June 24, 2022 ✒ Andrew Kantor
The FDA has ordered Juul to pull all its e-cig products from the market. In short, in its product application, the company provided insufficient or contradictory evidence that its vaping products were safe. [T]here is insufficient evidence to assess the potential toxicological risks of using the JUUL products. There is also no way to know the potential harms from using other authorized or unauthorized third-party e-liquid pods with the JUUL device or using JUULpods with a non-JUUL device. “Retailers should contact Juul with any questions about products in their inventory,” said the agency. Earlier this month, a small health system in Virginia agreed to pay a $4.36 million civil settlement (and avoid criminal charges) because two employees had diverted a whole lotta drugs for a whole lotta time. It’s not the first. But the big takeaway here, as FDA Law Blog explains, is that the employer was liable for the actions of its employees because it didn’t do enough to prevent it*. While the two employees in this case devised separate and independent schemes to divert controlled substances, the common element was a lack of an effective corporate security program and monitoring of existing policies and procedures to prevent and detect diversion. (Emphasis ours.) For extra fun, read the article and see the list of “extraordinary compliance terms” the health system is required to implement. Normal flu shots aren’t good enough for older people, a CDC panel says. They need to get the better, stronger vaccine that will offer more protection for their frail, weakened immune systems. Options include: Fluzone High-Dose, Fluad with an immune booster, or Flublok which is made with insect cells instead of chicken eggs. Polio — remember polio? (Hopefully not.) Polio is back in Britain, where the virus was detected in London sewage. It’s the first time in 40 years the virus has appeared. There haven’t been any cases of the disease, but British health authorities are telling people to be sure they’re up to date with their shots. And that’s a good reason not to worry. Even if it comes to America, we’ve got a good, proven vaccine that everyone will be sure to take so the deadly, crippling disease doesn’t spread. Meningococcal diseases have appeared (including meningitis) — at least 26 cases and seven deaths. T-cells are our friends … unless we have heart failure. Then they get a little over-enthusiastic and cause inflammation, making that heart failure worse. “How?” you ask. By increasing the amount of a protein called estrogen receptor alpha. “So stop it,” you say. That might not be possible, but what is possible — found researchers at an Ohio State University — is a new molecule “that activates estrogen receptor beta, which is known to have an opposite effect of estrogen receptor alpha.” Activate the beta, they say, and heart failure stops. “With this drug, we may be able to significantly improve the lifespan of patients, and if we stop the disease at an early stage, patients may not even need a heart transplant.” The research was partially funded with tax dollars, but naturally OSU (also funded with tax dollars) has patented the drug. Maybe you want to get a little side training: Apparently acupuncture can relieve headaches. Not all, but according to a paper in the journal of the American Academy of Neurology, Neurology, it does seem to relieve tension-type headaches. The study was small (218 people), but it did compare “true” acupuncture with “superficial” acupuncture and found that… At the end of the study, 68% of the people receiving true acupuncture reported at least a 50% reduction in the monthly number of headache days compared to 50% of the people who received superficial acupuncture. When the The U.S. Preventive Services Task Force said, earlier this year, that healthy people don’t need to take low-dose aspirin, that confused stroke patients. The problem is that the headlines have sounded definitive (‘Stop taking aspirin if you don’t have heart problems’) but the reality is more subtle. Most importantly, “For those who’ve had a past stroke or heart attack, that medical history doesn’t just go away, even if it’s been a number of years.” In other words, once a stroke patient, always a stroke patient. So health experts are urging people to talk to their doctors, not just follow the headlines. If, like most people, you’ve woken up at 3:00 am worried about mugwort allergy, there’s potential good news coming down the pike: Viennese researchers have uncovered how the major mugwort pollen allergen triggers a response. Knowing how it works is “the basis for the development of a vaccine against mugwort allergy,” which will hopefully be in the works soon. Rest easy. Sunscreens wear off in a few hours when the avobenzone it’s based on is broken down by the very sunlight it protects you from. Hence the reminder to reapply it often. But now NYU materials chemists have created a new, better molecule — essentially avobenzone with a “support structure” called a dendrimer. We found that the supported avobenzone did not decompose when exposed to UV light over time, even after 24 hours—and you’re not on the beach for 24 hours! Our tests even showed that adding the dendrimer support not only eliminated decomposition but increased avobenzone activity over time. They’ve of course patented this molecule and are hoping to test it in a lotion soon. But will sunscreen companies rush to create a new product that consumers will use much less of? The good news: [T]he US is not overly dependent on one country for its broader supply of antibiotics, with Canada, India, Italy, and China supplying the bulk of demand. The bad news: [F]or individual antibiotics, China is the main source of the ingredients for penicillin and cephalosporin, which represent approximately two-thirds of the antibiotics used in the US each day. And thus, across both government an industry, “US frets over pharma supply chain security.”Heart-failure stopper, hope you didn’t have Juul stock, polio and meningitis reappear, and more
ICYMI: It’s over for Juul
If your employees divert, you’re gonna get hurt
* The employees did both go to prison, by the way.
Seniors need the hi-test flu vax
Outbreak Watch™
In Britain
In Florida
Your heart can go on
Acupuncture vs tension
Stroke patients: Don’t (necessarily) drop aspirin
The mugwort nightmare could be ending
All-day sunscreen?
The Long Read: Supply Chain Worries edition
June 24, 2022 ✒ Andrew Kantor
Giving kids azithromycin three times a week seems to help control asthma — at least, according to a small study (120 young ‘uns) out of India. [T]he numbers of children with well-controlled asthma according to Global Initiative for Asthma guidelines were 41 of 56 in the azithromycin group versus 10 of 56 in the control groups. Of course there are other issues with using azithromycin as a maintenance drug, but it certaintly seems like a useful avenue to explore. Diagnosing ADHD and various forms of autism isn’t simple — it doesn’t show up on a blood test. But now a group of ophthalmological and neurological researchers from Australia, Canada, and the UK have found a biomarker. Or think they have. The key is in the activity of the retina. Using the ‘electroretinogram’ (ERG) — a diagnostic test that measures the electrical activity of the retina in response to a light stimulus — researchers found that children with ADHD showed higher overall ERG energy, whereas children with ASD showed less ERG energy. This doesn’t just mean a faster diagnosis; they hope the finding itself will lead to other quick diagnoses for neurodevelopmental conditions. “Contraceptive use is primarily driven by demand for reproductive control” You want to attack a tumor, but it’s surrounded by a “thick, hard-to-penetrate wall of molecular defenses.” What can you do? It’s 2022, so you turn to nanoparticles and genetic engineering, of course, just like University of Texas Southwestern Medical Center researchers did. Their creation: a type of nanoparticle that can “break down the physical barriers around tumors to reach cancer cells.” Once inside, the nanoparticles release their payload: CRISPR/Cas9. Yep, they drill in, then edit the tumor’s genes to make is susceptible to the body’s immune system, Trojan-horse-style. So far it works in mice. “More work is needed,” of course. I was almost tempted to pass this along to Captain Obvious, but she’s busy today. So I’ll simply share this: Being attracted to men* increases your risk of an eating disorder, according to Spanish researchers. Regardless of sexuality, men place higher emphasis on the physical attractiveness of their romantic partners than women do, causing researchers to hypothesize that attraction to men may be a risk factor for disordered eating. A Sanofi-GSK bivalent Covid-19 vaccine (half original strain, half beta variant) just passed a late-stage trial, and it worked well against Omicron. Apparently Beta “expresses similar mutations across multiple variants of concern, including Omicron,” making it a good choice for a vaccine. In a trial involving 13,000 adults, the vaccine demonstrated an efficacy rate of 64.7% against symptomatic COVID, and 72% efficacy against infections specifically caused by the Omicron variant. It’s even better if you’ve had Covid already — 75% effective against symptomatic disease overall, and 93.2% against Omicron specifically. Maybe not forever (there’s always accident and disease), but turtles can effectively turn off senescence — cell death — when they feel there are ample resources available. Those shifty Danes discovered that, contrary to some theories, even after sexual maturity some animals can devote resources to cellular repair and live a long, long time. “Contrary to widespread theories of aging, we show that many species of turtles and tortoises have found a way to slow down or even completely switch off senescence. This means that senescence is not inevitable for all organisms.” Drilling into tumors, ADHD giveaway, immortal turtles, and more!
Helping kids with asthma
ADHD: See it in your eyes
Captain Obvious isn’t ready for kids
Drill, baby, drill
Don’t hate us because we’re beautiful
A new Covid vaccine is comin’
This weekend’s cool non-pharma science story
Turtles can choose to live longer
June 23, 2022 ✒ Andrew Kantor
Antibiotic-resistant bacteria apparently has a weakness: heat. Warm the little buggers to about 50°C (about 122 in °Freedom) and (say medical researchers at the University of Hong Kong) they’re susceptible to conventional drugs again. Rather than send patients to a Finnish sauna, though, they came up with a much slicker idea: They created a “microwave-responsive microsphere encapsulated with conventional antibiotics” — that is, a tiny capsule filled with drugs that pops when microwaved. The microwaves heat the bacteria and release the antibiotics at the same time. Cruel, unusual, and awesome. Shots for kids are coming to Georgia, but it’s taking time to get the vaccine distributed. If you want to get it, your county health department should be your first stop. If you want to see about giving it, you want to go to the DPH and be enrolled as a provider. Want to help reduce the symptoms of Parkinson’s? Fight. Well, box. Researchers at Rush University did a small study and found that… A three-month community-based boxing program significantly eased both motor and non-motor symptoms in adults with early Parkinson’s disease. By that they mean it didn’t just help with their motor skills, but also reduced “problems like depression, anxiety, sleep problems, pain, apathy and memory problems.” The FDA has begun the process of reducing the amount of nicotine in cigarettes. No specifics yet — it’s going to open public comment next May. This gives everyone plenty of time to wring their hands and explain why this is the best/the worst idea in the history of ideas. Existing wrist sensors (like those that monitor fertility) could be tricked out to warn someone that they’ve got Covid even before symptoms appear. Using a bit of artificial intelligence, an international research team led out of Lichtenstein found they could use skin temperature, heart rate, and breathing rate to identify subtle signs of infection. Why whip out the sphygmomanometer over and over to check your blood pressure, when a little patch’ll do ya? They call it a tattoo, but engineers in Texas have created a continuous monitoring wrist patch that measures the body’s electrical resistance, aka bioimpedance. A computer is able to correlate those readings with blood pressure and — presto! — cuff-less blood pressure monitoring. It looks like a pill, works like a balloon, and costs $100 a month: It’s Plenity, a hot new prescription weight-loss … er, treatment. Patients (users?) pop six capsules a day, which expand in the stomach — a result that’s “comparable to consuming a big salad before lunch and dinner.” Problems: It’s not covered by insurance, and results are mixed at best. (A trial found that Plenity users lost on average 6.4% of body weight, compared to 4.4% weight loss for those taking a placebo.) But for people who hate vegetables and have some extra cash, why not? The Atlantic would like you to know that “Squirrels Could Make Monkeypox a Forever Problem.” One lasting interspecies hop, akin to the one that SARS-CoV-2 has made into white-tailed deer, and monkeypox will be “with us forever” in the U.S.Nuking bacteria, boxing for Parkinson’s, BP tattoos, and more
Nuke the bacteria from inside
(it’s the only way to be sure)Covid vaccines for kids are here
Fighting Parkinson’s
A pending nicotine cut
Wearing your health on your sleeve
Covid alerts on your wrist
Tattoo you
It plumps when you swallow it!
The Long Read: Fear the Squirrels edition
June 22, 2022 ✒ Andrew Kantor
Stand on one leg. Go ahead — do it. Now hold it for 10 seconds. If you can’t, an international group of researchers has bad news for you: An inability to stand on one leg for 10 seconds in middle to later life is linked to a near doubling in the risk of death from any cause within the next 10 years. The most exciting phrase to hear in science, the one that heralds new discoveries, is not “Eureka!” but “That’s funny …” — Isaac Asimov “Patients with type 2 diabetes who received empagliflozin were almost 40% less likely to have a kidney stone than patients who received placebo” — that’s what a Yale endocrinology researcher discovered after analyzing the data from 15,000 empagliflozin-receiving patients. (Note: The article is just 900 words detailing how the data were collected.) Women are more likely to suffer from long Covid than men “and will experience substantially different symptoms.” [F]emale patients were far more likely to experience mood disorders such as depression, ear, nose, and throat symptoms, musculoskeletal pain, and respiratory symptoms. Male patients, on the other hand, were more likely to suffer from renal disorders—those that affect the kidneys. You might think your second (blech) Covid infection would be milder than the first, what with your immune system better trained. But you’d be wrong. Researchers in St. Louis found the opposite is true, based on records from the VA database. [C]ompared to people with first infection, people with reinfection exhibited increased risks of all-cause mortality, hospitalization, and several pre-specified outcomes. And lest you think vaccination status matters*: “The risks were evident in subgroups including those who were unvaccinated, had 1 shot, or 2 or more shots prior to the second infection.” Some people who took Paxlovid were getting ‘rebound’ symptoms — there were plenty of anecdotes, although no solid proof yet. But UC San Diego infectious disease specialists think they know why it happens: The dose was too low. [N]ot enough of the drug was getting to infected cells to stop all viral replication. They suggested this may be due to the drug being metabolized more quickly in some individuals or that the drug needs to be delivered over a longer treatment duration. In case you haven’t noticed, artificial intelligence/machine learning is becoming a Very Big Deal in medicine. Computers see relationships we mere humans would miss. Thus, thanks to well-trained AI, British researchers can diagnose Alzheimer’s with a single MRI, as opposed to the battery of tests currently done. The researchers […] divided the brain into 115 regions and allocated 660 different features, such as size, shape, and texture, to assess each region. They then trained the algorithm to identify where changes to these features could accurately predict the existence of Alzheimer’s disease. We meat-heads wouldn’t recognize that ‘smaller this + oval that + smoother the other thing’ means a chance of dementia, but the computer does — with 98 percent accuracy. And it can do it much sooner in the disease’s progression. “Compared to a surgical face mask, it is most likely that […] transparent masks would allow for the better perception of facial expressions.” Helpful image: If Medicare had bought its generic drugs from Mark Cuban’s Cost Plus Drug Company, rather than from drug makers, it could have saved $3.6 billion … just in 2020. [T]he lower drug prices from a direct-to-consumer model highlight the inefficiencies in the current generic pharmaceutical distribution and reimbursement system composed of wholesalers, middlemen called pharmacy benefit managers, pharmacies and insurers. If you want to know the actual effect of something on driving, where do you look? The insurance companies, of course. And that’s just what researchers at Temple University and the University of Arkansas did. They actually examined insurance premiums in areas where marijuana was legalized; higher accidents would lead to higher premiums. In fact, they said, “We find that the legalization of medical cannabis leads to a decrease in auto insurance premiums on average of $22 per policy per year.” Additionally, the team found that areas with relatively high drunk driving rates prior to the legalization of medical cannabis experienced large declines in their premiums following legalization. They estimate that policyholders in the states which legalized weed saved around $500 million in premiums.Long Covid is sexist, second Covid is worse, the standing-on-one-leg test, and more
Are you likely to die within 10 years?
Empagliflozin and kidney stones: That’s funny
Covid quickies
Sexism in long Covid
Once more, with worse feeling
* It does matter — it can keep you from getting sick in the first place. But if you’re unlucky enough to have two breakthroughs … ugh.
Too little (but not too late)
One-scan Alzheimer’s test
Captain Obvious can see clearly now

ICYMI: $3.6 billion here, $3.6 billion there — pretty soon you’re talking real money
Cannabis lowers insurance rates
June 21, 2022 ✒ Andrew Kantor
When a kid gets a tonsillectomy, there’s a simple way to reduce their pain (and narcotic use): celecoxib, aka Celebrex. It’s an NSAID, of course, but it only works so-so for adults. For kids, though, researchers at Children’s Hospital of Philadelphia found that jacking up the dose and combining it with acetaminophen cuts down the need for opioids, big time. The higher dose is the trick — it works because kids clear drugs out of their systems much faster. The result of their study was a 36% drop in oxycodone consumption and no adverse effects. And for the kids in prolonged pain, it cut opioids down even more. They were so happy with the result that celecoxib after tonsillectomy is now routine procedure at the hospital. Let’s say a kid needs a kidney transplant. How can you do that without putting him on immunosuppressants for the rest of his life? Duh! You transplant the immune system, too. That’s what physicians at Stanford have done in a process called “Hematopoietic Chimerism.” Or, to avoid big science words, a “dual immune/solid organ transplant.” The Stanford innovation removes the possibility that the recipient will experience immune rejection of their transplanted organ. […] The new procedure also rids recipients of the substantial side effects of a lifetime of immune-suppressing medications, including increased risks for cancer, diabetes, infections and high blood pressure. The big breakthrough was devising the procedure that makes the bone-marrow (i.e., immune system) donation safe — a process called “alpha-beta T cell depletion.” The new immune system is able to take hold within 60 to 90 days, after which the new kidney can be plugged in. Ever being proactive, the CDC has issued a helpful PDF guide to having sex with someone who may have monkeypox; it includes this tidbit: “Consider having sex with your clothes on or covering areas where rash or sores are present.” Um. Forbes’s Bruce Lee (no relation) reports. Exercise is good for you; that’s not news. What is interesting is that exercise can help fight pancreatic cancer by helping drugs work better. Researchers at NYU (and elsewhere) found that mice that exercised more showed “both an enhanced antitumor immune response and increased sensitivity to chemotherapy.” How? Dominos: 1) Aerobic exercise releases interleukin-15, a cytokine; 2) the interleukin-15 then activated cancer-fighting CD8 T-cells, then 3) those T-cells infiltrated the tumors, and that 4) let the chemotherapy/immunotherapy do its job better. Next up: Now that they’ve found the mechanism, they want to duplicate the effect with drugs — superagonists — for patients who can’t exercise. The FDA is warning people not to try to remove warts, skin tags, or other yucky bits by using some treatment they find at the truck stop. First of all, they don’t work (says the agency); secondly, they can be dangerous if they have a lot of salicylic acid*, leaving scars … or worse — what do you think happened to Voldemort? Also, what you think is a mole might be skin cancer. Best to have a professional look at it to be sure. A strain of gonorrhea that’s resistant to both azithromycin and ceftriaxone has appeared in Austria, in a man who likely got it in Cambodia. It’s the second time since 2018 that a super-duper strain of gonorrhea has appeared — one that is essentially untreatable with current drugs. (It does seem to respond to a couple of experimental antibiotics, though — lefamulin and zoliflodacin.) Gonorrhea keeps evolving, though, leading to the article’s subhed: “Should these strains ever start to spread widely, ‘many gonorrhea cases might become untreatable,’ researchers warn.” Sometimes you need to deliver drugs to someone’s eyeball. And that means — yes — sticking a needle into it. But needles leave holes, and holes can mean infection. And if you have to do repeated injections you risk deflating the eyeball … ugh. Enter Korean biomedical engineers, who have developed a “self-plugging microneedle” that’s coated with a drug. Once inserted, the coating degrades, the drug is released, and when withdrawn the puncture is sealed. (The degrading is important — that means you don’t need to position the needle as accurately, so there’s less risk of damaging the retina.) They provided this useful image: Caffeine is good for the economy. Why? Everyone’s favorite stimulant increases the amount of impulse buying you’ll do while shopping. That’s what marketing researchers led by the University of South Florida discovered. [S]hoppers who drank a cup of complimentary caffeinated coffee prior to roaming the stores spent about 50% more money and bought nearly 30% more items than shoppers who drank decaf or water. The buzz also changes what they buy: More caffeine, more non-essential items (e.g., scented candles and fragrances.) Needle in the eye, transplanting an immune system, CDC’s odd sex advice, and more
And don’t forget the ice cream
Transplants without drugs
We don’t have to take our clothes off
How exercise fights cancer
Tag should not be removed
* The agency helpfully explains that this is “a chemical.”
Monogamy has its benefits
Aieeeeeeeeeeee

Why you need to set up an espresso bar
June 18, 2022 ✒ Andrew Kantor
Robot drug delivery is getting closer and closer — not the “giant machine chasing you with a syringe” kind, but the “nanobots in your blood” kind. A cool step in that direction comes from a Stanford engineer whose latest “millirobot” is controlled by a magnetic field (not new, actually); it’s based on origami, so it can fold and unfold and do all sorts of tricks to not only make its way through the body, but collect and deposit cargo, i.e., drugs (this is new). Check it out, including the cool videos of a prototype in action. The connection between the gut biome and depression might be explained by proline, a non-essential amino acid that is produced by some gut bacteria. Low levels (say Spanish researchers) are linked to depression. Annnnd, that’s it. The details have yet to be figured out. The article takes 1,400 words to say basically the same thing (although, to be fair, it details and details and details how this was determined). There’s apparently a lot of inhaler overuse in asthma patients — that is, patients are relying on their SABA inhalers rather than taking their corticosteroids to prevent a problem in the first place. Part of the problem, say the British researchers who sussed this out, is that physicians are over-prescribing the inhalers. “Working with patients to improve regular use of preventative inhalers should be central to reducing asthma-related hospital admissions. The solution (or part of it) is getting those prescribers and the pharmacists who fill prescriptions to watch for ‘high-risk’ patients and work with them to focus on the ounce of prevention. The FDA has authorized Covid vaccines for the littlest kids. (Bonus, I found a news story that calls it a “game-changer.”) We live in a world where computers and computer models are good enough to be used to predict how drugs will work. In this case, biomedical engineers at an Ohio State University have used computer modeling to predict which drugs are most likely to treat a heart attack. They made a mathematical model to figure… … how certain immune cells like myocytes, neutrophils and macrophages — cells imperative to fighting infection and combating necrosis (toxic injury to the heart) — react to four different immunomodulatory drugs over a period of one month. The computer told them that “certain combinations of these drug inhibitors were more efficient at reducing inflammation than others.” That doesn’t mean do this, not that quite yet, but the fact that they can model these kinds of interactions means future drug discovery could be sped up. A lot. Wide-scale Covid testing for infection is over, and the new interest seems to be in testing for antibodies. The other day we reported on a rapid test for immunity, and now we’ve got another: using a home glucose meter to test for antibodies. The idea is to add a protein to the test — one that would react with Covid antibodies in a patient’s blood to produce glucose. A glucose meter would read this and — bam! — tell you if you’re immune. The trick was creating that protein, which Johns Hopkins and MIT researchers say they have. No clue how long before it might be available, though. It’s still not clear what causes Covid-like symptoms to persist months or potentially years after infection for millions of people. Microscopic blood clots? The virus persisting but hidden? “An immune system gone haywire”? Science magazine has a detailed look in “Clues to Long Covid.” All agree that solo operators are unlikely. Lingering virus, for example, could attack the circulatory system, triggering blood clots or chronic inflammation. There’s good news about being in the middle of an Omicron wave: A British study found that you’re half as likely to get long Covid from Omicron as from Delta.Why proline matters, origami drug robots, asthma users need a lesson, and more!
Robots in your blood
Saving you a click: depression and proline
Inhaler overuse
ICYMI: You get a vaccine! You get a vaccine! Everybody gets a vaccine!
Drug modeling, 21st century-style
Got protection? (2)
The Long Read: Long Covid Causes edition
And a long-Covid quickie
June 17, 2022 ✒ Andrew Kantor
Paraphrased from our friends at NCPA: The Senate Commerce Committee is scheduled to mark-up S. 4293, the Pharmacy Benefit Manager Transparency Act of 2022, on Wednesday June 22. It would prohibit several abusive PBM practices, and grant the FTC and state attorneys general the ability to penalize and/or initiate legal action against PBMs in the commercial health insurance market. (Here’s NCPA’s one-page PDF overview of 4293.) NCPA is asking pharmacists to reach out to members of the Senate Commerce Committee and urge — nay, demand — they support the bill. We’re lucky: Georgia has a guy on the commitee — Raphael Warnock. Call his office (770-694-7828), email him (senator@warnock.senate.gov), surprise him with a fax (770-953-2678), or use the contact form on his website. If that’s too much for you, NCPA has a one-click online tool. (But really, a personal message is best.) The universe giveth, and the universe taketh away. Giveth: Some people have gene variants that lowers their LDL cholesterol, as if they were taking statins. Taketh away: People who have those variants are at higher risk for cataracts. That’s what those shifty Danes found when looking at records of British people who had mutations of the HMGCR gene. Compared with non-carriers, carriers of these rare mutations were more than four-and-a-half times as likely to develop cataracts and over five times as likely to have cataract surgery. Allergan (now Abbvie) reports that its Qulipta* migraine med works a treat. It’s what a group of American and Spanish researchers found in a clinical trial done on behalf of the company. About 56 to 60% of people taking it had their migraine days cut in half. (While not even 30% of the poor sops who got placebos saw that kind of reduction.) And almost 8% got rid of migraines completely. Grain of salt: It comes from the company itself. Less salty: It appears to be part of the testing and approval process. The American Medical Association is the latest group to call on the FDA to make oral contraceptives available over the counter, sans age restriction. The American College of Obstetricians and Gynecologists made such a request back in 2019, and two smaller drug makers (Cadence Health and HRA Pharma) have indicated they’ll apply for OTC status. Elsewhere: It’s already available without a prescription in North Carolina. Long Covid could join the family — The family, that is, of “conditions people have to live with” ranging from acne and seasonal allergies to lactose intolerance and chronic pain. A bare minimum of 25 million Americans have some symptoms of long Covid, and there’s no telling how long they’ll last (the symptoms, that is), and what effect it will have on the healthcare system. But the Atlantic is always there with a glass-half-empty view: Indeed, if—as these numbers suggest—one in six Americans already has long COVID, then a tidal wave of suffering should be crashing down at this very moment, all around us. Bonus: It refers to long Covid as a “Mass Deterioration Event.” Walgreens has announced that it’s launching a “clinical trial business.” Not that it will be running trials — rather, it plans to help recruit under-represented groups to participate. It explains with a bit of obtuse marketing speak: With Walgreens patient reach and access to an extensive foundation of pharmacy and patient-authorized clinical data, the company can proactively match diverse patient populations to trials across a range of disease areas based on race, gender, socioeconomic status and location. What it means: We know who you are, we know what conditions you have, so we’re going to start recruiting you for trials. Legally, of course — the process is “compliant, validated and secure.” And this bit: [W]e can provide another offering for patients with complex or chronic conditions in their care journey*, while helping sponsors advance treatment options for the diverse communities we serve. What it means: We might be able to help patients find new treatments, but we’ll certainly get paid for finding test subjects. Monkeypox, the WHO says, might be transmitted by close contact — meaning really close contact. Closer. Closer. World Health Organization officials from the European region said they were investigating whether reports from Germany and Italy — which showed a small number of patients had monkeypox DNA in semen samples — mean the disease could be transmitted through sexual intercourse. The major takeaway is that even people without the signs of the pox (do we really need to remind you?) can be contagious. “Clean on the streets, poxy in the sheets.” Fingers crossed and wood knocked: So far there have been no deaths, just a lot of really disgusted people. If you chose the Kyrgyzstan square in the game of “Where Did the Black Death Originate?” congrats! German archaeogeneticists (!), spurred on by Scottish historians, found genetic evidence of a ‘precursor’ strain of Yersinia pestis in 10 graves in the Kyrgyzstan village of Kara-Djigach. (The Scot had noticed the dates on the graves — 1338 and 1339 CE — and that the person had died of “pestilence.” The Black Death hit Europe in 1347.) “[I]t’s really like the big bang . . . of plague that we have there; the strain that gave rise to the majority of strains that are circulating in the world today.”Walgreens’ interesting plans, Black Death starting point, the push for OTC birth control, and more
Let’s hold PBMs accountable
Genetics ups and downs
Migraine med works (says the company)
* If you can’t pronounce it — koo-LIP-ta? kwill-IP-ta? — just say “atogepant.”
OTC birth control?
Another fact of life
What Walgreens will be doing with patient data
* Really?
Monkeypox and sweet, sweet love

Cool non-pharma science story of the day: the Plague
June 16, 2022 ✒ Andrew Kantor
In case you were worried, you can in fact get a transfusion of red blood cells from women and — despite what you may have heard — not die. And no, it’s not an urban legend or Marjorie Taylor-Greene press release: There actually have been studies showing the sex of a red blood cell-donor might affect the recipient*. But now Swedish researchers have decided to be definitive, using the records of almost 370,000 patients. The result: No, neither the “sex or previous pregnancy of blood donors affects survival in patients who receive red blood cell transfusions.” The WHO is warning that Europe is looking at a serious outbreak, and it needs to “to boost surveillance, engage with at-risk communities and collaborate internationally to curb transmission.” (No such warning for the U.S. because there’s no point — it’s not like we’re about to listen to health advice that isn’t on TikTok. Plus, did you know that all the monkeypox cases in the U.S. are within 500 miles of a 5G tower? Coincidence?) There’s a good reason it’s not going to be given out like the Covid shot: It’s disgusting. If nothing else, it leaves an ugly scab* for a few days that needs to be covered because its contagious. And as any union organizer will tell you: When you have a scab, you picket. Are you or someone you know in your 40s? Congrats: That’s rock-bottom, at least in terms of sleep. So report the good folks at August University’s Medical College of Georgia, who found that “A graph of how long Americans sleep forms a U-shaped pattern across our lives, with age 40 being the low point and hours of sleep.” Sleep duration starts to increase again at about 50. A bit of good news: Sleep efficiency — that is, how much of sleepytime you actually sleep — remains stable from 30 to 60. It’s just that the actual time is lower in middle age. Pfizer’s antiviral has become the go-to Covid-19 drug to keep people out of the hospital, but it doesn’t do much for people at low risk of serious disease. The company is saying the antiviral doesn’t really do much for people who have breakthrough infections, or for “standard-risk patients.” In fact, it stopped enrollment in a clinical trial when it realized the pills weren’t helping. It’s not that Paxlovid isn’t good, it’s that it’s not better than doing nothing — at least in terms of preventing severe illness. The clinical trial previously flopped on its primary goal, showing the Pfizer antiviral was no better than placebo at sustaining symptom relief for four consecutive days. Now, the company is calling it quits on the study after finding it hard to read any signs of potential benefit because of an already low rate of hospitalization or death in the standard-risk population. So low-risk people don’t have a treatment, but chances are they don’t need one. At least one pharmacist — the dean of USC’s School of Pharmacy — argues “It’s time to let pharmacists prescribe Covid-fighting pills like Paxlovid.” Time is critical, he says, and “Patients aren’t getting them because not enough prescriptions are being written.” So you’ve done what you can about Covid, you aren’t worried about monkeypox, and you’re ready for quail hunting knowing that bird flu will make chicken more expensive. Time to take a break from viruses for a bit. Not so fast. UGA’s John Drake would like to share “What You Need To Know About The Outbreak Of Japanese Encephalitis In Australia.” You thought it just affected pigs? Mais non! “As of June 1, Japanese encephalitis had sickened over 40 people and killed 5 Australians who lived in different states.” “[O]fficials and industry experts are worried that widespread transmission in Australia could result in introduction to other parts of the world, including North America.” Aussie researchers had heard (anecdotally) that limited coffee consumption was safe, but they wanted to prove it genetically. Huh? It seems there are certain genes that increase your coffee consumption*. So rather than ask real pregnant women to change their habits— and rely on them to be trustworthy — they examined the maternity records of moms with those genes. Assuming the genes predicted their behavior, they found that “there was no greater risk of miscarriage, stillbirth or premature birth.” No: higher alcohol intake. (It’s first metabolic product, acetaldehyde, “stimulates oxidative stress, generates DNA adducts, and modifies related genes.”) Yes: Coffee, tea, milk, and yogurt — all of them seem to be protective of the liver for various reasons, according to the researchers at the Chinese University of Hong Kong who used data from 200,000 patients to come to these conclusions. The difference: Unlike previous studies, they say, this one actually shows causality, not just association. It’s a good kind of beer gut, guys! Well, technically a lager gut. A small study out of Portugal found that… “[H]ealthy men who drank one alcoholic or non-alcoholic lager daily developed a more diverse set of gut microbes, which is associated with a lower risk of chronic illnesses such as diabetes and cardiovascular disease. For those who don’t know, there are two types of beer: lager and ale. The stuff you buy from the corner gas station — Coors Light, Budweiser, Miller Lite, etc. — are lagers. So really, this could be titled, “Beer is good for your guts.” (I will not get into lager vs. IPA, though.) *Note: I take everything from the ACS with a grain of salt. In this case, I can’t tell who funded the study without paying for it — it might be Anheuser Busch for all I know.Beer belly benefits, the worst years of sleep, yet another viral outbreak, and more
The blood of women
* Women’s blood contains less hemoglobin.
Monkeypox news
Warning! Warning!
As for vaccination…
* It’s much worse, but I will spare you the description.
Middle-age sleep
Paxlovid has its limits
Remove the roadblock
Just when you thought you might relax a bit
Beverages-and-health news
Coffee is safe during pregnancy
* What, you thought it was a choice?
Liver cancer yeses and nos
Lager for your gut
June 15, 2022 ✒ Andrew Kantor
There’s a hidden danger in tapering someone off opioids. These days (for obvious reasons), prescribers are trying to cut back on painkillers, even for patients who have chronic pain. What they think: Tapering is tough at first, but after a few months of struggle patients adapt to a lower dose and the danger of a rebound overdose is gone. The reality: “[F]or most tapering patients, elevated risks of overdose and mental health crisis persist for up to two years after taper initiation.” (Emphasis ours.) This comes from a study out of UC Davis, that also found the higher the initial dose, the greater the risk of tapering. The options, they say, are either to skip tapering altogether, or to monitor patients closely — over the long term. Blame the patients (says a Swedish researcher) — too many of them think they have a penicillin allergy (which are rare), so dentists go broad-spectrum instead. Now you know. Is the pneumonia viral or bacterial? Half the time you can’t easily tell — antibiotics could help, or they could just be wasted (along with the patient’s time). Enter MIT engineers who’ve designed a sensor that can distinguish between viral and bacterial pneumonia infections … in mice, at least. The trick is not trying to identify the pathogen, but to pinpoint the body’s response. Viral and bacterial infections provoke distinctive types of immune responses, which include the activation of enzymes called proteases, which break down proteins. The MIT team found that the pattern of activity of those enzymes can serve as a signature of bacterial or viral infection. They have a collection of 20 sensors (yes, yes, of course they use nanotechnology) and which one ‘lights up’ tells them what’s doing the infecting. Right now the sensors are injected, but they hope to create a home-test strip at some point, once they know it works on humans. Is your vision getting worse? Good news! It might not be because you’re getting older — it might be a whole new disease! It’s so new it doesn’t even have a name yet; it was just discovered by researchers at the NIH’s National Eye Institute. It’s a new kind of macular dystrophy caused by a gene mutation, and (because it affects the macula) it leads to blurrier central vision. So if someone’s giving you the side-eye, you can say, “Did I do something wrong, or do you have a newly discovered variant of the TIMP3 gene?” “Sleep is not a priority for men: many losing sleep to play video games and drink alcohol” — per the American Academy of Sleep Medicine. Controlling asthma means taking your medication. But adherence can be a problem. There are tools to help, from apps and alarms to (if you have the means) hiring Judge Judy to crack you over the head if you forget. But what tools work best? British researchers wanted to find out by reviewing previous studies. They didn’t get a definitive conclusion, but they got an overall picture. The tools: smart inhalers, electronic adherence monitors (which rat you out to your provider), mobile apps, text-message reminders, and game-based approaches. What works: smart inhalers and text messages work best, although digital “interventions” in general can improve adherence by about 15%, and they can cut asthma attacks in half (well, 32% to 91%). The latest condition that enough vitamin D can help prevent: dementia. So say Aussie researchers in what they call a “world-first study” — it found that “low levels of vitamin D were associated with lower brain volumes and an increased risk of dementia and stroke” and that there’s “a causal effect of vitamin D deficiency and dementia.” And the correlation is a strong one, too: in some populations as much as 17 per cent of dementia cases might be prevented by increasing everyone to normal levels of vitamin D. When someone addicted to nicotine has a stroke, sometimes that addiction disappears. Learning why is teaching us a lot about how addiction — and the brain — work. “They Were Cigarette Smokers. Then a Stroke Vanquished Their Addiction.”Pneumonia picker, new eye disease (yay), why men don’t sleep, and more
The long taper
Why do dentists overuse antibiotics?
Picking the pneumonia
The eyes might have it (a new disease, that is)
Dragonlord Placidusax isn’t going to defeat himself
Electronic adherence
* Judge Judy™ and Judge Judy’s Gavel of Pain™ are trademarks of Judge Judy Enterprises International.
D is for dementia
The Long Read: This Is Your Brain on Addiction edition
June 14, 2022 ✒ Andrew Kantor
When it comes to vaccines, mouth-breathers might have something going. Canadian researchers have found that, when it comes to respiratory viruses, inhaled vaccines provide better protection than nasal sprays. (And, at least in some studies, nasal sprays outperformed injections.) “The immune response you generate when you deliver the vaccine deep into the lung is much stronger than when you only deposit that material in the nose and throat because of the anatomy and nature of the tissue and the immune cells that are available to respond are very different.” It’s safe to drink coffee after taking levothyroxine. People on the thyroid hormone replacement therapy have been told they need to take it on an empty stomach, but now the folks at Vertice Pharma (which makes the drug) say the absorption isn’t affected by a cuppa joe. Drink up. (This hasn’t been released as a study, but it was presented at the Atlanta meeting of the Endocrine Society. Almost as good, right?) When later-born generations get old, they have more chronic conditions than their parents and grandparents. In a way, that’s not a bad thing — there’s a good chance this is a result of them living longer thanks to access to better medical treatment. The flip side, though, is that those chronic conditions will need to be treated (and paid for). And as the Penn State/Texas State researchers point out, that will put a strain on the U.S. health system, which is already behind the rest of the developed world: [T]he past 30 years has seen population health in the U.S. fall behind that in other high-income countries, and our findings suggest that the U.S. is likely to continue to fall further behind our peers.” Have you lain awake at night wondering “But what happens if there’s a Hendra virus outbreak?”? Fear not: Researchers at an Ohio State University say they’ve developed a cocktail of four antibodies that can neutralize the newest variant of the Hendra virus, which appeared in Australia earlier this year. They also found that an existing vaccine candidate seemed to work against the new virus. Now get to sleep! PFAs are quickly becoming the CFCs of the 21st century. They’re in lots of stuff, and it’s becoming clear they do a lot of damage. The latest: Exposure to them can lead to hypertension in women. University of Michigan researchers found that the higher the exposure (and the more PFAs you’re exposed to) the greater the risk. Women with higher concentrations of specific PFAS were more likely to develop high blood pressure: women in the highest one-third concentrations of [list of specific PFAs] had 42%, 47% and 42% higher risks, respectively, of developing high blood pressure, compared to women in the lowest one-third concentrations of these PFAS. Women in the highest one-third concentrations of all seven PFAS examined had a 71% increased risk of developing high blood pressure. By journalism rule, every story about PFAs must immediately refer to them as “forever chemicals.” Buuuuut … UC Riverside researchers have found a way to destroy them: Iodide, sulfite, and UV light “destroys up to 90% of carbon-fluorine atoms in PFAS forever chemicals in just a few hours.” They call it “The Dip” “CDC director: Monkeypox may be tricky to diagnose” “It’s important to be aware that monkeypox cases may present similar to some sexually transmitted infections and could be mistaken for other diagnose.” Old news: Rapid tests for Covid-19. New news, courtesy of researchers at Mount Sinai: a rapid test to measure Covid immunity. (Well, sort of rapid — it takes 24 hours.) The test measures T-cell response, not the shorter-lived antibodies. It’s can help vulnerable individuals, but also measure vaccine effectiveness in an wider area — useful, especially as new variants emerge. (Link above goes to news story. Click here for the paper.) The title isn’t as interesting as the article itself: “Breaking The Rules Of Healthcare: Overpaying For Drugs That Underachieve.” Today’s “blockbuster” (or worse, “game-changer”) drugs aren’t nearly the Very Big Deals that manufacturers make them out to be. That’s because in the 1980s, deregulated drug companies switched from focusing on creating great drugs to creating safe and profitable drugs. The companies behind Aduhelm and Trodelvy have issued a combined total of 70 press releases (34 from Biogen and 36 from Gilead) about their respective flagship drugs. [N]either drug will have a meaningfully positive impact on the lives of people with Alzheimer’s or breast cancer. Why you’ll be sicker than your parents, benefits of inhaling, testing for immunity, and more
Vaccines: Do inhale
Good news for thyroid patients
Live long and prosper less
Ready for Hendra
PFA pressure
Good news: They aren’t necessarily forever

You would think the pustules would be a hint
Got protection?
The Long Read: Today’s Drugs edition