June 06, 2024     Andrew Kantor

“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

 

 

 

June 04, 2024     Andrew Kantor

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.”

 

June 01, 2024     Andrew Kantor

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.

 

May 30, 2024     Andrew Kantor

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.

May 28, 2024     Andrew Kantor

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.

 

May 25, 2024     Andrew Kantor

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

May 23, 2024     Andrew Kantor

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.

May 21, 2024     Andrew Kantor

Reversal of fortune, hormone therapy edition

About 20 years ago, women were told that hormone therapy could increase their cancer risk. But it turns out the people who released that info were bureaucrats, not the scientists doing the study. They were half wrong — and it’s a major half.

It seems that — after a 20-year study of 160,000 women — there’s a very big difference depending on the hormone(s) used.

Estrogen plus progestin therapy does seem to lead to an increased cancer risk, but estrogen only therapy not only doesn’t have that cancer risk, but can reduce it as well as coronary heart disease.

In addition to its beneficial effects on menopause symptoms (which are widely acknowledged), the new study found that, after an average of 10.7 years, “rates of breast cancer were significantly lower in the [estrogen only] group compared with the placebo group.”

Specifically, the study found that “women who took estrogen had a 23% reduction in their risk of breast cancer.”

This jibes with a 2012 study by those shifty Danes that followed women for 26 years “and found that women taking estrogen had a lower risk of heart attack, heart failure or death—and no increased risk of cancer.”

Chantix can help stop vaping

Welp, we’ve now reached the point where we’re looking for ways to help people quit using e-cigarettes. Or, rather, to start treating nicotine addiction rather than just smoking.

The folks at Yale have been testing Chantix, aka varenicline, against vaping, and so far, so good. “We had a 15 percent difference in quit rates, with those in the medication group having a quit rate of 45 percent,” said the lead author of a new study.

What the Elis say about this study is that it mimics the real-world realities. Other studies have paired pharmaceuticals with various forms of therapy, but this one “took a much lighter touch.” Patients were given a brief discussion, a prescription for varenicline, and information about other resources, but then left to their own devices. So that 45% quit rate is pretty darned good.

Swedes find GLP-1 alternative

If you have fat mice, and you’re concerned that GLP-1 drugs are hard to get (and expensive), there’s some good news out of Sweden. A new drug seems to reverse obesity in mice.

While investigating the drug as a cancer treatment — it blocks mitochondrial function — the Swedes found that it …

… led to an unexpected increase in fat metabolism, resulting in a drastic weight loss, a reduction in fat accumulation in the liver and restored glucose tolerance.”

In other words, blocking the cells’ energy production made the mice lose weight. How? They don’t know yet, so the ol’ saw applies: More research is needed.

Oh, sheesh, enough already

Covid cases are likely rising in Georgia and 10 other states as well as Washington, DC.

It’s the same old song

But with different numbers since we last wrote about it.

In 2023 the US — meaning Medicare/-caid, private insurers, and individuals — spent $722 billion on drugs, up 14% (!) from 2022 and the largest increase in 20 years.

What changed? Semaglutide, that’s what. Ozempic, Rybelsus, and Wegovy together accounted for almost $39 billion in spending. (The other big new weight loss drug, tirzepatide, accounted for a mere $13 billion.)

Other factors were more utilization, higher prices for new drugs, an aging population, and of course drug makers raising their prices overall, although surprisingly the latter accounted for only a small bump.

Military drug manufacturing?

Some US senators are suggesting that it’s time for the military to look into producing some of its own medications, as it too grapples with supply-chain and shortage issues. It probably won’t apply to run-of-the-mill drugs, though.

“Most of the time DOD will continue to purchase drugs from the commercial drug market. But there are some instances where it makes sense for DOD to produce the medication itself, for example, when DOD is the only customer.”

There are treatments for infectious diseases that aren’t seen in the US (yet), and where there’s only one US manufacturer — if that. Many have stopped making some of the more obscure treatments because there’s no profit in it. But the military isn’t concerned about making a profit, so it might make sense for it to run its own factories, or at least look into the possibility.

Drug ads are changing

Yesterday a new rule, 14 years in the making, took effect requiring drug ads* to make their side effects clear and readable/hearable. Nolongerwilltheybeabletorattleoffadisclaimerattheend.

The “major statement” of an ad, where the known risks are enumerated, also has to be clear and conspicuous, by limiting distracting audio or visual elements, like a person dancing to an upbeat song.

The bad news or good news, depending on your position, is that pharma companies will still be able to run informercials on social media that say whatever they want because the “ads” come out of the mouths of “influencers.”

* Obligatory “Only the US and New Zealand allow direct-to-consumer drug ads.

May 18, 2024     Andrew Kantor

Dangers of hypertension drugs

Blood pressure meds can double the risk of fractures in nursing home patients. Yeah, double. It’s due to balance issues; standing up can cause a BP drop and enough dizziness to lead to a fall. And once a senior has a serious bone fracture, it’s often a “downward spiral” after that.

This comes out of a Rutgers study of the health records of 30,000 elderly patients in long-term care facilities from 2006 to 2019 to compare their fractures with the drugs they were taking.

It’s even worse for some patients:

Patients with dementia, systolic blood pressure above 139, diastolic blood pressure above 79, or no recent use of blood pressure medication all experienced at least triple the fracture risk of unmedicated patients.

Getting ahead of the next coronavirus

Why wait for the next coronavirus to appear before creating a vaccine? Apparently, that’s what Cambridge researchers were thinking, so they’ve developed a vaccine they say works against a wide variety of them.

It’s pretty simple, actually (well, the idea is): They’ve found regions that appear in a lot of coronaviruses and targeted those, rather than trying to match a specific one. They “trained” it on eight different viruses, and apparently that was enough to make it work against viruses it wasn’t trained on, “including ones that haven’t even been identified yet.”

Said the senior author:

“We don’t have to wait for new coronaviruses to emerge. We know enough about coronaviruses, and different immune responses to them, that we can get going with building protective vaccines against unknown coronaviruses now.”

Masks were overwhelmed by Omicron

When the original Covid-19 started to spread, masks protected a lot of people and probably saved a lot of lives. But here’s a surprise: British researchers figured out that masks made a lot less of a difference once the Omicron BA.2 variant became dominant.

Why? Omicron was so much more transmissible that, statistically, wearing a mask was overwhelmed by other risk factors. (Analogy: A padded dashboard may have saved lives when cars travelled at 15 mph, but by the time they were moving at 65 or 70, seat belts and air bags made much more of a difference.)

Low T, shorter life?

It used to be thought that having higher levels of testosterone could lead to shorter lives for men — that was based on studies of eunuchs* and neutered animals. And then there’s the fact that women generally live longer than men.

But a new Aussie study (a meta-analysis, actually) found that the opposite seems to be true. Men with lower T tended to die sooner.

But wait, there’s more.

A lot of those early-dying men had heart disease, and “the same process underlying heart disease might also contribute to erectile dysfunction.” So ED might not be due to lower testosterone directly, but to heart issues. And that leads to the question, is low testosterone causing heart disease or is it caused by it?

Regardless, the message “Keep your T levels healthy” remains.

* Historical ones in Korea — there probably aren’t many around today

Short takes

Yes, please use sunscreen

No, sunscreen won’t stop you from getting enough vitamin D, no matter what “experts” on social media claim. Even if it did, you can always take a supplement — melanoma is a much bigger concern.

Tampon news

There’s apparently a lot going on in the tampon market, thanks in part to the rise of women’s sports. There are some legit products, but also some products of … let’s just say questionable utility.

Store-brand naloxone

Walgreens is launching its own generic, over-the-counter naloxone nasal spray. It’s currently available online for $34.99 for a pack of two 4-mg doses — 10 bucks less than the Narcan brand — and should be on shelves by the end of May.

Alzheimer’s twist

Current understanding: Your genetics can increase your risk of developing Alzheimer’s.

New idea: For some patients at least, genetics can cause it, period. That means a test could determine years or decades in advance whether someone would develop it.

A new study out of Spain found that up to 1 in 5 Alzheimer’s patients has two copies of a gene variant called APOE4. Almost every one of them eventually developed Alzheimer’s or its markers, “and the authors say that two copies of APOE4 should now be considered a cause of Alzheimer’s — not simply a risk factor.”

By age 55, over 95 percent had biological markers associated with the disease. By 65, almost all had abnormal levels of a protein called amyloid that forms plaques in the brain, a hallmark of Alzheimer’s. And many started developing symptoms of cognitive decline at age 65, younger than most people without the APOE4 variant.

Questions still to be answered: Does this hold true across ethnicities? Could gene editing (looking at you, CRISPR) prevent it? You know the drill: More research is needed.

Warm proteins are different proteins

Drug design often relies on the shapes of various proteins. (You probably know this.) Researchers cool them to make them stable, then [insert science here] to see how various chemicals will react.

Well it turns out — shockingly — that cooling or freezing those proteins changes their shapes; they can be very different when they’re at 98.6°. So testing drug candidates on cold proteins might not reflect how they’ll behave in the body.

Scientists at Michigan’s Van Andel Institute not only figured this out, they also developed a method to study those proteins: They heat ’em to body temperature, then flash-freeze them — that preserves the shape so they can study it properly. And having an image of the body-temp protein is critical, especially with AI doing more and more of the work finding chemical matches.

The Van Andel folks did this with one protein, but they expect that publishing the method will allow other researchers to have more A-ha! moments.

May 16, 2024     Andrew Kantor

Measles vax and C-section kids

Here’s an unexpected finding: There’s almost a 1 in 8 chance that a single dose of the measles vaccine won’t work on a child born by caesarean section.

A study out of the University of Cambridge (with Chinese help) found that 12% of children born via C-section had little or no immune response to their first measles vaccination, compared to 5% of children born vaginally. That makes the second shot — which a lot of kids miss — a lot more important. (And yes, a second shot fixed the problem.)

Some new GLP-1 stats

The usage: A new poll found that about 12% of Americans has taken one of the new weight-loss drugs. Of note is that only 6% say they’re still taking one. Side effects are one reason people quit, but affordability is the big one. “About 54% of those who have taken GLP-1 drugs found it challenging to afford them, even with insurance.”

The payment: The same survey also found that insurance paid part of the cost of the drugs for 57% of people (many of whom still had trouble affording them), and another 24% said insurance paid the full cost.

And speaking of GLP-1s

Here’s an interesting twist. It’s known that GLP-1 agonists can improve patients’ heart health, and it was assumed that was because losing weight is, well, good for your heart. The twist is that a pair of new studies suggests that the heart benefits are due to other mechanisms of the drugs, not simply because of weight loss.

As one researcher put it:

“These two studies show that these anti-obesity medications are also heart-health drugs. The benefits to the heart for people with established cardiovascular disease or a certain type of heart failure occur regardless of the amount of weight loss.”

How did they figure this out? Simple: Not everyone loses weight on semaglutide, but the people who didn’t lose weight still saw the cardiovascular benefits. What these other mechanisms are isn’t clear yet, but enough eyebrows (and bank accounts) were raised to guarantee more research.

When antibiotics kill

When piperacillin/tazobactam went into shortage in 2015, researchers at the University of Michigan saw an opportunity. They were able to look at the data and see how patients who took those drugs compared with those who received cefepime.

After two weeks, there was little difference … “But the differences at three months were dramatic.”

[T]reatment with piperacillin-tazobactam was associated with a 5% increase in 90-day mortality, more days on a ventilator, and more time with organ failure.

Why the difference? Gut bacteria. Unlike cefepime, piperacillin/tazobactam can wipe out the GI tract’s anaerobic bacteria, and those “play important roles in the body’s metabolism, immunity, and prevention of infections.”

Said the lead researcher, “We need to think about antibiotics like chemotherapy. In the right context, treatment can be lifesaving, but in the wrong context it can be quite harmful.”

Overdose deaths drop

For the first time since 2018, overdose deaths have declined in the US — they dropped 3% from 2022 to 2023, according to CDC data.

There are important details, though. Overdose deaths from opioids, cocaine, and stimulants still killed more than 147,000 Americans in 2023. And while opioid OD deaths dropped, those from cocaine and stimulant overdoses both rose slightly.

The changes aren’t uniform across the country, either.

States including Nebraska, Kansas, Indiana and Maine saw declines of 15% or more in such deaths, mostly from opioids, while Alaska, Washington and Oregon reported notable increases of at least 27% compared to 2022, the data showed.

(Sorry, no data about Georgia was available.)

Short Takes

Protect your brain

In case you’re worried, Forbes offers some help with “How Worms Get Into Your Brain And How To Prevent It.”

Don’t use Cue Covid tests

The FDA is warning consumers to throw out any Covid-19 tests made by Cue Health. Apparently the company made changes to the tests without FDA approval, and now the results might be inaccurate.

Medical debt relief on the table

A bill in the US Senate would essentially wipe out Americans’ medical debt. The plan would “eliminate all $220 million in medical debt held by millions of Americans, wipe it from credit reports, and drastically limit the accrual of future medical debt.”

While federal plans to forgive student loans have been divisive politically, there may be more support for wiping out medical debt. The bill sponsors cited an October 2022 poll by the Medicare Plans Patient Resource Center that found 92% of Americans — including 84% of Republicans — favor medical debt forgiveness.