FDA’s half-full bias

A former FDA advisory committee member was concerned that the agency overruled the committee’s recommendation against Aduhelm approval. He quit the committee over it, but he also got curious. How often did the FDA overrule its advisors?

So he looked at 11 years worth of data. The answer was striking, and it showed how the agency has a strong bias towards approval.

• When the committee voted for approval, the FDA agreed 96.6% of the time.
• When the committee voted against approval, the FDA only agreed 66.6% of the time.

As one commentary writer put it:

“The FDA is no longer asking committees to determine whether a drug should be endorsed, she said in an interview. The advisory panels instead are being used to guide the agency toward easier paths to approval.”

GOP offers drug-shortage plan

As the reality of drug shortages — and our reliance on our Chinese friends — sinks in, legislators from both parties are on the case. The latest ideas come from Republicans on the House En­er­gy and Com­merce Com­mit­tee.

Although they blocked the Democrats’ plan to tackle shortages, they have their own: the Stop Drug Short­ages Act. It’s got a bunch of pieces including…

• Requiring generic drug makers disclose information about their active-ingredient suppliers
• Allowing 503B compounding pharmacies to compound drugs within 30 days of it going into shortage
• Require the FDA test conducting pre-ap­proval in­spec­tions for new man­u­fac­tur­ing fa­cil­i­ties in the US, which would hopefully speed up the li­cens­ing process.
• Exempt some makers of gener­ic, ster­ile in­jecta­bles from 340B rebates
• Cap some Medicaid rebates
• Reestablish Medicare rebates for drugs coming out of shortage

After a few weeks of feedback they intend to offer it up as a bill.

Let it out

Answering the question “Is venting good for your health?” the American Heart Association offers this helpful tidbit: Choose your audience wisely.

(The answer is it can be good as long as you vent to someone receptive. Maybe write stuff down instead.)

Magic mushrooms ‘reset’ anorexic brain

Anorexia is notoriously difficult to treat with medication because it’s “ego-syntonic,” meaning there’s a strong psychological component. But UC San Diego researchers say their small study found that a bit of psilocybin might do the trick.

(Key word: small.)

Participants reported positive changes three months after dosing, with some demonstrating clinically significant reductions in eating disorder psychopathology. Some participants had a robust positive response to just a single-dose treatment. No serious adverse events were reported.

They think that psilocybin gave the patients a dose of “cognitive flexibility” that could “disrupt eating disorder related preoccupations, rigid thinking styles and entrenched behavioral patterns.” But as always, more research is needed.

It’s so crazy it just … might … work

Strawberries vs dementia

“Eating strawberries daily may improve cognitive function in older adults,” according to a new study out of San Diego State University, “as well as lower blood pressure and boost antioxidant capacity.”

After strawberry intake, cognitive processing speed increased by 5.2%, systolic blood pressure decreased by 3.6% and total antioxidant capacity jumped by 10.2%. Waist circumference decreased by 1.1%.

Caveat: The study was of 35 people (healthy older men and women). They ate two servings worth of freeze-dried strawberry powder per day for 8 weeks. So yeah, larger studies will be needed.

Kombucha vs glucose

Got diabetes? Maybe drink some kombucha^*. That’s the conclusion from a small “feasibility” trial —just 12 people — led by Georgetown health researchers.

People with type 2 diabetes who drank the fermented tea drink kombucha for four weeks had lower fasting blood glucose levels compared to when they consumed a similar-tasting placebo beverage.

As always, “A lot more research needs to be done, but this is very promising.”

^* “A sweet, fizzy drink made from bacteria, yeast, sugar, and tea”

Pecans vs obesity

Eating pecans daily — and pronouncing the word properly — can prevent obesity, fatty liver disease, and diabetes, according to a study out of Texas A&M. Amazing! Fun fact: “This study was supported by the Texas Pecan Board.”

The Long Read: Conflict of Interest edition

A New York fertility doctor likes to prescribe DHEA supplements for his older patients — despite scant evidence that it works … and that he owns the company that sells the supplements.

The shape of pills to come

Round and oval pills are so last year. Sure, they go down easy, but they release their payloads willy-nilly. A better pill would be shaped to release its ingredients at exactly the right time.

That in mind, researchers at the Max Planck Institute (with help from UC Davis) turned to a bit of computer modeling and came up with pills where some parts dissolve faster than others based on the shape of the pill.

The idea is that when a drug is mixed evenly into a dissolvable carrier material, the shape of the pill (and therefore how it dissolves) is the key factor that determines how it releases the drug. So for instance, points and thinner sections would dissolve first, followed by thicker parts of the shape.

They came up with some interesting 3-D printed shapes that release their payloads at different rates:

A bit of experimentation showed it worked; the plan would be to encase those little works of art inside easy-to-swallow capsules. One thing’s unclear, though: Couldn’t they achieve the same results using different coatings on the grains within a capsule?

Presto: a whole new drug!

You’re a drug company about to face the prospect of having your biggest buyer (heavens forbid!) negotiate the price of your product, like some kind of free market!

But there’s a loophole. That buyer can only negotiate the prices of some drugs. Ha! So what do you do? You add hyaluronidase, an ingredient that makes the drug injectable, then claim that it’s an entirely new drug and thus you can charge whatever you want.

Lyme’s Achilles’ heel

Fun fact about the Lyme disease bacteria (Borrelia burgdorferi): It relies on glycolysis for its metabolism. That’s unusual.

Glycolysis works thanks to a molecule called lactate dehydrogenase (LDH). So if you block the LDH, you stop the disease. Hmm.

That’s why UMass researchers found themselves looking into LDH inhibitors. They’re out there as cancer treatments because — wait for it — cancer cells also rely on glycolysis.

So the UMassians did some tests, as researchers do, and they found two LDH inhibitors that “substantially impacted B. burgdorferi growth” in the lab: gossypol (aka AT-101) and oxamate.

It’s still early, of course, but they’re already saying these drugs could be the key to a better treatment for Lyme. And with cases on the rise, the timing is pretty darned good.

Endemic leprosy

Leprosy might be at the point where it’s endemic to the Southeast, especially Florida. It just might be this thing that’s always around — not even newsworthy.

“Steve’s got leprosy.”

“Hm? Oh, too bad. Hey, how’s that new shampoo working out?”

But at the moment it’s bad enough that the CDC has issued a travel warning for people going to Florida.

And yes, you can catch leprosy from armadillos.

Nothing to see here, Citizen

The US government has given Siga Technologies a $138 million contract to supply the national stockpile of the smallpox antiviral Tpoxx.

With age comes wisdom — and better statin response

How well will someone respond to statin therapy? It could depend on their age. Those shifty Danes did a study of more than 80,000 statin users and found that older patients (i.e., 75 or older) saw a bigger difference in their cholesterol levels.

Low- to moderate-intensity statins were associated with a greater reduction in LDL-C levels in older persons than younger persons and may be more appealing as initial treatment in older adults who are at increased risk for adverse events.

Double infection, double protection

A patient got sick with the original SARS virus (SARS-CoV as opposed to SARS-CoV-2). Then he went and got himself a Covid vaccine. That combo, Singaporean scientists found, “generated an extremely broad and powerful antibody response.” The patient ended up with …

Exceptionally potent antibodies that can neutralise virtually all known variants of the COVID-19 virus—including Omicron, as well as other dangerous animal coronaviruses that could potentially cause future outbreaks.

That’s the kind of response that would be perfect in a vaccine: short- and long-term protection. The question is, will they be able to figure out how to replicate it?

The next next opioid show

There’s a new miniseries coming to Netflix August 10: “Painkiller” — the “fictional story based on real events that transpired around the Sackler family, Purdue Pharma, and the marketing and distribution of their drug, OxyContin.”

It’s yet another take on the opioid epidemic (after “The Pharmacist,” “Dopesick,” and “The Crime of the Century.” But it does star Matthew Broderick, so there’s that.

Quick read: Funky old treatments

Ah, the good ol’ days of medicine, when treatments were a bit more … interesting. And we’re not talking about leeches or “Dr. McGillicuddy’s Cure-All.” Think instead about prescriptions for ground-up mummy, soaking in a whale carcass, or worse.

A gout drug fights Covid

Covid-19 may not be in the news much anymore, but searches for treatments continue, especially if those treatments are existing meds.

On that note we have probenecid — yeah, that old gout drug. Biotech researchers at UGA’s College of Veterinary Medicine tested probenecid on patients with mild or moderate Covid over 28 days, and they were happy with the results: “In comparison to other FDA-approved drugs used to treat the virus, probenecid helped clear symptoms several days faster.”

“The most effective treatment,” they say, “is for patients to take 1,000 mg tablets twice daily for approximately five days.”

Next up: Seeing how well probenecid works against other respiratory viruses.

Don’t forget your tickets for Day at the Braves!

Some tickets are still available for GPhA’s 2023 Day at the Braves — Sunday, September 10 at 1:35 pm when Atlanta will be hosting the Pittsburgh Pirates. Don’t wait to order yours!

Our seat block is in the Terrace Reserved Section 240 and tickets are just $50 each.

GPhA’s seating has sold out fast these last two years, so don’t wait — order your tickets today!

WHO updates essential meds list

The World Health Organization will soon release its latest list of essential medications — the drugs “that should be available in all functioning health systems” — bringing the total to 502.

Among the 36 drugs added:

• MS treatments cladribine, glatiramer acetate, and rituximab
• Monoclonal antibody treatments for Ebola anzuvimab and Inmazeb (atoltivimab, maftivimab, and odesivimab)
• Naltrexone and acamprosate for alcohol-use disorder

Not added: obesity drugs like liraglutide or semaglutide because of their “uncertain long-term clinical benefit and safety in this patient population” and the fact that they have to be taken for life.

Georgia lake proves deadly

A Georgia resident is the second person in the past two weeks to die from a brain-eating amoeba — i.e., a Naegleria fowleri infection — likely gotten from swimming in a freshwater lake or pond. (The DPH didn’t release details; the other person was a 2-year-old Nevada girl.)

The disease is almost always fatal because it’s so rarely diagnosed in time for treatment, which includes the antifungal medications amphotericin B and fluconazole and the antibiotics azithromycin and rifampin, according to the CDC.

This is only the sixth case of Naegleria fowleri infection in Georgia since 1962.

Signs of infection include fever, nausea, vomiting, a severe headache, stiff neck, seizures, altered mental state, hallucinations, and [coma].

There’s no way to control or test for the amoeba, so the only advice the CDC gives is that if you’re swimming in a lake or pond avoid getting water in your nose.

Note: A Florida man died earlier this year after using a neti pot with tap water.

FDA approves anti-inflammatory CVD treatment

The FDA has approved Lodoco (aka colchicine) for the prevention and treatment of cardiovascular disease, making it the first anti-inflammatory drug indicated for cardiovascular disease.

“With colchicine, we now have a unique way of lowering cardiovascular risk, which adds to and complements other medications that we currently use.”

Warning: Article includes the phrase “game-changer” three times.

An “atypical” med for pain

Neuropathic pain is tough to treat because those treatments include anticonvulsants and antidepressants — and their side effects. And, of course, opioids for pain have their own problems.

What could work? Tianeptine, the “atypical” antidepressant, according to a multi-university team of researchers.

The results showed that tianeptine had profound pain-relieving properties that lasted well after the drug was no longer present, which suggested it was the drug affected the expression of genes that were critical for the maintenance of pain symptoms.

Tianeptine isn’t approved in the U.S., but it is available by prescription in Europe (except Italy), Asia, and Mexico where it’s used as an antidepressant and for treating asthma and anxiety.

Advantages:

• Treats the chronic pain as well as the depression it can lead to
• Works faster than antidepressants
• Patients don’t build up tolerance
• Low risk of addiction

Disadvantages (as we reported back in 2022): There can be significant side effects and bad reactions, so this isn’t something you want over the counter. In fact, the researchers hope to reduce those side effects now that they’re confident of what tianeptine can do for pain.

“By further refining this molecule, we could arrive at a pain treatment that is more effective, fast acting, and has a mild side effect profile.”

Red ginseng might make hangovers easier

Korean scientists decided to see how Korean red ginseng (KRG) — a traditional folk remedy for everything from diabetes to erectile dysfunction — would work against hangovers, seeing as there’s evidence it can fight addiction.

First they got mice drunk (as one does). Some of them got KRG, some didn’t; then they let them stumble around make bad life decisions. Once everyone was sober, the researchers tested them in mazes to see how they handled withdrawal.

The tests revealed that the mice who had been given alcohol and then KRG retained more of their spatial memory and showed more resilience when the alcohol was removed.

Will Covid surge again?

The World’s Most Depressing Magazine™ wants to remind you that the pandemic part of Covid might be over, but health officials are concerned about the recent and continuing uptick in positive tests and hospitalizations. Could we have “One More COVID Summer?”

The absolute numbers are still small, and they may stay that way. But these are the clear and early signs of a brewing mid-year wave […] which would make this the fourth summer in a row with a distinct coronavirus bump.

Georgia students represent in biz-plan competition

A big shout out to the team from the UGA College of Pharmacy — it was named one of the three finalists for NCPA’s 2023 business plan competition^*. Again. Because these kids are just that good.

But wait: The Mercer College of Pharmacy team may not have gotten to the final three, but it was in the top 10, showing these folks that Georgia student pharmacists are ready to kick butt and take names … and they didn’t bring their notebooks.

The UGA folks — along with teams from the University of South Carolina and the University of Texas at Austin –

– will present their business plans in a live competition on Oct. 14, 2023, at the NCPA Annual Convention in Orlando. The winning team will be announced on Oct. 15 as part of the convention’s first General Session.

The Mercer CoP team of Samuel Smith, Kaitlyn Moss, and Natalie Novak (not pictured: the UGA team)

^* The 2023 Good Neighbor Pharmacy NCPA Pruitt-Schutte Student Business Plan Competition (GNPNPSSBPC)

Tick-bit allergy goes undiagnosed

You may have seen the news that cases are on the rise of alpha-gal syndrome (AGS) — where a tick bite causes an allergy to meat. As many as 450,000 Americans may have this nightmare condition, the CDC says.

Making matters worse is that a lot of healthcare providers aren’t aware of AGS, so they don’t even think to test for it when a patient has, um, let’s call it “non-insignificant gastro-intestinal distress” after eating meat.

So if one of your patients complains about severe abdominal pain after eating at Taco Bell, don’t dismiss it as “You and everyone else.” You might suggest a test for AGS.

Quadpill for BP saves money, too

Way back in 2021 we told you how Aussie researchers found that taking smaller doses of four different blood pressure meds was more effective than trying one after the other.

Now a different group of Aussies crunched the numbers and found that a so-called quadpill was also cost-effective.

The research team modelled the costs and benefits of lifetime treatment, including estimates of costs of medications and of predicted cardiovascular events in both groups. They found a quadpill would likely be cost effective to the Australian health system within a range of scenarios and for different kinds of patients.

Another anti-OD drug goes OTC

The FDA has approved Harm Reduction Therapeutics’ RiVive for over-the-counter sale, making it the second opioid overdose reversal drug to go OTC after Narcan.

Harm Reduction said it anticipates that RiVive will be available early next year, primarily to harm-reduction organizations and state governments. The not-for-profit drugmaker said it would make at least 200,000 doses available for free.

A ‘conversation’ to treat chronic pain

Scientists know that one of the causes of chronic pain involves a sodium ion channel called NaV1.7. When that channel is opened too far and more sodium gets through, the pain is worse.

Old idea: Block the channel to stop the pain. That, unfortunately, hasn’t worked.

New idea out of NYU: Instead of targeting NaV1.7 directly, talk to its friend — a protein called CRMP2. It seems that CRMP2 “talks” to NaV1.7 and regulates it. Then they dug deeper and figured out just how the protein does that talking.

With that figured out, they created a simple peptide to send the same message to NaV1.7: “Shut up and stop causing pain.” And then they engineered a virus to deliver that peptide. And what do you know: pain-free mice.

Not just mice. They’ve tested the virus on other rodents and even primates (it worked), so human testing could be around the corner.

When low-dose aspirin causes more harm than good

The latest blow against low-dose aspirin (for people who don’t have cardiovascular issues) comes out of a US-Australian study of more than 19,000 adults. It seems that taking it can increase a patient’s risk of brain bleeding if they suffer a stroke or head trauma.

It’s a significant risk, too — we’re talking a “38% increase in intracranial bleeding” after a stroke or intracerebral hemorrhage, and without providing any benefit.

These findings suggest that low-dose aspirin may have no role for the primary prevention of stroke and that caution should be taken with use of aspirin in older persons prone to head trauma (eg, from falls).

Not creepy at all

Apparently Duke researchers have watched “Mad Max: Fury Road” a few too many times. Their idea: Attaching the circulatory system of young mice to their elders, which turns out to “[slow] the aging process at the cellular level and lengthens the lifespan of the older animal by up to 10%.”

[A] team led by Duke Health researchers found that the longer the animals shared circulation, the longer the anti-aging benefits lasted once the two were no longer connected.

Geography isn’t our strong suit

Yesterday we referred to the Pfizer plant in Tennessee that was hit by the tornado. Whoops — it’s in North Carolina. Sorry for any confusion!

PBM bill passes Senate committee

The Senate Finance Committee all but unanimously (25-1) advanced a bill that would regulate PBMs — yet another show of bipartisan support for reining in those bloodsuckers.

Among other provisions, the legislation would delink PBM compensation from the price of the drug, which would remove an incentive for PBMs to favor higher priced drugs.

The legislation would also ban spread pricing, which is when a PBM charges Medicaid more for prescription drugs than they pay.

What’s next: This bill will likely be combined with other committees’ PBM reform bills, as well as those from the House, eventually creating one bill to rule them all.

Mercer grads are succeeding

Big shout-out to the Mercer College of Pharmacy! Its 2022 grads had a whopping 96% “career outcomes” rate — meaning they’re actually putting their shiny new degrees to use.

Click to expandonate:

Metformin for muscle recovery

Metformin can do a lot, and what “a lot” means keeps being discovered. (In January we shared how people on social media think it’s a miracle drug. It does seem to protect against osteoarthritis and long Covid.)

Anyway …

The latest superpower metformin might have is protecting muscles, especially in older people. University of Utah researchers found that it can help clear accumulated senescent cells — i.e., remove the dead bodies so the muscles can recover and function better. The result is less muscle fibrosis and atrophy after disuse, e.g., after a bunch of post-injury bed rest.

They’re still teasing out how best to use this info, but the Utahans are pretty happy so far.

“Metformin is cheap, effective and quite safe, so it’s exciting to see that we can use it to accelerate recovery for older individuals.”

Whooping cough: protection for me but not for thee

The rise in whooping cough cases may have a surprising culprit: vaccinated people.

In 1996 the US adopted a newer whooping cough shot called the acellular pertussis (aP) vaccine. Unlike the original 1948 version, aP only protects against four strains of B. pertussis in order to cut down on side effects.

But when they examined patients, scientists at California’s La Jolla Institute for Immunology noticed that people who got this newer vaccine had immunity to strains that weren’t in it.

“Huh,” they said.

That’s good, right? Yes and no. Upon further review, they discovered that vaccinated people themselves were well protected, but…

[T]he aP vaccine likely produces an immune response to the four main antigens that is effective enough to prevent severe disease, but not very good at preventing subclinical infections. This would lead a large number of people to unknowingly become infected and act as carriers of B. pertussis, spreading the bacteria to those more vulnerable to the disease. (Emphasis ours.)

Semaglutide in the news

Fixing the liver

There are a bunch of new treatments (“a robust marketplace”) coming out for nonalcoholic fatty liver disease — which will soon be called nonalcoholic steatohepatitis or NASH to avoid fat-shaming it. And at the top of the list? Semaglutide.

A majority of both gastroenterologists and hepatologists […] said they would be “very likely” to prescribe semaglutide to patients if it’s approved for either condition in the future. Another 10% to 20% said they would be “moderately likely” to prescribe it.

It’s not that semaglutide treats NASH directly — it’s that patients are often obese as well, and treating that could treat the NASH. “Reducing overall body fat helps reduce fat in the liver, which helps it recover.”

Mounjaro: good news and bad

The FDA seems poised to approve Eli Lilly’s Mounjaro for treating obesity, but there’s one problem: People are already using it off-label, and demand is outpacing supply. The company “is pumping cash into expanded manufacturing capacity,” but some doses are expected to be hard to get at least through September.

Wegovy is probably just fine

The factory that fills Novo Nordisk’s Wegovy injector pens looks like it’s been playing fast and loose with some sterile-safety rules, according to FDA records. Although the plant had “the most serious form of violations,” the agency let it stay open while it fixes the problems.

But like the fry cook who doesn’t always wash his hands, “There is no evidence that Catalent’s compliance failures resulted in harm to users of Wegovy.”

Olive oil might beat dementia

Just half a tablespoon of olive oil a day — especially if it’s a substitute for butter or margarine — “might trim the risk of death from dementia by up to 14%,” according to Harvard researchers. And people who consumed more than that could cut that death risk by 28%.

What’s interesting is that this study focused on olive oil alone, not on the whole Mediterranean diet; they think those good ol’ omega-3 fatty acids and olive oil’s various polyphenols are playing a role.

Caveat: “[S]tudies like this can only show correlations — and not proof that olive oil protects the aging brain.”

Note: A lot of “olive oil” out there is fake. Here’s a list of the real deal. Too lazy to click? California Olive Ranch and Costco Kirkland Toscano are good, inexpensive, and legit. You’re welcome.

Snot a good test

When it comes to a stuffy, runny nose, the old adage is that the color of the mucus tells you whether it’s a bacteria causing the problem: Yellow or green means bacteria, clear means viral or an allergy.

Not so fast say University of Pittsburgh pediatricians. They actually tested that theory, looking for a way to cut back on overuse of antibiotics to treat sinusitis.

“If kids with green or yellow discharge benefitted more from antibiotics than those with clear-colored discharge, we would know that color is relevant for bacterial infection. But we found no difference, which means that color should not be used to guide medical decisions.”

What’s necessary is a bacterial test, but those can take days. The U of P folks hope to develop a rapid antigen test once they find a useful biomarker.

You got your mRNA in my protein

When it comes to Covid-19, protein vaccines are good and mRNA vaccines are even better. But what if you combined them into the Reese’s Peanut Butter Cup of vaccines?

According to CalTech biomed engineers, the hybrid vaccine they created is the best of both worlds, combining features of mRNA technology (as in Pfizer and Moderna shots) with features of protein nanoparticle-based vaccines (as in the Novavax shot).

The result is a vaccine that elicits both an immediate burst of antibodies as well as a longer-term T cell response.

“Current mRNA vaccines mimic infected cells, while protein nanoparticle-based vaccines mimic free virus particles to stimulate immune responses. Our hybrid technology does both.”

Pfizer now warns of post-tornado shortages

First it looked like that Pfizer plant in Tennessee was erased off the map, and shortages were coming. Then they said, ‘Nope, it was but a scratch — only the warehouse was hit. All is well.’ Now we’ve done a 360 and are back to “Uh-oh.”

The company sent a letter late last week to its hospital customers saying it had identified around 64 different formulations or dosages of those more than 30 drugs produced at the plant that may experience continued or new supply disruptions.

Schoolkids gone wild

The nationwide shortage of Adderall isn’t just affecting college students looking to study late. The students who really need the stuff can’t get it, and teachers are noticing. As one Macon teacher explained, “You can usually tell when they don’t have what they have normally been having […] A day that would normally be very calm in a classroom would be very disrupted.”

How aging works

The chemistry of inflammation?

A hallmark of aging — besides reminiscing about your mother’s boiled meat — is good ol’ inflammation, responsible for just about everything that starts to ail us.

But why must inflammation plague us all? University of Virginia immunologists think they’ve found the answer, which could lead to treatments. It’s all about calcium and how mitochondria^* lose the ability to absorb it.

The researchers believe that increasing calcium uptake by the mitochondrial macrophages could prevent the harmful inflammation and its terrible effects. Because macrophages reside in all organs of our bodies, including the brain, targeting such “tissue-resident macrophages” with appropriate drugs may allow us to slow age-associated neurodegenerative diseases.

Obviously (unless you’re on TikTok) the answer isn’t taking more calcium — it’s the absorption that’s the problem. But now that the UVa researchers know how it works, we’re a big step closer to doing something about it.

^* The powerhouse of the cell

Protein problems and cognitive decline

Even without dementia, aging often brings cognitive decline, leading to people holding up the grocery line while trying to remember how to write a check. You might assume it’s just something that happens, but University of Colorado pharmacologist think they’ve found the mechanism.

That mechanism “involves the mis-regulation of a brain protein known as CaMKII which is crucial for memory and learning.” The article and paper go into the detail of the science, but it’s all about lower levels of nitric oxide eventually leading to the protein not being tweaked properly.

Just as with calcium (above), supplements won’t help; they’ll need to find a way to “normalize the nitrosylation of the protein,” which is obviously something you don’t do at home.

Short Takes

Livers and leprosy

Let’s say you’ve got a patient whose liver has been damaged too much too often to regrow. You might think it’s time for a transplant, but have you considered leprosy?

Apparently armadillos use the the bacteria Mycobacterium leprae to help regrow theirs without creating tumors.

[A]fter years of evolutionary coexistence, “bacteria have figured out how to” induce healthy organ growth in their hosts without damaging them.

“I” for incomplete

A new study out of Yale found that “More than 1 in 6 US children initiated but did not complete all doses in multidose vaccine series.” What that means, they suggest, is not that anti-vaxxers are at work, but more likely “structural barriers to vaccination,” e.g., financial or even transportation difficulties.

Maybe doxy should be OTC

“Hospital visits from tick bites jump 30%” according to the CDC. Lyme disease is the biggest culprit, but let’s not discount its bad-boy cousin, anaplasmosis.

Illegal drugs — hiding in plain sight

Drug traffickers, it seems, are pretty good at chemistry. The trick that’s appearing now: Creating drugs that only do their thing when metabolized by the body.

These prodrugs are hard to detect by the usual methods that look for, say, LSD because it’s not a drug when it’s in pill form — only when it’s metabolized. Typical screening tools aren’t looking for, say, ALD-52, “a prodrug that is converted by the body into LSD after the removal of two carbon and one oxygen atom.”

It’s not just LSD. There are prodrug versions of other meds like ecstasy and GHB, and possibly more than just haven’t been discovered — that’s the problem.

Since the list of these compounds is not known and minute chemical changes can lead to different patterns to be analysed, these new drugs are easy to miss.

Day at the Braves 2023!

Take you out to the ball game! Join GPhA staff, members, and their friends for Braves baseball at the third annual GPhA Day at the Braves! It’s Sunday, September 10 at 1:35 pm when Atlanta will be hosting the Pittsburgh Pirates.

Our seats are in the Terrace Reserved Section 240 and are only $50 per ticket.

Important: GPhA’s seating has sold out fast these last two years, so don’t wait — order your tickets today!

Prebiotics the hard way

Fun fact: There are (San Jose State University scientists say) just five foods that are best for getting your good bacteria the old fashioned way: Dandelion greens, garlic, Jerusalem artichokes, leeks, and onions.

Black-eyed peas and asparagus were also high on the list. At the other end of the list, with little to no prebiotic content, were dairy products, oils, eggs and meats.

Nothing against eating dandelions or artichokes, but it seems a lot simpler to choose one of the many options at — wait for it — your local pharmacy.

Another reason to take your D

A preliminary study finds that vitamin D supplements might reduce the severity of psoriasis. The key word being might.

As the author put it, “Our study suggests that following a vitamin D-rich diet or starting oral vitamin D supplementation may provide some benefit to psoriasis patients, but further research is certainly warranted.”

What’s not clear is whether it makes a difference in someone who has normal vitamin D levels, or only for people with low vitamin D. As the author said, “We found that lower serum vitamin D levels were associated with more severe psoriasis,” but didn’t look at how adding extra vitamin D might affect the severity.

Mom was right after all

It seems if you watched too much TV as a kid it really can make you sick — it just takes some time. Kiwi researchers found that kids who watched more television were more likely to have metabolic syndrome as an adult.

So that high blood pressure? High glucose? Excess body fat? High cholesterol? Maybe you can blame it on the tube: “[T]hose who watched more television between the ages of 5 and 15 were more likely to have these conditions at age 45.”

And if you’re thinking to cut back now, it’s too late. “There was little evidence that watching less television as an adult reduced the association between childhood television viewing and adult health.”

Insulin: lower price, higher demand

In January, the Inflation Reduction Act capped the price of insulin for Medicare beneficiaries at $35 a month. Will it make a difference? Turns out it already is.

The data are easy enough to find, so USC/University of Wisconsin researchers did just that. Since January, insulin fills among Medicare Part D patients has ticked up just under 1% a month. That’s a small percentage, obviously, but when you consider how many people take insulin, it’s more noticeable:

[T]he analysis suggests that Medicare beneficiaries filled about 50,000 more insulin prescriptions per month that were $35 or less, and about 20,000 of these fills would not have taken place if not for the policy.

Odd side note: The number of non-Medicare patients filling their insulin prescriptions fell during the same period, even when the out of pocket cost was $35 or lower.

Short Takes

Cigna in hot water over AI denials

AI is helping healthcare a lot, but there’s at least one area where it’s a problem: insurance claims. Cigna is facing a class action suit after a ProPublica investigation found that an AI was reviewing — and rejecting — claims “in a matter of seconds,” that physicians didn’t even bother to review.

Over two months last year, the company denied more than 300,000 claims, spending an average of 1.2 seconds on each claim, Propublica reported. While medical doctors signed off on the denials, the system didn’t require them to open patient medical records for the review.

Disease is purple

Please don’t let your political beliefs affect your judgement when it comes to your health. You can’t believe illness away.

Pfizer tornado not so bad

About the Pfizer plant hit by a tornado: Turns out it was the storage part of the plant that was in all the photos, not the production part.

“After an initial assessment, there does not appear to be any major damage to the medicine production areas.” […]

Most of the damage occurred at the site’s warehouse facility, which stores raw materials, packaging supplies and finished medicines awaiting release by quality assurance.

The company and the FDA don’t think there will be long term consequences, so it’s kind of the best possible outcome: A wakeup call to vulnerability without anyone getting hurt. This time.

Bill to help getting ahead of shortages

Speaking of drug shortages, the Senate Health, Energy, Labor, and Pensions committee has passed a bill that would give the FDA more power “to require manufacturers to notify them of potential product shortages outside the scope of a public health emergency.”

Under the bill, manufacturers, including those who produce over-the-counter drugs, would need to notify FDA within 10 business days of a potential shortage if circumstances, such as an increase in demand or export restrictions, would likely cause a shortfall in supply or a meaningful delay in the supply of a drug.

(There’s more to the bill (the Pandemic and All-Hazards Preparedness Act) than that, of course, but that’s by far the most interesting bit.)

Finding the dangerous drugs

If you think you’ve been seeing a lot of stories about artificial intelligence in medicine lately, you’re not wrong. We’ve reached the tipping point where there’s enough data for AIs to draw statistically relevant conclusions.

The latest example: Researchers at Mount Sinai have created an — you can call it an algorithm, an AI, or just a tool — that can “Better Predict Which Drugs May Cause Birth Defects.”

It does what AI does best: It found “previously unknown associations between genes, congenital disabilities, and drugs.” It’s kind of like discovering that Subaru drivers prefer sprinkles on their doughnuts. There’s undoubtedly a reason to be worked out, but for the moment what’s most important is the connection.

Specifically, the data included studies on genetic associations, drug- and preclinical-compound-induced gene expression changes in cell lines, known drug targets, genetic burden scores for human genes, and placental crossing scores for small molecule drugs.

That, they say, can eventually help determine which drugs are safe for moms-to-be and which aren’t — but right now it’s still just a research project.

Just think of them as Mystery Meals

On the one hand, you read about supposedly benign supplements having actual drugs in them. Here’s the flip side: Harvard Med researchers ordered 57 sports supplements each claiming to have “one of five botanical compounds with purported performance-enhancing properties.”

In a shock to no one — the industry is unregulated, after all — 40 out of the 57 (that’s 70%) “did not contain a detectable amount of the ingredient listed.” And just for fun, 12% had illegal additives.

FDA inspections have found that supplement manufacturers often fail to comply with basic manufacturing standards, such as establishing the identity, purity, or composition of the final product.”

Quick prostate cancer ID

Prostate cancer ranges from the slow moving, easier-to-treat variety, to the fast spreading kind where months or weeks can make a difference. It’s critical to know which a patient has.

That’s why it’s a big deal that Aussie researchers have found three biomarkers that can help pathologists differentiate the type of prostate cancer a patient has and how advanced it is.

The new biomarkers, when used together, will assist clinicians in determining which patients require immediate, radical treatment compared to those who need close monitoring.

They’re already in the process of developing a commercial test with Quest “You’ve probably heard of it” Diagnostics.

Bonus: They call it “lifesaving” but not once did anyone utter the phrase “game changing.”

Phages as snitches

So you probably know that bacteriophages are a potential weapon in the War on Germs™ — they’re virus killers that attack specific bacteria. That’s the issue, though: Phages are ultra-specific little buggers, so treating an infection means finding the phage that kills it^*.

Now Swiss researchers are trying the reverse. Or inverse. Converse? Anyway, they’re using phages to identify an infection — in this case a UTI — rather than treat it. They genetically modified phages that attack three different UTI bacteria so they “produce an easy-to-measure light signal.”

Using this method, the researchers were able to reliably detect the pathogenic bacteria directly from a urine sample in less than four hours. In the future, the method could make it possible to prescribe a suitable antibiotic immediately after diagnosis and thus minimize resistance development and improve antibiotic stewardship.

Bonus: If they want to use phages for treatment, they can tell by the strength of the light how well the patient is likely to respond.

^* Interestingly, the US Navy has one of the largest phage libraries in the world. 

You can have Captain Obvious’s Cheetos when you pry them from her cold, dead fingers

“Is Snacking Bad for Your Health? It Depends on What and When You Eat”

FTC cautions, PBMs ignore

In the Long Long Ago, the FTC made statements saying it opposed efforts to increase PBM transparency — competition, the agency said, would keep them in check. PBMs cite those statements today when they argue against oversight and regulation.

But on Thursday the agency said that times have changed, and it voted unanimously to rescind those statements. PBMs, it said, should no longer rely on FTC statements/guidance from a decade or two ago. Times have changed and the agency is taking a new look at PBMs.

For their part, the PBMs said they’re pretty much going to ignore this new advice. Yes, really.

“In the absence of further FTC guidance, the PCMA [Pharmaceutical Care Management Association] said it “will continue to cite previous FTC studies, statements, and enforcement actions that recognize the risks associated with proprietary pricing disclosure requirements….”

Our number-two story

Got a patient who buys Metamucil by the carton? You might want to suggest a visit to a neurologist. New research out of Harvard Medical School finds that “Constipation May Be a Marker for Dementia Risk.”

Researchers found that among more than 110,000 middle-aged and older U.S. adults, those who were chronically constipated — fewer than three bowel movements a week — also showed signs of an “older” brain.

That’s not to say that constipation causes Alzheimer’s. More likely (but still theoretical) is that problems with the gut biome cause both conditions.

We got through this entire item without a single inappropriate joke, even when the senior researcher’s name is Dong Wang.

Body building the brain

The body-builders’ supplement beta-hydroxy beta-methylbutyrate — aka HMB — might help treat Alzheimer’s. So report Rush University researchers who found that HMB helps stimulate the brain’s production of neurotrophic factors — proteins that are sorely lacking in Alzheimer’s patients.

“Our study found that after oral consumption, HMB enters into the brain to increase these beneficial proteins, restore neuronal connections and improve memory and learning in mice with Alzheimer’s-like pathology, such as plaques and tangles.”

At this point it’s only been tested in mice, but as HMB is considered safe even for long term use, human studies could be around the corner.

Track, trace … and secure

All eyes are on the drug supply chain these days. First off, the Drug Supply Chain Security Act — aka DSCSA aka track ’n’ trace — is supposed to come into effect later this year.

But with the pandemic, factory shutdowns, and Mother Nature wreaking havoc on manufacturing, the issue of making sure there actually is a supply chain is getting a lot more attention.

The latest: A bipartisan group of US senators wants to create a way to collect data on that supply chain. They’re proposing the “Mapping America’s Pharmaceutical Supply Act” so health officials can know what’s where, how much there is, and where it’s coming from.

It would require the Department of Health and Human Services (HHS) to catalog the origin of each drug, quantities available and the location of facilities used to manufacture them. It also would map inspections, recalls and import alerts.

Nobody, I mean nobody does logistics like the USA, so it makes sense to bring that expertise to the drug chain. Our prediction: We’re less than a decade away from the government manufacturing some of its own drugs to fill gaps of critical meds in the market.

CMS pauses Georgia’s Medicaid purge

Georgia is one of six states that CMS has told to stop removing people from Medicaid via “procedural terminations” — where someone is taken off the rolls for not filing paperwork.

Apparently database problems meant these states weren’t able to contact people the way the law requires. In Georgia, New Mexico, and South Carolina more than 90% of people removed from Medicaid were due to lack of paperwork rather than not being eligible, in part because the states couldn’t contact them.

CMS told the states to reenroll those people and fix their database problems so they can give residents the information they needed to complete the paperwork. All the states, the agency said, are on board and working with federal agencies to do just that.

Captain Obvious knows where that aisle is

“How to get vitamin D without spending too much time in the sun” — answer: Eat a balanced diet or take a supplement.

“Boron” rhymes with “moron”

The latest deeply stupid TikTok trend is — no joke — eating borax. The laundry booster. For health.

[S]ome have been claiming that consuming borax can help treat different things, ranging from joint pain to eye swelling to mouth swelling to menstrual cramps to even cancer.

Because, as one genius explained, “Boron, found in borax, is a mineral our body needs.” Fun fact: Cyanide contains carbon, something our bodies need too.

As Forbes’s Bruce Lee put it, “[U]nless you are a pair of dirty underwear, you should actually be limiting your direct exposure to borax as much as possible.”

Big Pfizer factor destroyed

Extreme weather courtesy of climate change just clobbered pharmacy in a big way, with a Pfizer manufacturing plant in North Carolina being damaged by an EF3 tornado. And not just any plant. This one makes — er, made — “nearly 25% of all sterile injectable medications used in U.S. hospitals.”

Erin Fox, senior pharmacy director at University of Utah Health, said the damage “will likely lead to long-term shortages while Pfizer works to either move production to other sites or rebuilds.”

This is what they mean by “damaged”:

If you thought there were drug shortage problems already, it’s about to get a lot worse. That part about Pfizer moving production? That could well mean that an existing plant is repurposed to provide more essential meds, meaning someone’s gonna have to decide what’s more important to produce.

Sidebar: Capitalism does a heck of a lot right, but it’s not perfect — something we’re seeing now as drug shortages continue to hit. So a health economist at USC explains “Why hundreds of decades-old yet vital drugs are nearly impossible to find.”

AIP members: Learn how to help diabetes patients help themselves

Are you interested in providing Diabetes Self-Management Education and Support (DSMES) in your community? If so, please join us on Tuesday, July 25 at 6:30 pm for a free informational webinar. Find out the benefits of DSMES and how easy it is to get started.

GPhA/AIP is working with the Georgia Department of Public Health to assist 10 pharmacies with DSMES accreditation.

DSMES is a program that helps patients with diabetes learn skills to take charge of their condition through healthy eating and lifestyle changes. Receiving diabetes education and support makes them better equipped to do that.

Unfortunately, participation is low. According to the CDC, fewer than 5% of Medicare beneficiaries with diabetes receive DSMES services. That means 95% are not getting the education and support they need. Even worse, 62% of rural counties don’t offer DSMES services.

That’s why Georgia needs you. Pharmacists are perfectly positioned to provide these services. You are accessible, knowledgeable, and trusted by your patients which means you can change behaviors resulting in better outcomes for your patients.

Step up to help your community, your patients, your practice, and your résumé.. Learn how to get started with DSMES.

Click here to register and get started!

Speaking of diabetes

If you have a hairless diabetic mouse, there’s a neat new invention in the works. It’s a “thin, invisible, and biodegradable patch” that changes color (well, under bright light) depending on blood glucose levels. The idea would be that the mouse — or a human user — would shine a smartphone flashlight onto the patch and an app would measure the light it emitted.

While that might seem a little clunky, keep in mind that this is still in development. How long do you think before someone comes up with a sensor that can read the patch directly?

What, you want something with more big science words? No problemo:

To measure glucose, the team chose a glucose fluorescent (GF) monomer composed of two parts. The first is a di-boronic acid, which binds to glucose in the interstitial fluid just underneath the skin. The other is a hydrophobic fluorescent molecule, which changes shape and emits fluorescence when glucose binds to the acid. When glucose binds to the GF monomer, the monomer absorbs blue light and emits red light.

TikTok bans semaglutide talk

The social media platform banned a whole bunch of accounts that were promoting weight-loss drugs like Ozempic and its kin. The logic: The platform’s terms of service bans “showing or promoting disordered eating or any dangerous weight loss behaviors,” which may include “compulsive exercise, and using potentially harmful medication or supplements.” It even prohibits ads for weight loss drugs.

Meanwhile, you can still try out various TikTok challenges, including ones that have you black yourself out with a scarf, shock yourself with an electric outlet, see how much Benadryl you can take, and snort condoms. Really.

A fluoride alternative

Using fluoride is the best way to prevent cavities, but there may be an alternative: hydroxyapatite, a mineral that’s already used in sensitive-teeth products but that’s never been tested on regular folks.

Until, that is, Polish researchers got involved. They conducted an 18-month study and found that “the patients using hydroxyapatite toothpaste were no more likely to develop cavities than the patients using fluoride.”

Why do we need an alternative? Mostly because little kids can swallow too much and get sick, so they tend to use less toothpaste and thus have less cavity protection.

Podcast of the week: The science podcast “Science Vs” did an episode on what really works to keep cavities away. Turns out the answer is fluoride, not even brushing —just getting fluoride onto your teeth by whatever means floats your boat prevents cavities. (But brushing and flossing are good for your gums.) Check it out here.

Espresso vs Alzheimer’s

If you’ve got a Petri dish full of tau protein tangles — you know, the stuff that starts a brain down the road to Alzheimer’s — here’s a neat trick: Italian researchers found that espresso (yes, espresso)…

…prevented tau protein clumps known as fibrils from forming long strands. This, in turn, prevented them from weaving themselves into the larger sheets that disrupt brain function.

It’s not just caffeine, although that helps. And it’s not just the caffeine and genistein (another compound in espresso). It’s the whole thing — “the full espresso extract had the biggest impact on tau.”

But you can’t just drink espresso and expec— wait, what?

Because many of the compounds in coffee can cross the blood-brain barrier, the researchers believe that simply drinking espresso might convey some of the same benefits seen in the study.