Reversal of fortune, hormone therapy edition

About 20 years ago, women were told that hormone therapy could increase their cancer risk. But it turns out the people who released that info were bureaucrats, not the scientists doing the study. They were half wrong — and it’s a major half.

It seems that — after a 20-year study of 160,000 women — there’s a very big difference depending on the hormone(s) used.

Estrogen plus progestin therapy does seem to lead to an increased cancer risk, but estrogen only therapy not only doesn’t have that cancer risk, but can reduce it as well as coronary heart disease.

In addition to its beneficial effects on menopause symptoms (which are widely acknowledged), the new study found that, after an average of 10.7 years, “rates of breast cancer were significantly lower in the [estrogen only] group compared with the placebo group.”

Specifically, the study found that “women who took estrogen had a 23% reduction in their risk of breast cancer.”

This jibes with a 2012 study by those shifty Danes that followed women for 26 years “and found that women taking estrogen had a lower risk of heart attack, heart failure or death—and no increased risk of cancer.”

Chantix can help stop vaping

Welp, we’ve now reached the point where we’re looking for ways to help people quit using e-cigarettes. Or, rather, to start treating nicotine addiction rather than just smoking.

The folks at Yale have been testing Chantix, aka varenicline, against vaping, and so far, so good. “We had a 15 percent difference in quit rates, with those in the medication group having a quit rate of 45 percent,” said the lead author of a new study.

What the Elis say about this study is that it mimics the real-world realities. Other studies have paired pharmaceuticals with various forms of therapy, but this one “took a much lighter touch.” Patients were given a brief discussion, a prescription for varenicline, and information about other resources, but then left to their own devices. So that 45% quit rate is pretty darned good.

Swedes find GLP-1 alternative

If you have fat mice, and you’re concerned that GLP-1 drugs are hard to get (and expensive), there’s some good news out of Sweden. A new drug seems to reverse obesity in mice.

While investigating the drug as a cancer treatment — it blocks mitochondrial function — the Swedes found that it …

… led to an unexpected increase in fat metabolism, resulting in a drastic weight loss, a reduction in fat accumulation in the liver and restored glucose tolerance.”

In other words, blocking the cells’ energy production made the mice lose weight. How? They don’t know yet, so the ol’ saw applies: More research is needed.

Oh, sheesh, enough already

Covid cases are likely rising in Georgia and 10 other states as well as Washington, DC.

It’s the same old song

But with different numbers since we last wrote about it.

In 2023 the US — meaning Medicare/-caid, private insurers, and individuals — spent $722 billion on drugs, up 14% (!) from 2022 and the largest increase in 20 years.

What changed? Semaglutide, that’s what. Ozempic, Rybelsus, and Wegovy together accounted for almost $39 billion in spending. (The other big new weight loss drug, tirzepatide, accounted for a mere $13 billion.)

Other factors were more utilization, higher prices for new drugs, an aging population, and of course drug makers raising their prices overall, although surprisingly the latter accounted for only a small bump.

Military drug manufacturing?

Some US senators are suggesting that it’s time for the military to look into producing some of its own medications, as it too grapples with supply-chain and shortage issues. It probably won’t apply to run-of-the-mill drugs, though.

“Most of the time DOD will continue to purchase drugs from the commercial drug market. But there are some instances where it makes sense for DOD to produce the medication itself, for example, when DOD is the only customer.”

There are treatments for infectious diseases that aren’t seen in the US (yet), and where there’s only one US manufacturer — if that. Many have stopped making some of the more obscure treatments because there’s no profit in it. But the military isn’t concerned about making a profit, so it might make sense for it to run its own factories, or at least look into the possibility.

Drug ads are changing

Yesterday a new rule, 14 years in the making, took effect requiring drug ads^* to make their side effects clear and readable/hearable. Nolongerwilltheybeabletorattleoffadisclaimerattheend.

The “major statement” of an ad, where the known risks are enumerated, also has to be clear and conspicuous, by limiting distracting audio or visual elements, like a person dancing to an upbeat song.

The bad news or good news, depending on your position, is that pharma companies will still be able to run informercials on social media that say whatever they want because the “ads” come out of the mouths of “influencers.”

^* Obligatory “Only the US and New Zealand allow direct-to-consumer drug ads.

Dangers of hypertension drugs

Blood pressure meds can double the risk of fractures in nursing home patients. Yeah, double. It’s due to balance issues; standing up can cause a BP drop and enough dizziness to lead to a fall. And once a senior has a serious bone fracture, it’s often a “downward spiral” after that.

This comes out of a Rutgers study of the health records of 30,000 elderly patients in long-term care facilities from 2006 to 2019 to compare their fractures with the drugs they were taking.

It’s even worse for some patients:

Patients with dementia, systolic blood pressure above 139, diastolic blood pressure above 79, or no recent use of blood pressure medication all experienced at least triple the fracture risk of unmedicated patients.

Getting ahead of the next coronavirus

Why wait for the next coronavirus to appear before creating a vaccine? Apparently, that’s what Cambridge researchers were thinking, so they’ve developed a vaccine they say works against a wide variety of them.

It’s pretty simple, actually (well, the idea is): They’ve found regions that appear in a lot of coronaviruses and targeted those, rather than trying to match a specific one. They “trained” it on eight different viruses, and apparently that was enough to make it work against viruses it wasn’t trained on, “including ones that haven’t even been identified yet.”

Said the senior author:

“We don’t have to wait for new coronaviruses to emerge. We know enough about coronaviruses, and different immune responses to them, that we can get going with building protective vaccines against unknown coronaviruses now.”

Masks were overwhelmed by Omicron

When the original Covid-19 started to spread, masks protected a lot of people and probably saved a lot of lives. But here’s a surprise: British researchers figured out that masks made a lot less of a difference once the Omicron BA.2 variant became dominant.

Why? Omicron was so much more transmissible that, statistically, wearing a mask was overwhelmed by other risk factors. (Analogy: A padded dashboard may have saved lives when cars travelled at 15 mph, but by the time they were moving at 65 or 70, seat belts and air bags made much more of a difference.)

Low T, shorter life?

It used to be thought that having higher levels of testosterone could lead to shorter lives for men — that was based on studies of eunuchs^* and neutered animals. And then there’s the fact that women generally live longer than men.

But a new Aussie study (a meta-analysis, actually) found that the opposite seems to be true. Men with lower T tended to die sooner.

But wait, there’s more.

A lot of those early-dying men had heart disease, and “the same process underlying heart disease might also contribute to erectile dysfunction.” So ED might not be due to lower testosterone directly, but to heart issues. And that leads to the question, is low testosterone causing heart disease or is it caused by it?

Regardless, the message “Keep your T levels healthy” remains.

^* Historical ones in Korea — there probably aren’t many around today

Short takes

Yes, please use sunscreen

No, sunscreen won’t stop you from getting enough vitamin D, no matter what “experts” on social media claim. Even if it did, you can always take a supplement — melanoma is a much bigger concern.

Tampon news

There’s apparently a lot going on in the tampon market, thanks in part to the rise of women’s sports. There are some legit products, but also some products of … let’s just say questionable utility.

Store-brand naloxone

Walgreens is launching its own generic, over-the-counter naloxone nasal spray. It’s currently available online for $34.99 for a pack of two 4-mg doses — 10 bucks less than the Narcan brand — and should be on shelves by the end of May.

Alzheimer’s twist

Current understanding: Your genetics can increase your risk of developing Alzheimer’s.

New idea: For some patients at least, genetics can cause it, period. That means a test could determine years or decades in advance whether someone would develop it.

A new study out of Spain found that up to 1 in 5 Alzheimer’s patients has two copies of a gene variant called APOE4. Almost every one of them eventually developed Alzheimer’s or its markers, “and the authors say that two copies of APOE4 should now be considered a cause of Alzheimer’s — not simply a risk factor.”

By age 55, over 95 percent had biological markers associated with the disease. By 65, almost all had abnormal levels of a protein called amyloid that forms plaques in the brain, a hallmark of Alzheimer’s. And many started developing symptoms of cognitive decline at age 65, younger than most people without the APOE4 variant.

Questions still to be answered: Does this hold true across ethnicities? Could gene editing (looking at you, CRISPR) prevent it? You know the drill: More research is needed.

Warm proteins are different proteins

Drug design often relies on the shapes of various proteins. (You probably know this.) Researchers cool them to make them stable, then [insert science here] to see how various chemicals will react.

Well it turns out — shockingly — that cooling or freezing those proteins changes their shapes; they can be very different when they’re at 98.6°. So testing drug candidates on cold proteins might not reflect how they’ll behave in the body.

Scientists at Michigan’s Van Andel Institute not only figured this out, they also developed a method to study those proteins: They heat ’em to body temperature, then flash-freeze them — that preserves the shape so they can study it properly. And having an image of the body-temp protein is critical, especially with AI doing more and more of the work finding chemical matches.

The Van Andel folks did this with one protein, but they expect that publishing the method will allow other researchers to have more A-ha! moments.

Measles vax and C-section kids

Here’s an unexpected finding: There’s almost a 1 in 8 chance that a single dose of the measles vaccine won’t work on a child born by caesarean section.

A study out of the University of Cambridge (with Chinese help) found that 12% of children born via C-section had little or no immune response to their first measles vaccination, compared to 5% of children born vaginally. That makes the second shot — which a lot of kids miss — a lot more important. (And yes, a second shot fixed the problem.)

Some new GLP-1 stats

The usage: A new poll found that about 12% of Americans has taken one of the new weight-loss drugs. Of note is that only 6% say they’re still taking one. Side effects are one reason people quit, but affordability is the big one. “About 54% of those who have taken GLP-1 drugs found it challenging to afford them, even with insurance.”

The payment: The same survey also found that insurance paid part of the cost of the drugs for 57% of people (many of whom still had trouble affording them), and another 24% said insurance paid the full cost.

And speaking of GLP-1s

Here’s an interesting twist. It’s known that GLP-1 agonists can improve patients’ heart health, and it was assumed that was because losing weight is, well, good for your heart. The twist is that a pair of new studies suggests that the heart benefits are due to other mechanisms of the drugs, not simply because of weight loss.

As one researcher put it:

“These two studies show that these anti-obesity medications are also heart-health drugs. The benefits to the heart for people with established cardiovascular disease or a certain type of heart failure occur regardless of the amount of weight loss.”

How did they figure this out? Simple: Not everyone loses weight on semaglutide, but the people who didn’t lose weight still saw the cardiovascular benefits. What these other mechanisms are isn’t clear yet, but enough eyebrows (and bank accounts) were raised to guarantee more research.

When antibiotics kill

When piperacillin/tazobactam went into shortage in 2015, researchers at the University of Michigan saw an opportunity. They were able to look at the data and see how patients who took those drugs compared with those who received cefepime.

After two weeks, there was little difference … “But the differences at three months were dramatic.”

[T]reatment with piperacillin-tazobactam was associated with a 5% increase in 90-day mortality, more days on a ventilator, and more time with organ failure.

Why the difference? Gut bacteria. Unlike cefepime, piperacillin/tazobactam can wipe out the GI tract’s anaerobic bacteria, and those “play important roles in the body’s metabolism, immunity, and prevention of infections.”

Said the lead researcher, “We need to think about antibiotics like chemotherapy. In the right context, treatment can be lifesaving, but in the wrong context it can be quite harmful.”

Overdose deaths drop

For the first time since 2018, overdose deaths have declined in the US — they dropped 3% from 2022 to 2023, according to CDC data.

There are important details, though. Overdose deaths from opioids, cocaine, and stimulants still killed more than 147,000 Americans in 2023. And while opioid OD deaths dropped, those from cocaine and stimulant overdoses both rose slightly.

The changes aren’t uniform across the country, either.

States including Nebraska, Kansas, Indiana and Maine saw declines of 15% or more in such deaths, mostly from opioids, while Alaska, Washington and Oregon reported notable increases of at least 27% compared to 2022, the data showed.

(Sorry, no data about Georgia was available.)

Short Takes

Protect your brain

In case you’re worried, Forbes offers some help with “How Worms Get Into Your Brain And How To Prevent It.”

Don’t use Cue Covid tests

The FDA is warning consumers to throw out any Covid-19 tests made by Cue Health. Apparently the company made changes to the tests without FDA approval, and now the results might be inaccurate.

Medical debt relief on the table

A bill in the US Senate would essentially wipe out Americans’ medical debt. The plan would “eliminate all $220 million in medical debt held by millions of Americans, wipe it from credit reports, and drastically limit the accrual of future medical debt.”

While federal plans to forgive student loans have been divisive politically, there may be more support for wiping out medical debt. The bill sponsors cited an October 2022 poll by the Medicare Plans Patient Resource Center that found 92% of Americans — including 84% of Republicans — favor medical debt forgiveness.

Protecting the pancreas (and stopping diabetes)

A new drug being developed seems to prevent and even reverse type 1 diabetes.

Created at Johns Hopkins, “mAb43” uses a different mechanism than other treatments; it works by creating a shield around the insulin-making beta cells in the pancreas, preventing the body’s immune system from attacking them. And when we say “shield,” that’s a literal shield. Check it out — mAb43 is in yellow:

Quoth the lead researcher:

“mAb43 in combination with insulin therapy may have the potential to gradually reduce insulin use while beta cells regenerate, ultimately eliminating the need to use insulin supplementation for glycemic control.”

The good news is that it worked in preliminary studies.

The bad news is that it’s only been tested in mice, using mouse-derived monoclonal antibodies. And if it works in humans it’ll be a long-term maintenance drug once it passes years of trials. Then it might be more convenient than insulin (the mice were given weekly shots), but you can bet the price tag won’t be small.

One week left…

… to register online for the 2024 Georgia Pharmacy Convention!

May 22 is the last day to pre-register online for the convention. After that registration will only be available on site, and the price will go up by $120. There’s a lot better stuff you can buy for $120^*!

Don’t miss out on the exciting events, more than 30 hours of CPE, the Saturday night President’s Bash, and of course all Amelia Island has to offer.

Register now, and we can’t wait to see you on Amelia Island June 13-16!

^* 2,000 glass marbles, for example

A little dab’ll do ya

An over-the-counter gel looks like it’ll be competing with Viagra in 2025. It’s called Eroxon (yes, seriously — it was originally “MED3000,” which sounds like something Wile E Coyote would use in “Looney Tunes After Dark”), and it works about 10 minutes after topical application … for at least 60% of men who tried it for erectile dysfunction.

It’s already got FDA approval because somehow it’s considered a device, and maker Futura says it’ll be on these shores next year. (It’s already for sale in the UK for $31 for four single-use tubes.)

The best part? It’s “slightly more effective if applied by a partner.” Indeed.

They doth protest too much

There are eight companies whose drugs are subject to Medicare price negotiations. All of them have claimed that cutting their profits will hurt their research and development efforts.

And yet another report proves that’s just not true. With one exception — Merck — they all spend more on either shareholder payments or admin and marketing than they do on research and development.

The folks at PhRMA, the industry’s lobbying group, did a nifty job of avoiding the question. Their statement simply answered a different question:

“The truth is the biopharmaceutical industry is one of the most research-intensive industries in America. Companies invested $122 billion in R&D in 2020, and we invest six times more on average in R&D as a share of sales than all other manufacturing industries.”

“Johnny, did you spend most of your allowance on junk food again?”

“The truth, Mom, is that I spend less on baseball cards than any other kid!”

Covid still lurks

There’s a new Covid-19 variant appearing in wastewater sampling, and to be sure to keep the naming conventions confusing, this one is called “FLiRT^*.”

It’s technically “KP.2,” and it’s related to the recent JN.1 variant but different enough to raise some scientific eyebrows, especially as it’s making up more than 35% of the strains currently active.

Should you worry? Probably not — we have a good track record of updating vaccines if necessary, and this doesn’t look any worse than what’s been out there.

^* Named for changes in some amino acids: F456L and R346T. Virologist humor is unique. 

Bird flu: What you need to know

If and when the H5N1 bird flu makes the jump from human to human, we’ll be a lot better off than when we were blindsided by the “mysterious Chinese illness” in 2019. If nothing else, we know how to make flu shots, even if it can take several months to grow a batch.

Then again, dealing with H5N1 isn’t quite as simple as cranking out the annual flu vaccines — this strain is a bit different. Read the details in one of the better “preparing for the bird flu” articles, from the Guardian.

The silly reason we don’t get the good sunscreen

Here’s an oversimplification of a story: There are better sunscreens available than what you sell — ones that block a lot more UVA (which causes cancer, as opposed to UVB, which causes sunburn). People in Europe use ’em all the time.

Why aren’t they available here? Because, in part, the FDA requires them to be tested on animals, while in Europe animal testing is banned. The result is that cosmetics companies don’t want to ruin their reputations overseas by doing animal testing here, so the US gets the second-rate sunscreen.

There’s also the issue of social media infomercials “influencers” convincing people that sunscreens in general are bad. (The exceptions are those using zinc-oxide because, they say, zinc oxide isn’t a chemical, it’s a physical barrier. News flash: Zinc-oxide is a chemical).

Bullying means bad teeth

If you’re thinking of bullying someone, consider an unexpected consequence: You might be hurting their dental health. No, not by knocking their teeth out^* — Norwegian researchers found “that bad childhood experiences, including bullying, are associated with bad teeth cleaning habits.”

Why? No clue. Heck, it’s just an association (so it could be the opposite — that kids who don’t brush get bullied), but they suggest that it’s something to be aware of. If a kid has bad teeth, it might be worth a conversation.

^* That’s assault, not bullying.

Probiotics vs IBD

After a bout of gastroenteritis, many people end up with some form of irritable bowel syndrome. Treatment is usually about managing the symptoms.

Italian microbiologists tried something different. Assuming that gut bacteria (or the lack thereof) might be part of the problem, they developed a personalized regimen for each patient in a study. They analyzed each person’s gut biota to see what bacteria they might be missing and what they had too much of. “Then, a personalized therapy was designed for each patient, based on their results, with the goal of rebalancing their gut microbiota.”

That therapy was a combination of an antibiotic to kill the unwanted gut bugs, followed by “prebiotics and/or postbiotics to enhance the numbers of protective bacteria.”

Twelve weeks after the start of treatment, 93% (12/13) of patients experienced an improvement in symptoms and 38.5% (5/13) achieved total remission.

This trial was more proof-of-concept, so next up will have to be bigger, broader studies.

Omalizumab and peanut allergies

For kids with peanut allergies, omalizumab — aka Xolair — can be a lifesaver, literally.

By taking omalizumab every two or four weeks, many patients had significant protection against allergic reactions from food allergen contamination, particularly life-threatening conditions like anaphylactic shock.

Still, it’s not a miracle drug; it has some significant limitations. Eat a peanut-butter sandwich? No. Ride on a bus with someone eating peanuts? Probably. The folks at the University of Rochester explain it all.

J&J settles ovarian cancer suits

The company will pay $6.5 billion (over the next 25 years) to settle nearly all the lawsuits that claimed its talcum powder caused ovarian cancer. Still outstanding are a different set of suits (but not nearly as many) claiming it caused mesothelioma.

The deal still needs buy-in from at least 75% of the claimants.

Reversible heparin replacement

How’s this for an anticoagulant trick: It’s instantly reversible. That means if something goes wrong and a patient starts to bleed, you just slip ’em the antidote and the bleeding stops (in theory).

How’s it work? The drug consists of two molecules that bond to each other and to thrombin, preventing the thrombin from helping blood coagulate. The antidote breaks the connection between the drug molecules — like breaking the bond between the Wonder Twins — and that releases the thrombin. Simple!

A group of Swiss and Australian researchers came up with the new drug. They say that there are 235,000 emergency visits for anticoagulant treatment in the US every year, so that’s a lot of people who’ll be happy to see it hit the market.

The X for Y Files: BP drug twist

If you have a roundworm you want to live longer, you might consider getting it a prescription for rilmenidine. It seems (found British researchers) that the hypertension drug might have the same effect as a calorie-restrictive diet, which is considered one of the best ways to increase lifespan.

And even if it doesn’t pan out in humans, the research identified the receptor that rilmenidine binds to, meaning it’s at least a big step towards an eventual pharmacological treatment.

AI’s latest trick

Protein molecules each have a unique 3-D structure, and that’s the target of drugs. The trick is finding what chemicals might interact with what proteins, and that can take a lot of work. Well, unless you turn AI onto the problem.

Swiss researchers did just that, and they say the result was “a real breakthrough for drug discovery.” Rather than spending weeks of computer and meat-brain time trying to fit a potential drug molecule into the protein, the AI speeds through it. But the biggest benefit is that the AI knows what can actually be synthesized, so it doesn’t bother suggesting impossible chemicals.

For any protein with a known three-dimensional shape, the algorithm generates the blueprints for potential drug molecules that increase or inhibit the activity of the protein. Chemists can then synthesise and test these molecules in the laboratory.

Quit vaping to get pregnant

Ladies, give up vaping if you want to get pregnant. With what they say is “the first piece of evidence to show a link between fertility and vaping across a large population,” British molecular geneticists found…

…that people who vape or smoke tobacco had lower levels of anti-Müllerian hormone (AMH), which indicates how many eggs women have left in their ovaries.

Women trying to get pregnant should be told “no drinking, no vaping, no smoking, no drugs,” they say. Plus there’s the whole nicotine-addiction, chemicals-in-your-lungs angle as well, but one battle at a time.

Side note: Vaping has gotten so bad over there that Welsh health authorities are talking about offering nicotine patches or gum to help kids break their nicotine habits.

PBMs vs grandma

It seems PBMs have found a new way to stick it to Medicare recipients: Moving their old generic drugs to higher formulary tiers — the ones that require a larger co-pay.

Seniors are finding that the meds they’ve been taking for years suddenly cost more out of pocket for no reason other than someone at a PBM threw a dart and decided to move it up a tier.

In 2011, 73% of generic drugs analyzed by Avalere were placed on Tier 1, which has a zero-dollar copay on average. Ten years later, only 15% of those drugs were still on Tier 1, despite the average price of those medicines falling by 38%.

Why would a PBM make cheaper drugs more expensive? The idea is to drive patients not to the best medications or the least expensive, but to the drugs that give the PBMs the highest kickback. That’s one reason biosimilars haven’t taken off, and why patients can be pushed to brand-name medication.

The Long Read: Prior Denial edition

Some investigative reporting, plus a former insurance company doctor, reveals the culture of “deny deny deny” inside health insurance companies.

All a Cigna doctor had to do was cut and paste the denial language that the nurse had prepared and quickly move on to the next case.

Feeling lighter in the wallet?

Pharmacists’ wages are going down, it seems, although it’s worse for retail positions than for folks in hospitals. And technicians and aides? Their wages are going up.

All this comes from a new study published by APhA (by a pharmacoeconomicist out of UC San Diego) that looked at how wages were being affected by market consolidation, where fewer employers mean each has more control over wages: “In other words, the employers become the wage setters, and the employees become the wage takers.”

From 2012 to 2022…

• Retail pharmacists saw their annual wages decrease by 16.6%.
• Hospital pharmacists saw a 2.5% decrease.
• Retail technicians had their salaries increase by 3.4%.
• Hospital technicians saw a 7% increase.

ICYMI: DEA looks to make pot C-III

The DEA has started the process of moving marijuana from schedule I (with heroin and LSD) to schedule III (with codeine). No, it wouldn’t legalize pot, it would just “acknowledge it has less potential for abuse than some of the nation’s most dangerous drugs.”

But first the new rule has to be officially proposed and reviewed by the Office of Management and Budget. If it passes OMB, it’ll be open for public comment before being dropped or finalized.

In the name of all that’s holy, don’t drink raw milk

Raw milk isn’t better, it never has been better, and these days it’s even more dangerous. Sure, pasteurization is still a new technology (it’s only been around since the 19th century), but they stopped adding the microchips back in the 1980s.

Jokes aside, the CDC says that “improperly handled raw milk is responsible for nearly three times more hospitalizations than any other food-borne disease source, making it one of the world’s most dangerous food products.”

And with bird flu in the mix? Just don’t.

“Bird Flu in Raw Cow Milk Has Killed Farm Cats in a Concerning First”

FTC challenges a whole lotta drug patents

The Federal Trade Commission has had enough of what it calls “junk patents” filed by pharma companies, and it’s challenging them — starting with a warning letter to 10 companies about 20 brand-name drugs and more than 300 patent filings.

What’s a junk patent? According to the agency, it’s a patent that really doesn’t affect the drug, but is included with the FDA filing anyway. Why? Because patents can block generic competition for up to 30 months — more patents means longer exclusivity.

These companies include Novo Nordisk, AstraZeneca, Boehringer Ingelheim, Covis Pharma, GlaxoSmithKline, Novartis, and Teva Pharmaceuticals and Amphastar Pharmaceuticals, as well as some of their subsidiaries.

The companies will hear from the FDA next, and will have 30 days to withdraw or edit their drug’s listing or pinkie promise certify under penalty of perjury that the patents are legit.

PharmPAC at work

Check it out: GPhA/AIP member Tommy Bryan, owner of St. Simon’s Drug Company, presents a PharmPAC donation to Senator Mike Hodges (left). Senator Hodges sits on the Senate Health and Human Services Committee and was a huge help getting our SB 198 to the Senate floor for a final vote. Thank you, Senator Hodges, and thank you, Tommy Bryan, for supporting PharmPAC!

You can help PharmPAC, too — invest in your practice and protect the future of pharmacy in Georgia at GPhA.org/pharmpac.

FDA expands test regulation

The FDA said it’s going to start regulating the diagnostic tests that testing companies like Labcorp and Quest have developed and are marketing to patients. These are the “lab developed tests” that claim to detect this or that, but that haven’t been formally reviewed to ensure they do what they say.

Under the new rules, these tests would be required to meet the same requirements as other diagnostic tests from medical device makers, including the FDA’s review of their applications and the reporting of adverse events.

Which brings up the obvious question: Weren’t they regulating these tests in the first place?

Medicare wins again

Pharma companies have lost yet another court challenge to drug price negotiations — that’s four losses, if you’re keeping score. This time it was Bristol Myers Squibb and Johnson & Johnson, and it was a U.S. district court in New Jersey.

The rulings are consistent: No one is forcing them to participate in Medicare, so they have no right to complain about capitalism at work.

The drug makers say they plan to appeal the ruling. Their argument, apparently, is that Medicare is such a large customer they are effectively forced to participate or they’ll make less of a profit. (Profit, apparently, is now a legal right.) And, of course, Medicare should be forced to accept whatever prices the companies wish to charge.

Perspective: Can you imagine if Walmart’s suppliers said the retailer was so big, it should be required to buy their products at any price they chose?

Side note: Remember, these are the companies that don’t pay taxes because they claim to be losing money.

Sleep and diabetes

“Go to sleep or you might end up with diabetes like that man on TV.”

Eat as healthily as you like, if you don’t get enough sleep you’re increasing your risk of type 2 diabetes.

Using data of 250,000 people over 12 ½ years, Swedish and Chinese researchers found that people sleeping for fewer than 6 hours a night “had a notably higher risk of developing T2D compared with those with 7 to 8 hours of sleep.” And the less sleep they got, the higher the risk — even among adults with healthy eating habits.

If they’re women, though…

They can chow down on avocados. A study by Mexican researchers found that “Females who ate 30-38 grams of avocado had significantly lower odds of diabetes than those who did not consume avocados.” But don’t hit the guac just yet (except with a few grains of salt) — the research was out of California’s Avocado Nutrition Center.

Bird flu news

It’s now been found in a dolphin. That is all.

But there’s good flu news, too

The US had a long flu season this year, but thankfully it wasn’t a severe one and it’s just about over. That’s cold comfort to the friends and families of the 24,000 people (including 148 children) who died from the flu, but it’s a lot lower number than it could have been.

Even at the peak, “we felt strained but never over-capacitated” said Dr. Jay Varkey, infectious disease physician at Atlanta’s Emory University Hospital. “It felt more like a traditional respiratory virus season than when we had massive upswings of COVID confounding it.”

US birth rate keeps dropping

The birth rate in the US has been going down for decades, and after a brief pandemic “baby bump,” it’s dropped again — to the point where it’s well below the “replacement rate.” In other words, the population will begin shrinking.

[T]his continued decline comes at a time of growing concern over access to reproductive healthcare and intensely politicized debate over abortion access, as well as concerns over the economy, a lack of rights for working parents and growing fears over the future of the planet.

It’ll be interesting to see how debates about reproductive and immigration issues are affected. After all, if we aren’t making enough Americans, that “portends sluggish growth, an aging population and an economy that one day may struggle to find enough workers to fill jobs and pay the taxes required to maintain the state and care for a large elderly population.”

A “new” med for UTIs

The FDA has approved Utility Therapeutics’ Pivya — aka pivmecillinam — to treat uncomplicated urinary tract infections. This is the first “new” antibiotic approved for UTIs in something like 20 years. (New in quotes because Pivya is an old drug that’s been used in Canada and Europe for 40 years.)

Pivya is a narrow-spectrum antibiotic […] For this reason, Pivya is only approved for use in UTIs caused by Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus.

11 new drugs in shortage

(Links go to more details from the American Society of Health-System Pharmacists or the FDA.)

• Cisatracurium besylate injection
• Clobetasol propionate cream
• Difluprednate ophthalmic emulsion
• Evolocumab injection
• Granisetron hydrochloride injection
• Hydroxocobalamin injection
• Isosorbide mononitrate immediate-release tablet
• Lacosamide tablet
• Rifaximin tablet
• Valproate sodium injection

Answering the hard questions

A British biochemist tackles the issue: “Does ejaculating often reduce your risk of prostate cancer?”

(Oh come now, we’re not going to spoil it by giving you the answer.)

Chances are your data was exposed

In case you thought the fallout from the Change Healthcare attack was ending, think again.

“[T]he personal health information and personally identifiable information found in the files ‘could cover a substantial proportion of people in America’,” according to UnitedHealth. But don’t worry, it may not have included full medical histories.

The company is offering two years of credit monitoring and identity theft protection to anyone who has been affected by the breach. (How to apply for that isn’t clear.)

Fun fact: UnitedHealth seems to have paid the hackers a ransom of $22 million.

The liver means timing matters

There are good reasons to consider what time of day to take a drug — sleep issues probably top the list. But now MIT researchers have found that it’s a lot more complicated thanks to enzymes in the liver. Drug metabolism, it seems, is affected by the body’s circadian rhythm.

These circadian variations affect how much of a drug is available and how effectively the body can break it down. For example, they found that enzymes that break down Tylenol and other drugs are more abundant at certain times of day.

What that means is it might be possible to fine-tune the use of drugs to take advantage of this fact, setting dosing times to get the most out of a medication.

Two unexpected vaccines

First: against antibiotic resistance

We hear a lot about antibiotics to treat infections, but not so much about vaccines. That might change. Michigan State chemists have developed a carbohydrate-based vaccine (rather than a typical protein-based one) that targets Staphylococcus aureus — specifically the methicillin-resistant kind, aka MRSA.

So far they’ve tested it in the lab and in animals, and obviously it works or we wouldn’t be writing about it.

Second: against melanoma

British researchers have just begun phase-3 trials of “the world’s first personalised mRNA cancer vaccine for melanoma,” which they are, of course, calling a “game changer.”

The personalized part is what’s important, as each vaccine has to be tailored to the individual.“[A] sample of tumour is removed during the patient’s surgery, followed by DNA sequencing and the use of artificial intelligence. The result is a custom-built anti-cancer jab that is specific to the patient’s tumour.”

I’m not sure what the lead investigator means by this, but it sounds good:

“To be able to sit there and say to your patients that you’re offering them something that’s effectively like the Fat Duck at Bray versus McDonald’s — it’s that level of cordon bleu that’s coming to them … The patients are really excited about them.”

Science at work

After their work on the groundbreaking 2022 paper “Fire is Hot,” researchers at the University of Chicago have a new study — in the journal Otolaryngology-Head and Neck Surgery — with a shocking conclusion: “TikTok Riddled With Misleading Info on Health.”

The team’s next paper: “What Color Is the Sky? A Multi-Modal Investigation of Lower-Atmosphere Chromatic Conditions”.

From stomachache to headache

People who take acid-reflux drugs — proton-pump inhibitors, H2 blockers, or even antacids — apparently have a greater risk of migraines. And if they also take magnesium, the risk is even higher.

That’s what University of Maryland nutritionists discovered after parsing the health data of almost 12,000 people who used some kind of acid reducer.

[T]hey found that people taking proton pump inhibitors were 70% more likely to have migraines than people not taking acid-reducing drugs. Those taking H2 blockers were 40% more likely and those taking antacid supplements were 30% more likely.

They can’t prove cause and effect yet, but the relationship, they say, is definitely clear.

Sour sweetener

One of the newest crop of artificial sweeteners, neotame, just went from “Well, it’s better than aspartame” to “Oh, geez, another one that’s unhealthy.” In the case of neotame, it…

…can cause previously healthy gut bacteria to become diseased and invade the gut wall – potentially leading to health issues including irritable bowel syndrome and sepsis.

Drug spending jumps

Americans — people, insurers, and the government — spent $772.5 billion on drugs in 2023, up a whopping 13.5% from the year before. What changed? GLP-1 agonist weight loss drugs, that’s what.

Spending for semaglutide doubled in 2023, making it the top-selling drug in the nation, replacing autoimmune disease drug adalimumab.

Interesting side note: “Hospitals’ drug spending fell by 1.1%, continuing a steady period of falling expenditures.”

Curious what the 25 most popular drugs are? Becker’s Hospital Review has you covered.

Pharmacy techs: You could win a 15-hour course

The good folks at the Alliance for Pharmacy Compounding Foundation are offering $495 grants for 10 pharmacy technicians to attend a 15-hour on-demand online course, “The Ethical, Legal, and Regulatory Foundations of Pharmacy Compounding” out of Virginia Commonwealth University.

If you’re interested in getting into compounding pharmacy, this is a great idea — it gives 15 hours of CE credit, not to mention a great line on your résumé.

The deadline to apply is June 30, 2024 at 11:59pm EST. Here’s the link to do just that. (Got questions, contact the Pharmacy Compounding Foundation at foundation@a4pc.org.