July 20, 2023 ✒ Andrew Kantor
Someday insulin will be inexpensive again, the way it was 100 years ago. But cheap meds still need expensive delivery systems for patients. But now Canadian engineers have potentially solved that little problem with an open source autoinjector that costs 1/10th the cost to make as commercial devices. Open source? It means they’ve designed plans that can be used with a 3-D printer, and they’re giving those plans away, including to companies that want to commercialize it. It’s not much to look at, but it’s a big deal. That’s great news for developing countries where, even if insulin is cheap, the pens can be too expensive for people or governments. But cutting the price from about $70 each to about $7, it becomes a lot more reasonable. And there’s no reason the tech couldn’t be used here — if it’s about $7 on a home printer, think how cheap it could be produced at scale. Would you recognize the signs of mental illness or substance abuse if they weren’t incredibly obvious? Face it: probably not. But catching those signs early is critical to getting patients on the right path. That’s why the Georgia Pharmacy Foundation is offering an important CE course: Mental Health First Aid. It’ll teach you to identify and respond to signs of mental illnesses and substance abuse sooner rather than later. The course: 5½ hours live training, plus 2 hours self study — a total of 7.5 hours of CPE credit for pharmacists and technicians. (You’re expected to complete the home study portion first.) The next date: Saturday, August 5, from 9:00 am – 3:30 pm at UGA’s campus in Tifton. GPhF is making this training available to pharmacists, pharmacy techs, and student pharmacists for just $49.00. (It’s normally $170.00.) In the US, even when a biosimilar is FDA approved it needs a second approval to be “interchangeable,” i.e., switchable by a pharmacist. In the EU, though, approval is approval, and now a bipartisan group of US senators wants to make that the case here. Said one senator: “The European Medicines Agency (EMA) has been approving biosimilars since 2006. In 2022, after analyzing more than fifteen years of data, the EMA stated that there is no evidence that switching between a biosimilar and its reference product increases the risk of immunogenicity.” If you were going to use one of your three wishes to eliminate mosquitoes and ticks from the Earth, hold off a second. Ticks may offer something useful. They have the ability to attach to their hosts and hang out there for a while without being detected — and that hints at a potential drug. Ticks are able to hide like that, Canadian researchers found, because they “have naturally evolved the ability to block chemokine-driven inflammation.” That ability comes from proteins in their saliva called A3 evasins, and the Canucks think they might be repurposed into a new kind of anti-inflammatory drug because they’ve got a distinct method of action. Then you can wish them off the face of the planet. They’re smarter than you think. The Biden administration said Covid vaccines will be free to the uninsured through the end of 2024. “The temporary program aims to fill the gaps after the federal government shifts Covid shots and treatments to the commercial market.” Based on hospital admissions and wastewater surveillance, it seems Covid is on the rise. Epidemiologists say this isn’t unexpected as new waves typically begin in the summer. At this point it’s more “That’s worth keeping an eye on” than “Oh, %$@& this again.” Emergency department visits for Covid at the national level were up 10.7% compared to the previous week, with Alaska, Florida, and Hawaii reporting percentages that were higher than other states. Also, test positivity at the national level was up slightly, by 0.7%, rising to 5.5% compared to the previous week. Yesterday we told you how a lot of people who think they have penicillin allergies were probably misdiagnosed. Turns out misdiagnosis overall is a bigger problem. Much bigger. A study out of Johns Hopkins found that “549,000 misdiagnoses lead to patients dying or becoming permanently disabled” every year — and that’s a conservative estimate. The big culprit is false negatives, and that makes sense; if you’re told you don’t have cancer you’re probably not likely to seek a second opinion. If that 549,000 figure doesn’t give you pause, how about this: “The overall average diagnosis error rate was estimated at 11.1%.” Yeah, more than 1 in 10 diagnoses is wrong. Doctors missing signs of stroke, sepsis, pneumonia, venous thromboembolism, and lung cancer make up almost 40% of those mistakes. The good news, the authors say, is that… “Just 15 diseases account for about half of all serious harms, so the problem may be more tractable than previously imagined.” The importance of tick spit, DIY autoinjector, what kills half a million Americans each year, and more
Making a cheaper autoinjector
Mental health: How to help
Smoothing the biosimilars path
Learning from ticks
Covid quickies
Free vax
Don’t you dare
Misdiagnosis is bigger than you think
July 19, 2023 ✒ Andrew Kantor
Most people who think they have penicillin allergies probably don’t, according to a new study out of Vanderbilt University Medical Center. It confirms what was until now limited evidence that a lot of people may have been diagnosed incorrectly as children. And by a lot, they mean a lot: “The majority of patients labeled as penicillin allergic, more than 90%, have low-risk histories, meaning they did not have a history to suggest a severe or more recent reaction to a penicillin. We would expect more than 95% of these patients to have negative testing and be able to take penicillin in the future.” That’s 95% of 90% of “penicillin-allergic” people who aren’t really allergic — patients who have been taking unnecessarily broad antibiotics. Takeaway: If someone was diagnosed as allergic as a kid by didn’t actually have a reaction to penicillin, it’s probably worth testing to be sure. Here’s a good reason to consider working more with patients and those newly authorized OTC hearing aids: Hearing better can help slow the effects of dementia. As the brain struggles to hear, scientists suspect, it might have less capacity for cognitive work like thinking or remembering. The brain shrinks faster when it absorbs less sound. Hearing loss can also lead to social isolation, leaving older folks less cognitively engaged. Of note: It seems to apply most to those who are at the highest risk of dementia, where “participants who wore a hearing aid had 48% less cognitive change after three years than those who didn’t.” Shameless plug: GPhA offers a home study CE course, “OTC Hearing Aids: How Pharmacists Can Support Safe Self-Care” — check it out at GPhA.org/hearingaids. Remember when drug companies promised to lower the price of insulin for the uninsured? Welp, it seems that it hasn’t actually happened yet. That’s what a report from Georgia Senator Reverend Raphael Warnock (as well as Sens. Richard Blumenthal and Elizabeth Warren) found when they had investigators call more than 300 pharmacies. The average cost of Lispro for uninsured patients was $97.51 — nearly four times higher than the $25 price cap set by Eli Lilly. In addition, 42 percent of the surveyed pharmacies did not have the lower-priced generic in stock. You’ve got baby teeth and adult teeth, and now Japanese researchers think they have a drug that can grow a third set of teeth. Their goal was to help people who have a genetic condition that prevents them from growing a full set of teeth (anodontia, if you feel like searching) but they think it could also be used for people who lose their teeth other ways, such as disease … or picking a fight with the guy who tattooed his own face. In short, their experimental drug deactivates a gene that creates a protein that limits tooth growth. “In other words, blocking the action of that protein could allow more teeth to grow.” They’re hoping to start human trials next year. “[W]e’re hoping to see a time when tooth-regrowth medicine is a third choice alongside dentures and implants.” (Bonus: includes the phrase “game-changer.”) If someone believes a placebo is actually a medication, there’s a good chance it will work for them. But if they think it’s “personalized to their genetic makeup and physiology,” it could work even better. So reported Canadian researchers in a new paper. Fun fact: The effect was even stronger for those who valued their individuality and had a high score on a personality trait called need for uniqueness. And here’s the backflip: It could mean that real personalized medical treatments work better not just because they’re actually tailored to an individaul, but “that psychological factors may also potentially play a role in their effectiveness.” This one comes from Eli Lilly, which is planning to submit it for FDA approval. Called donanemab, it “was shown to be 35% effective at slowing the rate of the disease, and 60% effective in early stage patients.” Why yes, someone did call it a “game-changer.” There is a potential downside, though: “Nearly 37% of donanemab patients experienced brain swelling or bleeding.” The FDA has approved the monoclonal antibody vaccine Beyfortus for newborns and infants “born during or entering their first RSV season, and for children up to 24 months of age who are vulnerable to severe RSV through their second RSV season.” “Fewer children around the world missed receiving routine vaccinations in 2022 compared to the year before, indicating a rebound in childhood immunizations following the Covid-19 pandemic.” A med for new teeth, penicillin allergies overblown, the power of personal placebos, and more
The odds against penicillin allergies
Why to pay attention to hearing aids
Promises, promises
The teeth are out there
A better … placebo?
The next next Alzheimer’s drug
Short Takes
RSV vax approved for babies
Vaccination rates are improving
July 18, 2023 ✒ Andrew Kantor
A new and big study found that cytisinicline (the chemical formerly known as cytisine) is an excellent drug to help smokers become non-smokers. This is a Pretty Big Deal because there hasn’t been a new smoking-cessation drug in 20 years. Actually it’s not really new, as it’s been used in deepest, darkest Eastern Europe for years for this very purpose. But there wasn’t much formal research until now. (In fact, “the dose in Europe is 1.5 mg six times per day for 25 days. However, there is no known scientific basis for this dosage.”) Regardless of the details, it works. Cytisine reduces nicotine cravings and withdrawal by binding to the same brain receptors as nicotine, acting as a partial agonist and reducing withdrawal symptoms and nicotine cravings. How good is it? About 20% of the people taking it for 12 weeks remained smoke-free after 24 weeks, and once you go that long without a hit, your odds of quitting altogether go way up. There was a story in the Atlanta Journal-Constitution the other day, “Legislators, activists continue push to regulate drug pricing middlemen,” all about the building fight against PBMs. It’s got plenty of info for laypeople about how PBMs work, why they’re making the healthcare system worse, and who’s looking to put the brakes on them. The important bit: GPhA worked behind the scenes, including an interview with the writer. We’re working hard to fight the long-term battles to protect your profession — and that includes getting the word out. And we’re happy to do it! Instead of a knee-jerk reaction to drug price negotiations, it’s worth looking at the actual cost of those drugs — that’s cash out of your pockets and mine, after all. In 2021, Medicare Part D covered about 3,500 drugs and spent about $48 billion. Of those 3,500 meds, just 10 of them accounted for 22% of that spending. That’s like finding out your space heater — Ol’ Sparky — is responsible for a quarter of your electric bill. It’s actually worse: One drug, Eliquis, accounted for 6% of all Part D spending. Medicare will soon be able to negotiate the prices of a whopping 10 out of those 3,500 drugs. Eliquis may be one. Something to keep in mind. “Harvard Medical faces another lawsuit over stolen body parts.” Do you want to live forever? Do you want to learn how to fly (high)? Harvard Medical School researchers just made a breakthrough you’ll want to take note of: They found a way to reverse cellular aging, but with chemistry rather than gene editing. The abstract from the paper was refreshingly clear: We identify six chemical cocktails, which, in less than a week and without compromising cellular identity, restore a youthful genome-wide transcript profile and reverse transcriptomic age. Thus, rejuvenation by age reversal can be achieved, not only by genetic, but also chemical means. And because it’s a chemical, i.e., a drug, this “offers the potential for lower costs and shorter timelines in development.” They’re already looking toward human trials, meaning this isn’t just in a Petri dish. Alzheimer’s experts are proposing a new eight-stage scale for rating how far along someone is with the disease. It goes from Stage 0 (asymptomatic but with abnormal biomarkers) to various levels of cognitive decline, with Stage 3 “roughly equivalent to the current presymptomatic stage known as mild cognitive impairment.” With new treatments coming out, they think it’s time for a more granular and objective scale than something like “moderate impairment.” Sure, the fact that America is about to get its first over-the-counter birth control pill. But, in a rare moment of positivity, the Atlantic explains that Opill is a lot more. Americans will also be able to grab an over-the-counter treatment for their heavy periods, cramps, headaches, and even migraines; they’ll have prescription-free access to a drug for endometriosis and polycystic ovary syndrome; and they’ll be able to buy a medication that can mitigate the symptoms of menopause. It’s all in the same, progestin-based pill.Stolen body parts, age-reversing drug, a new scale for dementia, and more
A new smoking cessation drug
Quietly at work
There’s a middle ground somewhere
Captain Obvious hands the mic to Lieutenant What the Heck
Drug cocktails reverse aging
Short Takes
New Alzheimer’s rating system
Opill does more
July 15, 2023 ✒ Andrew Kantor
To help ease the shortage of cancer drugs, the FDA said it will allow “10 additional lots of the common cancer drug cisplatin to be distributed by the Chinese company Qilu Pharmaceutical.” Technically, these lots are not FDA approved, but ‘needs must’ and all that. The shortage is also partly due to drug manufacturers lacking an incentive to invest in generic drugs, which have smaller profit margins. This has lead to a limited number of generic facilities operating at near-capacity levels. So a big portion of the Johnson & Johnson talcum powder/cancer connection is based testimony from four doctors who said they examined 75 people with malignant mesothelioma — people who claimed they weren’t exposed to anything that might have caused mesothelioma except baby powder. Now J&J is suing those doctors, claiming that not only was their testimony false — at least some of those people were exposed to asbestos in other ways — but that those doctors were involved in gaming the system for personal gain. According to the suit… “They publish their junk litigation opinions in scientific journals. They use their credentials to instill their publications with false credibility. They then build from that fraudulent foundation by citing to each other’s work.” GPhA member extraordinaire Ira Katz is on television once again, this time talking to Atlanta’s channel 11 about the coming OTC birth control pills. Having XX or XY chromosomes doesn’t just give you a different perspective on how to properly load a dishwasher. Scientists are learning “how sex chromosomes and hormones affect people’s risk for certain diseases — and whether the biology behind those differences can be harnessed to improve treatments.” That’s because, as always when it comes to genetics, genes often do double-, triple-, or even more-ple duty, leading to unexpected differences and explaining facts like “Men are more likely to develop severe Covid, but emerging evidence suggests long Covid is more common among women.” If you’re still paying off a student loan, the Biden administration has good news for you. The Supreme Court may have nixed its plan for broader loan forgiveness, but Biden & Co. has another idea that doesn’t involve Congress — but it (currently) would only affect people who have been paying back loans for 20 to 25 years. But it could take effect quickly. Dentists, apparently, can have a habit of overprescribing antibiotics, and at this point we all know why that’s a bad idea. Who can help cut down unnecessary prescriptions? If you said “An angry mob with torches and pitchforks,” you’re technically correct, but obviously we’re talking about pharmacists. Japan has an official program to reduce antimicrobial use, and researchers there wanted to see what effect a pharmacist-led program would have on dental prescriptions. It included “post-prescription feedback” along with a push to use penicillin instead of broader-range antibiotics, and “an educational program for dental students.” They tried this for 7 years and reviewed the results. Not surprisingly, it worked: Penicillin scripts were up and broad-spectrum antimicrobial scripts declined. No pitchforks needed. A two-drug combo for treating melanoma turns out to work on a rare type of brain cancer called papillary craniopharyngioma. The drugs — vemurafenib and cobimetinib, both marketed by Genentech — turned out to be incredibly effective, and tumors shrank by over 90% on average. Covid booster shots should be available by late September according to HHS, which is working with Moderna, Novavax , and Pfizer to make sure those XBB-specific vaccines “will remain available in the types of locations where the public currently receives them.” While these vaccines have moved to the private market (i.e., it’s up to individual insurers to pay for them, or for patients to pay out of pocket), the government will still pay for uninsured children to be vaccinated.J&J targets witnesses, when sex affects disease, FDA allowing unapproved cancer meds, and more
Coming soon from Prol-E-Fine Pharmaceuticals….
J&J sues docs for “junk litigation opinions”
Shout out to Ira
The Long Read: Sex, meds, and rock and roll
Attention 1998–2003 grads
Keeping dental antibiotics down
Short Takes
Unexpected brain cancer treatment
September boost
Do something nice this weekend
July 14, 2023 ✒ Andrew Kantor
The FDA has approved the Pill — specifically Perrigo’s Opill — for over the counter sale in the US. There is no age restriction, and pricing hasn’t been set; it’s expected to be on shelves by early next year. If you’re like a lot of practitioners, you’ve treated wounds with either honey or acetic acid (probably by using vinegar). But, found British microbiologists, it’s the combination of honey and vinegar that gives the best chance of curing a wound. By comparing the use of vinegar and acetic acid alone, then in combination with medical-grade honey, the researchers found that it was specifically the combination of the two substances which was best. “When we put these low doses together, we saw a large number of bacteria dying which is really exciting,” said the lead researchers. Oh, and pure acetic acid isn’t the way to go; you want vinegar — and pomegranate vinegar seemed to be the most promising. Surprisingly, not everyone likes the idea of getting a needle stuck in their eye, even if it’s to treat retinal vein occlusion, a not-that-uncommon eye disease. As an alternative, Columbia researchers have developed an eye drop that — at least in the lab — works just as well to reduce the swelling in the veins that cause the disease. The eye drops contain an experimental drug that blocks caspase-9, an enzyme that triggers cell death, and was found by Troy’s lab to be overactive in blood vessels injured by RVO. Next up: prepping for human trials. A phase-3 trial of insulin icodec, a once-weekly form of insulin for people with type 2 diabetes, found that it’s safe and effective “and helped them maintain healthy blood sugar levels better than insulin injected daily.” This is one of five phase-3 trials of the drug, each testing a slightly different use case. So far they’ve all shown the same ‘safe and effective’ results. Bonus: Includes our favorite phrase, “game-changing.” Normally you can count on either inflammation or gut bacteria to account for medical issues, but UC San Diego researchers found what they think is an important exception: Gulf War Illness. Formerly thought to have been an inflammation issue, the UCSD folks “suggest that impaired mitochondrial function, and not inflammation, is the main driver of GWI symptoms and should be the primary target of future clinical interventions.” “Inflammation does appear to be linked to GWI, but our work suggests that it’s actually a side effect of the primary issue, which is impaired cell energy.” Novartis has been accused by the UK’s Prescription Medicines Code of Practice Authority of ‘bringing discredit upon the pharma industry’ for providing misleading information about Entresto on its website. It’s not clear what the penalty will be, but dessert is clearly out of the question. How’s your cybersecurity? More specifically, if you were hit with an attack, could you handle it? If you think you’re not a target, you’re not thinking like a hacker. They don’t go after specific targets — they’ve got bots out there searching for any system that’s vulnerable, and healthcare is a juicy one to find. HCA Healthcare is one of the latest victims, with 11 million patient records being exposed. But don’t worry! The data breach was limited to patient names, addresses, telephone numbers, emails, dates of birth, gender, treatment locations, treatment dates, and next appointment dates. “There has been no disruption to the care and services HCA Healthcare provides.” So maybe chat with your data provider … and be sure you have insurance coverage. oi After a pretty rough flu season in the southern hemisphere — including a surprising number of younger people (5–16) being hospitalized — rates there are dropping. But that bad start doesn’t bode well for us this fall. Of note, all but one of the hospitalized kids had not been vaccinated. Weekly insulin gets one step closer, eye-needle alternative, why honey needs vinegar, and more
On the off chance you missed this…
Sweet and sour wound treatment
An eye drop instead of a needle
Weekly insulin aces its trial
A different culprit for Gulf War Illness
You have shamed our family!
Cybersecurity: This is not an ad, even if it sounds like one
Southern flu update
July 13, 2023 ✒ Andrew Kantor
How bad someone’s joint pain is could be dependent on which state they live in. That may seem odd, but it’s because of the breadth of each’s states social programs. “The risk of joint pain is over three times higher in some states compared to others, with states in the South, especially the lower Mississippi Valley and southern Appalachia, having particularly high prevalence of joint pain.” Essentially, found the University at Buffalo researchers who did the study, the better the social safety net for the poor, the less chronic pain overall — and it’s not just about medical care. Different states can have dramatically different policies that affect many aspects of life including opportunities, resources, and social relationships, which can in turn influence individuals’ pain. Food insecurity, for example, increases stress levels and thus inflammation … and pain. That makes working harder, leading to lower wages and a downward spiral that ends up costing everyone more. The EU is looking into reports that about 150 people have attempted suicide or self-harm after using one of the hot new GLP-1 inhibiting weight loss drugs (semaglutide or liraglutide). They don’t know that there’s a link — it might be underlying conditions — but there’s enough of whatever it is to be worth a look-see. The idea that gum disease and dementia are linked isn’t new, but now researchers at the Forsyth Institute have figured out that yes, periodontal disease can lead to Alzheimer’s — and they know how. In short, bacteria from gum disease can make its way to the brain, where it prevents microglial cells from doing their cleanup job. [W]hen exposed to oral bacteria the microglial cells became overstimulated and ate too much. “They basically became obese. They no longer could digest plaque formations.” A new CDC study found that not only does Covid-19 spread in white-tailed deer, it can go from deer to humans and back, increasing the risk of the virus mutating into yet another strain we’ll have to deal with. Yet another study confirms that the magical powers of coffee are about more than just caffeine. This time, Portuguese researchers scanned the brains of people who drank coffee and who drank caffeinated water. Caffeine alone, they found, caused a “readiness to transition from a state of rest to engaging in task-related activities.” However, drinking a cup of coffee also boosted connectivity in the higher visual network and the right executive control network, which are linked to working memory, cognitive control, and goal-directed behavior ― something that did not occur from drinking caffeinated water. It cost more than $6,000 to pay for the average American’s healthcare in 2021, up 24% from 2017. Sure, you might say, there was a pandemic in 2021! Good point. But the folks at the Health Care Cost Institute who crunched the numbers found that sure, “service use” was up 14%, but prices went up 9%. Why? It ain’t just inflation. Market consolidation and less competition — plus private equity firms getting into the game — are a big part. Who’s paying? Per the AMA, patients’ out-of-pocket costs are a bit more than 10%, while private insurance pays 28.5% and Medicare/Medicaid pays 38.4%.Semaglutide self-harm? Plus the states of pain, why coffee beats caffeine, and more
Why pain varies by state
Can semaglutide lead to suicide?
How gum disease can cause Alzheimer’s
Deer me (or, rather, don’t)
It’s the coffee
Health spending’s a-rising
July 12, 2023 ✒ Andrew Kantor
At this point, we might have to accept that people who get health advice from social media deserve what happens next. The latest: Did you know that the sun isn’t dangerous, and that the whole skin cancer/premature aging hoax is part of a conspiracy to sell more products? Mm hmm. Thousands of researchers and dermatologists around the world are in on it. That’s the logic being peddled by people who are, it seems, trying to influence the spread of skin cancer, like one chucklehead calling himself “Tan Man”… … who encourages tanning without sunscreen because he believes the product is “bad for the skin” and the environment, claiming the skin is meant to “absorb the full unadulterated power of the sun’s rays.” Another member of the brain trust says you don’t need sunscreen — just get lots of vitamin D “because the vitamin makes it ‘almost impossible to develop an autoimmune disease’.” When you sow the sun, you reap the melanoma. The White House has a plan to address the dangers of xylazine in street drugs. And the plan is … to come up with plans. Specifically, six plans to tackle six areas: testing, research, data collection, supply disruption, treatment, and harm reduction. But seriously, parts of the plan of plans include developing a naloxone-like antidote, considering rescheduling xylazine as a controlled substance, designating a specific diagnostic code to track deaths, and possibly working to legalize test strips*. The goal is to cut deaths by 15% within 2 years. * That’s right — we warn people about xylazine in drugs, but make it illegal for them to test for it. A molecule found in the dahlia plant, butein, can help stabilize blood sugar levels, according to Kiwi researchers. They already believed that butein by itself might do that, but when they looked at using the dahlia plant to get it, they found the improved glucose tolerance “was not mediated by butein alone but by butein combined with the closely related flavonoids, sulfuretin and/or isoliquiritigenin,” which happen to be in the flower. All this was in pre-clinical trials, but they’ve already started the process “to bring a natural dahlia-extract supplement to the market.” Make of that what you will. Can vitamin D help prevent heart problems? Maybe. An Aussie study hinted that “vitamin D supplements may reduce the risk of cardiovascular events such as heart attacks in people aged over 60,” but “The researchers emphasised that the findings are not conclusive.” That’s an understatement. Try to make sense of this logic-twisting quote: “While previous randomised controlled trials have not found that taking supplements is beneficial for this outcome, the findings of the D-Health Trial suggests it is premature to say vitamin D supplementation does not alter the risk.” The global shortage of semaglutide continues, with the UK’s health department now recommending that no new patients start on the drug, which is in shortage all over the place — even in Canada. That said, an analysis of claims by PBM Prime Therapeutics found that it may just be a matter of waiting a bit, as “Most patients using weight-loss drugs like Wegovy stop within a year.” (It might be due to side effects or cost; the company was only looking at records, so it doesn’t know for sure.) Because we don’t really need one. When seven of your 40 patients die and five others develop respiratory issues. (Although the company claims that “11 of the 12 events, including six of the seven deaths, were assessed as unlikely or unrelated to the study drug.”)How the Ozempic shortage could end, plus brain-dead influencers, the power of dahlias, and more
Some men just want to watch the world burn
… and they have a plan
Dahlia vs diabetes
Today’s non-story story
Semaglutide problem … and possible solution
Short Takes
Why isn’t a malaria vaccine available in the US?
When is it time to stop a study?
July 11, 2023 ✒ Andrew Kantor
Here’s an odd side effect of hormonal birth control pills: Being social doesn’t reduce stress. Normally, a bit of social activity (board games and singing songs, in this case) lowers the levels of the stress hormone ACTH in women. But when they did blood tests, a group of those shifty Danes working with US researchers found a big caveat: The study showed that 15 minutes of social activity after having a blood sample taken lowers stress hormone levels in women who are not on the birth-control pill. In contrast, women who are on birth-control pills do not experience any reduction of their ACTH levels. It might be due to the pills suppressing progesterone production, but they’re still working on the details. They also found that the effect of social activity on stress depends on where in their menstrual cycles the women were. Georgia (and every state) will be paying more for child-vaccination programs, as federal funds were reduced as part of the 2023 debt-ceiling deal; cutting vaccines for kids apparently seemed like a good idea. The CDC’s nationwide $680 million federal immunization grant is drying up, which will mean about a 10% cut in aid to states. A spokesperson for the Georgia Department of Public Health, Nancy Nydam, acknowledged that a funding cut for child immunizations was coming but said the agency hadn’t received additional details as of Monday afternoon. The CDC isn’t happy about it because unvaccinated kids are more likely to get sick — and that will require bigger spending down the road. “There will be no easy solution for this,” the agency wrote. “We know that this change will require some tough decisions.” Did you know that the ingredients in acetaminophen and ibuprofen are made from crude oil? Uh-huh. And with sustainability and, you know, not screwing up the Earth any more on a lot of company’s minds, British researchers have “developed a new method to make precursor materials for these drugs from renewable sources.” Those sources? Pine trees. Which is a lot better than saying “a chemical called beta-pinene, which is a component of turpentine.” The good thing is that it’s left over from paper manufacturing. And let’s say you don’t care about sustainability one way or the other. Getting away from oil-based production also means avoiding the price fluctuations oil is subject to every time Vladimir Putin sees something he wants. States are slowly but surely choosing who will decide how to spend their share of the Big Opioid Settlements, with a lot of juggling. Will the decision-making boards represent the right people geographically, demographically, and needs wise? Will there be too many law enforcement reps? Too many from cities? Too many from a particular specialty? Not enough racial diversity? Members run the gamut from doctors, researchers, and county health directors to law enforcement officers, town managers, and business owners, as well as people in recovery and parents who’ve lost children to addiction. Georgia’s board will consist of eight members: four appointed by the governor (plus a non-voting chair) and four chosen by local governments. Like many of the states’ boards, Georgia’s is advisory only; it doesn’t have decision-making power. So far only the governor’s reps have been chosen: Guess which country — thanks to a whole lot of “fur-farming, the exotic pet trade, hunting and trapping, industrial animal agriculture, backyard chicken production, roadside zoos, and more” combined with lax regulations — is a prime location for the emergence of the next zoonotic pandemic? You got it (assuming you figured out it was the USA). All of the animal industries the report examines are far less regulated than they should be and far less than the public believes they currently are. Today, wide regulatory gaps exist through which pathogens can spillover and spread, leaving the public constantly vulnerable to zoonotic disease. An artificial life form created at Indiana University — essentially cells with the absolute minimum amount of DNA needed to survive — is evolving despite “no wiggle room for mutations”. It really shouldn’t be able to. “It appears there’s something about life that’s really robust. We can simplify it down to just the bare essentials, but that doesn’t stop evolution from going to work.”Petroleum-free painkillers, birth control stress, life finds a way, and more
It’s harder to relax on the Pill
Child vax program cuts coming soon
Paper (well, pine) production for painkiller pills
Who holds the settlement wallet
Short Takes
The potential for a homegrown pandemic
Gonna have an evolution
July 08, 2023 ✒ Andrew Kantor
Did you know that Merck found making Keytruda in the microgravity of Earth orbit made the drug more stable? That the space-built version could be given by a shot instead of infusion? Now you know. With the concept proven, a startup called Varda Space Industries has launched a test of the first space-based drug factory. During the satellite’s first week in space, Varda will focus on testing its systems to make sure everything works as hoped. The second week will be dedicated to heating and cooling the old HIV-AIDS drug ritonavir repeatedly to study how its particles crystalize in microgravity. It will return to Earth in about a month so the Vardians can see how well it performed and prepare to create a working factory. Cipla is recalling 6 batches of albuterol because of a leak found in an inhaler. Check its press release (PDF) for the list of batch numbers. You know how a drug is approved to treat one condition, then gets approved to treat more? Turns out that it’s less effective for each new condition it’s approved for. In a commentary about the research the found this, the head of the Institute for Quality and Efficiency in Health Care’s drug assessment department pointed out that, even though a drug’s added value declines, “the pharmaceutical industry often succeeds in obtaining such supplemental indications to optimize resource use and extend the period of patent protection for its drugs.” Perhaps, she suggests, we should focus more on whether an indication is better rather than just new: “The system’s current performance does not meet the expectations of patients and the public, clinicians, or policy makers.” It turns out that a lot of people didn’t gargle or drink bleach to prevent Covid — but they said they did. Back in 2020, a CDC survey found that 4% of people claimed “they were drinking or gargling diluted bleach to prevent a Covid-19 infection.” It was believable because it seems logical that 4% of people are imbeciles. But a follow-up study found a large number of “problematic respondents.” So how did they know these folks were less than truthful? “[W]e also observed that 3–7% of respondents reported having never used the Internet while taking the survey online and having suffered a fatal heart attack.” Yeah, a fatal heart attack tends to make it harder to answer surveys. Those shifty Danes at Novo Nordisk are suing more compounding pharmacies, this time in Florida and Tennessee. Claim: The pharmacies aren’t allowed to create compounded versions of Ozempic and Wegovy. Reality: FDA rules say that compounding is permitted for drugs in shortage, as semaglutide is. Claim: The FDA hasn’t approved these compounding medications. Reality: The FDA doesn’t approve compounded products, just their active ingredients. Semaglutide is FDA-approved. Claim: “[T]he pharmacies are making the products with an unauthorized version of their active ingredient, semaglutide.” Analogy: Someone is using McDonalds’ beef supplier to make their own burgers. Claim: More than a decade ago, a compounding pharmacy broke the law and people died. Analogy: The Danes once murdered and pillaged their way across Europe. The Novo Nordisk Board of Directors (artist’s conception) Curious about the differences between hepatitis A, B, C, D, and E? HealthDay’s got you covered. Arizona becomes the latest state to allow adults to purchase contraceptives over the counter at pharmacies after completing a brief screening including a blood pressure test. Previously it required a pharmacist’s prescription. That makes the total 19, including DC; only 9 require the patient to be 18 or older (per the Guttmacher Institute). After falling during the pandemic, tuberculosis cases have been rising again worldwide and in the US. In fact, “tuberculosis numbers have quickly climbed back up to pre-pandemic levels, marking the first time in decades that cases and deaths have risen globally.” Caveats: Some of that 2020 drop is due to less testing (or confusion with Covid), and some of the 2021 rise is due to better testing. Sillier than drinking bleach, space drugs get closer, indication overload, and more
Drugs … in … spaaaaaaaace
Albuterol recall
More uses, less usefulness
Who lies to look stupid?
Novo hates compounders
Learn your hepatitis ABCDEs
Short Takes
Elsewhere: OTC birth control in Arizona
Consumption resumption
July 07, 2023 ✒ Andrew Kantor
It’s safe to give kids stimulants for ADHD — well, safe in terms of their developing substance abuse issues later in life. This had been a concern, or at least a reason to hesitate prescribing the meds, but a study out of the University of Pittsburgh found there’s nothing to worry about. The Pitt researchers studied kids over 16 years (!) and found that the chance of a child treated with stimulants turning into a young adult with a drug problem was no greater than kids who didn’t have the meds. On the other hand, taking stimulants didn’t protect the kids from having a substance-abuse problem, either. Hoping to avoid another “tripledemic*” this fall, the feds are gearing up to make sure people can get the shots they need to keep their lungs working: for flu, Covid-19, and RSV. The flu shot is, well, the flu shot. The Covid vaccine will be tuned specifically to the most common XBB variant. And the newly minted RSV shot is particularly important for the youngest and the oldest patients. “The number of elders who die of viral infection every winter in our intensive care units, and also sometimes in the summer, is large — it’s in the tens of thousands of individuals. Each of these vaccines is a huge win.” Pro tip: It might be good to space the flu and RSV shots a few weeks apart. There’s some evidence they can interfere with each other. * The fact that it’s still in quotes is a good sign. When taxpayers pay to develop a drug, they should be getting a fair price for them. Thus a proposal from Sen. Bernie “the Angry Grandpa” Sanders, chair of the Senate Health, Education, Labor and Pensions Committee, that would limit what they could charge when the federal government paid for the research. The proposal would “mandate price caps for drugs that were developed with the help of government funding” by prohibiting them from exceeding “the lowest price charged for it in Canada, France, Germany, Italy, Japan, or the U.K.” Because the US doesn’t do any kind of cost-benefit analysis on the value of a drug (we just pay whatever the drug company feels like charging)… This move would essentially leave the U.S. price of government-developed drugs in the hands of regulators in Europe, who assess therapies by way of cost-benefit analysis. This system keeps prices in check, much more so than in the U.S. Drug companies and their champions call this “price setting,” as opposed to what they do which is setting the price. The FDA is poised to approve Eisai/Biogen’s treatment for Alzheimer’s, but it comes with a load of caveats. First is safety, as three people died during trials. Then there’s cost to patients and taxpayers; the companies are charging $26,000 per year. Then there’s the limited number of specialists who are qualified to determine if it’ll actually help. Finally, the testing involved very few Black patients, and Alzheimer’s seems to affect them differently. Blacks are up to twice as likely as whites to be diagnosed with Alzheimer’s, while showing equivalent levels of amyloid in most major studies. No one is sure why, but the hypothesis is that having multiple simultaneous health conditions and being exposed to environmental stressors put Blacks as a group at higher risk. While Leqembi can’t reverse the signs of dementia, but it at least “delayed cognitive decline by 27% over 18 months.” How much that will actually mean to patients in the real world isn’t clear. That’s why CMS said Medicare will cover the drug, but it will require prescribers “to collect and share data about the drug’s real-world performance.” When it comes to hypertension drugs, there’s no one size fits all. Finding the best med can mean a lot of trial and error. So Boston U researchers set a computer on the task, teaching it about previous patient outcomes so the AI can recommend a treatment more likely to work. In other words, instead of considering just the benefits and risks of various meds, the program “generates a custom hypertension prescription using an individual patient’s profile, giving physicians a list of suggested medications with an associated probability of success” based on how effective a med was with similar patients. The initial training database was big, too — medical records of almost 43,000 patients over 8 years. It seems to have paid off: The researchers found [the AI] achieved a 70.3 percent larger reduction in systolic blood pressure than standard of care and performed 7.08 percent better than the second best model. Slowly but surely, vaccines against Lyme disease are making their way through clinical testing. Valneva’s candidate just passed its phase 1 trial, showing that it’s safe, tolerated, and generally effective. Larger phase 2 trials will further test its effectiveness. The downside so far is that it seems to require an initial shot and a booster, and then gives about 6 months of protection. As Veterinarian of Buzz told us, Lyme-carrying ticks are around all year, even if they’re most active in summer.AI BP med chooser, should taxpayers pay twice, stimulants are safe, and more
Stimulants aren’t a gateway
Feds prep for fall vax campaigns
Give us a break — we paid for the research: Sanders
Alzheimer’s drug is almost here … but
Let the computer choose the med
Lyme vax continues its approach