health

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.

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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.

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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 »

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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.

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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.

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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.

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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 »

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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.

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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 »

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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 »

the-gmo-tooth-microbe-that-is-supposed-to-prevent-cavities

The GMO tooth microbe that is supposed to prevent cavities

dentistry, health, syndication, tooth decay / /

oral hygiene —

Some experts have concerns over the safety of the genetically modified bacteria.

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It's a tooth

About seven years ago, Aaron Silverbook and his then-girlfriend, a biologist, were perusing old scientific literature online. “A romantic evening,” joked Silverbook. That night, he came across a study from 2000 that surprised him. Scientists had genetically engineered an oral bacterium that they said could possibly prevent tooth decay: “I read it and sort of boggled at it and said, ‘Wow, this is a cavity vaccine. Why don’t we have this?’”

So, Silverbook tracked down the primary author, Jeffrey Hillman, a now-retired oral biologist formerly at the University of Florida, to see if he could pick up the torch.

In 2023, Silverbook founded Lantern Bioworks, which made a deal with Oragenics, the company Hillman co-founded and that owned the technology, for the materials. Lantern Bioworks then launched the genetically engineered bacteria under the name Lumina Probiotic. “I didn’t expect it to happen in my lifetime,” said Hillman.

As recently as last month, a website for the product included language about cavity prevention. And a previously available press kit stated that “a one-time brushing with this genetically modified bacteria could indefinitely prevent dental cavities.” By the time Lumina became available for pre-orders last week, however, that wording and the press kit had been removed. Silverbook—who does not have a background in dentistry or microbiology—told Undark that his lawyer advised the change in wording on the website, as Lantern Bioworks is bringing the product to market as a cosmetic, meaning it can’t make health claims about Lumina. Cosmetics don’t need to go through the same rigorous trials a drug would. “If anything I said sounded like a medical claim,” Silverbook told Undark in an interview earlier this year, “it wasn’t.”

The product can be applied to teeth as a one-time application either at home or by a dentist. Additional applications can “expedite inoculation,” Silverbook wrote in a follow-up email. He said the company anticipates Lumina will ship by mid-June.

Some people have already received it. Silverbook said he introduced Lumina into his own mouth in October of 2023, and that Lantern Bioworks has also provided it to about 60 people, including attendees of Vitalia, a biotechnology conference held in Honduras earlier this year. At the conference, Lumina was offered for $20,000 per treatment, though the pre-order price has been reduced to $250 before taxes and shipping fees. (Silverbook would not comment on how many people went for Lumina at the conference.)

Experts, though, have safety and ethical concerns: Despite earlier efforts by Oragenics, the treatment has never successfully moved through human clinical trials. “Without human trials, you really can’t determine whether it’s safe or efficacious,” said Jennifer Kuzma, a professor and co-director of the Genetic Engineering and Society Center at North Carolina State University. In fact, it’s possible it could do the opposite of its original intention: She noted that subtle changes in the oral microbiome might lead to more cavities or other problems.

“I read it and sort of boggled at it and said, ‘Wow, this is a cavity vaccine. Why don’t we have this?’”

There’s also no data about whether it could spread between people, which brings up questions of informed consent. If someone doesn’t want to risk taking the untested bacteria, but kisses or shares spoons with someone who got the product, would it be transmitted? No one is quite sure.

Although Lantern Bioworks is bringing Lumina to market as a cosmetic product, precisely how it should be categorized isn’t entirely obvious, Kuzma points out: “The regulatory system isn’t 100 percent clear on this.”

The GMO tooth microbe that is supposed to prevent cavities Read More »

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Life-threatening rat pee infections reach record levels in NYC

health, Science / /

Epeedemic —

Between 2001 and 2020, there was an average of 3 cases per year. Last year’s tally was 24.

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A rat looks for food while on a subway platform at the Columbus Circle - 59th Street station on May 8, 2023, in New York City.

Enlarge / A rat looks for food while on a subway platform at the Columbus Circle – 59th Street station on May 8, 2023, in New York City.

A life-threatening bacterial infection typically spread through rat urine sickened a record number of people in New York City last year—and this year looks on track for another all-time high, the NYC Department of Health and Mental Hygiene reports.

The infection is leptospirosis, which can cause a range of symptoms, including non-specific ones like fever, headache, chills, muscle aches, vomiting, diarrhea, and cough. But, if left untreated, can become severe, causing kidney failure, liver damage, jaundice, hemorrhage, bloody eyes (conjunctival suffusion), respiratory distress, and potentially death.

The bacteria that causes it—spirochete bacteria of the genus Leptospira—infect rats, which shed the bacteria in their urine. The germs jump to people through direct contact with open wounds or mucous membranes.

New York City has long been in a (mostly losing) war with its rat population, which last year was estimated to be as many as 3 million. Mayor Eric Adams has made fighting the rat population a key initiative, and just last week, the city council proposed the latest strategy to curtail the furry brown rodent’s colony: birth control in the form of salty pellets.

Still, leptospirosis has not been a prime concern from the rats’ mischief until recently. Between 2001 and 2020, the city logged an average of just three leptospirosis cases a year—and some of those were travel related. But, things took a turn during the pandemic when the rat population seemed to boom. From 2021 and 2022, the average shot up to 15. In 2023, there were 24 cases, the highest number of cases ever recorded for a single year. And as of April 10, there have been six cases so far.

That number of cases so far this year is concerning given that Leptospira bacteria are “fragile,” as the NYC health department puts it. They die quickly in the freezing temperatures of winte and the dry heat of summer. Their main time to thrive is in warm, moist conditions. Last year, the months with the most cases were June and October. The health department noted that climate change, which is causing excessive rain and unseasonably warm temperatures, may be partly driving the uptick in cases.

In a health advisory released last week, the city’s health department advised clinicians to be on the lookout for cases, which are treated with common oral antibiotics when mild or intravenous doses when severe. Symptoms typically develop in 5 to 14 days after an exposure, but can show up anywhere from 2 to 30 days.

Of the 98 locally acquired cases that the city has recorded between 2001 and 2023, nearly all were in men (94 percent) and the median age was 50, with a range of 20 to 80 years. Most often, the cases occurred in the Bronx (37), followed by Manhattan (28), Brooklyn (19), Queens (10), and Staten Island (4). Cases presented to clinicians with acute kidney and liver failure and occasionally severe respiratory involvement. Of the 98 cases, six died.

The cases are typically related to living or working environments with rat urine, contaminated soil and water, or materials frequently contaminated with rat urine, such as trash bags or food waste bins. The health department noted that human-to-human transmission is rare.

New York isn’t the only city plagued by leptospirosis cases. Last year, doctors in the Netherlands reported the case of an 18-year-old with jaundiced, bloody eyes, who had developed leptospirosis after falling into a canal that was likely contaminated with rodent urine.

Life-threatening rat pee infections reach record levels in NYC Read More »

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Bogus Botox poisoning outbreak spreads to 9 states, CDC says

botox, botulism, CDC, health, injection, outbreak, Science / /

botched shots —

All of the case have been in women, nine of whom were hospitalized.

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A package of counterfeit Botox.

A package of counterfeit Botox.

At least 19 women across nine US states appear to have been poisoned by bogus injections of Botox, the Centers for Disease Control and Prevention reported late Monday.

Nine of the 19 cases—47 percent—were hospitalized and four—21 percent—were treated with botulinum anti-toxin. The CDC’s alert and outbreak investigation follows reports in recent days of botulism-like illnesses linked to shady injections in Tennessee, where officials reported four cases, and Illinois, where there were two. The CDC now reports that the list of affected states also includes: Colorado, Florida, Kentucky, Nebraska, New Jersey, New York, and Washington.

In a separate alert Tuesday, the Food and Drug Administration said that “unsafe, counterfeit” versions of Botox had been found in several states, and the toxic fakes were administered by unlicensed or untrained people and/or in non-medical or unlicensed settings, such as homes or spas. The counterfeit products appeared to have come from an unlicensed source, generally raising the risks that they’re “misbranded, adulterated, counterfeit, contaminated, improperly stored and transported, ineffective and/or unsafe,” the FDA said.

The CDC and the FDA listed the various symptoms that followed injections of the counterfeit Botox, which include: blurred or double vision, drooping eyelids, difficulty swallowing, dry mouth, slurred speech, constipation, incontinence, shortness of breath or difficulty breathing, weakness, and difficulty lifting one’s head. “These symptoms are similar to those seen when botulinum toxin spreads to other parts of the body,” the FDA wrote. Anyone experiencing those symptoms after an injection should go to the emergency room or contact a health care professional.

Botox is a regulated drug containing purified, controlled doses of botulinum toxin, a neurotoxin made by Clostridium bacteria that causes muscle paralysis by blocking a neurotransmitter. It’s often injected into the face to reduce the appearance of wrinkles. The CDC reported that all 19 cases identified so far are in women between the ages of 25 and 59. Eighteen of the 19 specifically reported getting the injections for cosmetic purposes.

But harmful exposure to the toxin—such as from an infection, eating contaminated foods, or use of counterfeit Botox—can cause botulism or at least botulism-like illnesses. In severe cases, botulism can progress to descending, symmetric muscle weakness, full muscle paralysis, and can sometimes be fatal. The CDC reported that some of the people in the outbreak were hospitalized and treated with anti-toxin out of concern that the toxin had spread beyond the injection site. However, the agency noted that five people were specifically tested for botulism, and all tested negative.

In an email to Ars late last week, the CDC recommended that anyone interested in a Botox injection do so using “an FDA-approved product, administered by licensed providers and in licensed settings.” The agency added in its alert Monday: ” If in doubt, don’t get the injection.”

The FDA, meanwhile, provided detailed information on how to ensure your shot of Botox is the real thing. FDA-approved Botox is made by AbbVie, and authentic Botox products come in unit doses of 50, 100, and 200. The outside of the box should say “BOTOX® COSMETIC / onabotulinumtoxinA / for Injection” or “OnabotulinumtoxinA / BOTOX® / for injection,” and it should list the manufacturer as either “Allergan Aesthetics / An AbbVie Company” or “abbvie.” The active ingredient should be listed as “OnabotulinumtoxinA” on the box.

In contrast, some of the counterfeit versions the FDA has tracked down so far were sold in 150-unit doses (not made by AbbVie), only appear to have “Allergan” on the box (not the full manufacturer name), and the active ingredient is displayed as “Botulinum Toxin Type A” instead of  “OnabotulinumtoxinA.” The counterfeit versions also have had non-English language text on the outside of the box and displayed a lot number of C3709C3. Any one of these features is a sign that the product is counterfeit. Images of the counterfeit products from the FDA are below.

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US drug shortages reach record high with 323 meds now in short supply

adderall, ASHP, cancer drugs, DEA, drug shortages, fda, generic drugs, health, pharmacists, pharmacy, Science / /

Terrible —

The shortages affect everything from generic cancer drugs to ADHD medication.

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Takeda Pharmaceutical Co. Adderall XR brand medication arranged at a pharmacy in Provo, Utah, in November 2023.

Enlarge / Takeda Pharmaceutical Co. Adderall XR brand medication arranged at a pharmacy in Provo, Utah, in November 2023.

Drug shortages in the US have reached an all-time high, with 323 active and ongoing shortages already tallied this year, according to data collected by the American Society of Health-System Pharmacists (ASHP).

The current drug shortage total surpasses the previous record of 320, set in 2014, and is the highest recorded since ASHP began tracking shortages in 2001.

“All drug classes are vulnerable to shortages,” ASHP CEO Paul Abramowitz said in a statement Thursday. “Some of the most worrying shortages involve generic sterile injectable medications, including cancer chemotherapy drugs and emergency medications stored in hospital crash carts and procedural areas. Ongoing national shortages of therapies for attention-deficit/hyperactivity disorder [ADHD] also remain a serious challenge for clinicians and patients.”

Erin Fox, associate chief pharmacy officer of University of Utah Health, told CBS MoneyWatch, that most of the drugs in short supply are generic, older products, and around half are injectable drugs that require more stringent manufacturing processes.

There are myriad reasons for the hundreds of drug shortages now facing doctors and patients, many of which remain unclear. But, as Ars has reported before, the root cause of shortages of low-cost, off-patent generic drugs is well established. These drugs have razor-thin to non-existent profit margins, driven by middle managers who have, in recent years, pushed down wholesale prices to rock-bottom levels. In some cases, generic manufacturers lose money on the drugs, disincentivizing other players in the pharmaceutical industry from stepping in to bolster fragile supply chains. Several generic manufacturers have filed for bankruptcy recently.

For other drugs, the situation is more complicated. The ADHD drug Adderall, for instance, has been in critical shortage since October 2022, causing millions of patients around the country to struggle to fill their prescriptions. It began when a manufacturing delay for one manufacturer kicked off a shortfall. Although that problem has since been resolved, it came amid a significant increase in Adderall prescriptions, which spiked further during the pandemic when telehealth prescribing became more common. Additionally, because Adderall—made of amphetamine-mixed salts—is a controlled substance, the Drug Enforcement Administration sets limits or “quotas” on how much of it manufacturers can make. Such quotas can exacerbate shortages, ASHP said.

But, in a joint letter with the Food and Drug Administration last August, the DEA said that, by its data, manufacturers of amphetamine products (including Adderall) only sold approximately 70 percent of their allotted quotas in 2022. That meant that there were approximately 1 billion more doses that they could have produced but did not make or ship. At the time, the agencies said its 2023 data was trending in the same direction.

In 60 percent of cases, manufacturers do not know or do not provide reasons why their drugs fall into short supply, ASHP found.

The organization has put forth policy recommendations to prevent shortages and improve supply chains, advocating for federal and regulatory changes. “Much work remains to be done at the federal level to fix the root causes of drug shortages,” Abramowitz said. “ASHP will continue to engage with policymakers regularly as we guide efforts to draft and pass new legislation to address drug shortages and continue to strongly advocate on behalf of our members for solutions that work.”

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Sketchy Botox shots spark multistate outbreak of botulism-like condition

botox, botulism, butulinum toxin, CDC, health, Illinois, Science, tennessee / /

Yikes —

So far at least six people in two states have fallen ill; four of them were hospitalized.

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A woman in New Jersey receiving a Botox treatment at a Botox party in a New Jersey salon hosted by a radio station.

Enlarge / A woman in New Jersey receiving a Botox treatment at a Botox party in a New Jersey salon hosted by a radio station.

Sketchy cosmetic injections of what seem to be counterfeit Botox are behind a multistate outbreak of botulism-like illnesses, state health officials report.

So far, at least six people have fallen ill in two states: four in Tennessee and two in Illinois. Four of the six people required hospitalization for their condition (two in Tennessee and both cases in Illinois).

The Centers for Disease Control and Prevention is reportedly planning to nationwide alert to notify clinicians of the potentially counterfeit Botox and advise them to be on the lookout for botulism-like illnesses. The agency did not immediately respond to Ars’ request for information.

Botox is a regulated drug product that contains purified, controlled quantities of the botulinum neurotoxin, which is made by certain Clostridium bacterial species, especially Clostridium botulinum. The toxin causes muscle paralysis by blocking the release of a neurotransmitter. When people are exposed to the toxin from wound infections or by accidentally eating contaminated foods, it can lead to full paralysis, including in muscles used for breathing. But, the toxin can also be used safely for cosmetic procedures to smooth facial wrinkles—when well-regulated and approved doses administered by licensed medical professionals are used.

All of those important conditions for use did not seem to be met in the cases identified so far. Tennessee reported that its four cases were linked to injections given in “non-medical settings such as homes or cosmetic spas.” Investigators found that the injections were of “products with unclear origin” and that information collected so far suggests the products were counterfeit.

The two people sickened in Illinois, meanwhile, both received injections from a nurse in LaSalle County who was “performing work outside her authority.” State officials said the injections were of Botox or a similar, possibly counterfeit product.

The early symptoms of botulism can include double or blurred vision, drooping eyelids, slurred speech, difficulty swallowing, dry mouth, and difficulty breathing, Tennessee health officials noted. After that, people may suffer descending, symmetric muscle weakness that progresses over hours to days, requiring hospitalization and treatment with an anti-toxin.

Illinois officials reported that the cases reported similar symptoms, such as blurred or double vision, droopy face, fatigue, shortness of breath, difficulty breathing, and a hoarse voice, after getting their injections.

“Illinois residents should exercise caution when considering cosmetic treatment,” Illinois Department of Public Health Director Sameer Vohra said in a statement. “Receiving these treatments in unlicensed, unapproved settings can put you or your loved ones at serious risk for health problems. Please only seek cosmetic services under the care of licensed professionals trained to do these procedures and who use FDA approved products. If you are experiencing any health problems after a recent cosmetic treatment, please contact your healthcare provider immediately for help and assistance.”

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