi study. Specifically, it “estimated that absolute iron deficiency affects 14% and functional iron deficiency affects 15% of adults in the US.”

They based that on the analysis of a survey of more than 8,000 adults between 2017 and 2020. Women, it seemed, were affected much more than men … at least until they were about 50. In fact, after age 50 the prevalence of iron deficiency dropped across the board.

Being overweight increased a person’s risk of being iron deficient, but interestingly alcohol use, food security, or even the amount of iron in a person’s diet had an effect.

The implication: Physicians should test more people for iron deficiency, not just children and pregnant women.

Targeting anxiety, not trips

We know that psychedelics can reduce anxiety, but it hasn’t been clear exactly what was affected that allowed them to work. Now Cornell researchers, with help from colleagues in India, think they know.

They studied a psychedelic called DOI (2,5-dimethoxy-4-iodoamphetamine) that helped mice and rats chill out. They found that when the drug hits the ventral hippocampus, it reduces anxiety but doesn’t cause any of the hallucinations that recreational DOI is known for. And there you have it … for now, at least.

As research on psychedelics as depression and anxiety treatments continues, knowing what area needs to be reached could allow for the development of targeted therapy, sans Lucy, the sky, or diamonds.

Treat inflammation, treat depression

When it’s not gut bacteria, it’s inflammation — and that just might be the case with … depression? Emory researchers found that the anti-inflammatory drug infliximab seems to help improve motivation in people with untreated depression. Motivation is kind of a big deal with depression as it can get patients into a downward spiral of inactivity.

But a bit of infliximab over a couple of weeks made a difference.

Patients who received infliximab demonstrated a greater willingness to exert effort in pursuit of rewards compared to those who received the placebo. This increase in effortful behavior was closely tied to a reduction in signaling pathways directly targeted by infliximab, particularly TNF.

And it wasn’t just self-reported — the changes were visible via fMRI as “alterations in brain activity within key regions associated with motivation, such as the dorsomedial prefrontal cortex, ventral striatum, and putamen.”

OD deaths drop

For the first time in … well, a long time, overdose deaths in the US dropped in a big way — about 10% from April 2023 to April 2024, according to CDC data. Health experts are cautiously optimistic that “a widespread, meaningful shift appears underway” for the first time since the opioid epidemic really took hold. As the White House drug czar put it, “This is the largest decrease on record and the fifth consecutive month of recorded decreases.”

Easier methadone access

New federal rules will allow people to take home a 28-day supply of methadone, rather than have to pick it up at a clinic every day. It’s the first major rule change for the addiction treatment in 20 years, and it takes effect Oct. 2.

Some states will need to update their laws to allow the new rule to take effect. Others may have to change their Medicaid payment system so clinics don’t have a financial incentive to deny patients the take-home meds. But most importantly:

Research showed the looser practice was safe. Overdose deaths and drug diversion didn’t increase. And people stayed in treatment longer.

The Long(ish) Read: Winners and Losers edition

Some Medicare recipients might soon be eligible for GLP-1 drugs for weight loss (not just for diabetes), but which ones? Everyone with obesity? Just those who also have diabetes? Heart conditions? Billions of dollars are at stake depending on the answers.

Shut up!

“Study finds staff and visitor voices are major source of excessive noise in hospital ICUs”

Coming: at-home flu shots

Of course, as soon as we closed the Buzz newsroom for the weekend, this story came through:

The FDA has approved the first self-administered flu vaccine. MedImmune’s FluMist has been approved for more than 20 years, but it had to be given by a professional. Now its approval has been expanded to allow for either doing it yourself or having some other adult do it for you at home.

It won’t be available at your pharmacy, though — at least for now, patients will need to go through MedImmune, which will do a quick screening and ship it to their home. Or office. Or wherever they want it, starting sometime next year.

Come for Tech U, stay for immunization training!

Technicians! GPhA’s got a great educational weekend for you — TechU on Saturday (Oct. 19) and Immunization Training for Pharmacy Technicians on Sunday (Oct. 20). Two great courses that taste great together!

TechU

Four hours of CE credits, a continental breakfast, lunch, a professional headshot, and a fun networking event. (The full list of CE sessions, hotel suggestions, and registration is at GPhA.org/techu.)

It’s Sat., October 19 from 8:00 am – 5:30 pm at the PIHC Pharmacy Corporate Office in Atlanta (map). $40 for GPhA members, $65 for non-members^*.

Immunization training

It covers the latest info on flu and Covid-19 vaccines, including how to give those jabs the right way (of course). We’ll also cover the legal details of tech vaccinations and a bit of background on vaccines and immunology — then toss in practical stuff like ordering vaccines with inventory management standards, billing and reimbursement, and all the documentation you need to use. And it’ll help you sit for PTCB’s Advanced Skill Exam.

It’s Sun., October 20 from 9:30 am – 1:30 pm at GPhA HQ in Sandy Springs (map). $199 for GPhA members, $249 for non-members^*.

^* Non-member rate includes a full GPhA Membership through December 31, 2025, for all attendees residing in the state of Georgia.

Short Takes

Try lullabies instead

The American Academy of Sleep Medicine suggests “Rethinking the use of melatonin as a sleep aid for kids.” That’s mostly because dosing is difficult to manage; supplements aren’t regulated, and 2022 saw a jump in overdose calls.

Antidepressant beats brain tumors

The bad news: Only in the lab and in mice.

The good news: Vortioxetine appears to be “one of the most effective agents” against glioblastoma, according to Swiss researchers, who are now preparing clinical trials (which are made easier because the drug is already approved).

Bone cancer breakthrough

If you add a little gallium to certain bioactive glasses — a filling material used for bone and tooth repair — you get a material that eliminates bone cancer. That’s what British researchers found, and when they say ‘eliminates,’ they mean it.

Tests in labs have found that bioactive glasses doped with the metal have a 99 percent success rate of eliminating cancerous cells and can even regenerate diseased bones.

Basically the glass particles get into the bone, where the cancer cells soak it up … with the gallium, which kills them. And then the glass gets to work rebuilding the bones. Said the orthopedic oncologist who led the team, “We believe that our findings could lead to a treatment that is more effective and localised, reducing side effects, and can even regenerate diseased bones.”

Shrooms beat Lexapro

A new study finds that, over the long haul, patients who take psilocybin for major depression do better than those who take escitalopram.

That’s what British researchers reported, and they imply it might hold true for other SSRIs. They found that both drugs reduce depression, but “psilocybin outperformed escitalopram in several measures of well-being, meaning in life, work, and social functioning” including not messing with patients’ libidos.

(The idea of psilocybin as a long-term treatment for depression isn’t news. Back in 2022, Johns Hopkins researchers reported that psilocybin treatment for major depression was effective for at least a year.)

Should we worry about this? It feels like we should worry about this

So there’s a guy in Missouri who got the H5N1 bird flu without having contact with infected animals. That’s mildly concerning. But now three people who have been in contact with him — a household member and two healthcare workers — have also contracted the flu. And these are only the symptomatic cases. (Thankfully the symptoms were mild.)

TikTokers gonna TikTok

Their latest health advice: Eat dirt! It’s got, you know, microorganisms! (They call themselves — I kid you not — “crunchers^*.”)

As Forbes’s Bruce Lee puts it:

[I]sn’t having a lot of microorganisms also kind of the reason why you typically try not to eat dirt? It’s the whole reason why if someone were to drop a burrito on the ground, roll it in the soil and then offer it to you, you wouldn’t immediately say, “Thanks” and not worry about getting a bad case of the runs or worse.

^* We have a different name.

Georgia pharmacist to DEA: Come get me, bro

The owner of Living Well Pharmacy in Augusta, Vic Johnson, is dispensing medical marijuana to Georgians who have a medical marijuana card … even though the DEA says that’s illegal.

Quick background: Georgia passed a law allowing certain independent pharmacies to dispense low-THC products to patients who have been approved to receive a medical marijuana card. That’s about 22,463 people so far.

But before the program could take off, the DEA stepped in and said pharmacies couldn’t dispense it, stopping the program in its tracks.

Now here comes Johnson willing to defy the feds.

Johnson said he is prepared to take drastic measures to keep selling medical marijuana products if the DEA takes steps to force him to stop.

“It’s a new frontier. I really think pharmacies are an ideal outlet for dispensing medical cannabis because if you come to my pharmacy already, we can talk about what medications you already are taking,” said Johnson.

FTC fires back

Tuesday: We wrote that PBMs were demanding that the FTC retract its conclusion that PBMs help increase the price of drugs.

Now: The FTC filed suit against Caremark, Express Scripts, and Optum “for Artificially Inflating Insulin Drug Prices.” The agency found that PBMs “chase the rebates” and thus steer patients to more expensive medications, making insulin unaffordable to millions of Americans.

The FTC alleges that the three PBMs created a perverse drug rebate system that prioritizes high rebates from drug manufacturers, leading to artificially inflated insulin list prices.

The complaint charges that even when lower list price insulins became available that could have been more affordable for vulnerable patients, the PBMs systemically excluded them in favor of high list price, highly rebated insulin products.

(The FTC also puts blame on drug makers for “driving up list prices of life-saving medications” and might sue them later.)

Triptans beat newer migraine drugs

As good as new migraine drugs like lasmiditan (Reyvow), rimegepant (Nurtec), and ubrogepant (Ubrelvy) are, it seems that older, less expensive drugs are actually better.

A British review/analysis with 90,000 participants (!) found that certain triptans — but not all — were actually the best drugs for acute migraine. According to the lead researcher:

“Our analysis identified eletriptan, rizatriptan, sumatriptan, and zolmitriptan as the most effective medications for treating acute migraine attacks.”

Meanwhile, the newer drugs were “comparable to paracetamol [acetaminophen] and less than the aforementioned four triptans.”

Ozempic up for negotiation?

Novo Nordisk says it expects Ozempic to be part of the next round of Medicare price negotiations. Considering the high price the company set (and the frightening effect on Medicare’s wallet), the good it can do for people’s health, and the high demand, that’s not surprising.

No, it’s not good for you

Even moderate alcohol

More and more the idea that moderate drinking is good for you is falling by the wayside. Yeah, it might reduce some cardiovascular issues, but — as a new report from the American Association for Cancer Research explains — the recent rise in certain cancers might be attributed to alcohol use.

In fact, there have been several studies lately that have solidified the link between alcohol and cancer while finding the cardiovascular effects are minimal.

As one epidemiologist put it, when it comes to moderate drinking, “[T]here are many ways to keep your heart healthy, and these potential benefits don’t really outweigh your cancer risks.”

Fruit and oats

Don’t give your kid(s) oatmeal or fruit for breakfast — you’re raising their risk of type 1 diabetes. A new Finnish study followed 5,700 children who had a genetic predisposition to type 1 diabetes and had their parents track their diets.

When they parsed the data, they found that “the more fruit, oats or rye children ate, the more their risk of T1D increased.”

But there’s good news:

In contrast, eating strawberries, blueberries, lingonberries, raspberries, blackcurrants, and other berries appeared to provide protection against T1D. The more berries a child ate, the less likely they were to develop T1D.

Commercial premiums are going up … again

Employers are going to see the cost of employees’ health plans jump an average of 5.8% in 2025 according to a projection from Mercer (the company, not the university).

• That would be the third year in a row of costs rising more than 5%
• It would be about 7% without employers’ cost-savings measures, like switching to higher-deductible plans or raising employee contributions.
• It’ll be worse for smaller businesses — 9% before any cost cutting.

Why the jump? Prescription drug costs, of course. And what’s leading the pack? GLP-1 agonists.

Correlation vs causation

Apparently there’s a link between slap fighting and brain trauma. (Captain Obvious wonders, though, which way it goes.)

Hard to imagine why.

Elsewhere: Sunshine State confusion

Trigger warning: This is a story about abortion. Remain calm.

Florida has effectively outlawed abortion, banning it after 6 weeks. Okey doke^*. There are exceptions “to save the life and health of the mother” and “when the pregnancy results from rape, incest, or human trafficking, or has a fatal fetal abnormality.”

But now the state’s health department has sent a memo to doctors saying that failure to provide an abortion in those circumstances is illegal and can result in malpractice charges.

^* That doesn’t mean we support or oppose it, just that it’s the law — let’s go on with the rest of the story.

Express Scripts gets offensive

Express Scripts is suing the FTC, saying the agency’s investigation into PBM practices reached “false and defamatory” conclusions. It wants the entire report quashed.

The company is demanding that the U.S. District Court for Eastern Missouri declare that the FTC’s interim report “is not in the public interest,” that the report be vacated, and it demands “FTC Chair Lina M. Khan’s recusal from all Commission actions pertaining to Express Scripts.”

The evidence Express Scripts cites for its conclusion? A study by a University of Chicago economist who has earned more than $100 million writing in support of mega-mergers. (It also cited a 17-page report from a company that also supports mega-mergers.) So not biased at all.

Thanking them for their service

Hims and Hers — the giant telehealth company — says it’ll give a 50% discount on compounded semaglutide injections to members of some public-service professions, including teachers, police, first responders, and members of the military.

People in those professions will be able to buy the drug for $99 per month, compared to the full price of $199/month for an annual plan. (And that compares to $1,349 per month for brand-name Wegovy, although insurance might cover it once it becomes accessible again.)

ICYMI: More coffee goodness

Okay, when there’s a story about coffee, step 1 is checking whether it’s actually about coffee or if it’s about caffeine. In this case, it’s about caffeine (despite the headlines).

The gist: Consuming 200-300 mg of caffeine per day — that’s about two 12-oz. mugs^* of coffee or seven cans of Diet Dr Pepper — seems to protect people from a list of cardiometabolic diseases … assuming they don’t have them already.

The Chinese study found that…

…compared with non-consumers or consumers of less than 100mg caffeine per day, consumers of moderate amounts of coffee or caffeine had a 48.1% or 40.7% reduced risk for new-onset CM [cardiometabolic multimorbidity].

That’s based on data from the ginormous UK Biobank: almost 190,000 participants aged 37-73 years.

^* That’s a typical full-size mug of drip coffee, but obviously there are a gazillion variables. 

Drugmakers want to fight social media

Pharma companies want more leeway from the FDA to respond to what they think is false or misleading statements online or on television.

The FDA’s proposed guidance would make it easier for drugmakers to respond to what they considered false or misleading info — they needn’t follow all the usual disclosure rules, for example.

But that guidance wouldn’t let the companies respond to a post or statement that was simply someone’s “own experience, opinion, and value judgments.”

So if someone wrote, “Ozempic turns you into a newt,” Novo Nordisk could respond quickly with “Actually, that’s not true.” But if someone said, “I took Ozempic and it turned me into a newt,” the shackles would remain in place because it’s an individual experience.

But PhRMA, the pharma trade association, doesn’t like that restriction.

[T]he trade group said the distinction the draft makes between fact and opinion “is overly simplistic.” The guidance lacks clear definitions of “opinion,” “value statements” or “representations of individual experience.”

Snail venom does it again

Ah, marine cone snails. Will you and your deadly venom never stop giving? According to University of Utah researchers, that venom “mimics a human hormone called somatostatin, which regulates the levels of blood sugar and various hormones in the body.”

What’s cool is that the toxin — consomatin — is actually more stable than somatostatin, plus it only reacts with a single protein (somatostatin reacts with several), making the snail toxin more targeted.

All this means the venom “could also help scientists design better drugs for people with diabetes or hormone disorders.”

Oh, and if you’re wondering why we say the venom ‘never stops giving,’ that’s because back in 2021 we reported how the same venom could help treat malaria, and in 2022 we covered how it can block pain better than morphine.

Short takes

Another victory for anti-vaxxers

A new CDC report finds that child flu deaths last year tied the record for the US, with 199 kids dying. Of that group, 158 were eligible for a flu shot, but only 17% were vaccinated. (Half the kids had an underlying health condition, which you would think would make parents want to be extra careful.)

The smell of plastic

The latest place microplastics have been found: human olfactory bulbs. What makes that concerning (besides the obvious) is that it’s a short trip from there to the brain.

It took a pandemic

A new report from LeapFrog finds that hospital staff has gotten better at washing their hands. Today, about 74% of staff washes in accordance with the WHO’s guidance, while in 2020 only 11% did.

That’s right: Today, more than a quarter of hospital workers don’t wash properly, and that’s considered good news.

Ketamine fights withdrawal

Quitting fentanyl is tough — the drug is strong and so are the withdrawal symptoms, so patients can have trouble starting either methadone and buprenorphine to kick the habit.

There might be a solution: ultra-low-dose ketamine. A study out of the University of Washington found that “a small amount of ketamine can reduce or eliminate the withdrawal symptoms associated with quitting fentanyl.”

The “ultra-low dose” is 16 mg, which is less than half what’s used for depression treatment. In the 14-month study of 24 patients, two-thirds transitioned to buprenorphine successfully.

“Methadone can be difficult to access due to strict federal regulations, and starting buprenorphine can cause severe withdrawal symptoms before those who start it become stabilized. Ketamine, at an imperceptibly low dose, helps bridge that gap.”

Pollution and antibiotics

Apparently when people are exposed to air pollution they’re prescribed more antibiotics. A Spanish study found that not only did antibiotic prescriptions rise on the day of high levels of particulate matter, but they also rose 7 to 10 days later.

Why the two peaks in usage? The hypothesis: One peak is caused by “immediate irritation of the respiratory tract” so people head to the ER, while the other is caused by an immune response that makes them more susceptible to bacterial infection.

And, as we all know, even today, ‘if you don’t know the cause, give ’em antibiotics.’

I think this is a good thing

In the six years from 2017 through 2022, prescriptions for naloxone that were dispensed to people 10 to 19 years old (!) went up by 669%.

Mushrooms can help

A new study out of Emory University, the University of Wisconsin, and UC Berkeley calculates that “More than 5 million Americans in treatment for depression could benefit from therapy with psilocybin.”

Anywhere from 56% to 62% of people who have a depression diagnosis could be eligible for psilocybin therapy, based on the researchers’ analysis of national survey data on depression prevalence and treatment.

That percentage amounts to somewhere between 5.1 million and 5.6 million people, the researchers projected.

Last month, the FDA rejected an application to use MDMA as a depression treatment, but that was because of “faulty data, problematic research conduct and major risks.

The agency is a bit more positive about psilocybin, which it already designated as a “breakthrough therapy^*” so the path to approving it for general medical use is a bit less rocky.

^* For drugs “that may demonstrate substantial improvement over available therapy for a serious condition.”

Walgreens pays for its mistake

Walgreens agreed to pay a fine of $106.8 million to the federal government for billing Medicare and Medicaid for prescriptions that were never picked up. This is on top of the $66.3 million the company had to refund for those meds.

The overbilling took place over an 11-year period. Walgreens blamed it on a software error.

Feds invest in a bit of domestic manufacturing

Ever since we realized that we’re a bit over-reliant on China for a lot of active pharmaceutical ingredients, there’s been a push to make them in the US of A.

The latest step toward that goal is a $14 million investment from HHS’s Administration for Strategic Preparedness and Response in a non-profit consortium called the API Innovation Center (APIIC).

The money is…

…for APIIC to lead the development and domestic production of three critical active pharmaceutical ingredients (APIs) used to treat asthma, diabetes and anxiety disorders.

(Specifically, it’ll be to develop and produce albuterol, desmopressin acetate, and lorazepam.)

There are a lot of organizations and initials involved in this, but the big takeaway is “The government is spending a little money to help increase manufacturing of some APIs here.” It’s a small step in a large process, but it’s a step.

Elsewhere: Florida bein’ Florida

Despite reality, and against the advice of just about every medical professional, Florida’s surgeon general (and health department) are telling older people not to get an mRNA Covid vaccine or booster.

“Health” officials are citing a couple of extremely rare side effects as a reason to recommend older folks spin the roulette wheel and hope for the best. Problem: Those issues are more likely after a Covid infection than after a vaccine.

Maybe next, the Florida Health Department will offer advice on balancing your four humors … and the best place to use leeches to treat a cough.

Bill would let FDA target influencers

Two senators — a D and an R — have decided they don’t like how pharma companies are skirting FDA rules by having infomercials influencers on social media spread false and misleading info.

They’ve written the Protecting Patients from Deceptive Drug Ads Online Act, which will give the FDA authority to target content that influencers get paid for but “contain false statements, omit facts, or fail to disclose risks and side effects.”

The companies would also have to report those payments to the Open Payments database.

Speaking of FDA warnings…

The agency issued a rare warning to AbbVie for having Serena Williams say that “one dose [of Ubrelvy] works fast to eliminate migraine pain” in a TV ad.

Why issue such an unusual warning? First, using a celeb makes the (unproven) message sound more believable. Second, this is the second time the agency has raised concerns about Ubrelvy marketing — the first time was in 2020 when the drug was owned by Allergen.

Gender and GLP-1s

Good news for women: They lose more weight than men when taking tirzepatide according to Eli Lilly research: Over about a year and a half, women lost an average of 24.6% of their body weight, compared to just 18.1% for men.

Bad news: They also “experienced nausea and vomiting […] at significantly higher rates than their male counterparts.”

Prize-winning pain

Congratulations to the winners of the 2024 Ig Nobel Prize in medicine: Lieven Schenk, Tahmine Fadai, and Christian Büchel, “for demonstrating that fake medicine that causes painful side-effects can be more effective than fake medicine that does not cause painful side-effects.”

Oral GLP-1 moves along

Novo Nordisk reports that a phase 1 trial of its oral weight-loss drug, amycretin, showed it’s at least safe and tolerable — which is what a phase 1 trial tests for.

Amycretin is a combo of a GLP-1 agonist and a drug that also targets the hunger hormone amylin. The company reports “a 13.1% weight loss with a side effect profile comparable to what we normally see with incretin-based therapy.”

Fezolinetant dangers

The FDA is warning prescribers to be careful giving women fezolinetant for hot flashes. Apparently it can cause “rare but serious liver injury.”

Symptoms include new-onset fatigue, nausea, vomiting, pruritus, jaundice, pale feces, dark urine, or right upper quadrant pain.

Fear not, though. Stopping fezolinetant “may potentially return liver function to normal.”

Jaundice is an issue.

DEA ponders telehealth limits (again)

A leaked document from the DEA indicated that it’s planning to reinstitute limits on telehealth prescriptions for controlleds — essentially requiring in-person visits.

Those limits had been lifted during the pandemic, and when the DEA first suggested reinstating them (in early 2023) it was met with, well, 38,000 comments, mostly saying, “Don’t do it.” So the agency kept the limits off until the end of 2024.

Well, that’s approaching, and once again people and organizations are sending a clear message: Telehealth is working, so don’t mess with it.

Numerous organizations — including Amazon, Mass General Brigham, Cleveland Clinic, Hims & Hers Health, Bicycle Health, and the College of Healthcare Information Management Executives — have now signed letters asking for the telehealth prescribing flexibility to be extended.

The best laid plans

Georgia’s plan for Medicaid work requirements — Pathways to Coverage — may have been a good idea on paper, but it’s apparently run headlong into something no one saw coming: bureaucracy.

The complexity of the program means patients are having trouble enrolling, and the agency running Pathways can’t keep up with the backlog of applications. On the other hand, it’s not kicking anyone off the program either, because it’s not able to verify that people continue to meet requirements.

As much fun as it can be to poke fun at government, though, new programs often have growing pains — there are a lot of moving parts to juggle. It’s not fair to judge a long-term program on short-term hiccups. But Georgia has about a year to get those kinks out before it needs CMS’s permission to continue.

Non-pharma, vaguely medical headline that caught our attention

“Man found dead inside catering oven at hospital; Police not treating man’s death as suspicious”

Fish vs autism

Omega-3 supplements have a lot of good science behind them for long-term cardiovascular health, and recommending them to patients is a good idea.

—BUT—

There seems to be one case where fish-oil supplements lose out to eating the fish themselves: for pregnant women. A new study funded by the National Institutes of Health found that…

Eating any amount of fish during pregnancy was associated with about a 20% lower likelihood of autism spectrum disorder diagnosis [in children].

1. The same wasn’t true for supplements.
2. The effect was greater in female children.
3. Mom doesn’t need much: “These results were consistent across all levels of fish consumption,” including less than once a week.

CVS to House committee: “Nuh uh.”

Last week we told you how House Oversight Committee Chair James Comer told PBMs he found out their CEOs lied to Congress when they testified that they didn’t treat their own pharmacies differently than they treated independents.

He offered them a mulligan — he demanded they correct their testimony or there would be … trouble.

Now CVS has responded, and it’s doubling down. It says the CEO told the truth, and that CVS Caremark doesn’t show CVS pharmacies any kind of favoritism. It said the FTC report that found otherwise was “lacking sufficient empirical data and analytical rigor” and that the people who wrote it were eating their neighbors’ dogs and cats^*.

Now the Oversight Committee is reading CVS’s response carefully before deciding what to do. Earlier Comer had threatened the CEOs with fines or even jail time. We shall see.

^* Kidding! Sheesh, take a joke!

Antidepressant doesn’t help breathing

Sometimes mirtazapine is prescribed off-label to help patients with breathlessness from various respiratory diseases. That’s a bad idea, at least according to British researchers, despite some early studies showing it could help.

They conducted a large-scale trial and found…

… that mirtazapine does not improve breathlessness in patients with respiratory disease compared with placebo. They also found that patients receiving mirtazapine had slightly more side effects and needed more care from hospitals and family members.

They also worry that those results could carry over to other antidepressants or benzos (although the trial focused on mirtazapine). But as there are no treatments for that breathlessness, the only effective option might be physical therapy.

Maybe they like the balloons

“Medical clowns shorten hospital stays for children with pneumonia” is the story. Whether they help the kids recover faster — or simply terrify them into getting out — isn’t clear.

Diabetes news

A new weekly insulin

Two new phase-3 trials have found that weekly shots of a new type of insulin— efsitora alfa — can control both type 1 and type 2 diabetes as well as daily or weekly injections of insulin degludec.

The only downside to efsitora is that there seemed to be more instances of hypoglycemia than with degludec, but that might be a matter of tweaking the dosage. As always, more research is needed.

The voice of diabetes

Using about 25 seconds of someone’s voice, AI can determine whether a patient has type 2 diabetes “with 66% accuracy in women and 71% accuracy in men.” And it’s almost as good as the American Diabetes Association’s questionnaire-based risk score. Coming soon, perhaps: A smartphone app to diagnose it at home.

Congrats to the ACA

For the first time, Obamacare enrollment is going to hit 50 million people according to the Treasury Department, with almost 21 million enrolling in 2024. (And 18.2 million of them have enrolled in an ACA plan for the first time.) That’s 1 out of every 7 Americans.

Elsewhere: Baltimore’s gamble pays off

The city of Baltimore wouldn’t sign on to Teva’s $4.25 billion national opioid settlement last year, instead opting to to negotiate on its own. It worked — now, instead of getting about $11 million over 13 years, the city will get $80 million over two years.

ICYMI: Bird flu news

A Missouri man has tested positive for H5N1 flu “despite having had no known contact with dairy cows or other animals associated with an ongoing outbreak.”

Cold comfort: salt

Here’s a simple solution to the common cold: saline nasal drops. Yeah, that easy. It turns out that, at least in kids, Scottish researchers found that “hypertonic saline nasal drops can reduce the length of the common cold in children by two days,” and also reduce the chances of transmitting it to family members.

Recipe: They used sea salt^* and (presumably) distilled water given three drops per nostril at least four times a day.

Science: “Salt is made up of sodium and chloride. Chloride is used by the cells lining the nose and windpipes to produce hypochlorous acid within cells, which they use to defend against virus infection.”

^* Sodium chloride, as opposed to regular salt (which is also sodium chloride), or Himalayan salt (which is also sodium chloride).

Next-gen GLP-1s

Now that we know what GLP-1 agonists can do, it’s time to move past the first-generation drugs, innit?

Slow-release semaglutide?

Instead of weekly injections, a French biotech company has developed a hydrogel version of semaglutide that can be given once a month with a subcutaneous injection. So far it worked in six lab rats, and the Frenchies are going to move to pig tests next.

Another pill contender

California-based Terns Pharmaceuticals says its oral weight-loss drug reduced patients’ weight by an average of almost 5% in early trials. The company joins Pfizer and Roche in the race to bring oral GLP-1 drugs to market. It expects to go to phase-2 trials next year.

Easy to predict

Last month: Bloomberg reported there’s benzene in Walgreen’s generic version of Mucinex.

This month: The lawsuits begin.

Walgreens customers Miriam Birdsong and Cheryl Mikel, both South Carolina residents, say they would not have purchased the products or would have paid less for them had they known they contained benzene, and are seeking damages and restitution.

A universal Covid antibody

Scientists led by the University of Texas say they’ve isolated an antibody from a patient that protects against every variant of SARS-CoV-2. Called SC27^*, like other antibodies it binds to the virus’s spike protein to keep it from attaching. What’s different about SC27 is that it binds to the spike protein of every Covid variant (that we know of).

The Longhorns “obtained the exact molecular sequence of the antibody, opening the possibility of manufacturing it on a larger scale for future treatments,” and — not wanting a financial opportunity to go to waste — have already filed a patent application for the antibody … which they took from a patient.

^* As opposed to SCP-027

Not-so-universal vaccines

American exceptionalism: Thanks to Congress gutting the federal Bridge Access Program, which provided Covid vaccines to low-income people, something like 25 million Americans can’t get Covid shots.

They don’t have private insurance and fall through the Medicaid cracks because they make just a little too much (especially in states that didn’t expand the program) and they obviously can’t afford the $200 out-of-pocket for the vaccine..

So they aren’t getting vaccinated, and that raises their risk of infection (and serious infection), and of course risks transmitting the virus to others — because these are the people who can’t afford to take time off work if they’re sick.

If you thought falling was bad…

Spare a moment to think of the people who experience “exploding head syndrome.” That’s where you’re jerked awake by the feeling of a bomb going off in your head. Fun.

Lyme vax update

Pfizer and Val­ne­va are very happy about the results from a phase-2 trial of their Lyme disease vaccine. Specifically, it was for a booster given a year after the initial shot.

Not only did subjects show “strong im­mune re­spons­es” from the booster (good for patients), but the trial shows that they’ll probably need an annual shot to keep up with the disease (good for the bottom line).

Goldilocks and the BP cuff

At-home sphygmomanometers^* are great for the home-health kit, but cuff sizes can be a big issue. How big? A new study out of Johns Hopkins found that “the standard arm-size ranges for these devices won’t appropriately fit millions of U.S. consumers.”

Yes, yes, mostly the cuffs are too small, but it points to a potentially bigger issue: Patients may not realize the fit is a problem and thus get erroneous readings. Some products come with multiple cuffs, while others (like one at Buzz HQ) include a coupon for a free larger cuff. If you’re selling them, it might be worth a word about accuracy.

^* I have to brag. I spelled that right on the first try. 

The Long(ish) Read: Diabetes and Dementia edition

People with type 2 diabetes who take SGLT-2 inhibitors are less likely — 35% less likely — to develop dementia than those who take DPP-4 inhibitors. (That’s what came out of a Korean study of 220,000 people with type 2 diabetes who were followed for about 2 years.)

Why would this be the case, though? What’s the connection? An Australian dementia expert looks into it.

5 is enough

When it comes to uncomplicated respiratory infections, a shorter course of antibiotics is probably all you need. There’s been mixed evidence supporting these shorter courses, so Dutch researchers decided to find the answer once and for all (until the next study, anyway).

What they found, in broad strokes, is that previous studies showed “moderate-quality evidence that 5 days of antibiotics is clinically non-inferior to a longer course” for either mild community-acquired pneumonia or acute exacerbation of COPD.

The number of the counting shall be five, though — ‘evidence for shorter durations was scarce.’

Potential big caveat — the source material the Dutchies used wasn’t great: “[T]he quality of the reviews was generally low and the quality of evidence varied between type of infection.”

Old antihistamine, new seizures?

Some kids are still given first-generation antihistamines — think chlorpheniramine maleate, hydroxyzine hydrochloride, or piprinhydrinate — usually for runny noses, itching, or, you know, to get them to fall asleep. But that might not be a good idea.

According to a study out of Korea, because these drugs cross the blood-brain barrier, they affect brain waves and result in a higher risk of seizures.

In particular, they can induce symptomatic seizures, affect electroencephalographic (EEG) activity and seizure thresholds in adults with inherent seizure susceptibility, and alter resting EEG activity.

An editorial accompanying the paper highlights the questions this study brings up, from “How should a relatively small risk translate into clinical practice?” to questioning whether newer antihistamines have similar effects and “Should antihistamines be avoided altogether in younger children?”

Gut check

We’ve often said that 95% of all diseases are either caused by inflammation or gut bacteria. Now Mayo Clinic scientists have developed a way to check #2. It can’t diagnose a specific disease, but it can analyze the bacteria and determine healthy vs. not so healthy with about 80% accuracy.

The process was simple in the age of AI: analyze 8,000 samples, tell the computer which belong to healthy people, and let it learn.

The tool, called Gut Microbiome Wellness Index 2, could detect even subtle changes in gut health, identifying whether a person may be progressing toward or recovering from a disease.

Because it’s AI-based, the researchers themselves don’t necessarily know what constitutes a healthy gut biome, just that the computer can sort it out for them.