The X for Y Files: brain cancer

Patients taking glitazones for cholesterol or diabetes could be seeing an extra benefit: They might lower the risk of brain cancer.

Or, put another way, glitazones “could be repurposed to prevent brain metastasis in cancer patients who are at high risk of secondary cancers.” That’s what British neuropathologists concluded after a study of more than 10,000 patients, including 7,500 with brain tumors:

The researchers found long-term glitazone drug use by diabetic patients was associated with reduced primary and secondary brain tumour risk compared with diabetic patients on other medications.

Interesting bits about the flu vaccine

October is the sweet spot

Kids tend to be vaccinated in their month they were born — that’s when they’re likely to go back for an annual checkup. And that led researchers at Harvard Med to check out how well they were protected from the flu.

Based on how many of those kids got sick, they were able to figure out that “The lowest rate of influenza diagnosis was seen for children born in October,” suggesting that October is the best month to get vaccinated.

Effectiveness fades

After about 41 days, the flu vax loses about 9% of its effectiveness every month.

That’s what Canadian researchers found based on “data from lab and health administration databases in the province [Ontario] from the 2010-11 through the 2018-19 flu seasons.”

The twist: That only applies to adults; the Canucks found the vaccine didn’t lose effectiveness in kids (i.e., people through age 17) at least up to about 153 days after vaccination.

The next big cancer treatment

CAR-T treatment was a major milestone for blood cancers, but now come tumor-infiltrating lymphocytes, or TIL — a potential Very Big Deal for solid tumors.

TIL works by taking immune cells from a patient’s tumor, beefing them up (“giving them the Club Med treatment,” as one researcher put it), then reinserting them into the tumor — kinda like the little weakling leaving the corrupt kingdom only to return as a conquering hero.

TIL isn’t new in the lab, but for the first time the FDA has given accelerated approval to a TIL therapy called Amtagvi.

Granted, the therapy isn’t simple — it involves chemo, the weakening of the immune system, and interleukin-2 — but this is just the beginning.

Drug interaction science

Which drugs might interact with one another? A lot of what we know is based on experience, but now there might be a way to determine interaction ahead of time.

It’s all about the transporter proteins that take the drugs out of the GI tract. Researchers at MIT, Brigham and Women’s Hospital, and Duke have found a way — using tissue samples and, of course, AI — to determine which transporters carry which drugs.

Identifying the transporters used by specific drugs could help to improve patient treatment because if two drugs rely on the same transporter, they can interfere with each other and should not be prescribed together.

Right now this process is pretty much in the proof-of-concept stage, but it could mean an easy way to flag interactions before they occur.

The Long Read/Elsewhere: Portugal

While the U.S. struggles to contain the opioid epidemic, Portugal took an entirely different tack. While here we turned to arrests and prison sentences, there they focused on “health care, drug treatment, job training, and housing.” And it’s working.

The contrast is striking. In the U.S., drug deaths are shatteringly common, killing roughly 112,000 people a year. In Portugal, weeks sometimes go by in the entire country without a single fatal overdose.

Here’s a comparison: Georgia, which has about the same population as Portugal, averages about 1,408 overdose deaths per year. (In 2021, more than 1,700 Georgians died of opioid-related overdoses.) Portugal sees about 80.

One word

Every single placenta tested by University of New Mexico Health Sciences researchers contained microplastics. Every. Single. One.

The researchers found the most prevalent polymer in placental tissue was polyethylene, which is used to make plastic bags and bottles. It accounted for 54% of the total plastics. Polyvinyl chloride (better known as PVC) and nylon each represented about 10% of the total, with the remainder consisting of nine other polymers.

In unrelated news, endocrine issues — including obesity, metabolic syndrome, and early puberty — have been rising steadily and concerningly over the past decades.

Quick Colorado follow-up

Just in case you’re interested: The other day we told you how Colorado’s Prescription Drug Affordability Board determined that the price of Enbrel was too high for patients to afford. Now the board has taken the next step and approved setting a price cap for the drug. Not the actual dollar amount, just the idea of a price cap.

The vote by the Prescription Drug Affordability Board kicks off a six-month process to determine what price would be appropriate for Enbrel. The board also has the option to ultimately vote against a price ceiling at the end of the process.

In case you’re somehow unaware….

UnitedHealth Group’s Change Healthcare division has been hit by a cyberattack from a “suspected nation-state associated cybersecurity threat actor” — e.g., Russia, China, or North Korea … not that we’d point fingers.

The cyberattack has thrown a wrench into the healthcare system’s operations, leaving many pharmacies unable to verify patient insurance coverage or determine copayment amounts.

And then comes the understatement of the day: “This inability to process prescriptions has caused considerable distress among pharmacists and patients alike” because pharmacies can’t verify insurance coverage or copays and thus some patients can’t get their meds.

Check out the story from Fox 5 Atlanta, featuring GPhA’s own Jonathan Marquess, VP of the Academy of Independent Pharmacy, or read the Reuters story for a bit more detail.

The X-for-Y Files: Propecia edition

Check it out, guys: The same drug that fights male-pattern baldness and enlarged prostate (finasteride, known as Propecia on the streets) also seems to reduce cholesterol, delay atherosclerosis, and lower liver inflammation.

Well, definitely in mice and probably in humans.

University of Illinois researchers noticed that men taking finasteride had cholesterol levels — 30 points lower than men not taking it. That was based on a survey, though, not a study. So off to the lab, where they tested the drug on mice. And it worked.

“Mice that were given a high dose of finasteride showed lower cholesterol levels within the plasma as well as in the arteries. There were also fewer lipids and inflammatory markers in the liver.”

Next up is a more thorough trial to prove the same effect on humans, but hopefully at a lower dose.

GLP-1 drugs are so effective…

How effective are they? So effective that Goldman Sachs thinks they’ll make workers much more efficient — enough to potentially boost the country’s GDP by a full 1% in the next few years. (“Academic studies find that obese individuals are both less likely to work and less productive when they do.”)

Elsewhere

Rocky Mountain High Prices edition

For the first time ever, a state — Colorado — has determined that a drug is officially unaffordable for patients. The drug is Enbrel, an injection that treats autoimmune diseases.

The state’s All-Payer Claims Database found Enbrel cost more than $46,000 a year per patient, with patients responsible for an average of $2,295 in 2022 if they were covered by commercial insurance or Medicare Advantage. The database found at least 3,400 people in the state used Enbrel that year.

That leaves it open for the state’s Prescription Drug Affordability Board to set a maximum price for Enbrel in Colorado, “which would be the first time any state took that step with any prescription drug” and will of course lead to months or years of court battles.

California tackles pharmacist overload

The Golden State has passed a new law “aiming to address understaffed chain pharmacies and reduce medication errors” by giving pharmacists an extra bit of clout.

The gist of the Stop Dangerous Pharmacies Act is making pharmacists in charge actually in charge. It starts by giving them the right to make staffing decisions “to ensure that the right personnel or at least enough personnel are present in the store.”

And if there aren’t enough staff (or there’s another dangerous situation)? The PiC is required to notify management, and management is required “to take immediate and reasonable steps to address these issues and resolve these conditions” within 24 hours. If that doesn’t happen, there’s a centralized reporting system for pharmacists to notify the state board.

There’s more to it, including reporting requirements for medication errors — hit the link above to read the Pharmacy Times article for the deets.

FDA: If it don’t prick, the results don’t stick

Smart watches or rings or bracelets or any other doodad that says it can monitor your glucose without a needle? No way, says the FDA — it hasn’t evaluated, let alone approved, any such device; patients can’t trust the readings.

Such devices are manufactured by dozens of companies and sold under multiple brand names. Their makers often claim the gadgets can measure blood glucose levels without requiring users to prick their skin.

The danger, of course, is that a patient would use a device like that to manage diabetes, and who know what would happen?

Long-Covid breakthroughs

Irish researchers have found what they think is the cause of long Covid’s brain fog: leaky blood vessels in the brain.

Using a new type of MRI scan, they discovered “that there was disruption to the integrity of the blood vessels in the brains of patients suffering from Long COVID and brain fog.”

Meanwhile, British researchers have found what they think is the cause of long Covid: a protein called interferon gamma (IFN-γ), that appears during an immune reaction. It usually disappears once the infection clears, “but the researchers found that high levels of IFN-γ persisted in some long Covid patients for up to 31 months.”

“Interferon gamma can be used to treat viral infections such as hepatitis C but it causes symptoms including fatigue, fever, headache, aching muscles and depression. These symptoms are all too familiar to long Covid patients. For us, that was another smoking gun.”

They aren’t sure if IFN-γ levels are the direct cause of the symptoms or a biomarker of some other process. Regardless, it’s something clear that can be tested for.

The Long Read: Empty Adderall Factory edition

Ascent Pharmaceuticals in New York makes generic Adderall, Concerta, and opioids. But the DEA, to show it was doing something about the opioid epidemic, shut the factory down because of “discrepancies” in record-keeping. Like what?

For example, orders struck from 222s [forms] must be crossed out with a line and the word cancel written next to them. Investigators found two instances in which Ascent employees had drawn the line but failed to write the word.

Horrors! Despite not a single pill going missing, the DEA shut down the plant, refusing to distinguish the ADHD-med production from opioid production. Now the company is suing, while other federal agencies are pressuring it to help ease the Adderall shortage … which it can’t.

Covid spring boosters may be coming

When it comes to Covid boosters, you can almost say “the more the merrier” — boosters don’t last forever, and no one wants to deal with long Covid. Thus the CDC is now weighing whether to recommend a spring booster for people who are at risk of serious Covid complications.

An advisory panel to the CDC is expected to vote on whether to recommend a spring booster during a Feb. 28 meeting. […] The panel is expected to focus on the safety of high-risk Americans, including people 65 and older and anyone with a weakened immune system.

The recommendation is important because that’ll determine whether insurance covers the shot, helping keep “the people who are most accepting of public health recommendations” safer.

Fertile summers (courtesy of UV)

We all know that UV radiation, especially when it comes from the big yellow ball in the sky, isn’t good for you. (You can insert the list of reasons here.) But Israeli biochemists think they’ve found an interesting exception: women between 30 and 40 who want to get pregnant.

It seems that during the summer, “likely due to increased exposure to ultraviolet radiation from the sun,” women’s ovaries secrete more of the anti-Müllerian hormone (AMH), which is linked to ovarian function — AMH level is one of the first tests fertility clinics run.

The researchers are super-very cautious to point out that this is a preliminary study and that (in a surprise to some) “Humans are not the same as mice.”

And if you think results might be skewed because Israel is, you know, near the equator, keep in mind that it’s at the same latitude as Amelia Island, Fla.^*

^* Site of the Georgia Pharmacy Convention. What? We’re allowed a shameless plug.

Senators want influencer crackdown

Face it, “influencers” are really just infomercials with G-list celebrities. Still, they’ll push whatever they’re paid to, including drugs. And now some US senators think pharma companies are skirting advertising laws by having people on TikTok and Snapchat promote their products. They’re asking the FDA to crack down on the “alarming proliferation of dangerous and misleading content promoting prescription drugs.”

“FDA’s guidance needs to clarify that these platforms are subject to its jurisdiction and should reflect the way that advertisements on these platforms must comply with federal requirements—such as conspicuousness and duration of statements, and size/contrast of imagery, including accounting for character counts and other limitations.”

RSV vax passes halfway mark

The latest CDC data show that more than half of newborns have received protection from RSV — the second leading cause of infant death.

• 40.5% of children 8 months or younger got the shot (Sanofi’s Beyfortus).
• 16.2% of women 32 or more weeks pregnant got theirs (Pfizer’s Abrysvo).

Reversible sperm disarmer

The hunt for a reliable, reversible male contraceptive continues, and the latest breakthrough comes from the Salk Institute.

There’s a process for sperm to mature: Retinoic acid binds to receptors, those receptors bind to a protein called SMRT, then SMRT brings in an enzyme called HDAC.

The trick is to stop at least one link in that chain. You can’t block retinoic acid because that’s used elsewhere in the body. So the Salk folks targeted that HDAC instead. Why? Because there’s already an HDAC inhibitor out there (MS-275, waiting for FDA approval and for the Blue Fairy to give it a real name).

Result? “By blocking the activity of the SMRT-retinoic acid receptor-HDAC complex, the drug successfully stopped sperm production without producing obvious side effects.” Even better, just 60 days off the drug and the mice they tested it on got their fertility back.

Now that they’ve found the pathway (in mice, at least), the next step is to see if a human drug can be developed. Stay tuned.

Halitosis solved

Japanese scientists have figured out which bacteria cause bad breath. They knew the compound that stinks (methyl mercaptan, or CH3SH), but now they know that it’s produced when two bacteria interact: Fusobacterium nucleatum and Streptococcus gordonii.

Unlike other researchers, these folks decided to go big — they “developed a large-volume anaerobic co-culture system” — which we assume had some of their colleagues wishing they had chosen the “go home” option instead.

But hey, if you think the road to halitosis is a simple one, think again:

Niacin and heart disease?

Vitamin B3 (aka niacin) used to be recommended to help lower cholesterol, but how the turns have tabled. A new study out of the Cleveland Clinic found that too much contributes to heart disease.

Here comes the science: Excess niacin breaks down into a metabolite called 4PY. And — via a new pathway the Clevelandians just discovered — “4PY directly triggers vascular inflammation [that] damages blood vessels and can lead to atherosclerosis over time.”

The new findings also might help explain why niacin is no longer a go-to treatment for lowering cholesterol. Niacin was one of the first treatments prescribed to lower LDL or “bad” cholesterol. However, eventually niacin showed to be less effective than other cholesterol-lowering drugs and was associated with other negative effects and higher mortality rates

A positive byproduct of the finding is that this new metabolic pathwa might be something that can be tested for, which could lead to new treatments. But you know the drill: More research is needed.

Science!

Chinese researchers, using US data, conclude that “Watching at least five hours of TV a day associated with higher risk of nocturia, or needing to get up and urinate twice or more a night.”

FDA approves food-allergy PrEP

No, there’s no cure for food allergies, but the FDA has finally approved Xolair — omalizumab to its enemies — to at least help when someone is accidentally exposed. (It’s been used this way off-label for a while.) Patients get an injection every few weeks to gradually build up a bit of immunity to a bunch of food allergens.

People who use Xolair must continue to avoid the foods that cause them reactions, such as peanuts, cashews, hazelnuts, walnuts, milk products, and eggs. The medication allows them to tolerate higher amounts of such foods without causing major reactions.

In case you forgot where you live, Xolair “ranges from about $2,900 a month for children to $5,000 a month for adults,” but hopefully is covered by insurance.

Inching toward an Alzheimer’s test

The medical world continues down the road that leads toward a simple blood test for dementia. The latest comes from a team of British and Chinese scientists who turned to the data — specifically, the UK’s Biobank research database.

They started with almost 53,000 blood samples more than a decade old, then looked at who among those sample-givers ended up developing dementia. Then they examined those patients’ proteins to see if there were biomarkers lurking within.

The good news: There were.

The less-good news: There were a whopping 1,463 proteins associated with dementia.

The good news: They were able to narrow it down to a handful.

They found that people whose blood carried higher levels of the proteins GFAP, NEFL, GDF15, and LTBP2 were consistently more likely to have developed Alzheimer’s disease, vascular dementia, or dementia from any cause.

What sets this apart from other Alzheimer’s blood tests is that it can predict the disease a decade before it actually shows up. They’re hoping to turn the info into a simple blood test that can help patients get a jump on treatment … and maybe even prevention.

Speaking of simple tests, there’s breast cancer

The paper: “High sensitivity saliva-based biosensor in detection of breast cancer biomarkers: HER2 and CA15-3”.

The gist: a handheld device that can detect breast cancer from a bit of saliva. It comes out of the University of Florida (with help from Taiwanese engineers) that “works by placing a saliva sample on a test strip, which is treated with specific antibodies that respond to cancer biomarkers” and takes about five seconds to give a result.

Oh, and it uses off-the-shelf components, including for the brains. Said the team that developed it, “The method is user-friendly and holds significant promise for widespread use by the general public in the future.”

An ounce of cure, a pound of prevention

Abatacept injections can be used to treat rheumatoid arthritis — that’s not news, although it’s a second- or third-line treatment.

But why wait till the arthritis is established? Why not give at-risk patients the abatacept before they get it? That’s what British researchers tested, and lo and behold, abatacept kept patients from coming down with arthritis in the first place.

After twelve months of treatment, 6% of patients treated with abatacept had developed arthritis compared to 29% in the placebo arm. By 24 months, the differences were still significant, with a total of 25% progressing to rheumatoid arthritis in the abatacept arm compared to 37% in the placebo arm.

The army around the lungs

Evolution doesn’t leave a lot of unnecessary parts lying around. If something seems useless, you should probably dig deeper (looking at you, appendix). The latest example is the pleural cavity — the big sac around the lungs. It was thought to just be a cushion, but it turns out it might be an organ in its own right.

UC Riverside researchers were surprised to find macrophages — immune cells that “gobble up bacteria, viruses, cancer cells, and dying cells” — where they hadn’t been seen: in the lungs of sick people. A bit of digging later, and they discovered that the macrophages were hanging out in the pleural cavity, ready for action.

[D]uring an influenza infection, macrophages leave the exterior cavity and cross into the lungs where they decrease inflammation and reduce levels of disease.

Down the road: perhaps a drug that can signal to those macrophages to enter the lungs sooner and in bigger numbers. But as always, more research is needed.

Your non-pharma medical breakthrough of the week

If you’ve never read the Amazon reviews for Sugarless Haribo Gummy Bears, you might want to take a gander. The operative phrase is non-insignificant gastrointestinal distress.

That said, UC Davis researchers think they’ve figured out why sugar-free gummy bears can rival Taco Bell for clearing a bathroom quickly.

Not surprisingly, it’s all about gut bacteria. It seems that some people don’t have enough Clostridia microbes in their digestive tracts. Clostridia breaks down the sorbitol used to sweeten the candy. No bacteria means sorbitol overload, and…

At high levels, sorbitol can cause bloating, cramps and diarrhea. For some people, even a small amount causes digestive upset, a condition known as sorbitol intolerance.

They call it “sorbitol intolerance,” but the Amazon reviewers have more, er, colorful phrases. (“Gastrointestinal Armageddon” was one.)

The latest dementia risk

It’s herpes simplex — aka cold sores. At any time in life. Yep, Swedish researchers found that “People who have had the herpes virus at some point in their lives are twice as likely to develop dementia compared to those who have never been infected.”

Once again, it’s a “correlation doesn’t mean causation” scenario, but that correlation part is strong. The Swedes’ conclusion is based on a study of 1,000 of their countrymen (all age 70) for 15 years, so there’s data a-plenty. What it means, though … well, that’s not clear. Next on their agenda is testing whether anti-herpes drugs might reduce the risk of dementia.

Two big cancer breakthroughs

Against breast cancer

The typical breast cancer treatment involves blocking estrogen, because the cancer needs it to spread. But that, for obvious reasons, leads to complications. So Australian researchers — being upside-down and all — tried something different. They targeted androgen receptors instead.

Specifically, they used a drug called enobosarm (which used to be called ostarine for some reason) that stimulates cells’ androgen receptors. And that, via [insert science here^*], “trigger[s] a natural defence mechanism in breast tissue.”

In a sense, instead of trying to starve the tumors (which causes all those side effects), they’re mustering the body’s troops to go on the attack.

In a test on 136 postmenopausal women with advanced breast cancer…

Enobosarm showed significant anti-tumour activity and was well-tolerated by patients, without adversely affecting their quality of life or causing masculinising symptoms.

^* Here’s the paper. Knock yourself out, but it’s beyond us.

Against mesothelioma

They’re calling it “the biggest breakthrough in two decades” against mesothelioma — it quadrupled test subjects’ three-year survival rates. That’s according to the British boffins who led a major^* study of a new drug called pegargiminase (or simply ADI-PEG20 if you want to fit it on a license plate).

To be clear about the numbers: ADI-PEG20 increased the median survival rate by just 1.6 months, but quadrupled number of patients who survived to 36 months. It works with good ol’ cisplatin to deplete the body’s arginine, an amino acid that mesothelioma needs to survive.

Oh, and even better, ““Pegargiminase-based chemotherapy was well tolerated with no new safety signals.”

^* Four years, 43 cancer centers, five countries

• • •

A drug to save and arm and a leg

ICYMI: The FDA has approved the first pharmaceutical treatment for frostbite. It’s an vasodilator injection called Aurlumyn (active ingredient: iloprost), that can reduce the chance of a limb having to be amputated.

“Side effects of the new frostbite treatment include headache, flushing, heart palpitations, fast heart rate, nausea, vomiting, dizziness, and hypotension,” which we think is a good trade-off for, you know, not losing a limb.

A different kind of lupus treatment

Canadian researchers have made what they think is a major breakthrough in lupus treatment. Instead of using broad immunosuppressants, they’ve developed a way to teach patients’ bodies not to attack certain proteins.

Both healthy people and those with lupus have a protein called “Sm”. The immune systems of healthy people know to leave it alone — they have immune regulators called regulatory T cells (aka T-regs) to limit the immune response. But people with lupus have a lot more of that Sm protein, and they’re also short on the T-regs that would keep their bodies from attacking it.

The Canucks figured the solution would be to 1) figure out how T-regs identify Sm, and 2) “train” the T-regs in lupus patients to do the same. Kind of like teaching soldiers to identify the friendlies they’re supposed to protect.

And that’s what they did — they found a way to program lupus patients’ T-regs “into the same powerfully protective T-regs that keep healthy people healthy.” Next step: Turn the technology into an actual testable treatment, which they hope to do in the next couple of years.

Pfizer settles anti-trust suit

Pfizer has settled a lawsuit by drug wholesalers that accused the company of conspiring with an Indian generic-drug maker to delay generic versions of Lipitor from entering the market. The company agreed to pay $93 million for the pay-to-delay shenanigans.

On the one hand, Pfizer denied any wrongdoing. On the other hand it said the settlement was “fair, reasonable, and the best way to resolve this litigation^*.”

^* “I didn’t steal the cookies, but sending me to bed without dessert is a fair and reasonable punishment.”

Sandalwood vs. cancer

Good news if you have mice with prostate cancer: Sandalwood oil — you know, the stuff that comes with your aromatherapy diffuser — appears to contain a compound that fights it. It’s another example of “olde timey treatments that actually have something to ’em.”

In this case, pharmacologists at Florida Atlantic University found that one of the many compounds in sandalwood, alpha-santalol, can convince prostate cancer cells to kill themselves. (More science-y, it “decreased the incidence of prostate tumors by decreasing cell proliferation and inducing apoptosis, without causing weight loss or any noticeable side effects.”)

Of course this is only in Petri dishes and lab mice, so you know the mantra: More research is needed.

A bone med for diabetes

Here’s an interesting correlation: People who take denosumab (aka Prolia) for osteoporosis are less likely to develop diabetes — 16% less likely, in fact, if they’re 65 and over. Such is the result of a Taiwanese cohort study of 65,500 patients over almost two years that found it was true across sexes and despite other health conditions.

“Our study suggests that when choosing anti-osteoporosis medication, physicians might also consider the potential benefit of lowering diabetes risk. This could be especially relevant for patients at high risk of diabetes or those with preexisting metabolic conditions.”

Health insurance news

Good news for Medicare enrollees

Starting next year, as part of the Inflation Reduction Act, people with Medicare Part D will have their out-of-pocket prescription drug spending capped at $2,000 per year.

That’s kind of a big deal because in 2021 about 1.5 million Americans spent more than that. In Georgia, between 2007 and 2021, something like 215,000 people spent more than $2,000 at least one year.

For those with catastrophic coverage it’s even better. Because the 5% co-pay has been removed, they’ll save big on expensive meds for serious conditions.

Preparing for climate change

There are people who believe that climate change is a conspiracy among 99.9% of the world’s climatologists. But you know who is sure it’s real? Insurance companies — specifically health insurers. The Wall Street Journal reports.

After the hottest year on record and increasingly extreme weather events, health insurers are battling to figure out how climate change is going to affect their business. The companies are building new models to reassess premiums, estimate risk and meet incoming climate reporting standards as coverage costs rise in a warming world.

Wrong RSV shot

There are three versions of the RSV vaccine — one for pregnant women, one for infants, and one for people over 60. Apparently there have been at least 143 members of the first two groups who were given the vaccine for the over-60 crowd.

There were only some minor complications (“adverse events”), but worth noting is that most of the mistakes were made “in outpatient settings or pharmacies,” so be sure to double-check those vials.

ICYMI: Alaskapox takes first victim

An elderly, immunocompromised man is the first person to die from a newly discovered virus: Alaskapox. It was first identified in 2015, and so far there have been just seven cases.

The man who died likely got it from a stray cat he was caring for — a cat that hunted small animals that carry the virus, and that had scratched the man.

You know they’re a bit flummoxed when this is all the advice they can give:

Health officials said there hasn’t been any documented cases of humans passing on the virus but they recommended people with skin lesions possibly caused by Alaskapox to cover the affected area with a bandage.

Legal news

Novo settles a couple of semaglutide suits

Novo Nordisk has settled two of its 12 lawsuits against spas, health centers, and compounding pharmacies for claiming they were selling Ozempic® or Wegovy® when they were in fact using compounded versions. In this case it was two spas — Cosmetic Laser Professionals Med Spa and Nuvida Rx Weight Loss, both in Florida.

The issue wasn’t that the clinics were selling compounded drugs — that’s completely legal — it was that they were claiming to be providing the brand-name stuff.

“[The companies] are immediately barred from claiming that their compounded drugs have approval from the U.S. Food and Drug Administration, Novo Nordisk said.”

Well, they never were legally allowed to say that, so they’ve now pinkie-promised to obey the law.

They are also forbidden from “misleading” advertising and using any Novo Nordisk trademarks or logos in their products.

Again, ditto — that’s kind of Trademark Law 101.

Judge tosses PhRMA suit against price negotiations

The Pharmaceutical Research and Manufacturers of America had its lawsuit challenging the legality of Medicare price negotiations tossed out of a federal court.

The suit wasn’t dismissed because of its merits (or lack thereof). Rather, the judge said the court “lacked jurisdiction to hear its claims because they arose under the Medicare Act and could only be heard by a court following an administrative review by the agency.”

So first Medicare has to review the law, then maybe PhRMA can sue. Still, it’s the second loss for PhRMA on the issue.

CDC loosens Covid-isolation recommendations

For the first time since 2021, the CDC is telling people they don’t have to isolate for five days if they test positive for Covid-19. Now they can go back out once they’re feeling better … well, almost.

Under the new approach, people would no longer need to stay home if they have been fever-free for at least 24 hours without the aid of medication and their symptoms are mild and improving.

Higher-dose naloxone doesn’t do more

Stopping an overdose with 4 mg of naloxone is just as effective as using 8 mg. So found a study out of Albany (NY) Medical College, based on 354 cases of state troopers giving the nasal spray in rural areas of the state.

“What was really remarkable was the survival was the same, but the amount of withdrawal symptoms^* was significantly larger in the people that got the 8-milligram dose.”

^* “[V]omiting, abdominal pain, sweating, shaking, and diarrhea.”

The X-for-Y Files

Vanoxerine was developed to help treat cocaine addiction, but here’s a twist: It might also work to fight colon cancer. What Canadian researchers found is that it “packs a powerful punch when suppressing cancer stem cell activity.”

In practical terms that means vanoxerine can make tumors more susceptible to the immune system by rewiring some genes leading to “reactivation of ancient viral DNA fragments” that the immune system can hone in on.

So far this has only been tested in animals and in vitro with human cells, but still, “This finding is quite significant, considering that colorectal tumours tend to show poor response to standard immunotherapy.”

Healthy viruses, lower stress

We talk a lot about the effects of gut bacteria on … well, on everything. But what about gut viruses? Maybe they haven’t been getting their due.

There’s plenty of evidence that transferring the gut bacteria of a healthy person into an unhealthy one can do a lot of good, but now scientists in Ireland have tried the same thing with viruses, specifically bacteriophages.

Phages are viruses that kill bacteria, but they’re targeted — each phage kills a particular germ. So transferring phages from one person (or mouse) to another effectively changes their gut biome once the phages start killing.

In the case of the Irish research, they tried transferring phages from chill, relaxed mice into stressed-out rodents. And what happened? “The research […] suggested these transplants reduced levels of stress hormones and curbed depression- and anxiety-like behaviour in the mice.”

Is this a lot different than transplanting the bacteria directly? Probably not, but it shows there are multiple paths to the same goal — and that gut bacteria can affect stress levels.

It looks like a good time to be a student pharmacist

Chain pharmacies are having a bit of trouble finding enough pharmacists, which is especially a problem as they look to expand the kinds of health services they offer.

You could blame burnout, but that’s actually only one part of the problem. The bigger issue is the pipeline, and how it’s not looking good for future hiring.

There’s been a steady drop in applications to pharmacy schools, falling 64% from nearly 100,000 in 2012 to about 36,000 in 2022, according to the American Association of Colleges of Pharmacy.

To help fill that pipeline, chains are looking at restoring pharmacy’s reputation as an attractive career, and one that commands a lot of community respect. And yes, they’re clear on the workload issue. They’re actually hoping to solve two problems at once: “Expanding the services that pharmacists provide, while cutting down other workloads” to attract students. (One tack is working with pharmacy schools to change how students are trained — they’re looking at more “comprehensive education around the business of health care.”)

AI and antidepressants

Antidepressants can be hit-or-miss, and it can take a month or two to determine if a particular one will work for a patient. Unless, of course, you ask an AI to look into it.

Our soon-to-be machine overlords are better at parsing patient data, and Dutch researchers found theirs takes only about a week to tell whether a drug is working. (Well, at least sertraline — that’s all they’ve tested it on so far.)

It uses a combination of brain scans and patients’ reported symptoms. After a week on the drug, the AI takes into account basic patient data and the blood flow to the anterior cingulate cortex to determine how well the sertraline is working. The severity of symptoms — or lack thereof — confirms it, meaning less time taking a drug that doesn’t help.

“With this method, we can already prevent 2/3 of the number of ‘erroneous’ prescriptions of sertraline and thus offer better quality of care for the patient.”

New antibiotic targets UTIs

A new antibiotic for urinary tract infections — GSK’s gepotidacin — did so well in its phase-3 trials that they stopped the trials. Gepotidacin was better than nitrofurantoin, and especially “in patients with uUTIs caused by Escherichia coli, including drug-resistant phenotypes of clinical importance.)

Science, if you’re interested: “[G]epotidacin is a first-in-class triazaacenaphthylene antibiotic that inhibits bacterial DNA replication by a novel mechanism of action.”

The right diabetes-drug message

When it’s time for someone with diabetes to move beyond metformin, what patients want may not be the same as what prescribers think they want.

A University of Maryland study found that doctors tend to think “This medication will lower your glucose and A1C.” Meanwhile, what patients need to hear is “This medication will keep you from dying or going blind.”

In other words, it might be a good idea to tweak the message to include the broader implications — “that it is not just glycemic control that is important but glycemic control in the context of a healthy lifestyle and good overall health.”

Fun fact: Topping patient concerns was preventing blindness (63% called it “very important”), while preventing death was in second place (60%). Take from that what you will.

A drug from the leftovers

Not only does a cancer drug fight cancer (as you would expect), but it seems that when you combine it with its byproduct, you get an even better cancer drug.

The original drug: Rucaparib (for recurrent ovarian, breast and, prostate cancers)

The metabolite by-product: M324

Combining the two: That “increased cancer cell inhibition more than using either compound singly. The biggest difference was seen in the prostate cancer cell line, with a difference in inhibition exceeding 30%.”

But wait, there’s more!

What about M324 on its own? Why that turns out to be a potential treatment for Parkinson’s.

They found that the metabolite effectively reduced the accumulation of ⍺-synuclein, a protein that, when misfolded into aggregates, causes neuroinflammation, neurodegeneration and cell death. It’s been linked genetically and neuropathologically to Parkinson’s disease.

Facebook’s algorithm is hitting pharma ads

Facebook parent Meta is, at least for the moment, cracking down on ads that violate its policy against … geez, who knows? The ones that go against its “so­cial, elec­tion, or po­lit­i­cal ad poli­cies” — that is, whatever the AI thinks make the platforms less “safe.”

Meta’s safety team at work

The point is that more pharma companies are seeing their ads flagged by the Meta algorithm and removed, even when they’re benign or even positive.

Those in­clud­ed a Gilead ad about ed­u­ca­tion eq­ui­ty in lo­cal com­mu­ni­ties, one from Sanofi with an AI avatar, and sev­er­al from Vi­iV Health­care fea­tur­ing R&D chief Kim­ber­ly Smith dis­cussing top­ics like HIV sta­tus and health in­equities.

It seems that Meta doesn’t want ads that “ad­dressed so­cial is­sues like eq­ui­ty, LGBTQ+ com­mu­ni­ty sup­port, or en­vi­ron­men­tal con­cerns” because that would, in some world, make Facebook and Instagram less safe.

That Gilead ad? It was about the company’s Cre­at­ing Pos­si­ble Fund, “which pro­motes ed­u­ca­tion eq­ui­ty for dis­ad­van­taged stu­dents in lo­cal com­mu­ni­ties.” It was allowed back up once the word “Spon­sored” was replaced by “Paid for by Gilead Sci­ences Inc.,” which is apparently … safer?

Covid deaths are higher than we thought

Officially, Covid-19 has killed about 1.2 million Americans since the pandemic began. But that, Boston University public health researchers say, is almost certainly a big undercount.

Their logic is simple and backed by data: They looked at deaths from natural causes reported during the pandemic (to eliminate accidents, homicide, and suicide) and compared those numbers to previous years.

What they calculated is that Covid deaths may have been undercounted by almost 14%. That is, 14% of excess deaths during the pandemic didn’t have Covid-19 listed as the cause, and it was more prevalent in areas where “political biases or stigma around Covid may have affected whether Covid-19 was listed on a death certificate.”

But could these excess deaths have been causes by delayed care thanks to overcrowded hospitals? Or maybe — as some conspiracy theorists claim — from the vaccine (or Bill Gates’s microchips)? Nope. The excess deaths tracked with Covid deaths, i.e., if it was a vaccine reaction or another cause, they wouldn’t have aligned with Covid peaks and valleys.

Gentlemen: Protect your big brain

Viagra might reduce your risk of Alzheimer’s. That’s what British pharmacoepidemiologists (!) found after a five-year study involving almost 270,000 men with erectile dysfunction.

It’s not proof that ED drugs actually prevent dementia, but there’s definitely an association; Men taking ED meds were about 18% less likely to develop Alzheimer’s than those not taking them.

Keep in mind that the incidence of dementia were low, so that’s 18% of a small number. But still, as one researcher put it, “These findings cautiously allude to greater benefit” of the medication.

The class is filling

There’s only about two weeks to sign up for the February 25 session of APhA’s Pharmacy-Based Immunization Delivery: A Certificate Program for Pharmacists at the GPhA World Headquarters in Sandy Springs.

This is the nation’s Godzilla^* of immunization training — the one that puts all other courses to shame (and occasionally crushes them beneath its metaphorically feet).

It gives 20 hours of CE credit, a spiffy certificate for your wall, and the impressive line on your CV.

The whole shebang is just $349 for GPhA members ($499 for non-members).

^* Yes, yes, it’s “Gojira.” Not enough people understand that, though.

Your next legislative update

Melissa Reybold is at it again at the capitol, and she’s got her latest update to show for it. Check it out to stay in the know about what’s happening under the Gold Dome.

Learning the “why”

Why are women more susceptible to autoimmune diseases?

Actually, they’re not just more susceptible, they’re a lot more susceptible — and now Stanford Medicine scientists think they know why. It’s all about that extra X chromosome that women carry.

Two X chromosomes could produce double the amount of certain proteins, and that would be bad. That’s why women’s bodies have a way of shutting it down: a molecule called Xist that causes X-chromosome inactivation.

But it seems that while Xist is preventing one of those X chromosomes from pumping out proteins, it’s also generating “long noncoding RNA molecules” that end up attracting bits of proteins and even DNA. That clumping can cause an autoimmune reaction.

They tested their hypothesis by inserting the Xist-making gene into male mice.

In these susceptible mice, males in which the Xist gene was activated developed lupus-like autoimmunity at a rate approaching that of females — and considerably more so than non-bioengineered males.

They’re hoping this discovery can at least lead to earlier detection of autoimmune disorders … at least in women.

Why do respiratory viruses hit some people harder?

When it comes to What causes ___?, if you bet on “gut bacteria” you’ve got a good chance of getting it right. Such is the case with catching a respiratory virus and how severe it is.

Georgia State researchers found that mice with segmented filamentous bacteria (SFBs) in their guts had a lot more protection against Covid-19, flu, and RSV. The bacteria, they found, altered immune cells in the lungs — alveolar macrophages — so they weren’t depleted as quickly and didn’t cause inflammation.

Sure, these are mice, and SFBs are only found in rodents, fish, and chickens. But they’re related to Clostridium, so it’s possible there’s a human equivalent. As always, more research is needed.

A reader weighs in

After Thursday’s story about Naloxone being free for everyone (either via a Medicare/caid or a Pfizer coupon, a “concerned independent pharmacy owner” wrote in with just a teeny bit of sarcasm to explain why indy pharmacies might not be in a hurry to offer Paxlovid:

I feel we should also spotlight the fact that 90%+ of insurance companies are reimbursing BELOW the cost of Paxlovid. We should spotlight how BELOW COST reimbursement is a HUGE incentive for independent pharmacies to stock/dispense Paxlovid. [eye roll]

Big Pharma and its coupon cards are here to save the day and continue the efforts to put independents out of business.

Vaccine arm twist

Back in August 2023 we reported on a study that found that getting a Covid vaccination and booster in the same arm was better than getting one in each arm — switching arms resulted in more killer T cells than being “unilaterally” vaccinated.

Now the twist: A different study, this one out of Oregon Health & Science University, found just the opposite. Researchers there report “as much as a four-fold increase in immune response when people alternate from one arm to the other when given a multi-dose vaccine.”

“By switching arms, you basically have memory formation in two locations instead of one,” said the senior author.

So which is it? You know the answer: More research is needed.

Formaldehyde ban coming?

The FDA is considering announcing in April that it might consider banning the chemical in hair-straightening products — after further consideration, of course — because the agency says it’s linked to reproductive cancers.

What’s odd is that scientists who know these things say that formaldehyde is linked to other cancers, but not reproductive ones. It shouldn’t be in hair products, but not for the reasons the FDA says.

And other scientists point out that it’s more than formaldehyde that makes hair straighteners dangerous:

Studies have shown that straightener ingredients include phthalates, parabens, and other endocrine-disrupting compounds that mimic the body’s hormones and have been linked to cancers as well as early puberty, fibroids, diabetes, and gestational high blood pressure.

So this ban seems like a good idea, although it’s taken the FDA a long time to get here … and then they arrived for the wrong reasons.

Let’s just take this in

In the richest, most powerful country in the history of the world, health professionals have begun suggesting that patients beg for money to pay their bills.

Resorting to crowdfunding to pay medical bills has become so routine, in some cases health professionals recommend it.

Reminder: Paxlovid is free for patients

People are being overcharged for Paxlovid, and HHS wants pharmacists to help it stop. Sure, the list price of Paxlovid is $1,400, but no one should be paying that — Pfizer has co-pay assistance programs. The trouble is that (at least anecdotally) some pharmacy staff aren’t telling patients about that option.

Health and Human Services Secretary Xavier Becerra “made it clear that no patient should be charged hundreds of dollars for Paxlovid at the pharmacy counter,” according to a readout of this week’s meeting with leaders from CVS, Walgreens, Walmart, Rite Aid and Kroger.

The Biden administration has an agreement with Pfizer that no one should be paying at all for Paxlovid. “Medicare and Medicaid enrollees can receive Paxlovid for free through 2024, and uninsured individuals can receive Paxlovid for free through 2028.”

There’s likely nothing sinister going on here; staff may simply be unaware of the options, and HHS wants to make sure that changes.

Eli Lilly: Mounjaro And Zepbound reduce blood pressure, too

First they were for diabetes, then for weight loss. Now at least two of the new GLP-1 drugs have yet another effect: According to Eli Lilly, they can also reduce blood pressure.

It’s tirzepatide specifically that the company says cuts BP, and it’s a Goldilocks dosage:

Participants taking 10 milligram doses of tirzepatide had the greatest systolic blood pressure reductions (10.6 points), followed by those on 15 milligram doses (8.0 points) and participants on 5 milligram doses (7.4 points).

The big caveat: “[T]he researchers aren’t sure if the drop in blood pressure was only due to tirzepatide, or if weight loss and diet change had an effect, as well.” And of course there’s the obvious connection to weight loss.

People with depression are hot

There’s a link between body temperature and depression. It seems (found UC San Francisco psychiatric researchers) that “with each increasing level of depression symptom severity, participants had higher body temperatures.”

They don’t know whether depression somehow causes temps to rise, or if a rise in temperature is a factor in depression. What they do think is that there might be a benefit to cooling the bodies of people suffering from depression — by heating them up.

A small body of existing, causal studies has found that using hot tubs or saunas can reduce depression, possibly by triggering the body to self-cool, for example, through sweating.

But you know the mantra: More research is needed.

AIP out and about

AIP folks were out in Griffin on the latest leg of their “DIR Hangover Tour” — VP Jonathan Marquess and Member Service Rep Catherine Daniel headed to Wynn’s Pharmacy where they met with co-owner and AIP board member Annette Duncan, PharmD, and talked about the solutions and programs AIP offers independent pharmacies.

Co-owners Brett and Annette Duncan; MSR Catherine Daniel; Jasper Eubanks, PharmD; and AIP VP Jonathan Marquess

Catherine and Annette talk about indy pharmacy issues

HPV vax: 100% success

This isn’t something you hear often: The HPV vaccine had a 100% success rate. That was in a study of Scottish women, and not a small one, either. It’s based on women who received the vaccine when they were 12 to 13 years old, starting in 2008. The researchers looked at cancer data in 2020, so that’s 12 years cancer free.

To be extra-super clear:

“[T]here have been no cervical cancer cases to date in fully vaccinated women who were given their first dose at age 12-13 years.”

Wow.

Is this irony? It might be irony

A Johnson & Johnson employee is suing the company saying it “didn’t make enough effort to get its workers a good deal for prescription drugs,” meaning employees ended up overpaying to the tune of millions of dollars.

J&J essentially self-insures rather than paying an insurance company to manage health benefits, which means it falls under the Employee Retirement Income Security Act, aka ERISA, which means it has “a fiduciary duty to prudently manage the funds.”

The lawsuit alleged J&J violated the company’s fiduciary duty under ERISA. J&J’s mismanagement of the drug benefits resulted in “higher payments for prescription drugs, higher premiums, higher deductibles, higher coinsurance, higher copays, and lower wages or limited wage growth,” the lawsuit said.

The fake-research problem

As a publication that relies on scientific papers a lot, this is scary stuff. Fake scientific papers — many from China where they take “publish or perish” to an extreme — are flooding academic journals “as increasing numbers of young ­scientists try to boost their careers by claiming false research experience.”

You might think the responsibility to verify work falls on journal editors and reviewers, but they’re only part of the problem. Even honest researchers can inadvertently cite falsified work in their own reviews, meaning the problem spreads. Worse, the result of a fake study can make it into the mainstream. Ivermectin is a great example:

Early laboratory studies indicated it could be used to treat Covid-19 and it was hailed as a miracle drug. However, it was later found these studies showed clear evidence of fraud, and medical authorities have refused to back it as a treatment for Covid.

Oh, and while it’s easy to blame the problem on Chinese “paper mills,” it’s bigger than that. Check out “The Harvard Professor and the Bloggers” to learn how pervasive fake research is.

Elsewhere: Brits’ new vending machines

To get more people to test for sexually transmitted infections, the Brits have experimented with vending machines that offered STI tests. They installed 11 of the machines in two medium-sized cities* and let them do their dispensing thing for a year.

These machines dispensed rapid HIV tests and self-sampling kits for other STIs, and the results were quite promising. According to the study, the vending machines were found to be effective and acceptable, especially for individuals who rarely or never get tested.

By “effective” they mean the machines dispensed 2,536 kits, and users seemed satisfied: “An impressive 92% of respondents found the machines user-friendly, and a whopping 97% were willing to recommend the service to others,” (We assume that means “Honey, why don’t you use that machine over there before we get coffee tea?”)

^* Bristol in the southwest and Brighton and Hove on the south shore, since you asked

Flu gets a second wind

Covid, flu, and RSV activity has been declining for several weeks, but now flu numbers have started to creep up again. And guess which state is on the short list of those with very high activity? Also:

CDC estimates that there have been at least 20 million illnesses, 230,000 hospitalizations and 14,000 deaths from flu so far this season.

Perspective: That’s the equivalent of having 93 Boeing 737s crash with no survivors — just this season. From the flu. (That’s almost six plane crashes every week.)

Covid note

There’s a new variant of Covid appearing, in case you need to fill a space on your bingo card. This one’s called BA.2.87, and “is probably the most divergence [sic] lineage identified this year.”

Opioid treatment rules relaxed

During the pandemic, the feds made it easier for opioid addicts people addicted to opioids to get the treatment they needed. They relaxed the rules so patients didn’t need to see a provider in person to get methadone or buprenorphine.

HHS (specifically the Substance Abuse and Mental Health Services Administration) has now made that rule final — the first time in 20 years there’s been a change like this. Patients will be able to take methadone home, and they’ll be able to start getting methadone or buprenorphine via telehealth rather than in person.

Federal health officials cited reports that those flexibilities increased treatment and patients’ satisfaction with their care without notable increases in diversion of methadone, which itself is an opioid.

Speaking of opioid addiction

Pregnant women who for obvious reasons want to get off opioids are slightly better off using buprenorphine than methadone, according to a study out of Harvard’s and Stanford’s schools of medicine.

Both, of course, are better for the baby than taking opioids, so if methadone is the only option, methadone is what they should take.

Blocking tumors’ accelerator pedal

In three quarters of cancers, a protein called MYC is like a nitro boost for tumor cells. As a UC Riverside researcher put it, “Normally, MYC’s activity is strictly controlled. In cancer cells, it becomes hyper active, and is not regulated properly.”

Not regulated properly? Challenge accepted.

The issue is that MYC is kind of shapeless, so it’s hard to find a structure to attack with drugs — it’s like trying to get a stranglehold on the Blob. But the Riversidians have developed and improved a peptide that binds to MYC using (as you may have guessed) sub-micro-molar affinity.

Once the peptide is in the cell, it will bind to MYC, changing MYC’s physical properties and preventing it from performing transcription activities.

They need to work on the delivery system before they can start on the road to making this into an actual drug that might keep tumors at bay.

For antipsychotics, a needle beats a pill

When someone is hospitalized for schizophrenia, they’re often given antipsychotics when they’re discharged. Those can be in the form of a long-acting injection or a daily pill.

But it seems that taking the pills is four times more likely to lead to readmission.

After 30 days, the readmission rate was 8.3 percent among patients who received oral medication and 1.9 percent among patients who received long-acting injections, which can last anywhere from two weeks to six months.

That’s what Rutgers researchers found in a new study of 30-day readmission rates at one hospital. Sure, current treatment guidelines say that injections are preferred, but patients often opt for pills instead for either financial reasons (i.e., insurance coverage) or simple fear of needles. But would they still make that choice if they knew how big the difference was?

Lawsuit to watch

PediaSure can help kids grow taller according to its maker, Abbott. Heck, it’s “clinically proven”! But a New York City grandmother is suing the company, saying that not only is that nonsense, but that the company knew it too. (She “cited three studies funded by Abbott itself that found no connection between PediaSure and growth in height.”)

Grandma says all PediaSure did was make her grandson overweight. Abbott said the case was without merit, but a judge said there was certainly enough evidence that it could go to trial. Get your popcorn.

Write on

The Non-Pharm Long Read: Oh Come On edition

Warning: Adults only, please.

What do you get when you mix screwy medical advice, conspiracy theories, anti-Semitism, misogyny, and probably a bit too much time on 4Chan? You get the anti-masturbation movement. No, seriously.