March 29, 2023     Andrew Kantor

Puff, the magic injector

The idea of sending an injection through the skin isn’t new, but it’s always been a bit painful and inexact. Now University of Texas engineers have developed a system that not only delivers a payload through the skin painlessly, but can encapsulate that payload (e.g., vaccines, cancer treatment) as a powder, eliminating the need for refrigeration.

They put the “cargo” inside a metal-oxide framework (MOF) that’s relatively simple and cheap to make. Then a puff of gas delivers a dose — as they’re in Texas, they call it a “bullet.”

Neat trick: By changing the gas used to propel the therapy, they can adjust how quickly the coating dissolves. “If you shoot it with carbon dioxide, it will release its cargo faster within cells; if you use regular air, it will take four or five days.”

They’re testing the system to treat melanoma now, and of course, “research is still ongoing.”

A grad student receives an injection via UT’s “MOF-Jet”

The Georgia DCH is moving…

…to a deluxe apartment in the sky-y-y. Specifically, to 2 Martin Luther King Jr. Drive SE, East Tower, Atlanta, GA 30334. Please make a note of it.

A new omega 3 for the eyes

One of the hallmarks of Alzheimer’s and diabetes is vision loss, but there may now be a treatment for that — a new omega-3 fatty acid that can enter the retina.

University of Illinois researchers have created a new form of docosahexaenoic acid (DHA) that, unlike the kind people can get from fish oil or fish-oil supplements, is able to cross from the bloodstream into the retina, where it “successfully increased DHA in the retina and reduced eye problems associated with Alzheimer’s-like processes.”

(The chemistry: The DHA you know and love is a triacylglycerol or TAG-DHA. This new for is a lysophospholipid or LPC-DHA.)

In case you didn’t know, DHA helps maintain photoreceptors in the retina:

People with Alzheimer’s disease, as well as those with diabetes, retinitis pigmentosa, age-related macular degeneration and peroxisomal disorders, frequently have abnormally low levels of retinal DHA, and visual impairments are common as a result.

The downside: So far this has only been tested in mice, but the UI folks hope it can someday be available as a supplement for we humans.

White House pushes bio development

As part of its plan for a growing US “bioeconomy,” the Biden administration wants to see the country a lot less dependent on drug ingredients from China and India.

The official goal is, “In 20 years, produce at least 30% of the U.S. chemical demand via sustainable and cost-effective biomanufacturing pathways,” and that includes more than just pharma. It’s part of a transition from petroleum-based to bio-based … well, everything.

Calm down there, ACS

The American Chemical Society headline: “Marijuana-derived compounds could reverse opioid overdoses”.

The reality: There are some CBD-based compounds that seem to reduce fentanyl’s ability to bind to opioid receptors, thus — in theory — boosting the effects of naloxone. It’s only been tested in mice, and a lot more research is needed.

The latest coffee research

Drinking a lot of coffee does a body good … and bad. Which of it applies depends on the latest study. That latest one is out of Germany, and it finds that high coffee consumption increases LDL cholesterol but lowers blood pressure — effects that, cardiovacularly, cancel each other out. Sort of.

[M]ajor cardiovascular diseases including heart failure and its diagnostic precursors were not associated with coffee consumption, connoting a neutral role of coffee in the context of cardiovascular health.

Is Himalayan sea salt better for you than store-brand table salt?

No. “Salt is sodium chloride, and Himalayan salt, pink salt, rock salt or sea salt, all of these are also sodium chloride.”

The Long Read: Fentanyl Fear edition

Fentanyl — or, rather, the fear of it — is a boon for pharmaceutical companies, which are coming out with new forms of naloxone with questionable benefits.. But it’s not just pharma companies; law enforcement is getting carried away as well:

The drug’s dangers have, however, have spawned a number of highly misleading, fear-driven narratives. The DEA warned last year of “rainbow fentanyl” disguised to appear like candy, implying that it was meant to target children (the drugs’ bright colors, experts said, have nothing to do with appealing to young people). Numerous police officers have claimed to have overdosed on fentanyl simply from touching it — medically speaking, a near-impossibility.

Short Takes

Pharma R&D: In case you’re curious

Fierce Biotech has the latest rankings of pharmaceutical company research and development spending, which has few surprises — that’s why it’s down here in Short Takes.

Roche spent the most as usual ($14.7 billion) followed by J&J ($14.6 billion) and Merck (a mere $13.6 billion).

Nuts — with a grain of salt

“Eating peanuts and peanut butter could have a beneficial impact on vascular health in young and healthy people” … according to a study funded by the Peanut Institute.

But …

Blueberries — thanks to their anthocyanins (which give them the “blue” part) — might help the body burn more fat during exercise, while decreasing the use of carbohydrates. And that’s according to a study NOT funded by Big Blueberry.

March 28, 2023     Andrew Kantor

A biomarker for type 1 diabetes

It’s possible to know if a baby is likely to grow up to develop type 1 diabetes. Swedish researchers found that “several microbial biomarkers associated with future disease may be present as early as one year” in the gut bacteria of infants, and then take 10 years or more to actually manifest.

The big question they’re hoping to answer next: Does that mean it’s possible to change that biome with, say, prebiotics, and prevent the diabetes from becoming established?

Pharmacy technicians: You need this training

We’ll spell it out for you:

A) People need immunizations this year — and every year. It’s kind of a big deal these days.

B) If you have training giving immunizations, you stand out from the crowd. You’re worth more.

C) The best immunization training you can get comes from the Georgia Pharmacy Association.

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PBM companion bill advances

You hopefully know about the House’s bill to make PBMs behave (see Friday’s Buzz) — the Drug Price Transparency in Medicaid Act. Across the Capitol, the Senate’s version (the Pharmacy Benefit Manager Transparency Act) is moving along as well.

Although the bill had bi-partisan support and passed the Senate Commerce Committee with an 18-9 vote, the PBMs jumped on the fact that the vote wasn’t unanimous, calling the bill “contentious legislation” and saying, “the legislation risks increasing prescription drug costs and would take away—” but the rest was cut off as the PBM spokeperson’s pants caught fire. Well, metaphorically.

The bill should now head to the full Senate.

Who Covid hit hardest

The Lancet just published the largest state-by-state analysis of the impact of the Covid pandemic to tease out what affected Covid’s impact.

It revealed some obvious connections: “States that imposed more protective mandates […] and maintained them for longer, experienced lower infection rates.”

But with a twist: Those mandates didn’t affect death rates — only vaccination coverage made a difference there.

There were some political differences (higher infection and death rates in states that voted heavily Republican in the 2020 presidential election) and some racial differences (higher infection and death rates in areas with the highest populations of Black people).

It also revealed what didn’t make a difference: higher state public health spending and more public health personnel per capita.

And then there’s nuance — having a great healthcare system didn’t always affect outcomes; it depended on the people:

[O]ur results suggest that the more robust a health system, the better a state performed in the pandemic, but only in states where the public was willing to make use of health care services for vaccination or to get early treatment.

FDA: Not so fast, there

Responding to criticism of its accelerated-approval process being a bit too accelerated, the FDA floated draft guidance that would — if it becomes real guidance — require cancer drugs to undergo more rigorous trials before (possibly) getting that accelerated approval.

Osteo drugs also prevent other death

People with osteoporosis have a risk of dying after a fracture, but it turns out that certain drugs for the condition also help reduce patients’ overall risk of death.

The drugs (to cut to the chase) are alendronate/risedronate, denosumab, and zoledronic acid. Sure, they can reduce the risk of hip fracture, but what’s unusual is that those drugs reduced the chances of patients dying from other conditions. Why? They don’t know yet.

As one endocrinologist not part of the study wrote separately:

This plus other evidence has led to the hypothesis that drugs for osteoporosis, particularly bisphosphonates, might have salutary effects on tissues other than bone.

While we’re talking about bones…

A Dutch study found that when people have weak bones, they’re also more likely to be diagnosed with dementia. Although it’s not entirely clear why there’s a connection, two (of many) possibilities are that poor nutrition results in both conditions, or that the poor bone mass is a result of dementia via a yet-unknown mechanism.

Covid Short Takes

It’s that time of year

It’s been so long since Covid boosters were a talking point that … welp, now it’s time to think about the next round of boosters. Britain and Canada gave them the A-OK, but the US is weighing options.

A preventative, but not a vaccine

Finnish researchers have developed a nasal spray that prevents Covid-19 infection and works against every known variant. The downside: It only works for a few hours. The upside: That’s long enough for, say, dinner and a movie during a future pandemic.

One thing that doesn’t increase Covid death

Old wisdom: Having a substance-abuse disorder increases someone’s risk of death from Covid-19. New data out of Boston Medical: Nope.

In this retrospective cohort study of patients admitted to a safety net hospital during the early phase of the Covid-19 pandemic, [substance-abuse disorder] was not associated with the primary outcome of Covid-19-associated inpatient mortality.

March 25, 2023     Andrew Kantor

Magnesium vs brain shrinkage

Getting at 550 mg of magnesium a day seems to reduce a person’s risk of dementia and make their brain younger — that’s according to Aussie researchers’ study of about 6,000 people.

[P]eople who consume more than 550 milligrams of magnesium each day have a brain age that is approximately one year younger by the time they reach 55 compared with someone with a normal magnesium intake of about 350 milligrams a day.

It doesn’t make magnesium a cure, but it does imply that “a higher intake of magnesium in our diets from a younger age may safeguard against neurodegenerative diseases and cognitive decline by the time we reach our 40s.”

Long Covid notes

Risk factors

There are plenty of mysteries around long Covid — who gets it, why the symptoms are so varied, how to treat it — but a new analysis by British researchers may have some clues.

Based on 41 studies of more than 860,000 patients, they’ve teased out who’s most at risk.

[insert drumroll here]

The answers, in order of the amount of risk (per the study, not the news article):

  1. Previous hospitalization with Covid
  2. Other medical conditions (e.g., immunosuppressive conditions, COPD, heart disease, asthma, anxiety, depression, chronic kidney disease, or diabetes)
  3. Being female
  4. Being over 40
  5. Obesity
  6. Smoking

And, not surprisingly, being vaccinated cut the risk substantially.

Nirmatrelvir helps

The antiviral that’s half of Paxlovid can cut the risk of long Covid by 26% in patients who had at least one risk factor (see above, although gender wasn’t a factor).

It can also cut their risk of death by 47%, which implies that, when it comes to Paxlovid, nirmatrelvir is doing a lot of the heavy lifting.

It’s changing our genome

Specifically, it’s messing with the chromatin architecture of cells — that’s what holds the genetic material together. When the chromatin is changed by the SARS-CoV-2 virus, that’s “known to exert long-term effects on gene expression and phenotypes,” as the University of Texas researcher explained.

More research is needed (always!), but they’re thinking this might be a clue to what causes long Covid.

Take note, but maybe not worry

The headline: “Hormonal Birth Control, No Matter Which Kind, Linked to Breast Cancer”.

The reality: Progestin-only contraceptives are linked to a slight increase in the risk of breast cancer. Previous studies had found that same slight risk with progestin/estrogen combos.

Better sleep, less harm

Young people at risk of suicide or self harm might do well to take melatonin to get better sleep. Swedish researchers doing an observational study found a connection between melatonin use and reduced self-harm rates.

The risk of self-harm increased shortly before melatonin was prescribed and decreased by about half in the months following the initiation of treatment. Risk reduction was particularly evident among adolescent girls with depression and/or anxiety disorders.

They were careful to point out that they’ve only found an association between reduced self-harm and melatonin, so they can’t assign cause and effect. You know the drill: More research is needed.

Yesterday, bird flu; today, cat poop

While you’re thinking about the possibility of bird flu jumping to humans, here’s another concern. Scientists in California have found a “particularly unusual strain” of Toxoplasma gondii — a parasite common in cat poop (and that pregnant women need to be wary of).

Unusual in the fact that it “appears to be capable of rapidly killing its host.” And when it doesn’t, T. gondii in humans is “linked to higher rates of suicide, rage, traffic accidents and schizophrenia.”

The new strain has already infected sea otters, so … yeah, add it to the list.

Short Takes

Elsewhere: And then there were 40

North Carolina became the 40th state to expand Medicaid to more lower-income people.

Dogs are getting resistant hookworms

Dogs in the U.S. are increasingly being infected by parasitic hookworms that are resistant to the normal benzimidazole treatment. (Benzimidazole is also used to treat hookworm infections in humans, although those worms are a different species.)

March 24, 2023     Andrew Kantor

Women fight better, not harder

We’ve known for a while that men are more vulnerable than women to infection. (Here’s an article from 11 years ago.) But why? A new study might have the answer — it’s all about a gene called UTX.

It’s weird, see, that men have more natural-killer (NK) immune cells, but women fight infection better. The reasons (UCLA researchers think) is that women’s NK cells are more efficient than men’s, thanks to an extra copy of that UTX gene.

UTX acts as an epigenetic regulator to boost NK cell anti-viral function […] “It turns out that females have more UTX in their NK cells than do males, which allows them to fight viral infections more efficiently.”

And that means, they say, “[W]e will need to incorporate sex as a biological factor in treatment decisions and immunotherapy design.”

Congress takes on PBM spread pricing

A big shout-out to Georgia’s US representatives Buddy Carter and Rick Allen — they were part of the bipartisan group that introduced the Drug Price Transparency in Medicaid Act, which would ban PBM spread pricing in Medicaid programs. I.e., no longer would PBMs be allowed to charge Medicaid more for a medication than it paid to pharmacies.

Said Carter:

“PBMs have been allowed to rob patients, small businesses, and taxpayers blind for decades. […] With this bill, we can hold PBMs accountable for their role in increasing the cost of health care and pocketing taxpayer money.”

Captain Obvious needs at least an hour

Thirty-Minute Lecture Not Enough for Residents to Develop a Thorough Understanding of Spinal Cord Injury Emergencies

Today Ozempic, tomorrow … something else

A not-always-healthy fixation not only on weight loss, but on quick-fix weight loss, won’t end with Ozempic. So muses a Northeastern U psychologist.

“There have been weight loss drugs since the 1930s. They inevitably are shown to have dangerous side effects. They are typically popular for a short term and then are revealed to be dangerous and are replaced with something else.”

Then again, anecdotes are pretty powerful

Got low-back pain? Pop an ibuprofen or Tylenol, right? Or maybe don’t bother. A new analysis in the BMJ found that there’s actually very little evidence (of the non-anecdotal variety) that analgesics actually work for acute low- back pain. In fact, that even extends to muscle relaxants and anti-convulsants.

That’s not to say they don’t work, just that there’s “considerable uncertainty around effects for pain intensity and safety.”

Help for hamsters

With all the effort put into human vaccines against Covid-19, you’re probably wondering “What about the hamsters?” Fear not, dear reader, for UCLA researchers were also concerned, and they’ve gone ahead and developed not only a Covid-19 vaccine for hamsters, but one that’s inexpensive, universal, and given orally.

Unlike current human vaccines, this one is based on the nucleocapsid protein — that’s important because it tends to evolve more slowly than other proteins, giving the vaccine its “universal” feature — “the vaccine is resistant to the incessant mutations of the SARS-CoV-2 spike protein upon which virtually all current vaccines are based.”

The Long Read: Cannabis and brain formation

Smoking while pregnant: bad. Alcohol while pregnant: bad. So why would cannabis (or its derivatives) be any different?

They’re not, as a psychiatrist and neuroscientist explains — they’re dangerous for developing brains, period.

Short Takes

Breaking (up) bad

The Biden Administration will be breaking up the Congress-created United Network for Organ Sharing (UNOS) — the almost 40-year-old non-profit that has been running the nation’s organ-transplant network … poorly.

Shortages are widespread

New drug shortages rose 30% in just a year — between 2021 and 2022. “Towards the end of 2022, a peak of 295 individual drugs were considered in short supply — impacting treatment for everything from colds to cancer.”

Side note: Somatropin, the growth hormone, is the latest to get press.

March 23, 2023     Andrew Kantor

A tune full of music helps the chemotherapy go down (maybe)

The right music might reduce the nausea from chemo. And by “right music” Michigan State researchers mean “your favorite tunes.”

Their hypothesis: Music can improve a mood and thus reduce pain an anxiety, i.e., it has neurological effects. And, the MSU folks figured, “Chemotherapy-induced nausea is not a stomach condition; it is a neurological one.”

The small study (12 patients, 64 “events”) found that nausea severity did in fact decrease with the music, although they caution that it could be “the gradual release of the medication doing its job” rather than the music. Thus the next step will be to measure serotonin levels at the same time to determine the music’s effect.

Eat what you want!

Look out, Ozempic. University of Texas medical researchers have tested a drug that lets mice eat a Western high-sugar, high-fat diet and still lose weight.

The trick is cutting down the amount of magnesium that mitochondria can transport. When magnesium is plentiful, the mitochondria produce less energy and store more for later — as fat, of course. (And yes, the article is sure to explain that mitochondria “are cells’ power plants.”)

Deleting MRS2, a gene that promotes magnesium transport into the mitochondria, resulted in more efficient metabolism of sugar and fat in the power plants. The result: skinny, healthy mice.

The drug, which the researchers call CPACC, accomplishes the same thing. It restricts the amount of magnesium transfer into the power plants.

First they filed for a patent. Now they’re doing more research, including seeing if the results carry over to humans.

New drugs, positive trials

For ovarian cancer

Upifitamab rilsodotin has been considered as a treatment for ovarian cancer, and now it’s showing serious promise — it passed its phase-2 trials (it’s safe and effective) and is now going into phase-3 to find the right dosage and determine just how well it works in the real world.

For leukemia

A small, early trial found that revumenib, an experimental drug, achieved complete remission in 18 patients with leukemia.

“Revumenib works by inhibiting the activity of a protein called menin, which scientists say plays an important role in certain forms of leukemia.”

(But wait. If menin sounds familiar, that’s because it’s the target of a supplement that hopes to increase menin levels — low levels have been associated with low bone mass and skin thickness, cognitive decline, and even reduced lifespan.)

Good news about long Covid

For most people now, catching Covid-19 means at worst a dose of Paxlovid and a really bad cold. The big fear isn’t Covid itself, but long Covid — brain fog and muscle aches and worse for a year or more.

Good news: It seems that catching Omicron means having a much lower risk of long Covid.

A group in the United Kingdom, Spain, and Italy reported this month in The Lancet Oncology that the risk of Long Covid among cancer patients fell from about 17% in 2021 to 6% more recently, as cases shifted to Omicron.

Is it “an intrinsic property of Omicron”? The fact that that many people have been vaccinated or exposed? They aren’t sure, and one researcher point out that low risk isn’t no risk. “ “I definitely don’t want to get the virus.”

It could be a tick bite

People with unexplained gastrointestinal issues might have been a victim of a bite from the lone star tick … months ago.

The American Gastroenterological Association is letting healthcare folks know that it’s worth checking if “unexplained digestive symptoms are due to alpha-gal syndrome” caused by the tick. (Alpha-gal syndrome essentially makes you allergic to meat from mammals — the best kind of meat.)

Clinicians should consider alpha-gal syndrome in patients with unexplained gastrointestinal symptoms of abdominal pain, diarrhea, nausea and vomiting, particularly those who live or have lived in an alpha-gal–prevalent area (this includes the Southeast, mid-Atlantic, Midwest and East Central U.S. regions)

Not creepy at all

You go to the hospital and get a routine(ish) ECG. No big whoop. But then the robotic voice of the hospital’s AI says, “You will die within 8 months. Accuracy: 85 percent.” And worse, it’s in a Canadian accent.

A research team at the University of Alberta has developed just such a system. Trained on 1.6 million ECGs done on 244,077 patients over 12+ years…

The algorithm predicted the risk of death from that point for each patient from all causes within one month, one year and five years with an 85 per cent accuracy rate, sorting patients into five categories from lowest to highest risk.

And if it has age, sex, and other lab results it’s even more accurate.

Short Takes

The feds won’t be marching in

No, the National Institute of Health won’t use the federal government’s “march-in” rights to essentially take over Astellas and Pfizer’s Xtandi patent. Xtandi is widely available and “NIH does not believe that use of the march-in authority would be an effective means of lowering the price of the drug.”

P&G gets NyQuil warning

The ingredients are supposed to be acetaminophen, dextromethorphan HBR, phenylephrine, and guaifenesin.

The ingredients on the label are acetaminophen, dextromethorphan HBR, doxylamine succinate, and phenylephrine.

The FDA is … displeased.

March 22, 2023     Andrew Kantor

Shortages hit onco meds

The Adderall shortage gets the most press, but there are a lot more drugs in shortage — especially those for cancer patients. It’s a perfect storm of manufacturing problems, few companies making them, and little incentive for private industry to bother thanks to low profit margins.

There’s not much the FDA can do other than ‘quickly approving acceptable workarounds.’ As one FDA official put it, “[T]he underlying reality of this market remains what it is.”

Latest peanut-allergy treatment

The quest for a peanut-allergy preventative continues. The latest contender comes out of the University of North Carolina, where researchers have created a dissolving sublingual … lozenge? patch? that contains the equivalent of 175 of a peanut kernel.

In testing with (human) children, they found that the treatment, called SLIT (sub-lingual immunotherapy), protected kids from reactions to accidental peanut exposure for more than 17 weeks.

Important caveats: It’s not clear how often the kids take the treatment — possibly daily. And the kids who were desensitized had taken the treatment for 48 months, so it’s not a quick solution.

The Origin of Covid

All American info to be released

President Biden signed a bill — passed unanimously* by Congress — requiring US agencies to declassify all information we have related to the origin of Covid-19. That presumably includes any reports in Biden’s Delaware garage or on Donald Trump’s Mar-a-Lago nightstand.

Some data that could expose our intel-collecting methods would still be redacted, but you kinda have to wonder why we’re classifying this kind of information in the first place.

* Holy moly!

Yet more data points to raccoon dogs

Chinese genomic data from the Huanan market in Whuan was uploaded to an international database and then removed, but it was available long enough for a group of American and French scientists to snag it and parse it.

The info it contained furthered the idea — which came out last week — that the SARS-CoV-2 virus jumped naturally, possibly from raccoon dogs.

The sequences showed that raccoon dogs and other animals susceptible to the coronavirus were present in the market and may have been infected, providing a new clue in the chain of transmission that eventually reached humans […]

“This adds to the body of evidence identifying the Huanan market as the spillover location of Sars-CoV-2 and the epicentre of the Covid-19 pandemic.”

Preparing for the bird flu

Seals, porpoises, bears, pigs — the “bird” flu (soon to be renamed bflu, right?) is infecting more and more mammals. It’s only a matter of time before it jumps to humans in a spreadable way.

Good news for those of us living in a rich nation: Vaccine makers are preparing or making the vaccine (or updating it to match the latest variants), and the countries that can are guaranteeing their supplies ahead of time. Just in case.

The polite word is chutzpah

The CEO of Moderna says that the $10 billion of US-taxpayer dollars given the company to develop its Covid-19 vaccine “played little role in the vaccine’s development.” It was private investors, he claimed, that paid for it.

Uh-huh.

This is his way of justifying jacking up the vaccine’s price by 400%. But of course he didn’t address the federally funded research that also helped develop the mRNA technology:

Moderna developed its vaccine with federal researchers at the National Institutes of Health. Moderna partnered with the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) in 2016 to create a general design for mRNA vaccines. In December, Moderna paid the NIH $400 million for borrowing a molecular technique developed by NIH researchers for the design of the company’s vaccine.

…nor the company’s $36 billion in vaccine sales. Nor the fact that Moderna conveniently left off the names of NIAID from its vaccine patent….

ICYMI: Stick with Woolite

If you have a lot of dry cleaning done, consider this: A new paper in the Journal of Parkinson’s Disease explains that one of the popular chemicals used, trichloroethylene, is linked to Parkinson’s. (“Linked” doesn’t necessarily mean “causes” — more research is needed.)

TCE is lipophilic, meaning that it tends to dissolve in fatty tissues. Because of this, it is able to easily move into the brain and other body tissues and wreak havoc on cell mitochondrial function. Dopamine-producing cells are particularly sensitive to this type of toxin, which could explain why TCE exposure can lead to Parkinson’s disease.

Coffee drinkers: Trichloroethylene is also used in some decaffeination processes, so maybe look for “Swiss Water Process” instead….

The Long(ish) Read: Gut drugs to fight depression

The future of antidepressants could be drugs that adjust the gut microbiome.

One study found that taking a probiotic was associated with a reduction in negative mood. Another found that administering Bifidobacterium longum to patients with irritable bowel syndrome reduced depression, while 2022 research found that gut microbes are associated with levels of depressive symptoms.

Short Takes

From pandemic to endemic … finally?

COVID-19 Deaths in U.S. Drop to Near Pandemic Low”: Last week saw 1,706 Covid-19 deaths in the US — the lowest number since March 25, 2020, and fewer than 250 Americans a day.

New eczema treatment

Two clinical trials have found that Eli Lilly’s lebrikizumab works well against atopic dermatitis, meaning the drug could soon have FDA approval and add to the arsenal of eczema treatments.

March 21, 2023     Andrew Kantor

Xtandi expands

Patients with non-metastatic hormone-sensitive prostate cancer often take leuprolide monotherapy, but now a new study from Astellas and Pfizer shows that the 800-lb. gorilla in the prostate cancer space is a better choice:

Both Xtandi alone and a combination of Xtandi and hormone therapy leuprolide beat leuprolide monotherapy in patients who had high-risk recurrence.

(That in mind, Pfizer is looking to see if Xtandi can also be paired with PARP inhibitor Talzenna.)

MRSA killer, qu’est-ce que c’est?

When simple staphylococcus aureus goes MRSA, it’s practically the poster child for antibiotic resistance.

Now a group of those shifty Danes has found a potential treatment for both resistant and non-resistant staph infections: a new, artificially produced lysin (or endolysin if you prefer) that’s staph-specific.

“The great thing about this enzyme is that it has been designed to penetrate the wall of staphylococcus aureus. This enables it to target and kill the harmful staphylococcus and leave harmless skin bacteria unharmed.”

Assuming it pans out, it would not only be a useful staph/MRSA treatment in general, it could be a very big deal for skin lymphoma patients for whom staph infections can be deadly.

Sucralose danger … and therapeutic potential

Mice who eat a lot of sucralose — aka Splenda, the artificial sweetener found in a ton of soft drinks and other foods*, have a lower immune response. Sounds bad, but But wait! The Francis Crick Institute scientists who discovered this are a glass-half-full group. Their takeaway:

If found to have similar effects in humans, one day it could be used therapeutically to help dampen T-cell responses. For example, in patients with autoimmune diseases who suffer from uncontrolled T cell activation.

* Are soft drinks “foods”? Discuss.

Building a better cancer-fighter cell

Immunotherapy for cancer is effective, but getting enough immune cells can be a problem — they aren’t something a donor can provide. But wait! Swiss researchers have found a way to replace some proteins in donor cells with Folger’s Crystals synthetic molecules, allowing patients to receive donated white blood cells.

In short: The tweak keeps donated antibodies from attacking a patient’s body (and vice -versa), but — by using a bit of chemistry — those antibodies can be attached to a tumor where it will attack.

If the work pans out (“The technology has been tested in the lab in human cells, but it will take more time and development before the patients can benefit from the technology”), it could be a huge boost for cancer treatment.

Captain Obvious knows you can’t eat the Oreos if you don’t have the Oreos

Odds of Opioid Overdose Up With Household Opioid Availability

The Long Read: When Politics Trumps Science edition

How the Covid-from-a-lab-leak idea went from crazy idea to slightly less crazy idea to political theater with science on the sidelines.

(Of course the big question is, if we could determine with 100% accuracy where the virus came from, how would that info change what we’re doing?)

Short Takes

10,000 Instagrammers sigh in relief

Supplies of Mounjaro and Ozempic have been replenished.

Elsewhere: Californ-I-A’s insulin project

California’s homegrown, affordable insulin project continues apace. The state has announced that Civica will be its partner in producing and selling the $30/10ml insulin (glargine, lispro and aspart). It’s expected to save the state (patients and taxpayers) millions.

Two blind mice

Using CRISPR-based gene editing, Chinese scientists were able “to bring back vision in mice with retinitis pigmentosa,” a retinal condition that’s one of the major causes of human blindness (i.e., 1 in 4,000 people have some vision loss because of it).

 

March 18, 2023     Andrew Kantor

Facing big clawbacks, another insulin price cut

Sanofi is the latest company to cut its insulin prices in the US. Like Eli Lilly and Novo Nordisk before it, the company was facing millions in Medicaid rebates if it didn’t.

The companies said they decided to lower costs to ensure that patients could afford their medications. But Novo Nordisk and Sanofi’s changes kick in on Jan. 1 and coincide with the elimination of a cap that limits how much manufacturers have to rebate Medicaid.

Cooling the hot flashes

It was developed to treat schizophrenia, but British scientists found that a compound (with the memorable name MLE4901) can also prevent hot flashes in menopausal women. In fact, it knocked out 72% of those flashes — and started working within 3 days.

Also, the women reported that the number of hot flashes that disrupted their sleep at night fell by 82 percent and that they experienced 77 percent less impairment to concentration when on the drug.

Bonus: Includes our favorite phrase: “game-changer”!

Tomorrow, on your supplement shelf….

The quest for immortal mice continues. The latest target: effects of the protein menin. When menin levels get lower with age, it leads to “reductions in bone mass and skin thickness, cognitive decline, and modestly reduced lifespan.”

It also means less production of the amino acid D-serine. So what happens if you increase that D-serine level? Would it counteract the menin loss? As a matter of fact, yes. When Chinese scientists gave mice supplements of D-serine…

…[they] found improved skin thickness and bone mass, along with better learning, cognition, and balance, which correlated with an increase in D-serine within the hippocampus.

And that was after just three weeks. So should you rush out to take D-serine supplements? Probably not. It’s hard to find and, of course, more research is needed.

Thinner people, thinner wallets

If Medicare opts to cover the new crop of obesity meds, it could clobber the system’s finances. Not only are drug companies charging through the roof for the meds, they need to be taken for life to have continued effect.

Presently, Medicare is forbidden by law from paying for antiobesity prescriptions. But should the bipartisan The Treat and Reduce Obesity Act get reintroduced and passed by Congress, Medicare will be compelled to cover drugs for weight loss.

Health economists estimate that those drugs would make up almost 20% of Medicare’s entire budget.

A prescription for breakup food

The good news: Eating after a breakup can soothe your broken heart.

The bad news: Artichokes top the list of best foods to do the job.

The better news: Dark chocolate isn’t far behind.

The unsurprising news: Soup is on the list, too.

And so the pendulum swings

New science indicates that the Covid-19 pandemic did, in fact, originate from wild animals in the Wuhan market, not from a lab leak. (For what it’s worth, this is from a team of virus experts, not a government department.) The possible culprit: raccoon dogs.

[T]he analysis did establish that raccoon dogs — fluffy animals that are related to foxes and are known to be able to transmit the coronavirus — deposited genetic signatures in the same place where genetic material from the virus was left, the three scientists said. That evidence, they said, was consistent with a scenario in which the virus had spilled into humans from a wild animal.

The Long Read: Better Cardio Marker edition

Instead of LDL cholesterol levels, lipids called ceramides are gaining attention as better biomarkers for cardiovascular disease. There’s only one testing lab, and cardiologists are only now learning to look at them. But…

The first drugs specifically designed to lower ceramide levels are also on the horizon, with at least two companies hoping to begin clinical trials within the next year or so.

Short Takes

But will it be in time?

The Dutch have two potential vaccines against bird flu.

ICYMI: We’ve got a maternal problem

The maternal death rate in the United States rose 38% in 2021 to its highest rate in 60 years, likely in large part because of the pandemic. We continue to have highest rate in the developed world — we’re talking triple that of the European Union and worse than Kazakhstan, Iran, and even North Macedonia.

 

March 17, 2023     Andrew Kantor

Pfizer’s bad packaging

Pfizer is recalling its Nurtec ODT migraine med because the packaging isn’t child resistant. It’s going to release the drug with new, safer packaging shortly, in the meantime patients should lock it up, and …

As an interim measure, the company has instructed pharmacists to place the drug packet in a child-resistant vial before dispensing it to patients.

To be clear: There’s nothing at all wrong with the drug, it’s just the packaging that’s an issue.

Common cold comfort

Why did Covid-19 hit kids less hard than adults? It might be because kids get colds more often, and the common could could protect them from the ravages of Covid.

Swedish researchers, in fact, have some good evidence of that: They found that one of the viruses that causes the common cold — OC43 — boosts the immune system against SARS-CoV-2, so kids already have T-cells programmed to attack. And because the response grows weaker as we age, it gives kids that extra oomph of protection.

Probiotics vs depression?

Could probiotics help treat depression? Yes, say Malaysian researchers, but. And — despite what you might read on social media — it’s a big but.

The yes: “It has been proven that different strains of probiotics exert anti-depressive potential via distinct mechanisms,” they write. Low amounts of Lactobacillus and Bifidobacterium, for example, seem to correlate with higher depression risk, while higher levels of Eggerthella is associated with major depressive disorders.

The but: That’s all great in theory, but finding the actual probiotic cocktails to help treat depression — a simple pill or food — “will be challenging and elusive.” There just haven’t been enough studies, and we know how complex the microbiome is.

Still, they say, it’s worth studying:

[I]t seems only fitting that scientists and industrialists consider developing probiotic strains that effectively ameliorate depression by tackling different neurobiological and genetic bases of this disorder.

Methadone in the news

Help when cocaine is a problem, too

Enough people who are being treated with methadone for opioid abuse also use cocaine. When treating someone for abusing one drug, it’s hard to also treat them for abusing another, even though most of them want help. But there may be a solution: bupropion and cash.

Johns Hopkins researchers found that a combination of giving participants bupropion and paying them for negative cocaine tests reduced their cocaine use — but only getting cash or only getting bupropion didn’t do much.

That said, the scientists think that after the initial help from the cash/bupropion combo, bupropion alone might help keep them off the drugs.

Closer clinics in Canada

How easy is it for someone to get methadone treatment for opioid-use disorder? A lot easier in Canada than in the US. Not because of getting approval, but because of distance.

[T]he average driving distance to the closest methadone clinic accepting new patients was more than three times greater in the U.S. compared to Canada.

And that’s for treatment, period. If someone needs it fast — within 48 hours — those in the US have travel more than five times farther than the Canucks, and that’s even with our Canadian friends swerving to avoid moose and Tim Horton’s randomly popping up.

The Long(ish) Read: So Many Viruses edition

What’s with all the viruses in the news lately? Are more appearing, or are we just better at tracking them? A virologist explains why it’s a bit of both.

Short Takes

Upcoming for Paxlovid

Pfizer has said that once its anti-viral Paxlovid gets full FDA approval for adults, it will still be covered by the emergency-use authorization for high-risk adolescents. (Eventually the company hopes to have full approval for the younger set, too.)

Elsewhere: Ketamine clinics close suddenly

The 9-state chain of Ketamine Wellness Centers has closed without warning — apparently for patients or for staff.

 

March 16, 2023     Andrew Kantor

Feds sue Rite-Aid

It’s not quite part of the whole opioid mess, but it’s close. The DoJ is suing Rite-Aid for filling obviously unnecessary or off-label-in-a-questionable-way prescriptions, like “‘trinities,’ a combination of opioids, benzodiazepine, and muscle relaxants preferred by drug abusers for their increased euphoric effect.”

But it wasn’t entirely about the pharmacists, some of whom knew something was afoot.

The Justice Department also said Rite Aid intentionally deleted some pharmacists’ internal warnings about suspicious prescribers, such as “cash only pill mill???”, while admonishing them to “be mindful of everything that is put in writing.”

Saving you a click

Too much of this ingredient leads to autoimmune diseases”.

Salt. It’s too much salt.

[I]t is bad for immune cells, creating patterns of gene expression and activity seen in a variety of autoimmune diseases such as multiple sclerosis, lupus, rheumatoid arthritis, and type-1 diabetes.

27 drugs slated for clawbacks

HHS has released the list of the first 27 drugs that pharmaceutical companies will have to pay rebates on because they raised the prices faster than the rate of inflation.

Not only will the companies be refunding taxpayers’ money, but going forward Medicare’s 20% co-pay will be adjusted for those drugs to be 20% of the inflation-adjusted price rather than the pharma-companies’ price. (That co-insurance amount will be adjusted each quarter as HHS tracks drug prices and the inflation rate.)

Here’s a chart that helps (click to enbiggen):

Once again, the tired old line about paying for research and development is shown to be a load of hooey: One of the drugs affected, Pfizer’s Fragmin, was approved almost 30 years ago.

CMS’s detailed explanation is here (2-page PDF).

Down the road: a bitter asthma treatment

There are bitter-taste receptors outside of the mouth, including in the lungs, and they have an interesting quality: When activated, they help open the airways.

Hmm. Sounds like a potential target for asthma or COPD treatment. That’s what German researchers thought, and they also knew that the NSAID flufenamic acid can activate some of those receptors … just not very well.

The next step: Create a more potent analog and test it therapeutically. They found that — as you probably guessed — “replacing a phenyl ring with a 2-aminopyrimidine and substituting a tetrazole for a carboxylic acid group was a promising strategy” — and have already created a compound that’s six times more potent than flufenamic acid.

Right now it’s all in the lab stage, but new treatment pathways are always welcome.

Use pharmacy techs to help cancer patients

Patients who need oral oncolytics probably have a high enough level of stress already, and being hit by the high cost of the meds just adds to the pain.

Who can help? Pharmacy technicians — especially those trained in retail pharmacies. So explains one CPhT in Drug Topics.

“We know how the pharmacy system works and how prescriptions are billed. And we are familiar with copay cards and the terms they work under.”

They also know where to look for copay cards (beyond a Google search), which ones will work with Medicare part D, and what other patient assistance programs are available.

Captain Obvious sticks to this week’s challenge

Mpox Information On TikTok Videos Often ‘Unreliable And Incomplete,’ Study Finds”

Short Takes

Cough syrups off the shelves

Both the EU’s and UK’s version of the FDA* are pulling OTC cough meds that contain pholcodine because of potential allergic reactions.

* The European Medicines Agency and the Medicines and Healthcare products Regulatory Agency, respectively

Just gonna put this out there

Skunks in Canada were found to have been killed by the H5N1 bird flu.