Working harder, not smarter

If you take Adderall or Ritalin and you don’t have ADHD, you might be hurting your cognitive performance. So found a study out of Australia’s University of Melbourne.

It seems that taking a stimulant when you don’t need one does make you try to work harder — hello, dopamine — but “[W]e discovered that this exertion caused more erratic thinking” and didn’t increase performance.

“Our research shows drugs that are expected to improve cognitive performance in patients may actually be leading to healthy users working harder while producing a lower quality of work in a longer amount of time.”

Don’t do this, but here’s how

MIT researchers are warning that AI can be used to create new, potentially pandemic viruses — and they give instructions for how to do it.

Giving non-science students some instructions and access to ChatGPT and other AI chatbots, the preprint’s author, one Kevin Esvelt, asked them to find a way to, essentially, start a new pandemic.

After only an hour, the class came up with lists of candidate viruses, companies that could help synthesize the pathogens’ genetic code, and contract research companies that might put the pieces together.

But don’t worry. Esvelter said he tested the process himself and “it wouldn’t come up with truly threatening suggestions” so obviously other people couldn’t either.

A better, plant-based insulin

The artificial insulin most diabetics take has a drawback — it’s missing one of the three peptides found in natural insulin. That means when it’s in pill form, it’s processed in the stomach … and processed quickly. That can lead to a see-saw^* effect on blood sugar as the insulin is absorbed too quickly.

But now dental researchers at UPenn have developed a way to add human insulin genes to lettuce, so the plant’s germline is altered to produce insulin— specifically proinsulin — that contains all three of the peptides found in the natural variety.

The resulting seeds permanently retained insulin genes, and subsequently grown lettuce was freeze dried, ground, and prepared for oral delivery following FDA regulatory guidelines.

The big advantage is that the extra peptide protects the insulin so it’s absorbed in the gut rather than the stomach. That means it’s a bit slower acting and “it works just like natural insulin, which minimizes the risk of hypoglycemia.”

^* Aka “teeter-totter” or “pendulum.” Pick your metaphor.

A laxative for brain function?

Many people with mood disorders also suffer from cognitive defects. Antidepressants target serotonin, but British researchers found that (not surprisingly) “resolving mood disturbances often does not resolve cognitive symptoms.”

Here’s the interesting bit: They found that taking low doses of prucalopride — yes, the laxative — saw patients’ cognitive symptoms reduced, and the improvement even showed up in brain scans.

Apparently prucalopride helps by adjusting the connectivity between specific brain regions, increasing some (those involved in information processing) and decreasing others (those “activated during mind wandering”).

You want the heavy science? Sure thing.

Participants who received the medication displayed more functional connectivity in their resting-state (rsFC) between major cognitive networks. This included more rsFC between the central executive network, a brain network used for processing thoughts, and the posterior and anterior cingulate cortex — brain areas that regulate information processing and attention in the brain.

Bottom line: It’s worth considering prucalopride “as a pro-cognitive treatment in disorders such as depression.”

Short Takes

Now semaglutide has a stigma

People who lose weight are saying that now there’s a stigma for using drugs to do it.

Wegovy and other drugs expose a social tension between a quest to medicate illness and a stigmatizing belief that obese people lack sufficient willpower to lose weight.

Choosing the booster

An FDA advisory panel has recommended that this year’s Covid-19 booster shot focus on a single variant — XBB. “If the F.D.A. agrees, the advice would start the manufacturing of millions of shots.”

Metformin fights long Covid

Waaaaay back in 2021 we told you how diabetics who were taking metformin had a lower risk of dying from Covid-19.

Now a new study out of the University of Minnesota found that metformin can also help prevent long Covid.

Patients who had tested positive were given either metformin, ivermectin, fluvoxamine, or placebo, and only metformin showed any effect: a 39.4% lower incidence of long Covid than those who took a placebo, and it was even better if they started on the metformin sooner (a 63% lower risk).

“Without an alternative treatment of SARS-CoV-2 infection to prevent subsequent long Covid, some providers may choose to prescribe metformin to patients presenting with Covid symptoms and a positive Covid test.”

Coming to a shortage list near you

Penicillin. Yep, Pfizer reports that the OG antibiotic — at least in its Bicillin prefilled syringe forms — is going to be in shortage for at least a year.

Pfizer attributes the supply hiccup to “complex combination” of factors, including “significant” demand increases and a rise in syphilis infection rates.

The company is working to increase production, and it expects the long-acting version to be available by the mid-2024 and the combo doses in the fall of that year.

The editor would remove any good headline we came up with

The name sounds like a joke, but it’s real: The FDA has approved Futura Medical’s Eroxon as the first OTC gel for treating erectile dysfunction. Not only is “Eroxon” the winner of the Best Product Name So Far in 2023, even better, it’s over-the-counter.

The important bits: Eroxon is rubbed on where it’s needed and works in about 10 minutes — long enough to say, “Be right back, honey, lemme make sure the kids are asleep.” According to the company, it “lasts long enough for successful sex in about 65% of people and should naturally subside.” (We take note of the words “successful” and “should.”)

Eroxon sells for the equivalent of about $31 in Belgium and the UK, and it could be available in the US of A in 2025.

Don’t look so surprised

In what should be a shock to absolutely no one, when the feds outsource Medicare to private companies, it overpays for treatment. In fact, an analysis out of USC found that taxpayers overpay those private companies to the tune of $75 billion a year — much higher than the $27 billion the Medicare Payment Advisory Commission had estimated.

Why so?

First, “coding intensity”: Private companies will come up with all sorts of conditions, tests, and treatments they can bill for — much more than traditional Medicare does.

Second, “biased selection”: Medicare Advantage payment rates are based on the assumption that beneficiaries are, overall, about average when it comes to their health. But MA patients tend to be healthier, so they need much less treatment.

All this means that the government needs to continue to audit the private companies to check those diagnosis codes, and — the USC folks recommend — revisit the idea of basing Medicare Advantage rates on what those sicker fee-for-service patients pay, calling that “increasingly problematic and costly to the government.”

Short Takes

Do we get a cut of the profits?

A new study out of Harvard found that prescriptions for oral minoxidil skyrocketed after a GPhA Buzz story in August 2022 touting the off-label (but effective) use of the hair-loss drug.

The weekly rate of first-time low-dose oral minoxidil (LDOM) prescriptions per 10,000 outpatient encounters was “significantly higher 8 weeks after vs. 8 weeks before article publication.”

Repeat after me

“Cutting back on social media reduces anxiety, depression, loneliness” — this time it’s from an Iowa State study.

Facebook spies on suicide hotlines

You can promise patients anonymity all you want, but when Facebook sticks its nose in, all bets are off. The company, it seems, has been collecting data from people who visit websites connected with the national 988 suicide-prevention hotline.

Many of the sites included buttons that allowed users to directly call either 988 or a local line for mental health help. But clicking on those buttons often triggered a signal to be sent to Facebook that shared information about what a visitor clicked on. A pixel on one site sent data to Facebook on visitors who clicked a button labeled “24-Hour Crisis Line” that called local crisis services.

Another day, another vitamin D story

This time it’s about mothers and kids. Moms — well, mice moms — who are vitamin D deficient are more likely to have kids who develop diabetes sometime in their lives. That comes out of Washington University in St. Louis, where researchers think the lack of vitamin D affects the development of certain stem cells — stem cells that develop into immune cells in the babies.

Not only does that mean the offspring are more likely to develop diabetes, by the time they’re born it’s too late to fix.

“In studies of mice born to vitamin D-deficient mothers, we have found that the animals go on to develop insulin resistance and diabetes later in life. That was true even when pups were treated with adequate amounts of vitamin D after birth. Those animals improved their glucose control, but they never normalized.”

Just two days left!

You only have until 11:59 pm this coming Thursday — the day after tomorrow! — to cast your vote for members of the 2023–24 GPhA Board of Directors.

You should have received your electronic ballot from AssociationVoting to the email address GPhA has on file for you. Can’t find your ballot or have a question? Reach out to Lia Andros, GPhA’s governance manager, at (404) 419-8173 or landros@gpha.org.

Our national nightmare is over

“FDA Approves First Treatment for Constipation in Kids”

(The FDA “has expanded the indication for linaclotide to children as young as age 6 years with functional constipation, making it the first approved treatment for pediatric functional constipation. The recommended dosage in pediatric patients is 72 mcg orally once daily.”)

Hypertension and the Pill

Swedish researchers have confirmed what’s long been suspected: Oral contraceptives can raise the risk of depression, especially for teenagers. Raise by how much? For adults, about 92%. (Yes, that’s almost double the risk.) But for teens it’s “a 130% higher incidence of depression symptoms.”

Worse, the symptoms persist for teens even after they stop using the Pill.

This is based on medical records of more than a quarter of a million women “from birth to menopause.” So … yeah, pretty comprehensive. The good news is that risk is only confirmed with progestogen/estrogen pills:

“Since we only investigated combined contraceptive pills in this study, we cannot draw conclusions about other contraceptive options, such as mini pills, contraceptive patches, hormonal spirals, vaginal rings or contraceptive rods. In a future study, we plan to examine different formulations and methods of administration.”

Captain Obvious knows how time works

“Going to bed a little earlier greatly increases total sleep time for teens”

Keep the soap gentle

A new study out of the UK’s University of Sheffield found that — despite what you might think — gentle soaps are as good at killing viruses and bacteria than harsh ones.

The problem was that healthcare workers were using harsh soaps, getting contact dermatitis, and either washing less or switching to a quick dab of sanitizer — neither of which is as good as washing properly. But now it’s confirmed that you don’t need something harsh to kill SARS-CoV-2. In fact, additives designed to make the soaps less harsh didn’t affect their virus-killing ability one whit.

The one big caveat: Non-enveloped viruses like the norovirus aren’t killed by soap, harsh or otherwise. “Bleach was the only agent [that] affected the virus.” So come winter, clean those surfaces (and still wash your hands).

Oh, the other caveat? The study was funded by CeraVe, the moisturizer maker.

Short Take

Doesn’t even taste like chicken

About one in four — a quarter! — of people who contracted Covid-19 still don’t have their senses of smell and taste back at full power. (24% of patients reported only partial recovery of smell, while over 3% had no recovery at all.) The worse the initial symptoms, the less likely the sensory recovery.

Senate tackles drug pricing

This is funny: There’s a fight brewing in the Senate over drug-pricing legislation. What’s funny about that? The two political sides are handling it like adults^* — disagreeing while remaining civil — while the PBMs and pharmaceutical companies are bickering, sniping at each other, and predicting the end of the world as we know it if they don’t get what they want.

The main provisions of the bill would try to prevent pharmaceutical companies from making minor tweaks to a drugs’ chemistry in order to extend the patents, and to cap the price of insulin at $35 a month for private insurance the way it is for Medicare and Medicaid.

^* Kids, ask your parents about the Long, Long Ago when the major parties disagreed on issues, but didn’t think the Other Side was actually evil.

ICYMI: Alzheimer’s drug

An FDA advisory panel voted unanimously to recommend full approval of Eisai’s lecanemab Alzheimer’s treatment. If approved, it stands a good chance of being covered by Medicare and Medicaid, so expect costs and premiums to shoot up for both Medicare/caid and private insurance.

Eisai is charging $26,500 per year per patient for the drug, which means it would cost Medicare $17.8 billion per year if only 10% of older Alzheimer’s patients take lecanemab. Perspective: NASA’s entire budget is only $23 billion.

Twist: CMS said it would cover the drug, but only for patients whose “physician and clinical team participate in the collection of evidence about how these drugs work in the real world.” That would mean using a trial registry of some sort, which as you might imagine has caused some consternation.

This was just a committee vote; a decision from the FDA is expected by July 6.

More Part B rebates a-comin’

Drug manufacturers will have to pay rebates on 25 more drugs if they raise prices faster than the rate of inflation. That brings the total to 43 drugs covered under that section of the Inflation Reduction Act, which allows the federal government to levy fines against drug manufacturers who raise the cost of Part B drugs higher than the rate of inflation.

That means, explained HHS, that Part B patients could see lower co-pays, co-pay rebates, or both.

Alcohol cuts stress

Moderate drinking, good or bad? It’s time to spin the ol’ wheel of destiny!

[whirrrrrr click click clack]

Today’s answer, courtesy of Mass General researchers, is that, “Alcohol in moderation may lower stress-related risk of heart disease.” How? By reducing the amount of stress signalling the brain does.

Brain: Aieeeeeee!!!

Alcohol: Yo, chill.

Brain: Oh, right. Mmmmmmm.

Cardiovascular system: Whew!

That said, they’re quick to point out that no, alcohol isn’t a good method of protecting your heart because it has plenty of detrimental effects that probably outweigh any stress reduction. Instead, they hope they can mimic the calming effect through non-alcoholic chemistry.

Drug shortages at 10-year high

The latest data from the American Society of Health-System Pharmacists shows that, as the headline says, drug shortages in the US have hit a 10-year high thanks to a combination of … well, we don’t know the reason for more than half the shortages. But of the ones we do know about, demand outstripping supply is the biggest issue, followed closely by manufacturing issues (e.g., a plant in India with, shall we say, contamination problems).

The FDA has said it will relax some of its rules to allow probably-just-fine meds into the country to help ease the shortages, but there’s not much else it can do. Cheap, safe, plentiful — pick any two.

The Long Read: Joy to the World? edition

How do you measure when a medication or treatment plan is working? There are obvious signs — the infection clears, the pain stops, the bone heals — but what about patients’ happiness?

The idea of measuring not just physical recovery but the overall effect on quality of life is gaining traction, as are ways to objectively measure that.

Experts are finding that a critical missing ingredient of modern health research is the ability to objectively measure changes in happiness over the long term, including throughout peoples’ experiences with illness, diagnosis and recovery.

Non-pharma interesting medical story of the day

You don’t often find a major discovery in the world of dentistry and yet Penn researchers have done just that.

A bacteria called Streptococcus mutans causes cavities — we’ve known that forever. (Technically it’s not S. mutans, but its acidic excretions.) But now it seems it has a partner in crime: Streptococcus sputigena.

S. sputigena is no saint — it can cause gum disease — but the Penn folks found that it also “can work as a key partner of S. mutans, greatly enhancing its cavity-making power.”

So what does this mean?

The findings […] show a more complex microbial interaction than was thought to occur, and provide a better understanding of how childhood cavities develop—an understanding that could lead to better ways of preventing cavities.

An “elixir of life”?

Taurine — which is added to energy drinks and taken by coffee drinkers to keep down the caffeine jitters — might be more important than we thought. According to Columbia U researchers, it might be not only essential to healthy aging, but also “taurine supplements can slow down the aging process in worms, mice, and monkeys and can even extend the healthy lifespans of middle-aged mice by up to 12%.”

So let’s see … if you’d normally be reasonably healthy till age 80, it could give you an extra 9.6 years before you welcomed the cold embrace of death.

Hyperbole? Probably, but the lead author did say, “This study suggests that taurine could be an elixir of life within us that helps us live longer and healthier lives.”

Another breast cancer drug success

Novartis’s breast cancer drug Kisqali cut breast cancer recurrence risk by 25% — at least when it’s diagnosed early. (And it’s often caught early, too.)

This isn’t quite as good as Lilly’s similar Verzenio^*, but Kisqali has fewer side effects, and as it’s a long-term med that’s kind of important.

At this point Verzenio is approved for women at high risk of recurrence after surgery, while Kisqali is approved only for cancer that has spread. This new study might change that.

^* I could swear that’s the name of a Shakespearean character.

High-five me, Kate!

A welcoming high-five to Kate O’Reilly, who was just named senior director of development at UGA’s College of Pharmacy. Look for her signature on the letters you’ll be getting asking for money, and based on her creds you’ll have trouble saying No.

Kate will be at the Georgia Pharmacy Convention — if you see her, say hello and deliver our high-five in person — she looks like this:

Captain Obvious just uses it for the cat memes

“Have anxiety? Social media not the best source for coping advice, researchers say”

Locust brains find cancer

If you were looking for a new way to detect cancer, chances are you wouldn’t think, “What if we performed brain surgery on a locust and inserted electrodes into the brain regions that process smell and used that to detect the scent of cancer cells?”

Yeah, well, you’re not Michigan State bioengineer Debajit Saha and team, who “tapped into the odor-sensing circuitry of the locust brain to detect the scent signatures of human oral cancers.”

They wafted the gas samples—each of which contained a distinct mixture of VOCs from the corresponding cells—over the locust’s antennae and recorded the brain’s electrical activity. After pooling the results from multiple locusts, Saha’s team found that their brains produced a distinct electrical pattern for each of the different cell types. The locusts not only distinguished cancer from healthy cells but discriminated between the subtle scent fingerprints of the different oral cancers.

Short Takes

Take it easy on Monday (and maybe Sunday too)

“Serious heart attacks are more likely to happen at the start of the working week than at any other time,” according to an Northern Irish study based on an analysis of more than 10,000 patients.

The researchers found a spike in rates of STEMI [ST-segment elevation myocardial infarction] heart attacks at the start of the working week, with rates highest on a Monday. There were also higher rates of STEMI than expected on a Sunday.

RSV vax coming to infants (probably)

The FDA’s Antimicrobial Drugs Advisory Committee voted unanimously to recommend AstraZeneca/Sanofi’s mRNA RSV vaccine for infants. “The panel also voted 19-2 to recommend a second dose of the treatment to children up to age two that are prone to severe infections.”

Talkin’ scope of practice

The gathering storm

In the wake of the pandemic and its expansion of the care pharmacists can provide to patients, there’s trouble a-brewin’ between the folks who have traditionally provided those services (and been paid to do so) and the pharmacists who are finally being recognized as true healthcare providers.

Pharmacy companies in particular feel they’ve proven what they can do in a crisis. They are seeking to capitalize on that, but the evolution of their business still depends on whether or not they can get paid for it.

Axios takes a broad look at all those brewing issues — and there are plenty.

Half empty, half full

The editor of Drug Store News worries that expanding pharmacists’ scope of practice — even though it’s objectively led to better outcomes — will lead to more bickering between pharmacists and physicians, and “is only the tip of the iceberg of a larger issue that is brewing between retail pharmacy and the medical community in the United States.”

Still, the magazine’s cover story (read it here — 4-page PDF) has a more positive spin and looks at the ways physicians and pharmacists can and should work together.

Semaglutide just keeps on giving

It’s not only a diabetes drug, a weight loss drug, a floor wax, and a dessert topping, now it seems semaglutide might treat alcohol dependence.

We wrote last month about anecdotes that it cut addictive behavior like shopping, gambling, and yes, drinking. Now Swedish researchers have tested that theory hypothesis on rats. They found that “[semaglutide] significantly reduced their alcohol consumption and even reduced the drinking of alcohol in conjunction with relapses. And by “significantly” we mean in half.

Of course what works on rats might not translate to humans, but when combined with those anecdotes it seems that something is going on. More tests will, of course, be needed to suss out the details.

Covid brain fog explained

Why does long Covid cause brain fog? It’s the signature symptom of the condition, but the cause is unclear. Aussie researchers, though, might have figured it out.

SARS-CoV-2, it seems, “can infect the brain and cause brain cells to fuse together and either malfunction or stop working completely.”

Yep, you can add “Are your brain cells fused today?” to your list of insults.

As an analogy, Professor Hilliard [of the University of Queensland] likened the role of neurons to that of wires connecting switches to the lights in a kitchen and a bathroom. “Once fusion takes place, each switch either turns on both the kitchen and bathroom lights at the same time, or neither of them,” he said. “It’s bad news for the two independent circuits.”

But wait, there’s more. From a scientific point of view it adds a third possible outcome to a viral brain infection: fusion (the others are cell death and inflammation). And it also explains other symptoms like loss of smell and headaches — and why the virus can still be detected in some patients months after infection.

Boosting cancer treatment

Some cancers are resistant to immunotherapy because a patient’s T cells aren’t up to the task of destroying them. As the news is teaching us, you can give an army an order but it won’t win many battles if it’s too weak to follow it.

But what can boost that T cell army are blood-pressure drugs. One of the drugs’ mechanisms, found Ludwig Cancer Research researchers, can alert T cells of abnormalities and trigger an immune response — waking them up and giving them a boost.

[A]longside their known hypotensive and anesthetic effects, α2AR agonists can also stimulate macrophages in their role as sentinels, making T cells more reactive and more effective at rejecting cancer cells.

They don’t recommend just adding BP drugs to immunotherapy because there are issues of toxicity. Instead, this is opening a door to a better cancer treatment once more research is done.

Non-pharma (but interesting) health news

New method means more hearts for transplant

A new method of heart transplants can make more organs available — maybe as much as 30% more. It’s already in use in some places around the country, and proponents would like it to be the new standard.

Rather than waiting for donors to be brain dead and putting their hearts on ice, the new method removes life support earlier — right after cardiac death — then removes the heart and uses a machine to keep it alive while it’s being transported. By not waiting until brain death, more hearts are viable and the pool of available organs increases — and even better, there’s a higher survival rate for recipients.

Detach today, have a better tomorrow

Had a long day? A rough one? If you want tomorrow to be better, you need to unwind properly — that’s according to a study out of Germany, where unwinding isn’t exactly a way of life.

The trick, based on interviews with and diaries of 124 people over more than two years, is using psychological detachment. In other words, disconnect from work — no emails, no texting the boss, no “I’ll just work a little…”. Detach.

“The findings indicated that that psychological detachment was indirectly related to the next day wakefulness, calmness, and pleasantness via sleep quality — meaning that detaching from work was linked to better sleep quality and sleep quality was related to positive mood states.”

It’s stuff like this that keeps Gwyneth Paltrow in business

Tennis star Novak Djokovic wears a patch that he (and the manufacturer) claim boost performance as “nanocrystals emit photons towards the body providing several health benefits.”

This is the guy who claims he’s gluten intolerant because a doctor told him he had less strength when holding a piece of bread.

Hormones: Don’t swallow, rub

Taking estrogen might cause high blood pressure, but here’s the kicker: only in pill form. So found a study published by the American Heart Association of 112,000 women^* 45 and older. Given transdermally, it’s no problemo. In fact, the safest way to get it is, um, down yonder:

Oral estrogen was associated with a 14% higher risk of high blood pressure compared to transdermal estrogen creams and a 19% greater risk of high blood pressure compared to vaginal estrogen creams or suppositories.

Why so? Because the oral form is metabolized via the liver, which has an effect on blood sugar levels.

If you feel like channeling Santa from Miracle on 34th Street, you could refer your patients taking oral estrogen to a compounding pharmacist, or at least suggesting they monitor their BP.

^* “a large group of [more than]112,000 women,” as opposed to a small group of 112,000 women. Or a group of 112,000 large women.

Support Buddy at the convention!

Coming to the Georgia Pharmacy Convention? Get out your checkbooks and come to the fundraiser for Buddy Carter’s 2024 reelection campaign.

The deets:

Saturday, June 17, 2023, 2:15 – 3:15 pm Sapelo Room at the Omni Amelia Island Resort

• Sponsor $3,3,00 per person
• Friend $1,000 per person
• Attendee $250 per person

Click here for the reservation/contribution form.

Can a heart med help hot flashes?

Ladies, if you’ve had hot flashes, chances are you’ve thought, “I wonder if nitroglycerin would help with that?” The good folks at UC San Francisco thought the same thing.

The logic is that nitroglycerin helps with chest pain by increasing blood flow, but over the long term it might “prevent or suppress the type of rapid, increased blood flow under the skin that causes sensations of heat and flushing during hot flashes.”

Alas, bad news: The women they treated with nitroglycerin patches saw some improvement briefly, but after a few months it was no better than a placebo. But hey, they tried!

GCSU gets fast track to Mercer

Good news for students at Georgia College & State University: If they’re looking to get a PharmD at Mercer, their applications will get priority reviews thanks to a transfer admission agreement between the schools.

The students will do their prereqs at GCSU, then enroll in Mercer’s PharmD program. Their first year of Mercer credits will transfer back to GCSU so they end up earning their bachelor’s degrees a year early. It’s like fuzzy math!

Reversing MS

For mice with multiple sclerosis, a big breakthrough from Johns Hopkins: “the ability to reverse — and in many cases, completely alleviate — MS-like symptoms.”

MS is caused by (to be overly simplistic) some of the body’s immune cells mistakenly attacking the myelin that protects nerve cells. What the Hopkins folks did is find a way to reduce the number of those errant cells (called effectors) in favor of “regulatory T cells, or T regs, that modulate the immune system and have been shown to prevent autoimmune reactions.”

How? By using payload-carrying microparticles injected near lymphatic tissues. (If you’ve seen the news, microparticles have a habit of getting into things — in this case it’s in a good way.) Once inside, the particles, um, do science. Result:

[I]n all of our mice, the T regs stopped the autoimmune activity of the effectors against myelin, prevented further damage to the nerves and gave them the time needed to recover.”

Oh, and 38% of the mice were completely cured. Next up: More tests!

Merck sues feds over price negotiations

Merck is suing the federal government in order to prevent it from negotiating the prices of medication.

The company’s argument: By allowing Medicare government to negotiate prices (rather than pay whatever the companies feel like charging), “[T]he law allows the government to force drugmakers to sell their property without ‘just compensation,’ which the company argues violates the Fifth Amendment.”

Yes, apparently the Constitution protects drug company profits. Who knew?

All snideness aside, it’s a nut that needs to be cracked. A transaction requires an agreement between the buyer and the seller, and forcing either one to agree to the other’s demands is either bad for taxpayers or for the pharma companies.

But unlike, say, buying a car, in this case both sides have tremendous power: pharma companies because Medicare has to buy their meds, and Medicare because it commands so much of the market. For the moment it’s up to the courts.

In related news…

States — not Georgia yet — are looking at their Medicaid budgets and starting to look at drug payments the way they look at utility and transportation payments: something the state needs to set the rates for. They’re called ‘drug price boards.’

Beyond price caps, states are considering capped co-pays, reference pricing and so-called “Netflix-model” subscription arrangements to cut the costs of prescription drugs.

Some boards have teeth, others don’t, but the message is clear: States are willing to pay fair value, but not any price, and regulation is coming. Of course, the pharma industry provided its usual measured response: “This spells disaster for patients as they could face barriers to obtaining life-saving medication.”

Tiny carriers of doom

A study of about 850,000 households found that children, far from being the sweet innocent bringers of joy, are more likely the bringers of Covid-19.

Of all households transmissions, 70.4% began with a child, with the proportion fluctuating weekly between 36.9% and 87.5%.

And the smaller they were, the more typhoid and the less Mary:

Children aged 8 years and younger were more likely to be the source of transmission than those aged 9 to 17 (7.6% vs 5.8%).

But it looks good on paper

A toothless safety board that’s been handicapped from the get-go? That’s the idea behind a “National Patient Safety Board” akin to the National Transportation Safety Board, but for unsafe medical care, e.g., what can happen in a hospital.

The problem: It would require the permission and cooperation of the facilities it wants to investigate. And even if investigators were allowed in, their reports couldn’t name the facilities. Why not? As one patient advocate put it, ‘public reporting would compromise data integrity by leading hospitals to scrub records to hide bad events.’

Short Takes

Don’t self-treat those bumps

The FDA is warning people not to treat molluscum — small skin bumps also known as water warts — with anything that claims to treat it.

Do not use products that claim to treat molluscum, even if they say they are “FDA-approved” or “made in an FDA facility.” There are no FDA-approved products to treat molluscum.

Just deal with it. “Molluscum eventually goes away on its own without treatment, usually in six to 12 months.”

One shot spaying

Instead of surgery to spay kittens, researchers at Mass General Hospital have developed a single shot that effectively does it via chemistry — they use a harmless virus to deliver a gene called AMH to the kittens’ ovaries; it prevents the ovaries from creating eggs.

[T]he treated cats did not ovulate. And when they were placed in a room with a male for several hours a day over a 4-month period—an experiment repeated both 8 months and 20 months after the gene therapy—none became pregnant. Four of the females refused to mate; the other two mated but could not conceive.

The elevated AMH levels remained for at least five years, but more work will need to be done before the research is out of the preliminary stage. But if it pans out, it could make a huge difference, especially to spay-and-release programs.

The influencers’ Ozempic alternative

When a story begins with “The latest health trend on TikTok….” you know to get out a big grain of salt.

In this case it’s berberine, an over-the-counter isoquinoline alkaloid related to morphine. And — if you believe the “influencers”^* — it’s a great substitute for Ozempic.

In fact, some small and questionable studies have shown that yeah, for extremely overweight women berberine was “associated with modest reductions in body mass index, waist circumference, and body weight (around 6½ lbs).” But there’s no information about side effects, long-term use, drug interactions, or how it will work for people who aren’t obese.

And, because the people taking it are likely to be influenced by TikTok, there’s zero reason to believe they’ll take safe or reasonable doses.

^* Don’t.

Did you vote yet?

GPhA members — don’t forget that you have only until Thursday, June 15 at 11:59:59 pm to cast your vote for members of the 2023–24 board of directors.

You should have received your electronic ballot from AssociationVoting to the email address GPhA has on file for you. Can’t find your ballot or have a question? Reach out to Lia Andros, GPhA’s governance manager, at (404) 419-8173 or landros@gpha.org.

FDA relaxes import rules

To help ease the shortage of cancer drugs, the FDA will be allowing imports from foreign manufacturers that aren’t approved to distribute to the US.

It’s one of the few things the government can do to ease the shortages of cisplatin and carboplatin. The drugs are privately made, and one of the major manufacturers has temporarily shut down with no clear start-up date. Still, despite the fact that the FDA doesn’t have a big red “Ease Drug Shortage” button to press, and that medication doesn’t just magically appear, people are demanding that Someone Do Something, sometimes with amusing analogies:

Philip Schwieterman, director of oncology and infusion services at the University of Kentucky health system, said, “If I go in the grocery store and I want a kiwi, there are usually kiwis there. It boggles my mind that if I want some cisplatin, I can’t get cisplatin even though it saves lives.”

What could be done, though, is to create a national stockpile of medications — but first we need to get through the current shortage.

Sorry, there is no Medication Fairy

Anti-steering law is back (and not everyone is happy)

With the end of the pandemic’s public health emergency, a law that had been set aside is back in play. It says that prescribers can’t steer Medicare and Medicaid patients ‘to facilities and services in which they have a financial interest.’

That makes sense on the surface, but, as always, there are broad strokes and there is nuance. In this case the issue is specialty drugs that aren’t available at community pharmacies. CMS’s interpretation says that those can’t be provided by, say, oncologists. The oncologists for their part say that sending scripts out to mail-order pharmacies causes delays and can even mean patients don’t get their meds because the drug is in shortage.

As one oncology-practice manager put it:

“I know my inventory level. I know how many weeks on hand I’ve got and I can work with the providers proactively before I run out. When you go to a mail-order facility, you’re just sending a prescription out. You don’t know.”

Of course both sides are making huge, definitive statements — ‘there won’t be any problem’ vs. ‘patients will be dropping like flies.’ (“They have ripped seamless medical care out of the hands of providers,” said one. Yet the law has been in place since 2001; enforcement was simply waived during the pandemic.)

A group of US representatives, including several from Georgia, is asking CMS to retract the guidance that’s causing the kerfuffle, and one patient-advocacy group is considering a lawsuit. Whatever happens, knowing the rulemaking process it’s unlikely to happen quickly.

Big cancer breakthroughs

A new drug against glioma

For patients with treatment-resistant glioma, there’s great news. A phase 3 trial of a new drug dubbed vorasidenib didn’t just work, it worked gangbusters.

The team found the drug vorasidenib more than doubled progression-free survival in people with recurrent grade 2 glioma with IDH1 and IDH2 mutations. Compared with people who received a placebo, those who took vorasidenib went for nearly 17 more months without their cancer worsening, delaying the time before they needed to begin chemotherapy and radiation.

Because glioma often strikes younger people, and the treatment for it can do nasty things to their brains, being able to delay or reduce traditional chemo/radiation treatment can make a huge difference. And vorasidenib is targeted only at cancer cells, so it doesn’t damage healthy ones.

With the phase 3 trial complete, FDA approval could (should?) be coming soon.

For some patients, huge lung cancer news

About a quarter of people diagnosed with lung cancer have a mutation in their EGFR gene. For those people, great news: “Taking the drug osimertinib after surgery dramatically reduced the risk of patients dying by 51%.”

The survival benefit “was observed consistently” in an analysis across all study subgroups, including those with stage one, stage two, and stage three lung cancer. Chemotherapy had been given to 60% of those in the study, and the survival benefit of osimertinib was seen regardless of whether prior chemotherapy was received.

That’s a big enough deal that one researcher said osimertinib — aka Tagrisso — should become the standard of care for those patients.

Short Takes

Send in the bot

Endoscopy, schmendoscopy. Why stick a tube into someone when you can not just send in a tiny camera robot, but (now, thanks to George Washington University engineers) one that can be steered to the right location?

Think about this one for a bit

“Intelligent minds take longer to solve difficult problems”.

[B]rains with less synchrony among various regions were prone to making hasty decisions without waiting for upstream brain regions to process the necessary information for solving the problem. However, for those with higher intelligence, their brain simulations took longer to solve the tougher tasks but committed fewer errors.

Fentanyl as a weapon

With fentanyl overdoses killing people to the point that the drug is “already the number one killer of Americans under 50,” Rutgers University researchers wondered Can fentanyl be weaponized?

Why yes, they concluded. Yes it can. It would just have to be in really high concentrations, like a lot of powder being dumped into a building’s air handler. At least until someone comes up with an even more powerful analog.

(The good news is that currently (despite what some police are claiming) “There has never been an overdose through skin contact or accidentally inhaling fentanyl.”)

Alumni receptions at the convention

Three of Georgia’s four pharmacy schools are planning alumni receptions at the Georgia Pharmacy Convention. Be sure to sign up for yours!

• Mercer University: Thursday, June 15 from 6:00–7:30 pm in the Oceanview Room & Terrace. (Click here to register; questions go to Genice Johnson)
• South University: Thursday, June 15 from 6:00–9:00 pm in the Sunrise Café. (Registration info to come; questions go to Ajay Singh.)
• UGA: Thursday, June 15 from 6:00–7:00 pm in the Magnolia Garden. (Click here to register; questions go to Kim Hamby.)

PCOM shout-out!

Congrats to the 76 pharmacists who just graduated from PCOM Georgia, now set to embark on what’s sure to be an exciting, lucrative, confusing, important, stressful, and fun career. Welcome to the PharmD world, everyone!

A better atropine for kids’ myopia

Atropine has uses in fighting some poisonings and in some surgeries, but off-label (as eye drops) it can treat myopia in kids. That’s good, but the eye drops are only available from compounding pharmacies — that’s not bad, but it means it’s harder to get and includes preservatives, which aren’t the first choice of what you want to put into your kid’s eyes.

But researchers at an Ohio State University have tested a preservative-free version of low-dose atropine eye drops that “led to significant improvements in several markers of myopia in children” with no serious side effects. In fact, the lower dose they tested (0.01%) did better than the higher dose (0.02%).

Cool fact: Atropine slows the growth of the eyeball, which is why it needs to be used on kids. And it’s not a lifelong treatment — it’s just used during the formative years. A second study is looking at what happens when treatment is over, and it’s hoped the drug can eventually get on-label FDA approval as a myopia treatment.

Basic research: how brown fat works

You probably know that there’s good fat (brown, which burns calories) and bad fat (white, which stores calories).

Now researchers from the US, Britain, and even Belgium have teased out the molecular structure of a protein called UCP1, which is the found the big difference between the two fats; it’s what gives brown fat its calorie-burning abilities.

And, as we all know, once the scientists get into this level of detailed understanding the possibilities of (in this case) either turning white fat brown or making brown fat more effective increase yugely.

The Long Read: Brother vs Brother edition

More and more weapons are being brought to bear in the fight against antibiotic-resistant bacteria. The latest: Engineering one strain of E. coli to kill another strain of E. coli.

In fact, different strains of the bacteria will already try to kill each other off so they can colonize the same space, kind of like the British when they discover a new continent. They use some interesting techniques, like intercepting chemical signals sent by the ‘other side.’ By harnessing this information-processing skill, biologists can create E. coli that releases toxins at just the right time.

Read more about the promise of synthetic biology from Leaps.org.

Short Takes

A new buprenorphine

The FDA has approved two formulations of Braeburn’s Brixadi transmucosal buprenorphine for treating opioid use disorder.

Brixadi is approved in both weekly and monthly subcutaneous injectable formulations at varying doses, including lower doses that may be appropriate for those who do not tolerate higher doses of extended-release buprenorphine that are currently available.

The next CDC head

Mandy Cohen is (almost certainly) President Biden’s pick to take over at the CDC. Who is she? What’s her experience. Newsweek has the deets.