health

“outrageously”-priced-weight-loss-drugs-could-bankrupt-us-health-care

“Outrageously” priced weight-loss drugs could bankrupt US health care

bernie sanders, GLP-1, health, health care costs, medicaid, medicare, premiums, Science, wegovy, weight loss / /

Collision course —

Prices would need to be dramatically slashed to avoid increasing the national deficit.

–

Packaging for Wegovy, manufactured by Novo Nordisk, is seen in this illustration photo.

Enlarge / Packaging for Wegovy, manufactured by Novo Nordisk, is seen in this illustration photo.

With the debut of remarkably effective weight-loss drugs, America’s high obesity rate and its uniquely astronomical prescription drug pricing appear to be set on a catastrophic collision course—one that threatens to “bankrupt our entire health care system,” according to a new Senate report that modeled the economic impact of the drugs in different uptake scenarios.

If just half of the adults in the US with obesity start taking a new weight-loss drug, such as Wegovy, the collective cost would total an estimated $411 billion per year, the analysis found. That’s more than the $406 billion Americans spent in 2022 on all prescription drugs combined.

While the bulk of the spending on weight-loss drugs will occur in the commercial market—which could easily lead to spikes in health insurance premiums—taxpayer-funded Medicare and Medicaid programs will also see an extraordinary financial burden. In the scenario that half of adults with obesity go on the drug, the cost to those federal programs would total $166 billion per year, rivaling the programs’ total 2022 drug costs of $175 billion.

In all, by 2031, total US spending on prescription drugs is poised to reach over $1 trillion per year due to weight-loss drugs. Without them, the baseline projected spending on all prescription drugs would be just under $600 billion.

The analysis was put together by the Senate’s Health, Education, Labor, and Pensions (HELP) committee, chaired by staunch drug-pricing critic Bernie Sanders (I-Vt). And it’s quick to knock down a common argument about the high prices for smash-hit weight-loss drugs. That is, with their high effectiveness, the drugs will improve people’s health in wide-ranging ways, including controlling diabetes, improving cardiovascular health, and potentially more. And, with those improvements, people won’t need as much health care, generally, lowering health care costs across the board.

But, while the drugs do appear to have wide-ranging, life-altering benefits for overall health, the prices of the drugs are still set too high to be entirely offset by any savings in health care use. The HELP committee analysis cited a March Congressional Budget Office (CBO) report that found: “at their current prices, [anti-obesity medicines] would cost the federal government more than it would save from reducing other health care spending—which would lead to an overall increase in the deficit over the next 10 years.” Moreover, in April, the head of the CBO said that the drugmakers would have to slash prices of their weight-loss drugs by 90 percent to “get in the ballpark” of not increasing the national deficit.

The HELP committee report offered a relatively simple solution to the problem: Drugmakers should set their US prices to match the relatively low prices they’ve set in other countries. The report focused on Wegovy because it currently accounts for the most US prescriptions in the new class of weight-loss drugs (GLP-1 drugs). Wegovy is made by Denmark-based Novo Nordisk.

In the US, the estimated net price (after rebates) of Wegovy is $809 per month. In Denmark, the price is $186 per month. A study by researchers at Yale estimated that drugs like Wegovy can be profitably manufactured for less than $5 per month.

If Novo Nordisk set its US prices for Wegovy to match the Danish price, spending to treat half of US adults with obesity would drop from $411 billion to $94.5 billion, a roughly $316.5 billion savings.

Without a dramatic price cut, Americans will likely face either losing access to the drugs or shouldering higher overall health care costs, or some of both. The HELP committee report highlighted how this recently played out in North Carolina. In January, the board of trustees for the state employee health plan voted to end all coverage of Wegovy and other GLP-1 drugs due to the cost. Estimates found that if the plan continued to cover the drugs, the state would need to nearly double health insurance premiums to offset the costs.

“Outrageously” priced weight-loss drugs could bankrupt US health care Read More »

ultra-spicy-one-chip-challenge-chip-contributed-to-teen’s-death,-report-says

Ultra-spicy One Chip Challenge chip contributed to teen’s death, report says

capsaicin, Carolina Reaper pepper, death, died, health, heart defect, Naga Viper Pepper, One Chip Challenge, Paqui, Science, teen / /

Tragic —

The high dose of capsaicin paired with a heart defect appear to have contributed.

–

Ultra-spicy One Chip Challenge chip contributed to teen’s death, report says

An autopsy report of a Massachusetts teen who tragically died hours after eating an ultra-spicy tortilla chip suggested that his death was due to the high dose of spice in the chip and a congenital heart defect, according to reporting by the Associated Press.

Harris Wolobah, a previously healthy 14-year-old from Worcester, died September 1, 2023 hours after eating the chip—a 2023 Paqui One Chip Challenge chip—which were sold individually, wrapped in tin foil, and seasoned with two of hottest peppers in the world, the Naga Viper pepper and the Carolina Reaper pepper. Paqui sold the chip with a challenge in which eaters were dared to consume the chip, wait as long as possible before eating or drinking anything, and post the aftermath on social media, where the challenge went viral.

Harris’ mother, Lois Wolobah, immediately suspected the chip was involved in his untimely death. At the time, she reportedly said she picked him up from school after getting a call from the nurse. He was clutching his stomach and, about two hours later, lost consciousness and was rushed to the hospital, where he died. She reported that he had no known medical conditions at the time.

According to the autopsy report, Harris died of cardiopulmonary arrest “in the setting of recent ingestion of food substance with high capsaicin concentration,” the AP reported. Capsaicin is the compound in peppers that gives them their heat.

The report also noted that Harris had an enlarged heart and a congenital anomaly called “myocardial bridging.” This is a common and generally benign condition in which one or more of the arteries delivering blood to the heart go through the heart’s muscle instead of lying on its surface, according to Stanford Medicine. In Harris’ case, the condition involved his left anterior descending coronary artery. An analysis on the American Academy of Cardiology’s website noted that myocardial bridging is “clinically silent” in the majority of cases.

Dr. James Udelson, chief of cardiology at Tufts Medical Center, confirmed to the AP that the chip could have played a role in the teen’s death. “It is possible that with significant stimulation of the heart, the muscle beyond the bridge suddenly had abnormal blood flow (‘ischemia’) and could have been a cause of a severe arrhythmia,” Udelson told the AP in an email. “There have been reports of acute toxicity with capsaicin causing ischemia of the heart muscle.”

A second expert, Dr. Syed Haider, a cardiologist at MedStar Washington Hospital Center, added to the AP that the large doses of capsaicin can increase how the heart squeezes, putting extra pressure on the artery.

Even if Harris’ heart defect made him more vulnerable to the effects of the chip, other case studies have found dangerous and life-threatening effects of high doses of capsaicin in people without heart anomalies. Ultra-hot peppers have also been linked to conditions in which arteries in the brain constrict, causing thunderclap headaches and neurological symptoms.

Paqui, a subsidiary of Hershey, pulled the chip from the market shortly after Harris’ death.

Ultra-spicy One Chip Challenge chip contributed to teen’s death, report says Read More »

it-could-soon-be-illegal-to-publicly-wear-a-mask-for-health-reasons-in-nc

It could soon be illegal to publicly wear a mask for health reasons in NC

cancer, health, house bill, immunocompromised, Infectious disease, masks, North Carolina, pandemic, public health, Science / /

Freedumb —

Senators skeptical of legal trouble for harmless masking after moving to make it illegal.

–

It could soon be illegal to publicly wear a mask for health reasons in NC

The North Carolina State Senate on Wednesday voted 30–15, along party lines, in favor of a Republican bill that would make it illegal for people in the state to wear a mask in public for health reasons. The bill is now moving to the House, where it could potentially see changes.

The proposed ban on health-based masking is part of a larger bill otherwise aimed at increasing penalties for people wearing masks to conceal their identity while committing a crime or impeding traffic. The bill was largely spurred by recent protests on university and college campuses across the country, including North Carolina-based schools, against the war in Gaza. In recent months, there have been demonstrations in Raleigh and Durham that have blocked roadways, as well as clashes on the nearby campus of the University of North Carolina at Chapel Hill. Some demonstrators were seen wearing masks in those events.

But the bill, House Bill 237, goes a step further by making it illegal to wear a mask in public for health and safety reasons, either to protect the wearer, those around them, or both. Specifically, the bill repeals a 2020 legal exemption enacted amid the COVID-19 pandemic, which allowed for public health-based masking for the first time in decades.

Prior to 2020, laws dating back to 1953 largely prohibited public masking. The prohibition was part of a crackdown on “secret societies” at the time, or more specifically, an attempt to curtail the activities of the Ku Klux Clan in the state. Exemptions only existed for things like holiday costumes, theater productions, gas masks, and members of public parades or ceremonies that had obtained permits.

On Wednesday, North Carolina residents with compromised immune systems spoke—while masked—during a public comment section. Simone Hetherington told lawmakers that masking was the only way to protect herself in public from illness and feared passage of the bill would prevent her from doing so, according to reporting by the Associated Press.

But, according to The News & Observer, Republicans were dismissive of that possibility, arguing that in the decades prior to the pandemic, when public masking was largely illegal, they couldn’t recall anyone being prosecuted for wearing a mask for health reasons.

Raleigh-based news outlet WRAL quoted Sen. Sydney Batch, a Democrat from Wake, who criticized the bill along with fellow Democratic colleagues. Batch, a cancer survivor, spoke of how her husband and children wore masks to protect her while she underwent cancer treatments that weakened her immune system. “This bill criminalizes their behavior and mine,” she said. “We talk a lot about freedoms in this chamber. I hear it all the time. I should have the freedom—my children and my husband should have the freedom—to wear masks in order to protect and save my life, without fear of being arrested and charged.”

It could soon be illegal to publicly wear a mask for health reasons in NC Read More »

raw-milk-fans-plan-to-drink-up-as-experts-warn-of-high-levels-of-h5n1-virus

Raw-milk fans plan to drink up as experts warn of high levels of H5N1 virus

avian influenza, bird flu, CDC, cows, fda, H5N1, health, mammary glands, milk, raw milk, Science / /

facepalm —

Raw milk fans called warnings “fear mongering,” despite 52% fatality rate in humans.

–

A glass of fresh raw milk in the hand of a farmer.

Enlarge / A glass of fresh raw milk in the hand of a farmer.

To drink raw milk at any time is to flirt with dangerous germs. But, amid an unprecedented outbreak of H5N1 bird flu in US dairy cows, the risks have ratcheted up considerably. Health experts have stepped up warnings against drinking raw milk during the outbreak, the scope of which is still unknown.

Yet, raw milk enthusiasts are undaunted by the heightened risk. The California-based Raw Milk Institute called the warnings “clearly fearmongering.” The institute’s founder, Mark McAfee, told the Los Angeles Times this weekend that his customers are, in fact, specifically requesting raw milk from H5N1-infected cows. According to McAfee, his customers believe, without evidence, that directly drinking high levels of the avian influenza virus will give them immunity to the deadly pathogen.

Expert Michael Payne told the LA Times that the idea amounts to “playing Russian roulette with your health.” Payne, a researcher and dairy outreach coordinator at the Western Institute for Food Safety and Security at UC Davis, added, “Deliberately trying to infect yourself with a known pathogen flies in the face of all medical knowledge and common sense.”

Much remains unknown about the biology of avian influenza in cattle. Until March 25, when the US Department of Agriculture confirmed the virus in a dairy herd in Texas, cattle were generally considered virtually resistant to H5N1. But since then, the USDA has tallied 42 herds in nine states that have contracted the virus. Epidemiological data so far suggests that there has been cow-to-cow transmission following a single spillover event and that the 42 outbreak herds are connected by the movement of cattle between farms.

The limited data on the cows so far suggests that the animals largely develop mild illness from the infection and recover in a few weeks. Their mammary glands are the primary target of the virus. A preprint published earlier this month found that cows’ udders are rife with the molecular receptors that bird flu viruses latch onto to spark an infection. Moreover, the glands contain multiple types receptors, including ones targeted by human flu viruses as well as those targeted by bird flu viruses. Thus, dairy cows could potentially act as a mixing vessel for the different types of flu viruses to reassemble into new, outbreak-sparking variants.

With the virus apparently having a field day in cows’ udders, researchers have found raw milk to be brimming with high levels of H5N1 viral particles—and those particles appear readily capable of spilling over to other mammals. In a case study last month, researchers reported that a group of about two dozen farm cats developed severe illness after drinking milk from H5N1-infected cows. Some developed severe neurological symptoms. More than half the cats died in a matter of days.

Deadly virus

Data on flu receptors in the two animals may explain the difference between cows and cats. While the cow’s mammary gland had loads of multiple types of flu receptors, those receptors were less common in other parts of the cow, including the respiratory tract and brain. This may explain why they tend to have a mild infection. Cats, on the other hand, appear to have receptors more widely distributed, with infected cats showing viral invasion of the lungs, hearts, eyes, and brains.

Raw milk devotees—who claim without evidence that drinking raw milk provides health benefits over drinking pasteurized milk—dismiss the risk of exposure to H5N1. They confidently argue—also without evidence—that the human digestive system will destroy the virus. And they highlight that there is no documented evidence of a human ever becoming infected with H5N1 from drinking tainted milk.

The latter point on the lack of evidence of milkborne H5N1 transmission is true. However, the current outbreak is the first known spillover of highly pathogenic avian influenza (HPAI) to dairy cow mammary glands. As such, it presents the first known opportunity for such milk-based transmission to occur.

Before pasteurization became routine for commercial milk production, raw milk was a common source of infections, serving up a cornucopia of germs. According to the FDA, in 1938, milkborne outbreaks accounted for 25 percent of all foodborne disease outbreaks. In more recent times, milk has been linked to less than 1 percent of such outbreaks. The Centers for Disease Control and Prevention notes that areas where raw milk was sold legally between 1998 and 2018 had 3.2 times more outbreaks than areas where the sale of raw milk was illegal.

In a Q&A document, the Food and Drug Administration notes that it does “not know at this time if HPAI A (H5N1) viruses can be transmitted through consumption of unpasteurized (raw) milk and products (such as cheese) made from raw milk from infected cows.” However, the agency goes on, because of that lack of data and the potential for infection, the FDA recommends halting all sales of raw milk and raw milk products from H5N1 infected or exposed cattle. In general, the agency recommends against consuming raw milk.

Globally, as of March 28, there have been 888 cases of H5N1 reported in humans in 23 countries. Of those 888 cases, 463 were fatal. That represents a 52 percent fatality rate; however, it’s possible that there are asymptomatic or undiagnosed cases that could alter that rate. In the US, only one human so far is known to have been infected with H5N1 in connection with the dairy cow outbreak—a farm worker who developed pink eye. The man had no respiratory symptoms and recovered. He did not consent to further follow-up, and researchers did not get consent to test the man’s household contacts to see if they, too, were infected.

Raw-milk fans plan to drink up as experts warn of high levels of H5N1 virus Read More »

more-children-gain-hearing-as-gene-therapy-for-profound-deafness-advances

More children gain hearing as gene therapy for profound deafness advances

gene therapy, health, profound deafness, Science / /

Success —

The therapy treats a rare type of deafness, but experts hope it’s a “jumping point.”

–

Opal Sandy (center), who was born completely deaf because of a rare genetic condition, can now hear unaided for the first time after receiving gene therapy at 11-months-old. She is shown with her mother, father, and sister at their home in Eynsham, Oxfordshire, on May 7, 2024.

Enlarge / Opal Sandy (center), who was born completely deaf because of a rare genetic condition, can now hear unaided for the first time after receiving gene therapy at 11-months-old. She is shown with her mother, father, and sister at their home in Eynsham, Oxfordshire, on May 7, 2024.

There are few things more heartwarming than videos of children with deafness gaining the ability to hear, showing them happily turning their heads at the sound of their parents’ voices and joyfully bobbing to newly discovered music. Thanks to recent advances in gene therapy, more kids are getting those sweet and triumphant moments—with no hearing aids or cochlear implants needed.

At the annual conference of the American Society for Gene & Cell Therapy held in Baltimore this week, researchers showed many of those videos to their audiences of experts. On Wednesday, Larry Lustig, an otolaryngologist at Columbia University, presented clinical trial data of two children with profound deafness—the most severe type of deafness—who are now able to hear at normal levels after receiving an experimental gene therapy. One of the children was 11 months old at the time of the treatment, marking her as the youngest child in the world to date to receive gene therapy for genetic deafness.

On Thursday, Yilai Shu, an otolaryngologist at Fudan University in Shanghai, provided a one-year progress report on six children who were treated in the first in-human trial of gene therapy for genetic therapy. Five of the six had their hearing restored.

That trial, like the one Lustig presented, involved treating just one ear in all of the children—a safety precaution for such early trials. But Shu and colleagues have already moved on to both ears, or bilateral treatment. After presenting a progress report on the first trial, Shu presented unpublished early data on five additional patients who participated in the first in-human trial of bilateral treatment. All had bilateral hearing restoration and speech perception improvement.

“The opportunity of providing the full complexity and spectrum of sound in children born with profound genetic deafness is a phenomenon I did not expect to see in my lifetime,” Lustig said in a statement.

Jumping point

Shu and Lustig’s trials are separate but the treatments are, in broad strokes, similar. Both are aimed at restoring hearing loss caused by mutations in the OTOF gene the codes for the protein otoferlin. Normally, otoferlin is a critical protein for transmitting sound signals to the brain, specifically playing a key role in synaptic transmission between the ear’s inner hair cells and the auditory nerve. Using gutted adeno-associated viruses as vectors for gene delivery, the therapies provide the inner ear with a functional version of the OTOF gene. Once in the ear, the gene can be translated into functional otoferlin, restoring auditory signaling.

In the trial Lustig presented, the two patients saw a gradual improvement of hearing as otoferlin protein built up after treatment. For the 11-month-old, normal levels of hearing were restored within 24 weeks of treatment. For the second patient, a 4-year-old, improvements were detected at a six-week assessment. In the trial Shu presented, children began seeing hearing improvements at three- and four-week assessments. The children will continue to be followed into the future, which holds some uncertainties. It’s unclear if they will, at some point in their lives, need additional treatments to sustain their hearing. In mice, at least, the treatment lasts for the duration of the animals’ lives—but they only live for a few years.

“We expect this to last a long time,” Lustig said Wednesday. But “we don’t know what’s going to happen and we don’t know whether we can do a second dose. But, probably, I would guess, at some point that would have to be done.”

For now, the treatment is considered low-hanging fruit for the burgeoning field of gene therapy since it targets a severe condition caused by recessive mutations in a single gene. Otoferlin mutations lead to a very specific type of deafness called auditory neuropathy, in which the ear fails to send signals to the brain but works perfectly fine otherwise. This is an ultra-rare form of deafness affecting 1–8 percent of people with deafness globally. Only about 30 to 50 people in the US are born with this type of deafness each year.

However, Lustig calls it a “jumping point.” Now that researchers have shown that this gene therapy can work, “This is going to really spark, we hope, the development of gene therapy for more common types of deafness,” he said.

More children gain hearing as gene therapy for profound deafness advances Read More »

chemical-tweaks-to-a-toad-hallucinogen-turns-it-into-a-potential-drug

Chemical tweaks to a toad hallucinogen turns it into a potential drug

biochemistry, Biology, hallucinogen, health, neurobiology, psychedelic, Science, toads / /

No licking toads! —

Targets a different serotonin receptor from other popular hallucinogens.

–

Image of the face of a large toad.

Enlarge / The Colorado River toad, also known as the Sonoran Desert Toad.

It is becoming increasingly accepted that classic psychedelics like LSD, psilocybin, ayahuasca, and mescaline can act as antidepressants and anti-anxiety treatments in addition to causing hallucinations. They act by binding to a serotonin receptor. But there are 14 known types of serotonin receptors, and most of the research into these compounds has focused on only one of them—the one these molecules like, called 5-HT2A. (5-HT, short for 5-hydroxytryptamine, is the chemical name for serotonin.)

The Colorado River toad (Incilius alvarius), also known as the Sonoran Desert toad, secretes a psychedelic compound that likes to bind to a different serotonin receptor subtype called 5-HT1A. And that difference may be the key to developing an entirely distinct class of antidepressants.

Uncovering novel biology

Like other psychedelics, the one the toad produces decreases depression and anxiety and induces meaningful and spiritually significant experiences. It has been used clinically to treat vets with post-traumatic stress disorder and is being developed as a treatment for other neurological disorders and drug abuse. 5-HT1A is a validated therapeutic target, as approved drugs, including the antidepressant Viibryd and the anti-anxiety med Buspar, bind to it. But little is known about how psychedelics engage with this receptor and which effects it mediates, so Daniel Wacker’s lab decided to look into it.

The researchers started by making chemical modifications to the frog psychedelic and noting how each of the tweaked molecules bound to both 5-HT2A  and 5-HT1A. As a group, these psychedelics are known as “designer tryptamines”—that’s tryp with a “y”, mind you—because they are metabolites of the amino acid tryptophan.

The lab made 10 variants and found one that is more than 800-fold selective about sticking to 5-HT1A as compared to 5-HT2A. That makes it a great research tool for elucidating the structure-activity relationship of the 5-HT1A receptor, as well as the molecular mechanisms behind the pharmacology of the drugs on the market that bind to it. The lab used it to explore both of those avenues. However, the variant’s ultimate utility might be as a new therapeutic for psychiatric disorders, so they tested it in mice.

Improving the lives of mice

The compound did not induce hallucinations in mice, as measured by the “head-twitch response.” But it did alleviate depression, as measured by a “chronic social defeat stress model.” In this model, for 10 days in a row, the experimental mouse was introduced to an “aggressor mouse” for “10-minute defeat bouts”; essentially, it got beat up by a bully at recess for two weeks. Understandably, after this experience, the experimental mouse tended not to be that friendly with new mice, as controls usually are. But when injected with the modified toad psychedelic, the bullied mice were more likely to interact positively with new mice they met.

Depressed mice, like depressed people, also suffer from anhedonia: a reduced ability to experience pleasure. In mice, this manifests in not taking advantage of drinking sugar water when given the opportunity. But treated bullied mice regained their preference for the sweet drink. About a third of mice seem to be “stress-resilient” in this model; the bullying doesn’t seem to phase them. The drug increased the number of resilient mice.

The 5-HT2A receptor has hogged all of the research love because it mediates the hallucinogenic effects of many popular psychedelics, so people assumed that it must mediate their therapeutic effects, too. However, Wacker argues that there is little evidence supporting this assumption. Wacker’s new toad-based psychedelic variant and its preference for the 5-HT1A receptor will help elucidate the complementary roles these two receptor subtypes play in mediating the cellular and psychological effects of psychedelic molecules. And it might provide the basis for a new tryptamine-based mental health treatment as well—one without hallucinatory side effects, disappointing as that may be to some.

Nature, 2024.  DOI: 10.1038/s41586-024-07403-2

Chemical tweaks to a toad hallucinogen turns it into a potential drug Read More »

amid-two-wrongful-death-lawsuits,-panera-to-pull-the-plug-on-“charged”-drinks

Amid two wrongful death lawsuits, Panera to pull the plug on “charged” drinks

caffeine, charged, deaths, fast food, health, lemonade, panera, Science / /

Zapped —

A large previously contained nearly as much caffeine as the FDA’s daily safe limit.

–

Dispensers for Charged Lemondade, a caffeinated lemonade drink, at Panera Bread, Walnut Creek, California, March 27, 2023.

Enlarge / Dispensers for Charged Lemondade, a caffeinated lemonade drink, at Panera Bread, Walnut Creek, California, March 27, 2023.

Panera Bread will stop selling its highly caffeinated “Charged” drinks, which have been the subject of at least three lawsuits and linked to at least two deaths.

It is unclear when exactly the company will pull the plug on the potent potables, but in a statement to Ars Tuesday, Panera said it was undergoing a “menu transformation” that includes an “enhanced beverage portfolio.” The company plans to roll out various new drinks, including a lemonade and tea, but a spokesperson confirmed that the new flavors would not contain added caffeine as the “charged” drinks did.

The fast-casual cafe-style chain drew national attention in 2022 for the unexpectedly high caffeine levels in the drinks, which were initially offered as self-serve with free refills.

The versions of the drinks at the time were labeled as containing 389 mg to 390 mg of caffeine in a large, 30-ounce drink, while the other option, a 20-ounce regular, contained 260 mg. According to the Food and Drug Administration, a limit of 400 mg of caffeine per day is generally considered safe for healthy adults, but a smaller amount is advised for adults with certain medical conditions or who are pregnant or breastfeeding. A standard 8-ounce cup of coffee generally contains between 80 to 100 mg of caffeine, while a Red Bull energy drink also contains 80 mg.

In September 2022, Sarah Katz, a 21-year-old with a heart condition, died after allegedly drinking one of the highly caffeinated lemonades from a restaurant in Philadelphia. In a wrongful death lawsuit filed against Panera in October 2023, Katz’s parents alleged that she didn’t know the drink contained potentially dangerous amounts of caffeine. Rather, she was “reasonably confident it was a traditional lemonade and/or electrolyte sports drink containing a reasonable amount of caffeine safe for her to drink,” the lawsuit stated.

Also in October, Dennis Brown, a 46-year-old man in Florida, went into cardiac arrest while walking home from a Panera, where he allegedly drank a charged lemonade and then had two refills. His family filed a lawsuit against Panera in December.

According to CNN, a third lawsuit was filed in January by a woman who claims she developed an irregularly fast heartbeat and palpitations after drinking the two-and-a-half caffeinated lemonades in April 2023. “The primary reason she ordered this drink was because it was advertised as ‘plant-based’ and ‘clean,’” the complaint states.

In a statement to Ars in December, Panera said it “stands firmly by the safety of our products.” However, the company increased warnings on the drinks last year and moved containers behind the counter in some stores. Most notably, it also reduced the labeled amount of caffeine in the drinks. The current menu lists the “Charged Sips” drinks as having between 155 mg to 302 mg, depending on the flavor and size.

Amid two wrongful death lawsuits, Panera to pull the plug on “charged” drinks Read More »

dea-to-reclassify-marijuana-as-a-lower-risk-drug,-reports-say

DEA to reclassify marijuana as a lower-risk drug, reports say

cannabis, DEA, fda, health, marijuana, Policy, research, Scheduling, Science / /

downgrade —

Marijuana to move from Schedule 1, the most dangerous drug group, to Schedule 3.

–

Medical marijuana growing in a facility in Canada.

Enlarge / Medical marijuana growing in a facility in Canada.

The US Drug Enforcement Administration is preparing to reclassify marijuana to a lower-risk drug category, a major federal policy change that is in line with recommendations from the US health department last year. The upcoming move was first reported by the Associated Press on Tuesday afternoon and has since been confirmed by several other outlets.

The DEA currently designates marijuana as a Schedule 1 drug, defined as drugs “with no currently accepted medical use and a high potential for abuse.” It puts marijuana in league with LSD and heroin. According to the reports today, the DEA is moving to reclassify it as a Schedule 3 drug, defined as having “a moderate to low potential for physical and psychological dependence.” The move would place marijuana in the ranks of ketamine, testosterone, and products containing less than 90 milligrams of codeine.

Marijuana’s rescheduling would be a nod to its potential medical benefits and would shift federal policy in line with many states. To date, 38 states have already legalized medical marijuana.

In August, the Department of Health and Human Services advised the DEA to move marijuana from Schedule 1 to Schedule 3 based on a review of data by the Food and Drug Administration. The recommendation came after the FDA, in August, granted the first approval of a marijuana-based drug. The drug, Epidiolex (cannabidiol), is approved to treat rare and severe forms of epilepsy. The approval was expected to spur the DEA to downgrade marijuana’s scheduling, though some had predicted it would have occurred earlier. Independent expert advisors for the FDA voted unanimously in favor of approval, convinced by data from three high-quality clinical trials that indicated benefits and a “negligible abuse potential.”

The shift may have a limited effect on consumers in states that have already eased access to marijuana. In addition to the 38 states with medical marijuana access, 24 states have legalized recreational use. But, as a Schedule 3 drug, marijuana would still be regulated by the DEA. The Associated Press notes that the rule change means that roughly 15,000 dispensaries would need to register with the DEA, much like pharmacies, and follow strict reporting requirements.

One area that will clearly benefit from the change is scientific research on marijuana’s effects. Many academic scientists are federally funded and, as such, they must follow federal regulations. Researching a Schedule 1 drug carries extensive restrictions and rules, even for researchers in states where marijuana is legalized. A lower scheduling will allow researchers better access to conduct long-awaited studies.

It’s unclear exactly when the move will be announced and finalized. The DEA must get sign-off from the White House Office of Management and Budget (OMB) before proceeding. A source for NBC News said Attorney General Merrick Garland may submit the rescheduling to the OMB as early as Tuesday afternoon. After that, the DEA will open a public comment period before it can finalize the rule.

The US Department of Justice told several outlets that it “continues to work on this rule. We have no further comment at this time.”

DEA to reclassify marijuana as a lower-risk drug, reports say Read More »

cats-suffer-h5n1-brain-infections,-blindness,-death-after-drinking-raw-milk

Cats suffer H5N1 brain infections, blindness, death after drinking raw milk

bird flu, Cats, cows, dairy cows, H5N1, health, herds, infectious diseases, influenza, milk, Science / /

Spillover —

Mammal-to-mammal transmission raises new concerns about the virus’s ability to spread.

–

Farm cats drinking from a trough of milk from cows that were just milked.

Enlarge / Farm cats drinking from a trough of milk from cows that were just milked.

On March 16, cows on a Texas dairy farm began showing symptoms of a mysterious illness now known to be H5N1 bird flu. Their symptoms were nondescript, but their milk production dramatically dropped and turned thick and creamy yellow. The next day, cats on the farm that had consumed some of the raw milk from the sick cows also became ill. While the cows would go on to largely recover, the cats weren’t so lucky. They developed depressed mental states, stiff body movements, loss of coordination, circling, copious discharge from their eyes and noses, and blindness. By March 20, over half of the farm’s 24 or so cats died from the flu.

In a study published today in the journal Emerging Infectious Diseases, researchers in Iowa, Texas, and Kansas found that the cats had H5N1 not just in their lungs but also in their brains, hearts, and eyes. The findings are similar to those seen in cats that were experimentally infected with H5N1, aka highly pathogenic avian influenza virus (HPAI). But, on the Texas dairy farm, they present an ominous warning of the potential for transmission of this dangerous and evolving virus.

The contaminated milk was the most likely source of the cat’s fatal infections, the study authors concluded. Although it can’t be entirely ruled out that the cats got sick from eating infected wild birds, the milk they drank from the sick cows was brimming with virus particles, and genetic data shows almost exact matches between the cows, their milk, and the cats. “Therefore, our findings suggest cross-species mammal-to-mammal transmission of HPAI H5N1 virus and raise new concerns regarding the potential for virus spread within mammal populations,” wrote the authors, who are veterinary researchers from Iowa, Texas, and Kansas.

The early outbreak data from the Texas farm suggests the virus is getting better and better at jumping to mammals, and data from elsewhere shows the virus is spreading widely in its newest host. On March 25, the US Department of Agriculture confirmed the presence of H5N1 in a dairy herd in Texas, marking the first time H5N1 had ever been known to cross over to cows. Since then, the USDA has tallied infections in at least 34 herds in nine states: Texas, Kansas, Michigan, New Mexico, Idaho, Ohio, South Dakota, North Carolina, and Colorado.

The Food and Drug Administration, meanwhile, has detected genetic traces of H5N1 in roughly 20 percent of commercial milk samples. While commercial milk is still considered safe—pasteurization is expected to destroy the virus and early testing by the FDA and other federal scientists confirms that expectation—the finding suggests yet wider spread of the virus among the country’s milk-producing cows.

Cows are only the latest addition to H5N1’s surprisingly broad host range. Amid a global outbreak over the past several years that has devastated wild bird populations and poultry farms, researchers have documented unexpected and often deadly outbreaks in mammals. Since 2022, the USDA has found H5N1 in over 200 mammals, from big cats in zoos to harbor seals, mountain lions, raccoons, skunks, squirrels, polar bears, black bears, foxes, and bottlenose dolphins.

“The recurring nature of global HPAI H5N1 virus outbreaks and detection of spillover events in a broad host range is concerning and suggests increasing virus adaptation in mammals,” the authors wrote. “Surveillance of HPAI viruses in domestic production animals, including cattle, is needed to elucidate influenza virus evolution and ecology and prevent cross-species transmission.”

In the meantime, it’s definitely not the time to start drinking raw cow’s milk. While drinking raw milk is always dangerous because it carries the threat of various nasty bacterial infections, H5N1 also appears to be infectious in raw milk. And, unlike other influenza viruses, H5N1 has the potential to infect organs beyond the lungs and respiratory tract, as seen in the cats. The authors of the new study note that a 2019 consumer survey found that 4.4 percent of adults in the US consumed raw milk more than once in the previous year, suggesting more public awareness of the dangers of raw milk is necessary.

Cats suffer H5N1 brain infections, blindness, death after drinking raw milk Read More »

20%-of-grocery-store-milk-has-traces-of-bird-flu,-suggesting-wider-outbreak

20% of grocery store milk has traces of bird flu, suggesting wider outbreak

bird flu, CDC, cows, fda, H5N1, health, Infectious disease, milk, Science, USDA, virus / /

widespread —

The milk is still considered safe, but disease experts are alarmed by the prevalence.

–

20% of grocery store milk has traces of bird flu, suggesting wider outbreak

The Food and Drug Administration reported late Thursday that about 20 percent of retail milk samples from around the country tested positive for genetic fragments of the bird flu, aka highly pathogenic avian influenza (HPAI) virus H5N1. While retail milk is still considered to be safe, the finding suggests that the spread of the virus in cows is more extensive than is currently known.

The FDA used a test called quantitative polymerase chain reaction (qPCR), which can only detect the presence of genetic fragments. In pasteurized retail milk, it is highly likely that those genetic snippets are merely remnants of virus particles destroyed during pasteurization. The FDA is currently conducting additional testing using egg inoculation tests, a gold standard for detecting a live virus, to confirm the effectiveness of pasteurization. Meanwhile, the director of the National Institute of Allergy and Infectious Diseases, Jeanne Marrazzo, told reporters Wednesday that tests at the agency’s federal labs so far did not identify live virus from any of its sampling. Additionally, several previous studies have found that pasteurization of eggs—which is done at a lower temperature than it is for milk—was effective at destroying H5N1.

While experts are largely unconcerned with the safety of commercial milk, the potential for wide, unrecognized spread of bird flu in dairy herds is alarming. To date, the US Department of Agriculture has only confirmed infections in 33 herds in eight states. The FDA acknowledged that of its positive samples, “a greater proportion of positive results [are] coming from milk in areas with infected herds.” But with tens of thousands of dairy herds in the US, the finding suggests that infections are being missed. It does not necessarily suggest that 20 percent of all cows are affected, since milk is pooled for commercial distribution. But 33 herds alone are unlikely to explain the high prevalence.

Last week, The New York Times reported that the one dairy herd that tested positive for bird flu in North Carolina did not show any symptoms of the infection. The possibility of asymptomatic spread of the virus among cows will make containment and monitoring far more difficult—and could explain why infections may be easily missed. On Wednesday, the USDA issued a federal order requiring dairy cattle to have a negative H5N1 test before being moved across state lines.

For now, the risk to the public is still considered low by the Centers for Disease Control and Prevention. But the more the bird flu virus spreads among mammals—and mammals with close contact with humans—the more opportunities it has to evolve to jump to and among people, experts warn.

20% of grocery store milk has traces of bird flu, suggesting wider outbreak Read More »

three-women-contract-hiv-from-dirty-“vampire-facials”-at-unlicensed-spa

Three women contract HIV from dirty “vampire facials” at unlicensed spa

CDC, health, HIV, Infectious disease, outbreak, outbreak investigation, platelet-rich plasma, Science, spa, vampire facials / /

Yikes —

Five patients with links to the spa had viral genetic sequences that closely matched.

–

Drops of the blood going onto an HIV quick test.

Enlarge / Drops of the blood going onto an HIV quick test.

Trendy, unproven “vampire facials” performed at an unlicensed spa in New Mexico left at least three women with HIV infections. This marks the first time that cosmetic procedures have been associated with an HIV outbreak, according to a detailed report of the outbreak investigation published today.

Ars reported on the cluster last year when state health officials announced they were still identifying cases linked to the spa despite it being shut down in September 2018. But today’s investigation report offers more insight into the unprecedented outbreak, which linked five people with HIV infections to the spa and spurred investigators to contact and test nearly 200 other spa clients. The report appears in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.

The investigation began when a woman between the ages of 40 and 50 turned up positive on a rapid HIV test taken while she was traveling abroad in the summer of 2018. She had a stage 1 acute infection. It was a result that was as dumbfounding as it was likely distressing. The woman had no clear risk factors for acquiring the infection: no injection drug use, no blood transfusions, and her current and only recent sexual partner tested negative. But, she did report getting a vampire facial in the spring of 2018 at a spa in Albuquerque called VIP Spa.

“Vampire facial” is the common name for a platelet-rich plasma microneedling procedure. In this treatment, a patient’s blood is drawn, spun down to separate out plasma from blood cells, and the platelet-rich plasma is then injected into the face with microneedles. It’s claimed—with little evidence—that it can rejuvenate and improve the look of skin, and got notable promotions from celebrities, including Gwyneth Paltrow and Kim Kardashian.

The woman’s case led investigators to VIP Spa, which was unlicensed, had no appointment scheduling system, and did not store client contact information. In an inspection in the fall of 2018, health investigators found shocking conditions: unwrapped syringes in drawers and counters, unlabeled tubes of blood sitting out on a kitchen counter, more unlabeled blood and medical injectables alongside food in a kitchen fridge, and disposable equipment—electric desiccator tips—that were reused. The facility also did not have an autoclave—a pressurized oven—for sterilizing equipment.

A novel and challenging investigation

The spa was quickly shut down, and the owner Maria de Lourdes Ramos De Ruiz, 62, was charged with practicing medicine without a license. In 2022, she pleaded guilty to five counts and is serving a three-and-a-half-year prison sentence.

A second spa client, another woman between the ages of 40 and 50, tested positive for HIV in a screen in the fall of 2018 and received a diagnosis in early 2019. She has received a vampire facial in the summer of 2018. Her HIV infection was also at stage 1. Investigators scrambled to track down dozens of other clients, who mostly spoke Spanish as their first language. The next two identified cases weren’t diagnosed until the fall of 2021.

The two cases diagnosed in 2021 were sexual partners: a woman who received three vampire facials in the spring and summer of 2018 from the spa and her male partner. Both had a stage 3 HIV infection, which is when the infection has developed into Acquired Immunodeficiency Syndrome (AIDS). The severity of the infections suggested the two had been infected prior to the woman’s 2018 spa treatments. Health officials uncovered that the woman had tested positive in an HIV screen in 2016, though she did not report being notified of the result.

The health officials reopened their outbreak investigation in 2023 and found a fifth case that was diagnosed in the spring of 2023, which was also in a woman aged 40 to 50 who had received a vampire facial in the summer of 2018. She had a stage 3 infection and was hospitalized with an AIDS-defining illness.

Viral genetic sequencing from the five cases shows that the infections are all closely related. But, given the extent of the unsanitary and contaminated conditions at the facility, investigators were unable to determine precisely how the infections spread in the spa. In all, 198 spa clients were tested for HIV between 2018 and 2023, the investigators report.

“Incomplete spa client records posed a substantial challenge during this investigation, necessitating a large-scale outreach approach to identify potential cases,” the authors acknowledge. However, the investigation’s finding “underscores the importance of determining possible novel sources of HIV transmission among persons with no known HIV risk factors.”

Three women contract HIV from dirty “vampire facials” at unlicensed spa Read More »

the-fungi-in-our-guts-can-make-cases-of-covid-worse

The fungi in our guts can make cases of Covid worse

fungus, gut microbiome, health, syndication / /
Microscopic image of blue bulbs on stalks against violet background.

Enlarge / Computer illustration of Candida fungi.

Kateryna Kon | Science Photo Library | Getty

Fungi are an indispensable part of your microbiome, keeping the body’s host of microorganisms healthy as part of a system of checks and balances. But when you’re hit by an infection, fungi can be thrown out of equilibrium with other organisms inside you, leading to a more severe infection and other symptoms of illness.

For this reason, the pandemic immediately set off alarms for Iliyan Iliev, an immunologist at Weill Cornell Medical School. “We were thinking, the first thing that’s going to happen is people will start getting fungal co-infections,” he says. With the microbiome unbalanced, fungi might start running riot inside Covidpatients, Iliev reasoned. His fears were soon realized.

In research published in Nature Immunology, he and his team discovered that in patients with severe Covid, certain strains of gut fungi—knocked off-kilter by the virus—set off a prolonged immune response that could last long after the initial infection. This response potentially led to some of the respiratory symptoms experienced by these patients. These results, Iliev says, point to the critical role of the gut microbiome in the human immune response and could lead to better disease treatments down the line.

Imbalance of the gut microbiome has long been linked to disease. Ken Cadwell, an immunologist at the Perelman School of Medicine at the University of Pennsylvania, thinks of the microbiome as a metaphorical rainforest. “It’s a nice ecosystem—but if you cut down too many trees or bring in invasive species, you could make things go out of whack,” he says.

To see how the body’s internal fungi were affected during Covid and how this triggered the immune system, Iliev and his team started by looking at patients’ blood. After collecting samples from 91 people with Covid, they measured levels of antibodies against several fungi, to figure out if the body’s immune system was reacting against these. Significantly more anti-fungal antibodies, for instance, would indicate fungal overgrowth or invasion.

Takato Kusakabe, a postdoctoral fellow in Iliev’s lab and study author, ran plate after plate of experiments—a painstaking process—to quantify these antibody levels. The team found in patients with severe Covid, several fungi commonly found in the gut had increased antibodies against them (in comparison to uninfected people). Notably, these included Candida albicans, which is a common culprit of yeast infections. When the team then ran tests on fecal samples from 10 of the hospitalized Covid patients, these confirmed that the fungi being targeted by the antibodies were present in the patients’ guts—and at seemingly at higher levels than in uninfected controls, suggesting an imbalance in their microbiome.

The fungi in our guts can make cases of Covid worse Read More »