Arachnophobes can relax

Every kid knows that when it comes to dangers lurking in the world, black widow spider bites top the list^*. Good news: German researchers think they’ve found an antidote.

Today, the only antivenom (or antivenin, if you’re that sort) comes from horses; it can trigger all sorts of allergic reactions. If the Germans’ human-specific antibody pans out — so far it’s only been tested in the lab — it could finally end the scourge that has taken so many lives on late-night TV movies.

Bad news: So far they’ve only created an antibody for two of the three varieties of black widows in the US. But they’re working on it.

^* Followed by quicksand and being trapped in a refrigerator

Statin overuse?

Do too many people take statins? Maybe. A new analysis from the University of Pittsburgh, based on the American Heart Association’s new risk calculator, suggests as many as 40% fewer people need statins that then current model suggests.

Essentially the Pittsburghians compared the 2013 calculator’s results with the 2023 version when applied to the records of 3,785 adults.

Overall, 4% of people had a 10-year risk of developing cardiovascular disease, compared to the 8% previously predicted by the [equations]. The number of adults recommended for statins could drop from 45.4 million to 28.3 million.

Medicare rule clobbers pharmacies

Biden administration: New rule! Medicare and Medicaid patients are gonna pay less for their meds. We’ll make price adjustments first, at the pharmacy counter, rather than later.

PBMs: Ah, so essentially our clawbacks will happen immediately.

Administration: Um, yeah. But it will save patients and the government money.

Independent pharmacists: Wait a second! That cuts my reimbursement from the PBM — sometimes it’s less than what I pay for the drug!

CMS: “We cannot interfere in the negotiations that occur between the plans and pharmacy benefits managers. We cannot tell a plan how much to pay a pharmacy or a PBM.”

Independent pharmacists: [expletive deleted]

The X for Y files: melatonin

Sleep, shleep — taking melatonin supplements might reduce the risk of age-related macular degeneration. That’s what researchers at Case Western Reserve University found when they parsed the medical records of almost 190,000 people aged 60 and older.

In fact, they found that melatonin use both reduced the risk of developing macular degeneration (in patients didn’t have it) and reduced the chance of it worsening (in patients who did).

CVS faces store-brand recalls

Even the big guys can have serious manufacturing problems. Several factories that make CVS-branded products have had conditions bad enough to force product recalls, according to a Bloomberg investigation.

One factory making CVS-branded pain and fever medications for children used contaminated water. Another made drugs for kids that were too potent. And a third made nasal sprays for babies on the same machines it used to produce pesticides.

Bloomberg focused on CVS, but the company isn’t alone. One of the issues for large chains that contract with manufacturers is that the FDA considers them “private-label distributors,” who are themselves responsible for the quality of the drugs, rather than the FDA.

Elsewhere: Baltimore edition

The city of Baltimore opted not to participate in the Big Opioid Settlement, and it seems to have been the right choice. The city just won a $45 million settlement from Allergan for its role in the opioid epidemic — $38 million more than it would have received if it had joined the big settlement.

The Allergan victory is just the beginning.

The city is still suing Johnson & Johnson, McKesson, Cardinal Health, AmerisourceBergen, Walgreens, CVS, Teva, former Insys CEO John Kapoor, members of the Sackler family and others.

People are still researching this

Researchers at the University of Chicago have just reported a shocker: You can’t get good health information on TikTok.

The research group’s next study will question whether it’s safe to tug on Superman’s cape or spit into the wind.

The Long Read: Could Covid cause weird cancers?

During the height of the pandemic, oncologists began noticing “an uptick in aggressive, late-stage cancers” — anecdotes later borne out by data.

Could it simply be caused by disruptions to care? If so, how would that explain the emergence of unusual cancers? Or could it be that Covid can cause a chain reaction — “an inflammatory cascade and other responses that, in theory, could exacerbate the growth of cancer cells”?

RSV shot coming to the 50s set

Good news for people aged 50–59 at high risk from RSV: The FDA gave its stamp of approval to giving them GlaxoSmithKline’s vaccine. Right now you have to be at least 60 to get it, but GSK says that ‘More than 13 million Americans ages 50 to 59 have a medical condition that increases their risk of having a severe RSV outcome.’

That doesn’t mean those folks can get it immediately. The CDC hasn’t blessed the vax yet, and it won’t until July at the earliest. And insurers, including Medicaid, won’t cover it without the CDC’s thumbs-up.

Coming soon: Moderna’s combo vax?

The idea of a combo Covid/flu shot has been floated ever since we realized we’ll probably need annual updates for both. Now good news from (and for) Moderna: The company says its combo mRNA vaccine elicited…

…‘significantly higher immune responses’ against a number of influenza strains, as well as against SARSs-CoV-2, the virus that causes Covid-19, after a single dose.

That’s compared to Moderna’s existing Covid vaccine and the Fluzone HD flu shot, so yeah — it’s better than what’s out there, and faster to produce, too.

Danger of a stronger nicotine

Vape makers are getting around nicotine regulations by creating nicotine variants — e.g., 6-methyl nicotine — that are more addictive than nicotine. That lets them skip FDA approval while still getting kids hooked on e-cigs.

Twist: That was brought to the FDA’s attention by legit e-cig companies including Altria (née Philip Morris) and British American Tobacco.

[Altria] urged the agency to evaluate the compounds and establish what authority it had over them, warning they posed a “new threat” to regulation of the sector.

In related news

The feds, it seems, are going to crack down on illegal e-cigarettes.

There are only 23 approved tobacco-flavored vapes, but you wouldn’t know that looking at what’s for sale in some places. So the FDA and the Justice Department have launched a new task force — it includes the ATF, US Marshals Service, and even the US Postal Inspection Service and the FTC — to ensure “vigorous enforcement of the tobacco laws” including “criminal and civil prosecutions, seizures, and forfeitures.”

Short Takes

Paxlovid fails against long Covid

Paxlovid might help shorten Covid symptoms, but it doesn’t help relieve long Covid. That’s the result of a study out of Stanford University, where they were hoping to find a treatment for the brain fog and exhaustion that affects a lot of people (10%?) who have recovered from the disease.

Another needle-free insulin candidate

This one consists of drops placed under the tongue. The trick is a “unique cell-penetrating peptide” developed at the University of British Columbia that allows the insulin to squeeze through the lining of the mouth and into the bloodstream. Still, it’s only in pre-clinical trials.

FDA committee backs Lilly’s Alzheimer’s drug

After a delay earlier this year, an FDA ad­vi­so­ry com­mit­tee gave an 11-0 thumbs-up to Eli Lil­ly’s Alzheimer’s drug do­nanemab. (That’s just the adcomm, though. The FDA still has to make the formal approval decision.)

When ferrets are canaries

Give ferrets the (human) seasonal flu, and they get sick. Give them the bird flu that infected a Texas dairy worker and they die. That’s not a good sign.

Ferrets are considered the best small mammal for studying influenza virus infection and transmission and are commonly used as a tool to inform public health risk assessments of emerging influenza viruses, according to the CDC.

The good news is that “The virus was less efficient than other influenza strains at spreading by respiratory droplets,” meaning it “would need to undergo changes to spread efficiently by droplets through the air.”

And really, what are the chances of a virus mutating like that?

News shocker: Pharmacies are closing

The Associated Press has just realized that a heck of a lot of pharmacies are closing, and that’s not good for anyone (especially rural areas and Black and Latino neighborhoods). Chains have shareholders to cater to, so they close less-profitable locations, while independents having fight tooth-and-nail to get fair reimbursements from PBMs.

Across the U.S., more than 7,000 pharmacies have closed since 2019, according to data from University of Pittsburgh researcher Lucas Berenbrok, who considers that estimate conservative. Of those pharmacies, 54% were independent drugstores.

Blame the closings on problems like sliding revenue and rising expenses. For years, the reimbursement that drugstores receive for filling most prescriptions has shrunk while things like utilities and employee pay continue to climb.

Eventually we’ll need to worry

The first human has died from bird flu — a man in Mexico. What’s notable is that he died from the H5N2 strain, not the H5N1 variant that’s sickened at least three people in the US of A. It’s also the first documented human case of H5N2.

If you’re the worrying type, here are a couple of other tidbits to feed your unease:

1. The gentleman in question had significant underlying health issues, but he didn’t have contact with poultry or livestock.
2. “Twelve additional people the patient came into contact with — seven with symptoms and five without — were identified near the patient’s residence.” Those could be the first human-to-human transmission of bird flu.

Fear not, though! “The Ministry of Health informs that there is no risk of contagion for the population with the detection of the first human case of low pathogenic avian influenza A (H5N2) in Mexico, since there is no identified source of infection.”

Yep: Since they don’t know where it came from, there’s no risk!

Good news from two studies

Melanoma vax leads to long-term survival

Moderna and Merck’s cancer vaccine — combined with Keytruda — worked incredibly well against melanoma.

[A]fter two and a half years, melanoma patients that had received the cancer vaccine combination showed an overall survival rate of 96%, compared with 90.2% with Keytruda alone.

Multiple myeloma breakthrough

GSK’s multiple myeloma drug Blenrep “nearly halved the risk of disease progression or death compared to standard-of-care treatments” according to a phase-3 study.

In the trial of 302 patients with relapsed or difficult-to-treat multiple myeloma, 71% of those who received Blenrep in combination with the steroid dexamethasone and pomalidomide were alive without their disease worsening at the end of a year.

Even better, Blenrep is an outpatient drug that’s (relatively) easy to produce.

A spoonful of AF-353 helps the medicine go down

Some medication is so bitter — and some people are so sensitive to tastes — that a spoonful of sugar ain’t gonna help it go down. Adults can (usually) buck up and swallow, but try convincing a five-year-old how important it is to take his Augmentin.

To the rescue are the researchers at the Monell Chemical Senses Center in Philly. Despite living in Eagles territory, they actually have something useful to contribute to society: They’ve identified “the first temporary, universal taste blocker.”

“Remarkably, and unlike our experience with blockers of bitter taste receptors, the taste-nerve blocker we tested worked for every subject and every bitter compound we tested.”

That’s a breakthrough because the tongue has several kinds of bitter taste buds, and blocking one didn’t mean blocking the others; you would need a different “bitter blocker” for each yucky med.

The only downsides to their new compound, called AF-353, is that once you put it on the tongue it lasts 60-90 minutes and it also affects other tastes. That means you couldn’t give Junior some ice cream as a treat for taking his meds.

Four scary words

“Drug-resistant jock itch.”

Cases of highly contagious and tough-to-treat cases of ringworm are appearing across the country from two different strains of fungus.

One outbreak is caused by Trichophyton mentagrophytes type VII (TMVII), which, while it seems to respond to terbinafine, can take months to clear up.

The other comes from Trichophyton indotineae — and that is resistant to terbinafine. (Even 42 days of treatment didn’t help.) It’s a new mutation that has “several variations in the genetic code that prevent terbinafine from hooking onto fungal cells and poking holes in their protective membranes.”

The good(ish) news is that Trichophyton indotineae can be treated with itraconazole. The bad news is that itraconazole has a long list of side effects.

Oh, and compounding the issue is that both “may instead be confused for lesions caused by eczema and can therefore go without proper treatment for months,” and that’s coupled with the fact that folks don’t always want to talk about issues down there.

Inhaler prices drop (probably)

The price of asthma inhalers from AstraZeneca and Boehringer Ingelheim has dropped (at least it’s supposed to have dropped) to $35 per month out of pocket. GlaxoSmithKline said it’ll be following suit in January.

The price drops come as the government has turned its attention to the fact that inhalers cost Americans a heck of a lot more than they do people in other countries. (“AstraZeneca charges $645 in the U.S. for the same inhaler it charges $49 for in the U.K. Teva Pharmaceuticals […] charges $286 in the U.S. for an inhaler that costs $9 in Germany.”)

Manufacturers are afraid that they’ll be forced to lower prices, and this way they can do it on their terms and reap the PR value. How easy it’ll be for patients remains to be seen

A spokesperson for Boehringer Ingelheim said the $35 cap will be automatically applied at the pharmacy counter for the majority of eligible patients with commercial insurance. For those without insurance or whose pharmacies aren’t participating, they’ll be able to visit the company’s website starting Saturday, where they can enroll in a copay card that will reduce the out-of-pocket cost to $35.

As one immunologist put it, “I think what you’ll find is most doctors saying, ‘I’ll believe it when it happens’.”

Short Takes

Pharma pollution

We’re drugging a heck of a lot of animals and plants. And by “we” I mean pharmaceutical manufacturers.

Swedish and British researchers have found that “discharges to the environment during drug production, use, and disposal have resulted in ecosystems around the globe being polluted with mixtures of pharmaceuticals, posing a growing danger to wildlife and human health.”

Any day now

The next next candidate for male birth control comes from YourChoice Therapeutics, which just completed a phase-1 study on 16 men “showing that doses of their drug YCT-529 are safe for men.”

What’s interesting is that the drug might be able to be taken every two weeks, making compliance less of an issue.

The Long Read

“Pharmacies are in shambles.”

The gathering tsunami of pharmacy shutdowns highlights a worsening national crisis for the United States, where health care is the most expensive in the world. As U.S. health care companies continue getting bigger and more consolidated, while the number of primary care doctors shrinks, pharmacies could have filled in some of the gaps. Instead, they’re becoming dystopian nightmares—or vanishing entirely.

“No” to MDMA

An FDA advisory committee voted 9-2 to not recommend authorizing midomafetamine (aka MDMA) for treating PTSD in combo with therapy … at least not yet.

Those opposed to its approval said there’s not enough data showing the drug effectively treats PTSD.

A larger majority also said the proposed treatment’s potential risks outweigh its potential benefits while only one disagreed in a 10-1 vote on its efficacy.

USP warns about drug shortages

If it feels like drug shortages are lasting longer, you’re not imagining things^*. A new report from USP found that a number of factors are contributing to the issue, especially lately.

Low prices, manufacturing complexity, geographic concentration of production, and quality issues can each raise the risk of a shortage, either alone or in tandem with one another.

Essentially, the profit margin for many drugs is too low for companies to bother making them, which leads to fewer suppliers and more places for the system to fail.

As one USP exec put it, “Unexpected shocks can break the system and disrupt the supply of quality medicines. This worrisome trajectory leads to more frequent drug shortages, prolonged scarcity, and more people at risk of not getting the medicines they need, when they need them.”

^* You’re not imagining the drug shortages. You might be imagining other things.

Does this taste like weight loss to you?

Women taking semaglutide have their taste perception enhanced, possibly making sweets less tasty (or, rather, more overwhelming). That’s the result of a Slovenian study that compared MRI scans of obese women who received either semaglutide or a placebo and then had a sweet liquid put on their tongues.

Women receiving semaglutide experienced changes in their taste perception, in the ways their taste bud genes expressed themselves and the way their brain responded to sweets.

It might not be that semaglutide makes taste buds more sensitive, but that obesity makes them less sensitive. You know the drill: More research is needed.

Short takes

Still doing wrong by moms

The US continues to lag every other high-income nation in maternal mortality … well, except for Asian-Americans. And Black women have twice the rate as the rest.

Nearly two of three maternal deaths in the U.S. occur during the postpartum period, up to 42 days following birth. Compared to women in the other countries we studied, U.S. women are the least likely to have supports such as home visits and guaranteed paid leave during this critical time.

Liquid ADHD med approved

The FDA has approved Tris Pharma’s Onyda XR (clonidine hydrochloride) as the first liquid non-stimulant ADHD med. It’s a once-a-day oral suspension to be taken at night, and should be available later this year.

Preparing this year’s Covid vax

An FDA panel is recommending that this year’s Covid-19 vaccines target the JN.1 variant, rather than the KP.2 (aka “FLiRT”) strain. At the moment JN.1 is dominant across the country, but FLiRT is catching up fast.

Good news: Vaccine makers say that their JN.1 vaccines are effective against FLiRT — maybe not as good as a FLiRT-specific vax, but better than last year’s shot.

GLP-1 drugs vs cancer

There are enough cancers related to obesity that a study found that “weight-loss drugs cut cancer risk by a fifth.” Research out of Case Western Reserve University found that “patients taking the [new weight-loss] drugs were 19% less likely to develop 13 obesity-related cancers, including ovarian, liver, colorectal, pancreatic, bowel and breast cancer.”

Oh, and….

A second study published at the American Society of Clinical Oncology annual meeting suggested weight-loss drugs could reduce the risk of cancer coming back in breast cancer patients — and boost their prospects of long-term survival.

Science marches on

“Research Reveals How Heavy Metal Singers Scream and Squeal”

Fast, simple, accurate prostate cancer test

In most cases, prostate cancer is something men die with, not of, but there’s always the risk of the fast-moving deadly kind. You want to catch it early. PSA blood tests are helpful, but they’re not shiny enough to be a gold standard.

Now there’s something better: a simple saliva test developed by British scientists. The mechanism itself isn’t new — it’s essentially a DNA test — but what it tests for is: It looks at 130 genetic variations that are linked to prostate cancer.

In those with the highest genetic risk, the test returned fewer false positives than the PSA test, picked up people with cancer who would have been missed by the PSA test alone, and picked up a higher proportion of the aggressive cancers than the PSA test, the ICR said.

Oh, and it also beat MRI tests for IDing the cancer, too.

Antibiotic kills only the bad bacteria

Here’s a new antibiotic with an important trick up its sleeve: Called lolamicin^*, it kills even drug-resistant infections but without killing the good gut bacteria.

How so? It’s about a particular lipoprotein-transport system that, in a bit of really good luck, happens to be “genetically different in pathogenic and beneficial microbes.”

Treatment with standard antibiotics amoxicillin and clindamycin caused dramatic shifts in the overall structure of bacterial populations in the mouse gut, diminishing the abundance [of] several beneficial microbial groups, the team found.

“In contrast, lolamicin did not cause any drastic changes in taxonomic composition over the course of the three-day treatment or the following 28-day recovery.”

Good news, for sure. The bad news is that it’s many years away from even being a testable drug.

^* L-O-L-A lola(micin)

Post-partum pill: in case you’re curious

It’s been a bit more than six months since zuranolone, the first drug ever approved for postpartum depression, became available.

The results so far: Anecdotally, patients are really liking it. It seems to work with a minimum of side effects (e.g., drowsiness). The big issue, though, is getting insurance to pay for it without a lot of hoop-jumping.

Med chooser: A great idea not fully realized

You know how finding an antidepressant that works is so hit or miss? George Mason University scientists claim to have an answer. It’s an AI-based tool (natch) that asks a handful of questions about the patient, then compares those answers to its database of 3.7 million patients who took 10.2 million antidepressants.

“The system recommends to the patient what has worked for at least 100 other patients with the same exact^* relevant medical history,” said the team’s leader.

It’s available to use right now: Check out MeAgainMeds. (They’re clear that this is experimental — that “We are not providing medical advice, we are providing options to discuss with your physician.”)

In reality…

Sounds cool, right? Unfortunately, our quick and dirty test gave pretty useless results. For starters, it only asks age, gender, what antidepressants you’ve tried, and whether they worked.

In our test case, a middle-aged man who tried bupropion and paroxetine without success was told that “Uncommon or Multiple Antidepressants gives you the highest chances for remission.” Not helpful. And another test where the “patient” reported multiple failures was given bupropion as a suggestion … despite indicating that bupropion had been ineffective.

So it’s a cool press release, but not the most helpful tool in the toolbox.

^* Not just the same, not just the exact, but the same exact.

US, Moderna prepare for bird flu — mRNA style

It looks like the federal government is going to be funding the late-stage testing of Moderna’s bird flu mRNA vaccine. The money — “tens of millions of dollars” — will be coming from BARDA, the Biomedical Advanced Research and Development Authority. The goal, of course, is to get ahead of H5N1 for when it makes the jump to humans in a big way.

So far, only three people have caught bird flu from other animals (cows), but we all know that viruses tend to mutate. For its part, Moderna says, “The H5 vaccines in this trial cover the same clade as the currently circulating variant in the United States.”

Stress and dry eye

Stress has a lot of downsides, and one you may not realize is that it can make dry eyes worse. How?

• Stress leads to inflammation and white blood cells rushing to the eye surface.
• It can increase sensitivity to pain and discomfort, making symptoms stand out.
• It can cause you to have sleep issues, and sleep meds can make it worse.

The only solution — aside from reducing stress — is eyedrops, early and often.

Weird syphilis

You know the typical symptoms of syphilis, so I won’t repeat them here. (Eew.) But lately some new, different ones are cropping up more often and doctors don’t always recognize them.

That’s in part because sometimes the docs in question are ophthalmologists. The new symptoms are all eye-related, and they’re appearing without the typical ones showing up first.

For some, the world suddenly goes blurry. Others describe it as having a dust storm in your eyes, or being shaken up in a snow globe. People might see flashing lights or black spots drifting through their field of vision, or acquire a sudden sensitivity to light, worse than walking into the sunlight after having your eyes dilated.

When there are no other symptoms, it’s easy to assume something else is at work, like an eye infection or sinus issue. But left untreated, eye syphilis can lead to blindness. The question is, is this just statistics at work with all the new cases, or is this a different strain? Time will tell.

Don’t let the raccoons know about this

If, like most of us, you’ve wondered how easy it would be to get used to having a second thumb, wonder no more. Researchers at Cambridge tested a prosthetic additional thumb on members of the public and found that most people were comfortable using it almost immediately: “98% of participants were able to successfully manipulate objects using the Third Thumb during the first minute of use.”

Preventing antipsychotic weight gain

Antipsychotics often cause a major side effect: weight gain. But Aussie researchers have found a method that not only prevents weight gain in patients but also increases serotonin levels by more than 250%.

It’s not a new drug; it’s a coating on an existing one, lurasidone. That coating does double duty: Inulin fiber feeds beneficial gut bacteria, while triglycerides help lurasidone absorb into the bloodstream.

The former is the big deal. ‘Normal’ antipsychotics disrupt the gut biome, leading to side effects like weight gain. The coating keeps that in check. (The speedier absorption means it doesn’t need to be taken with food, which can be a problem for some patients.)

Even better, because this is considered a reformulation, the approval path is a lot shorter.

“Unprecedented” lung cancer breakthrough

A phase-3 trial of lorlatinib — Pfizer’s cancer drug — against non-small cell lung cancer resulted in “the longest progression-free survival outcomes ever recorded” according to the Australian researchers who conducted the study with about 300 patients..

More than half of patients (60%) diagnosed with advanced forms of lung cancer who took lorlatinib were still alive five years later with no progression in their disease, data presented at the world’s largest cancer conference showed. The rate was 8% in patients treated with a standard drug, the trial found.

Accolades were coming fast and furious: “off the chart,” “unprecedented,” “unheard of,” “groundbreaking.” (Bucking tradition, no one said “game-changer.”)

Sleep apnea pill?

Instead of a clumsy CPAP machine (or surgery), why isn’t there a pharmaceutical treatment for sleep apnea? I want my solution in a pill, dagnabit!

Researchers at Cambridge, Mass.-based ApniMed (get it?) have heard the call, and their ED-209 AD-109 is entering stage-3 trials.

If it’s successful and approved, it’ll be the first drug approved for treating obstructive sleep apnea, and millions of CPAP machines will find themselves given the “Office Space” printer treatment.

AD-109 worked in phase-2 trials. It’s a combination of aroxybutynin and atomoxetine, showing “clinically meaningful improvement in [sleep apnea].” By that they mean that there was a reduction in the number of times someone stopped breathing while sleeping.

Oh, but the caveats. The drug worked pretty well for people with mild apnea, but not so well for patients with severe cases. (It dropped their apnea index, but they still had the condition, kinda like getting Lasik surgery but still needing lower-power glasses.)

And while the study saw a drop in stop-breathing events, they didn’t look at O₂ saturation, which is pretty darned important. So even after these phase-3 trials, more research will be needed.

Latest GLP-1 quitting data

A new study based on records of almost 200,000 people found that about 26% of patients taking GLP-1 medications quit within 3 months, and 36.5% quit after a year.

Researchers at Evernorth Research Institute in St. Louis didn’t examine why people quit, but they noticed that quit rates were higher in poorer areas,, so price is a likely culprit. “Each 1–percentage point increase in out-of-pocket cost per a 30-day supply of GLP-1 agonist was associated with increased odds of discontinuation.”

Of note is that people who were obese but did not have diabetes were much more likely to quit than those who were diabetic. The researchers speculated that some people quit once they met their weight-loss goals (and didn’t realize they needed to keep taking the medication), or the side effects became too much of an issue.

Speaking of GLP-1 drugs….

They’re so hard to find that telehealth company Ro has set up a system where patients can sign up for email alerts when someone finds a GLP-1 drug available in their area — crowdsourcing the hunt as it were.

When supply is found, the company will automatically email patients nearby with the pharmacy, address, and phone number so they can call and ask the pharmacy to transfer their Rx from their current pharmacy.

Growing teeth with drugs

Japanese scientists are about to begin testing a new drug that grows teeth. Yep, you read that right. It’s designed to treat congenital tooth deficiency — when people don’t develop a full set of teeth — with initial results expected in about a year. (That first study will be on adult men who are missing teeth, followed by a second one for little kids who have been missing teeth since birth.)

The tooth regrowth medicine deactivates a protein called USAG-1, which inhibits the growth of teeth. The team believes that in the future it may be possible to grow teeth not only in people with congenital conditions, but also in those who have lost teeth due to cavities or injuries.

The Long Read: The unclear future of psychoactives

Psychoactive drugs like MDMA, ketamine, shrooms, and even LSD are getting a lot of attention lately. Depending on who you ask, they’re either incredible potential treatments for depression and PTSD, or a whole lot of wishful thinking.

It’s a maze of information and a minefield of opinions, and into that mess is strolling the FDA. Read more from KFF Health News.

Pharmacists could save us big

Shocking news: Pharmacists could save the healthcare system (i.e., insurers, patients, taxpayers) millions if they were allowed to treat more medical issues.

A study out of Washington State University found that if minor illnesses were handled in pharmacies “it would have saved an estimated $23 million in health care expenses” over three years.

The study found that care for a range of minor health issues — including urinary tract infections, shingles, animal bites and headaches — costs an average of about $278 less when treated in pharmacies compared to patients with similar conditions treated at “traditional sites” of primary care, urgent care, or emergency room settings.

That’s based on data from 500 patients, 175 pharmacists, and 46 pharmacies, from 2016 to 2019.

In the interest of fairness, we do have to include this caveat: The study was supported by a grant from the National Association of Chain Drug Stores Foundation.

Older folks should use statins too

Statins are safe and effective for older people, according to a multi-year study out of Hong Kong that followed more than 120,000 people aged 60 and over who had never had heart disease. They found that …

Reduction for [cardio-vascular disease] after statin therapy were seen in patients aged 75 years or older without increasing risks for severe adverse effects. Of note, the benefits and safety of statin therapy were consistently found in adults aged 85 years or older.

The U.S. Preventive Services Task Force has been iffy about the value of statins for people 75 and older, and physicians are often reluctant to prescribe them. This new, big study might change that.

Weekly insulin nixed

The other day we told you that Novo Nordisk’s once-a-week insulin, Awiqli, came with a notable risk of of hypoglycemia. An FDA advisory committee was going to decide whether to recommend that the agency approve it.

Well, that committee gave Awiqli a thumbs-down, voting 7-to-4 that “the weekly insulin icodec’s benefits do not outweigh the risks.”

Novo thought it could get around the issue simply by having a warning label, but the committee didn’t agree. The company will now “work closely with the FDA to identify the next steps needed to bring the treatment to market.”

Any day now

The latest “promising approach to develop a birth control pill for men” comes from the Baylor College of Medicine. It works by inhibiting a protein (STK33) that’s required for fertility in both mice and men, and the effect fades away once the gentleman in question stops taking it.

Heart-helping drugs don’t work the way we thought

Old idea: SGLT2 inhibitors — developed for diabetes but used to treat heart failure — act as diuretics.

New data: “Contrary to common assumptions, these drugs may improve cardiac outcomes and heart health without acting as diuretics.” That’s from a joint US-Singaporean-German study that found that …

[T]he body responded [to the drug] by releasing more vasopressin, a brain hormone that instructs the kidneys to conserve water. This minimised any rise in urine volume and even after 24 hours, patients’ urine volume remained stable despite persistent glucose excretion from dapagliflozin.

The brain won’t let hydration levels get that low, which means SGLT2 inhibitors help the heart by some other mechanism. As usual, more research is needed.

Feeding infants peanuts protects them from allergies

It makes sense, but now there’s science to prove it: Giving kids peanut products early can reduce their risk of peanut allergies at least into adolescence, according to a multi-year study by researchers at King’s College London. At age 6–12…

• 4.4% of kids who ate peanuts from infancy had a peanut allergy.
• 15.4% of kids who avoided peanuts for their first five years had a peanut allergy.

“These results show that regular, early peanut consumption reduce the risk of peanut allergy in adolescence by 71% compared to early peanut avoidance.”

Sugar doesn’t make kids hyperactive

An Australian neuroscientist explains how every parent is wrong — “[T]oday’s scientific evidence does not support the claim sugar makes kids hyperactive.”

Rigorous research conducted by experts has consistently failed to find a connection between sugar and hyperactivity. Numerous placebo-controlled studies have demonstrated sugar does not significantly impact children’s behaviour or attention span.

She does admit that a dopamine rush from unexpected candy can lead to “increased activity,” thus “the excited behaviour of children towards sugary foods may be attributed to a burst of dopamine.” Potato, po-tah-to.

Suit over SSRI labels

SSRIs and SNRIs are missing an important warning, says a Howard University scientist, and if the FDA is ignoring his petition to have that change, he’s taking it to court (with the help of non-profit group Public Citizen).

That petition was actually filed by 22 scientists in 2018, and the FDA’s regs require it to respond petitions like this within 180 days. Hence the lawsuit to act as a kick in the pants to the agency.

The issue is sexual side effects, specifically sexual ones, that can last long after the drugs are discontinued. There are warnings about this in Canada and Europe, so it’s not as if they’re pulling it out of thin air.

So far, nothing from the FDA.

Covid can damage your eyes

That twinkle in your eye might be Covid-19 — the SARS-CoV-2 virus turns out to able to slip past the blood-retina barrier.

By damaging that barrier, the virus is able to start damaging the retina itself, according to TK scientists, specificially “retinal microaneurysm, retinal artery and vein occlusion, and vascular leakage,” none of which sounds good.

The damage can happen in who are otherwise healthy, too. “Even those who were asymptomatic could suffer from damage in the eyes over time because of Covid-19 associated complications.”

Semaglutide’s next trick

This week it’s [throws dart] preventing kidney damage.

A trial with about 17,600 people was designed to see Wegovy’s effect on heart disease in overweight patients, but when they parsed the results the folks at Novo Nordisk found that, as the lead author put it, “semaglutide…may contribute to a significant reduction in the risk of kidney-related complications, including chronic kidney disease and end-stage renal disease.”

In the new analysis, semaglutide led to a slower decline in a certain measure of kidney function known as eGFR (estimated glomerular filtration rate), particularly in individuals with a pre-existing kidney impairment.

There was also a significant reduction in the urinary albumin-to-creatine ratio (UACR), another important marker of kidney health.

Speaking of semaglutide….

Taking birth control while using it is probably a good idea. There are a lot of anecdotes about women getting pregnant while using GLP-1 drugs, to the point where medical folks are recommending that birth control and semaglutide be ‘paired.’

There’s a logic to the pregnancy angle. As on Aussie doc put it, “Women with obesity often have irregular or no periods because they don’t ovulate. Once they lose some weight, ovulation becomes more regular and this is how their fertility improves.”

There’s another important reason to use birth control. While drug makers didn’t test the meds on pregnant people, there’s some evidence from animal studies that having a baby while using them can lead to fetal abnormalities.

According to Novo Nordisk, when semaglutide was given to pregnant rats, the unborn offspring showed both structural abnormalities and alterations to growth.

Tattoo danger

Tattoos might increase your risk of lymphoma. A Swedish study of about 12,000 7,200 people found that there was a significantly higher rate of lymphoma in those who had tattoos:

“After taking into account other relevant factors, such as smoking and age, we found that the risk of developing lymphoma was 21 percent higher among those who were tattooed.”

What’s extra interesting is that tattoo size didn’t make a difference — a full-body tat or just a teddy bear on your butt both increased the risk. That’s one reason they’re careful to say that this is just a preliminary result (‘more studies are needed’). It’s one that makes sense, though: “A large part of the ink is transported away from the skin, to the lymph nodes where it is deposited,” said the lead author.

Adderall is back, baby!

Teva reports that all of its Adderall products are now available, i.e., they’re off the FDA’s shortage list. Well, the brand-name versions; there are still some generics in shortage.

The company says manufacturing is back to full strength but demand is at an all-time high. And other ADHD meds are still hard to get hold of (but you know that).

The urban legend is true

Almost two-thirds of US currency tested has traces of fentanyl on it, and just about every bill has traces of cocaine and methamphetamine, according to a study out of Thomas Jefferson University.

“[T]his insight suggests that analyzing currency could serve as a valuable tool for tracking drug trends on a regional and national scale.”

Bonus: Stock image includes a $2 bill, which happens to feature namesake Thomas Jefferson.

Weekly insulin candidate has a downside

Use of Novo Nordisk’s Awiqli — its once-a-week insulin icodec injection (which is awaiting FDA approval) — leads to a “significantly higher” rate of hypoglycemic episodes for type-1 diabetes patients, based on a clinical trial.

In the trial, patients with type 1 diabetes on insulin icodec showed 50% to 80% more clinically significant or severe hypoglycemia compared to once-daily insulin degludec.

Novo proposes limiting the Awiqli’s use to patients with continuous glucose monitors and add a label warning prescribers about the risk. The FDA staff isn’t convinced, and the relevant advisory committee will be considering whether the risks outweigh the benefits.

Cancer-killing letter bombs

To communicate, cells use bubbles called extracellular vesticles — they extend from the cell and contain various molecules that send a message to other cells. So Swedish researchers had an idea: Why not include their own message inside those vesticles? A message of death.

They loaded anti-cancer meds into the vesticles (to kill the cancer), then coated them with antibodies that would be attracted to the tumor (to deliver it). Initial tests on mice worked as they hoped, so now they’re expanding their testing with new payloads.

“By attaching different antibodies to extracellular vesicles, we can target them to virtually any tissue and we can load them with other types of drugs as well. Therefore, the treatment has the potential to be used against other diseases and cancer types.”

Elsewhere: Sunburnt Country edition

A hamburger restaurant in Australia was found by the country’s health department to have a horribly unsanitary kitchen — against the law, of course. That has led the government to ban every restaurant in the country from selling hamburgers, even those with legal, pristine kitchens.

Oh, wait. Just kidding.

Actually, it was a single compounder (we won’t use the word “pharmacy”) that was found to be making semaglutide in the equivalent of a garage lab. Still, that one bad compounder has led the Aussie government to forbid any pharmacy from making or selling compounded semaglutide.

Next up: Single reckless driver causes Australia to revoke everyone’s license.

The Long Read: Virus Preppers edition

“The Disease Detectives Trying to Keep the World Safe From Bird Flu”

Science that make us uncomfortable

• Perhaps now isn’t the time to encourage “cow-cuddling.”
• “Robots could be surgically swapping heads within the decade”

Ozempic-sized meals

Nestlé, one of the world’s largest food companies, is jumping on the GLP-1 bandwagon. It’s releasing a new line of $5 pizzas, pastas, and sandwiches “designed specifically for people taking drugs such as Wegovy or Ozempic for weight loss.”

ICYMI: When fish oil hurts

Fish oil supplements to get those omega-3s and protect your heart? Turns out it might not be a good idea. Well, maybe.

A Chinese-American study found that rather than doing good for your heart, “people with no history of heart problems who regularly took fish oil supplements actually increased their risk of atrial fibrillation.” (It’s based on 12 years of data from 415,000 people in the UK, so it’s not a small sample size.)

That first part is the nuance: This only applies to people without heart issues. For those who already have heart disease, “regular fish oil supplementation was linked to a 15% lower risk of progressing to more severe heart problems.”

Big ol’ caveats: This was just observational, and it doesn’t take into account the dose that patients were using. (Higher doses had already been associated with heart issues.) Nor does it determine whether the fish oil is the issue or the omega-3s — what about people who take algae-based versions?

Plant virus vs metastases

The cowpea mosaic virus might not be good for black-eyed peas, but it has the mouse world a-tizzy. Scientists at UC San Diego say a treatment made from the virus “is effective at protecting against a broad range of metastatic cancers in mice.”

By “broad range” they meant colon, ovarian, melanoma, and breast cancer. And note that “protecting” part — it prevents tumors, rather than eliminating them. “We are providing a systemic treatment to wake up the body’s immune system to eliminate the disease before metastases even form and settle,” said the lead researcher.

That’s a useful tool post-tumor surgery, when there’s always a risk of “metastatic seeding” from bits of the tumor that a surgeon missed.

Next up: Expanding the testing beyond mice.

Thems’ offers cheap semaglutide

Hims and Hers, the telehealth company, says it’s going to start selling compounded versions of semaglutide … for $199 a month, cash only. It can do this while the drug is in shortage — after that, the FDA won’t allow compounded versions of the drug.

Axios made much of the Hims and Hers stock price going up, but once the shortage is over that’s gonna take a hit. (And don’t forget the patients who suddenly lose that $199 price and realize they have to keep taking semaglutide….) We’re not suggesting you short-sell the stock, but ….

Captain Obvious knows everything floats down there

“Sewage overflows linked to increase in gastrointestinal illnesses”

Repeat after me

Getting repeated Covid-19 vaccines does not, as some scientists worried, mean the shots become less effective. (The thought was that immunity from the first shots might reduce the effect of later ones.) In fact, Washington University School of Medicine researchers found that more shots might actually be merrier.

[P]eople who were repeatedly vaccinated for COVID-19 — initially receiving shots aimed at the original variant, followed by boosters and updated vaccines targeting variants — generated antibodies capable of neutralizing a wide range of SARS-CoV-2 variants and even some distantly related coronaviruses.

It’s possible that getting regular Covid shots might not only protect against existing Covid variants, but eventually help the body build immunity to new variants as well as “some other coronavirus species as well, even ones that have not yet emerged to infect humans.”

What about the flu vaccine?

If immunity can wane from multiple vaccinations, what about the flu vaccine that we get every year? Chinese scientists looked at about 4,000 patients — half who got the flu, half who didn’t — over four flu seasons. They found that nope, repeated vaccinations didn’t reduce the effectiveness. (They also found that having been vaccinated in the last two seasons helped reduce the risk in the current year, but obviously not as much as getting the latest shot.)

Still nothing to see here

A Michigan farm worker has become the second person to contract H5N1 bird flu from working with cows.