health

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Microdosing candies finally recalled after psychoactive muscimol found

CDC, diamond shruumz, fda, health, illnesses, muscimol, Mushroom, neurotransmitter, poisoning, recall, Science / /

Finally —

Muscimol, found in the candy, is from hallucinogenic Amanita muscaria mushrooms.

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Microdosing candies finally recalled after psychoactive muscimol found

After weeks of reports of severe illnesses across the country, the maker of Diamond Shruumz microdosing chocolates, gummies, and candy cones has finally issued a recall. It covers all lots and all flavors of all the brand’s products.

The illnesses have been marked by several severe symptoms, which notably include seizures, loss of consciousness, and the need for intubation and intensive care. To date, there have been 39 people sickened, including 23 hospitalizations across 20 states, according to the Food and Drug Administration and the Centers for Disease Control and Prevention. The FDA first issued a warning on the brand’s chocolate bars on June 7, when there were reports of eight cases, including six hospitalizations, in four states.

Diamond Shruumz’s parent company, Prophet Premium Blends, said in the recall notice that it had received only two complaints about the products to date and, upon receiving those complaints, reviewed recent laboratory analyses (Certificates of Analysis) of its products. According to the company, those CoAs noted “higher than normal amounts of muscimol,” which is one of two key compounds found in hallucinogenic Amanita mushrooms. Muscimol “could be a potential cause of symptoms consistent with those observed in persons who became ill after eating Diamond Shruumz products,” the company said in the recall notice.

In a statement posted on Diamond Shruumz’s website, Prophet Premium Blends announced the recall and added that it has also ceased production and distribution of all of the brand’s products.

“Due to consumers becoming ill after consuming the entire chocolate bar and some products containing higher levels of Muscimol than normal, it is crucial that all of our consumers refrain from ingesting this product while we, alongside the FDA, continue our investigation as to what is the cause of the serious adverse effects,” Prophet Premium Blends wrote on its website.

Diamond Shruumz has not responded to multiple requests for comment from Ars. Prophet Premium Blends did not respond to a request for comment and a list of questions.

What’s normal?

It’s unclear what amounts of muscimol were found in the company’s products and which products were affected. While the company reported only “higher than normal” amounts, it’s also unclear what the “normal” amount is. Diamond Shruumz posts third-party lab reports on its website, most of which indicate that the products are tested for muscimol. For instance, the reports show muscimol testing for all flavors of Cones and Extreme Gummies. For the brand’s chocolate bars, which the FDA first linked to the illnesses, all the bars except for the dark chocolate flavor showed muscimol results. For the gummies, only the report for the Hawaiian Punch flavor shows muscimol results. Of all the reports that include results for muscimol, all indicate that the amounts are lower than the limit of quantitation, which suggests that they are not supposed to contain any amount of muscimol. All of the reports reviewed by Ars were dated at various times throughout 2023.

Muscimol, along with related ibotenic acid, are both key psychoactive components of some Amanita mushrooms. That includes the hallucinogenic toadstool mushroom A. muscaria var. muscaria, which is notable for its unique bright red-orange caps with white warts. Both muscimol and ibotenic acid resemble neurotransmitters, namely GABA and glutamate, respectively. Muscimol is associated with depression of the central nervous system, while Ibotenic acid is associated with excitation of the central nervous system.

Fuzzy findings

According to the recall notice, it’s possible that the muscimol could cause some of the symptoms in people sickened, which included seizures, agitation, involuntary muscle contractions, loss of consciousness, confusion, sleepiness, nausea and vomiting, abnormal heart rates, and hyper/hypotension. The FDA said in its own update that it was “evaluating this information.”

The agency had previously identified the undisclosed synthetic psychedelic compound 4-AcO-DMT in the company’s chocolates, as well as undisclosed compounds found in a potentially toxic Kava plant (Piper methysticum). It remains unclear if any of those compounds explain the illnesses.

The totality of the ingredients in Diamond Shruumz’s products remains unclear. The company does not list the ingredients on its website, selling the products only with terms indicating they contain psychedelic compounds and the vague, buzzword-loaded description of having a “primo proprietary blend of nootropic and functional mushrooms.”

The CDC warns that such “edibles” are often sold as candies and snack food and might contain undisclosed ingredients, including illicit substances, adulterants, or potentially harmful contaminants. Common marketing terms to look out for include “microdosing,” “adaptogens,” “nootropics,” and “functional mushrooms,” the CDC warns.

Consumers should not eat, sell, or serve any Diamond Shruumz product. For those who have already purchased the products, they can be returned for a full refund to 1019 Arlington St., Orlando, Florida, 32805, according to Diamond Shruumz’s website.

Microdosing candies finally recalled after psychoactive muscimol found Read More »

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Man suffers rare bee sting directly to the eyeball—it didn’t go well

bee sting, eye, health, NEJM, ophthalmology, Science / /

Nightmare fuel —

He did recover. No disturbing images in the article, but a link for those who dare.

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Bees fly to their hive.

Enlarge / Bees fly to their hive.

In what may be the biological equivalent to getting struck by lightning, a very unlucky man in the Philadelphia area took a very rare bee sting directly to the eyeball—and things went badly from there.

As one might expect, the 55-year-old went to the emergency department, where doctors tried to extract the injurious insect’s stinger from the man’s right eye. But it soon became apparent that they didn’t get it all.

Two days after the bee attack, the man went to the Wills Eye Hospital with worsening vision and pain in the pierced eye. At that point, the vision in his right eye had deteriorated to only being able to count fingers. The eye was swollen, inflamed, and bloodshot. Blood was visibly pooling at the bottom of his iris. And right at the border between the man’s cornea and the white of his eye, ophthalmologists spotted the problem: a teeny spear-like fragment of the bee’s stinger still stuck in place.

(Images of the eye and stinger fragment are here for those who aren’t squeamish. The white arrow in Panel A shows the location of the stinger fragment while the asterisk marks the pooled blood.)

Get thee to an ophthalmologist

In a report published recently in the New England Journal of Medicine, treating ophthalmology experts Talia Shoshany and Zeba Syed made a critical recommendation: If you happen to be among the ill-fated few who are stung in the eye by a bee, you should make sure to see an eye doctor specifically.

“I am not surprised that the ER missed a small fragment,” Shoshany told Ars over email. “They pulled out the majority of the stinger, but the small fragment was only able to be visualized at a slit lamp,” she said, referring to a microscope with a bright light used in eye exams. In this case, they visualized the stinger at 10X or 16X magnification with the additional help of a fluorescent dye. Moreover, after spotting it, the stinger fragment “needed to be pulled out with ophthalmic-specific micro-forceps.”

After finally getting the entirety of the wee dagger out, Shoshany and Syed prescribed a topical antibacterial and prednisolone eye drops (a steroid for inflammation). At a five-month follow-up, the patient had recovered and the vision in his right eye had improved to 20/25.

For those now in fear of eye stings, Soshany has some comforting words: “Ocular bee stings are very rare.” She noted this was the first one she had seen in her career. Although there are documented cases in the scientific literature, the incidence rate is unknown. The odds of getting struck by lightning, meanwhile, are 1 in 15,300, according to the National Weather Service.

But one troubling aspect of this case is that it’s unclear why the man was stung to begin with. According to Shoshany, the man worked on a property with a beehive, but he didn’t work with the insects himself. “He reports he was just walking by and several bees flew up to him; one stung him in the eye,” she said. It’s unclear what provoked them.

Man suffers rare bee sting directly to the eyeball—it didn’t go well Read More »

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Drugmaker to testify on why weight-loss drugs cost 15x more in the US

bernie sanders, drug pricing, health, Novo Nordisk, obesity, Ozempic, Pharmaceutical industry, Science, wegovy, weight loss / /

On second thought —

Bernie Sanders cancels subpoena vote.

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Lars Fruergaard Jorgensen, chief executive officer Novo Nordisk A/S, during an interview at the company's headquarters in Bagsvaerd, Denmark, on Monday, June 12, 2023.

Enlarge / Lars Fruergaard Jorgensen, chief executive officer Novo Nordisk A/S, during an interview at the company’s headquarters in Bagsvaerd, Denmark, on Monday, June 12, 2023.

After some persuasion from Sen. Bernie Sanders (I-Vt.), the CEO of Novo Nordisk will testify before lawmakers later this year on the “outrageously high cost” of the company’s diabetes and weight-loss drugs—Ozempic and Wegovy—in the US.

CEO Lars Jørgensen will appear before the Senate Committee on Health, Education, Labor, and Pensions (HELP), which is chaired by Sanders, in early September. The agreement came after a conversation with Sanders in which the CEO reportedly “reconsidered his position” and agreed to testify voluntarily. As such, Sanders has canceled a vote scheduled for June 18 on whether to subpoena Novo Nordisk to discuss its US prices, which are considerably higher than those of other countries.

The independent lawmaker has been working for months to pressure Novo Nordisk into lowering its prices and appearing before the committee. In April, Sanders sent Jørgensen a letter announcing an investigation into the prices and included a lengthy set of information requests. In May, the committee’s investigation released a report suggesting that Novo Nordisk’s current pricing threatens to “bankrupt our entire health care system.”

Sanders has repeatedly hammered not only the high prices of Novo Nordisk’s two blockbuster drugs but also the huge disparity between US prices and those in other countries.

Up to 15x more in the US

“Novo Nordisk currently charges Americans with type 2 diabetes $969 a month for Ozempic, while this same exact drug can be purchased for just $155 in Canada and just $59 in Germany,” Sanders wrote in April. “Novo Nordisk also charges Americans with obesity $1,349 a month for Wegovy, while this same exact product can be purchased for just $140 in Germany and $92 in the United Kingdom.”

Yale researchers, meanwhile, published a study in JAMA in March estimating that both drugs could be manufactured for less than $5.

In May, Novo Nordisk responded with a letter to Sanders, arguing that blame for high prices in the US lies with the country’s complex health system and with middle managers who take cuts, according to Bloomberg. Novo Nordisk said in the letter that it is prepared to address “systemic issues so that everyone who can benefit from its medicines is able to get them,” the outlet reported. The company also said it has spent over $10 billion on research and development to bring Wegovy and Ozempic to the market.

Still, that number is small in comparison to the projected revenue from the drugs. Bloomberg noted that analysts estimate that Novo Nordisk will make $27 billion from the two drugs this year alone. The May analysis by the HELP committee found that 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 be around $411 billion per year. Another report by the Congressional Budget Office found that the drugs’ costs are so high that they will not be offset by any financial gains from improved health outcomes.

“The Committee looks forward to Mr. Jørgensen explaining why Americans are paying up to 10 or 15 times more for these medications than people in other countries,” Sanders said last week.

Drugmaker to testify on why weight-loss drugs cost 15x more in the US Read More »

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Surgeon general’s proposed social media warning label for kids could hurt kids

facebook, health, Mental Health, Meta, online child safety, Policy, social media platforms, us surgeon general, Vivek Murthy, youth mental health crisis / /
Surgeon general’s proposed social media warning label for kids could hurt kids

US Surgeon General Vivek Murthy wants to put a warning label on social media platforms, alerting young users of potential mental health harms.

“It is time to require a surgeon general’s warning label on social media platforms stating that social media is associated with significant mental health harms for adolescents,” Murthy wrote in a New York Times op-ed published Monday.

Murthy argued that a warning label is urgently needed because the “mental health crisis among young people is an emergency,” and adolescents overusing social media can increase risks of anxiety and depression and negatively impact body image.

Spiking mental health issues for young people began long before the surgeon general declared a youth behavioral health crisis during the pandemic, an April report from a New York nonprofit called the United Health Fund found. Between 2010 and 2022, “adolescents ages 12–17 have experienced the highest year-over-year increase in having a major depressive episode,” the report said. By 2022, 6.7 million adolescents in the US were reporting “suffering from one or more behavioral health condition.”

However, mental health experts have maintained that the science is divided, showing that kids can also benefit from social media depending on how they use it. Murthy’s warning label seems to ignore that tension, prioritizing raising awareness of potential harms even though parents potentially restricting online access due to the proposed label could end up harming some kids. The label also would seemingly fail to acknowledge known risks to young adults, whose brains continue developing after the age of 18.

To create the proposed warning label, Murthy is seeking better data from social media companies that have not always been transparent about studying or publicizing alleged harms to kids on their platforms. Last year, a Meta whistleblower, Arturo Bejar, testified to a US Senate subcommittee that Meta overlooks obvious reforms and “continues to publicly misrepresent the level and frequency of harm that users, especially children, experience” on its platforms Facebook and Instagram.

According to Murthy, the US is past the point of accepting promises from social media companies to make their platforms safer. “We need proof,” Murthy wrote.

“Companies must be required to share all of their data on health effects with independent scientists and the public—currently they do not—and allow independent safety audits,” Murthy wrote, arguing that parents need “assurance that trusted experts have investigated and ensured that these platforms are safe for our kids.”

“A surgeon general’s warning label, which requires congressional action, would regularly remind parents and adolescents that social media has not been proved safe,” Murthy wrote.

Kids need safer platforms, not a warning label

Leaving parents to police kids’ use of platforms is unacceptable, Murthy said, because their efforts are “pitted against some of the best product engineers and most well-resourced companies in the world.”

That is nearly an impossible battle for parents, Murthy argued. If platforms are allowed to ignore harms to kids while pursuing financial gains by developing features that are laser-focused on maximizing young users’ online engagement, platforms will “likely” perpetuate the cycle of problematic use that Murthy described in his op-ed, the American Psychological Association (APA) warned this year.

Downplayed in Murthy’s op-ed, however, is the fact that social media use is not universally harmful to kids and can be beneficial to some, especially children in marginalized groups. Monitoring this tension remains a focal point of the APA’s most recent guidance, which noted that in April 2024 that “society continues to wrestle with ways to maximize the benefits of these platforms while protecting youth from the potential harms associated with them.”

“Psychological science continues to reveal benefits from social media use, as well as risks and opportunities that certain content, features, and functions present to young social media users,” APA reported.

According to the APA, platforms urgently need to enact responsible safety standards that diminish risks without restricting kids’ access to beneficial social media use.

“By early 2024, few meaningful changes to social media platforms had been enacted by industry, and no federal policies had been adopted,” the APA report said. “There remains a need for social media companies to make fundamental changes to their platforms.”

The APA has recommended a range of platform reforms, including limiting infinite scroll, imposing time limits on young users, reducing kids’ push notifications, and adding protections to shield kids from malicious actors.

Bejar agreed with the APA that platforms owe it to parents to make meaningful reforms. His ideal future would see platforms gathering more granular feedback from young users to expose harms and confront them faster. He provided senators with recommendations that platforms could use to “radically improve the experience of our children on social media” without “eliminating the joy and value they otherwise get from using such services” and without “significantly” affecting profits.

Bejar’s reforms included platforms providing young users with open-ended ways to report harassment, abuse, and harmful content that allow users to explain exactly why a contact or content was unwanted—rather than platforms limiting feedback to certain categories they want to track. This could help ensure that companies that strategically limit language in reporting categories don’t obscure the harms and also provide platforms with more information to improve services, Bejar suggested.

By improving feedback mechanisms, Bejar said, platforms could more easily adjust kids’ feeds to stop recommending unwanted content. The APA’s report agreed that this was an obvious area for platform improvement, finding that “the absence of clear and transparent processes for addressing reports of harmful content makes it harder for youth to feel protected or able to get help in the face of harmful content.”

Ultimately, the APA, Bejar, and Murthy all seem to agree that it is important to bring in outside experts to help platforms come up with better solutions, especially as technology advances. The APA warned that “AI-recommended content has the potential to be especially influential and hard to resist” for some of the youngest users online (ages 10–13).

Surgeon general’s proposed social media warning label for kids could hurt kids Read More »

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Huge telehealth fraud indictment may wreak havoc for Adderall users, CDC warns

adderall, ADHD, CDC, department of justice, Done Global, fentanyl, fraud, health, illicit drugs, overdose, prescription drug, Science, stimulants, telehealth / /

Tragic —

The consequences are dangerous, possibly even deadly, for patients across the US.

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Ten milligram tablets of the hyperactivity drug, Adderall, made by Shire Plc, is shown in a Cambridge, Massachusetts pharmacy Thursday, January 19, 2006.

Enlarge / Ten milligram tablets of the hyperactivity drug, Adderall, made by Shire Plc, is shown in a Cambridge, Massachusetts pharmacy Thursday, January 19, 2006.

The Centers for Disease Control and Prevention on Thursday warned that a federal indictment of an allegedly fraudulent telehealth company may lead to a massive, nationwide disruption in access to ADHD medications—namely Adderall, but also other stimulants—and could possibly increase the risk of injuries and overdoses.

“A disruption involving this large telehealth company could impact as many as 30,000 to 50,000 patients ages 18 years and older across all 50 US states,” the CDC wrote in its health alert.

The CDC warning came on the heels of an announcement from the Justice Department Thursday that federal agents had arrested two people in connection with an alleged scheme to illegally distribute Adderall and other stimulants through a subscription-based online telehealth company called Done Global.  The company’s CEO and founder, Ruthia He, was arrested in Los Angeles, and its clinical president, David Brody, was arrested in San Rafael, California.

“As alleged, these defendants exploited the COVID-19 pandemic to develop and carry out a $100 million scheme to defraud taxpayers and provide easy access to Adderall and other stimulants for no legitimate medical purpose,” Attorney General Merrick Garland said in a statement. “Those seeking to profit from addiction by illegally distributing controlled substances over the Internet should know that they cannot hide their crimes and that the Justice Department will hold them accountable.”

Deadly consequences

According to the Justice Department, Done Global generated $100 million in revenue by arranging for the prescription of over 40 million pills of Adderall and other stimulants, which are addictive medications used to treat ADHD (attention-deficit/hyperactivity disorder). Done Global allegedly eased access to the drugs by limiting the information available to prescribers, instructing prescribers to prescribe Adderall and other stimulants even if the patient didn’t qualify, and mandating that the prescribing appointments last no longer than 30 minutes. The company also discouraged prescriber follow-up appointments and added an “auto-refill” feature.

Prosecutors further allege that He and Brody continued with their scheme after becoming aware that patients had overdosed and died.

The CDC cautioned that the disruption from lost access to Done Global prescriptions comes amid a long-standing, nationwide shortage of Adderall and other stimulant medications. For patients with ADHD, the disruption could be harmful. “Untreated ADHD is associated with adverse outcomes, including social and emotional impairment, increased risk of drug or alcohol use disorder, unintentional injuries, such as motor vehicle crashes, and suicide,” the CDC warns. Further, a loss of access could drive some to seek illicit sources of the drugs, which could turn deadly.

“Patients whose care or access to prescription stimulant medications is disrupted, and who seek medication outside of the regulated healthcare system, might significantly increase their risk of overdose due to the prevalence of counterfeit pills in the illegal drug market that could contain unexpected substances, including fentanyl,” the CDC said. Fentanyl is a synthetic opioid that is up to 50 times stronger than heroin and 100 times stronger than morphine.

The Drug Enforcement Administration recently reported that seven out of every 10 pills seized from the illegal drug market contain a potentially lethal dose of illegally made fentanyl, the CDC noted.

This post was updated to clarify that the DEA’s data indicated that 70 percent of illicit pills seized contained “potentially” lethal doses, which was not included in the CDC’s warning.

Huge telehealth fraud indictment may wreak havoc for Adderall users, CDC warns Read More »

more-seizures,-intubation-from-microdose-candies:-12-sickened,-10-hospitalized

More seizures, intubation from microdose candies: 12 sickened, 10 hospitalized

CDC, chocolates, diamond shruumz, fda, health, microdose, mushrooms, outbreak, poison, psychelics, Science / /

Potent microdoses —

FDA updates alert after the latest case fell ill on June 9.

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Diamond Shruumz's

Enlarge / Diamond Shruumz’s “extremely potent” infused cones in “sprinkles” flavor.

More people have reported severe poisonings in an ongoing outbreak marked by people seizing and needing to be intubated after consuming microdose candies made by Diamond Shruumz, the Food and Drug Administration reported Tuesday.

There are now at least 12 reported cases across eight states. All 12 people were ill enough to seek medical care, and 10 needed to be hospitalized. The symptoms reported so far include seizures, central nervous system depression (loss of consciousness, confusion, sleepiness), agitation, abnormal heart rates, hyper/hypotension, nausea, and vomiting, the FDA reported.

In Tuesday’s update, the FDA also expanded the products linked to the illnesses. In addition to all flavors of Diamond Shruumz’s Microdosing Chocolate Bars, the agency’s warning now covers all flavors of the brand’s Infused Cones and Micro Dose and Macro Dose Gummies.

According to the FDA, the most recent case fell ill on June 9. On June 7, the FDA issued its initial warning on Diamond Shruumz’s chocolates, reporting that eight people had been sickened in four states, with six people hospitalized. The agency advised the public not to sell, serve, buy, or consume the chocolates and instead discard them.

The candies are available nationwide. They are sold online—where they remain available for purchase as of Tuesday evening—and can also be found in various retail locations throughout the US, including smoke/vape shops and retailers that sell hemp-derived products.

The current tally of cases includes one from Alabama, four from Arizona, two from Indiana, one from Kentucky, one from Missouri, one from Nevada, one from Pennsylvania, and one from South Carolina.

Diamond Schruumz has not responded to multiple requests for comment from Ars. The New York Times also reported that the company was unresponsive.

It remains unclear what exactly is in the candies and what could cause such severe toxicity. The company does not provide ingredient lists for its products on its website. The term “microdosing” typically suggests a small amount of psychedelic compound is present, and Diamond Shruumz markets its products as “trippy,” “psychedelic,” and “hallucinogenic.” But lab reports posted on Diamond Shruumz’s website indicate that its candies do not contain the notable mushroom-derived psychedelic compound, psilocybin.

The company only says that its candies contain a “primo proprietary blend of nootropic and functional mushrooms.” Nootropics are compounds said to affect cognition, though supplement makers have used the term dubiously in marketing.

In an April 2023 blog, Diamond Shruumz said its chocolate bars contain a blend of Lion’s mane, Reishi, and Chaga mushrooms, which are all non-hallucinogenic mushrooms used in herbal and traditional medicines and supplements. “Lion’s mane is a natural nootropic that can enhance cognitive function, while Reishi is an adaptogen that helps the body adapt to stress and boosts the immune system,” the company claimed. “Finally, Chaga is rich in antioxidants and can help reduce inflammation in the body.”

The FDA, along with America’s Poison Centers and the Centers for Disease Control and Prevention, is still investigating the cases and working to determine the cause. In a response to an inquiry from Ars, the FDA declined to comment on whether it is in contact with the company and if it is recommending a voluntary recall.

6/12/2024 3: 50pm ET: This story was updated to include the response from the FDA. 

More seizures, intubation from microdose candies: 12 sickened, 10 hospitalized Read More »

people-are-seizing,-being-intubated-after-eating-microdose-chocolates

People are seizing, being intubated after eating microdose chocolates

CDC, chocolate, fda, health, illnesses, microdosing, outbreak, outbreak investigation, poison control centers, Science, toxin / /

Yikes —

“Extreme caution” urged as at least 8 people in 4 states sickened, 6 hospitalized.

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A Diamond Shruumz chocolate bar, which come in a variety of flavors.

Enlarge / A Diamond Shruumz chocolate bar, which come in a variety of flavors.

Various federal and state health officials are sounding the alarm on Diamond Shruumz-brand Microdosing Chocolate Bars. The candy, said to be infused with mushrooms, has been linked to severe illnesses, including seizures, loss of consciousness, confusion, sleepiness, agitation, abnormal heart rates, hyper/hypotension, nausea, and vomiting, according to an outbreak alert released by the Food and Drug Administration on Friday.

So far, eight people across four states have been sickened—four in Arizona, two in Indiana, one in Nevada, and one in Pennsylvania, the FDA reported. Of the eight, six have been hospitalized.

“We are urging the public to use extreme caution due to the very serious effects of these products,” Maureen Roland, director of the Banner Poison and Drug Information Center in Phoenix, said in a press release earlier this week.

Steve Dudley, director of the Arizona Poison and Drug Information Center, added that there’s “clearly something toxic occurring” with the chocolates. “We’ve seen the same phenomenon of people eating the chocolate bar then seizing, losing consciousness, and having to be intubated.” Dudley noted that the state is aware of additional cases beyond the eight reported Friday by the FDA. Those cases were reported from Nebraska and Utah.

It’s not entirely clear what is in the chocolates or what could be causing the illnesses. The FDA said it was working with the Centers for Disease Control and Prevention as well as America’s Poison Centers to “determine the cause of these illnesses and is considering the appropriate next steps.”

On its website, Diamond Shruumz says that its chocolate bars contain a “primo proprietary blend of nootropic and functional mushrooms.” The website also contains reports of laboratory analyses on their products, some of which indicate the absence of select known fungal toxins and compounds such as the hallucinogen psilocybin and cannabinoids.

Diamond Shruumz did not immediately respond to Ars’ request for comment.

The chocolate bars are still available for sale online but the FDA said that consumers should not eat, sell, or serve them. Any bars already purchased should be discarded. Likewise, retailers should not sell or distribute them. The FDA noted that, in addition to being available online, the bars are also sold in various retail locations nationwide, including smoke/vape shops and retailers that sell hemp-derived products.

People are seizing, being intubated after eating microdose chocolates Read More »

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Ars chats with Precision, the brain-chip maker taking the road less invasive

brain computer interface, health, musk, Neuralink, Neuroscience, neurosurgery, Precision, Science / /

Brain-chip buzz —

Precision tested its BCI on 14 people so far. Two more are scheduled this month.

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Precision’s Layer 7 Cortical Interface array.

Enlarge / Precision’s Layer 7 Cortical Interface array.

Work toward brain-computer interfaces has never been more charged. Though neuroscientists have toiled for decades to tap directly into human thoughts, recent advances have the field buzzing with anticipation—and the involvement of one polarizing billionaire has drawn a new level of attention.

With competition amping up in this space, Ars spoke with Ben Rapoport, who is a neurosurgeon, electrical engineer, and co-founder of the brain-computer interface (BCI) company Precision Neuroscience. Precision is at the forefront of the field, having placed its BCI on the brains of 14 human patients so far, with two more scheduled this month. Rapoport says he hopes to at least double that number of human participants by the end of this year. In fact, the 3-year-old company expects to have its first BCI on the market next year.

In addition to the swift progress, Precision is notable for its divergence from its competitor’s strategies, namely Neuralink, the most high-profile BCI company and headed by Elon Musk. In 2016, Rapoport co-founded Neuralink alongside Musk and other scientists. But he didn’t stay long and went on to co-found Precision in 2021. In previous interviews, Rapoport suggested his split from Neuralink related to the issues of safety and invasiveness of the BCI design. While Neuralink’s device is going deeper into the brain—trying to eavesdrop on neuron signals with electrodes at close range to decode thoughts and intended motions and speech—Precision is staying at the surface, where there is little to no risk of damaging brain tissue.

Shallow signals

“It used to be thought that you needed to put needle-like electrodes into the brain surface in order to listen to signals of adequate quality,” Rapoport told Ars. Early BCIs developed decades ago used electrode arrays with tiny needles that sink up to 1.5 millimeters into brain tissue. Competitors such as Blackrock Neurotech and Paradromics are still developing such designs. (Another competitor, Synchron, is developing a stent-like device threaded into a major blood vessel in the brain.) Meanwhile, Neuralink is going deeper, using a robot to surgically implant electrodes into brain tissue, reportedly between 3 mm and 8 mm deep.

However, Rapoport eschews this approach. Anytime something essentially cuts into the brain, there’s damage, he notes. Scar tissue and fibrous tissue can form—which is bad for the patient and the BCI’s functioning. “So, there’s not infinite scalability [to such designs],” Rapoport notes, “because when you try to scale that up to making lots of little penetrations into the brain, at some point you can run into a limitation to how many times you can penetrate the brain without causing irreversible and undetectable damage.”

Further, he says, penetrating the brain is just unnecessary. Rapoport says there is no fundamental data that suggests that penetration is necessary for BCIs advances. Rather, the idea was based on the state of knowledge and technology from decades ago. “It was just that it was an accident that that’s how the field got started,” he said. But, since the 1970s, when centimeter-scale electrodes were first being used to capture brain activity, the technology has advanced from the macroscopic to microscopic range, creating more powerful devices.

“All of conscious thought—movement, sensation, intention, vision, etc.—all of that is coordinated at the level of the neocortex, which is the outermost two millimeters of the brain,” Rapoport said. “So, everything, all of the signals of interest—the cognitive processing signals that are interesting to the brain-computer interface world—that’s all happening within millimeters of the brain surface … we’re talking about very small spatial scales.” With the more potent technology of today, Precision thinks it can collect the data it needs without physically traversing those tiny distances.

Ars chats with Precision, the brain-chip maker taking the road less invasive Read More »

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Surgeons remove pig kidney transplant from woman

health, organ transplants, pig kidney, syndication / /

Interspecies —

No rejection, just a matter of blood flow.

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Transplant team

Courtesy of NYU Langone

Surgeons in New York have removed a pig kidney less than two months after transplanting it into Lisa Pisano, a 54-year-old woman with kidney failure who also needed a mechanical heart pump. The team behind the transplant says there were problems with the heart pump, not the pig kidney, and that the patient is in stable condition.

Pisano was facing heart and kidney failure and required routine dialysis. She wasn’t eligible to receive a traditional heart and kidney transplant from a human donor because of several chronic medical conditions that reduced the likelihood of a good outcome.

Pisano first received a heart pump at NYU Langone Health on April 4, followed by the pig kidney transplant on April 12. The heart pump, a device called a left ventricular assist device or LVAD, is used in patients who are either awaiting heart transplantation or otherwise aren’t a candidate for a heart transplant.

In a statement provided to WIRED, Pisano’s medical team explained that they electively removed the pig kidney on May 29—47 days after transplant—after several episodes of the heart pump not being able to pass enough blood through the transplanted kidney. Steady blood flow is important so that the kidney can produce urine and filter waste. Without it, Pisano’s kidney function began to decline.

“On balance, the kidney was no longer contributing enough to justify continuing the immunosuppression regimen,” said Robert Montgomery, director of the NYU Langone Transplant Institute, in the statement. Like traditional transplant patients, Pisano needed to take immunosuppressive drugs to prevent her immune system from rejecting the donor organ.

The kidney came from a pig genetically engineered by Virginia biotech company Revivicor to lack a gene responsible for the production of a sugar known as alpha-gal. In previous studies at NYU Langone, researchers found that removing this sugar prevented immediate rejection of the organ when transplanted into brain-dead patients. During Pisano’s surgery, the donor pig’s thymus gland, which is responsible for “educating” the immune system, was also transplanted to reduce the likelihood of rejection.

A recent biopsy did not show signs of rejection, but Pisano’s kidney was injured due to a lack of blood flow, according to the statement. The team plans to study the explanted pig kidney to learn more.

Pisano is now back on dialysis, a treatment for kidney-failure patients, and her heart pump is still functioning. She would not have been a candidate for the heart pump if she had not received the pig kidney.

“We are hoping to get Lisa back home to her family soon,” Montgomery said, calling Pisano a “pioneer and a hero in the effort to create a sustainable option for people waiting for an organ transplant.”

Pisano was the second living person to receive a kidney from a genetically engineered pig. The first, Richard Slayman of Massachusetts, died in May just two months after the historic transplant. The surgery was carried out on March 16 at Massachusetts General Hospital. In a statement released on May 11, the hospital said it had “no indication” that Slayman’s death was the result of the pig kidney transplant. The donor pig used in Slayman’s procedure had a total of 69 different genetic edits.

The global donor organ shortage has led researchers including the NYU and Massachusetts teams to pursue the possibility of using pigs as an alternative source. But the body immediately recognizes pig tissue as foreign, so scientists are using gene editing in an effort to make pig organs look more like human ones to the immune system. Just how many gene edits will be needed to keep pig organs working in people is a topic of much debate.

Pig heart transplants have also been carried out in two individuals—one in 2022 and the other in 2023—at the University of Maryland. In both cases, the patients were not eligible for human ones. Those donor pigs had 10 genetic edits and were also bred by Revivcor. Both recipients died around two months after their transplants.

This story originally appeared on wired.com.

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To pee or not to pee? That is a question for the bladder—and the brain

health, Science, syndication, urine / /

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The basic urge to pee is surprisingly complex and can go awry as we age.

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Cut view of man covering urine with hands. He has some pain and problem. Isolated on striped and blue background

You’re driving somewhere, eyes on the road, when you start to feel a tingling sensation in your lower abdomen. That extra-large Coke you drank an hour ago has made its way through your kidneys into your bladder. “Time to pull over,” you think, scanning for an exit ramp.

To most people, pulling into a highway rest stop is a profoundly mundane experience. But not to neuroscientist Rita Valentino, who has studied how the brain senses, interprets, and acts on the bladder’s signals. She’s fascinated by the brain’s ability to take in sensations from the bladder, combine them with signals from outside of the body, like the sights and sounds of the road, then use that information to act—in this scenario, to find a safe, socially appropriate place to pee. “To me, it’s really an example of one of the beautiful things that the brain does,” she says.

Scientists used to think that our bladders were ruled by a relatively straightforward reflex—an “on-off” switch between storing urine and letting it go. “Now we realize it’s much more complex than that,” says Valentino, now director of the division of neuroscience and behavior at the National Institute of Drug Abuse. An intricate network of brain regions that contribute to functions like decision-making, social interactions, and awareness of our body’s internal state, also called interoception, participates in making the call.

In addition to being mind-bogglingly complex, the system is also delicate. Scientists estimate, for example, that more than 1 in 10 adults have overactive bladder syndrome—a common constellation of symptoms that includes urinary urgency (the sensation of needing to pee even when the bladder isn’t full), nocturia (the need for frequent nightly bathroom visits) and incontinence. Although existing treatments can improve symptoms for some, they don’t work for many people, says Martin Michel, a pharmacologist at Johannes Gutenberg University in Mainz, Germany, who researches therapies for bladder disorders. Developing better drugs has proven so challenging that all major pharmaceutical companies have abandoned the effort, he adds.

Recently, however, a surge of new research is opening the field to fresh hypotheses and treatment approaches. Although therapies for bladder disorders have historically focused on the bladder itself, the new studies point to the brain as another potential target, says Valentino. Combined with studies aimed at explaining why certain groups, such as post-menopausal women, are more prone to bladder problems, the research suggests that we shouldn’t simply accept symptoms like incontinence as inevitable, says Indira Mysorekar, a microbiologist at Baylor College of Medicine in Houston. We’re often told such problems are just part of getting old, particularly for women—“and that’s true to some extent,” she says. But many common issues are avoidable and can be treated successfully, she says: “We don’t have to live with pain or discomfort.”

A delicate balance

The human bladder is, at the most basic level, a stretchy bag. To fill to capacity—a volume of 400 to 500 milliliters (about 2 cups) of urine in most healthy adults—it must undergo one of the most extreme expansions of any organ in the human body, expanding roughly sixfold from its wrinkled, empty state.

To stretch that far, the smooth muscle wall that wraps around the bladder, called the detrusor, must relax. Simultaneously, sphincter muscles that surround the bladder’s lower opening, or urethra, must contract, in what scientists call the guarding reflex.

It’s not just sensory neurons (purple) that can detect stretch, pressure, pain and other sensations in the bladder. Other types of cells, like the umbrella-shaped cells that form the urothelium’s barrier against urine, can also sense and respond to mechanical forces — for example, by releasing chemical signaling molecules such as adenosine triphosphate (ATP) as the organ expands to fill with urine.

Enlarge / It’s not just sensory neurons (purple) that can detect stretch, pressure, pain and other sensations in the bladder. Other types of cells, like the umbrella-shaped cells that form the urothelium’s barrier against urine, can also sense and respond to mechanical forces — for example, by releasing chemical signaling molecules such as adenosine triphosphate (ATP) as the organ expands to fill with urine.

Filling or full, the bladder spends more than 95 percent of its time in storage mode, allowing us to carry out our daily activities without leaks. At some point—ideally, when we decide it’s time to pee—the organ switches from storage to release mode. For this, the detrusor muscle must contract forcefully to expel urine, while the sphincter muscles surrounding the urethra simultaneously relax to let urine flow out.

For a century, physiologists have puzzled over how the body coordinates the switch between storage and release. In the 1920s, a surgeon named Frederick Barrington, of University College London, went looking for the on-off switch in the brainstem, the lowermost part of the brain that connects with the spinal cord.

Working with sedated cats, Barrington used an electrified needle to damage slightly different areas in the pons, part of the brainstem that handles vital functions like sleeping and breathing. When the cats recovered, Barrington noticed that some demonstrated a desire to urinate—by scratching, circling, or squatting—but were unable to voluntarily go. Meanwhile, cats with lesions in a different part of the pons seemed to have lost any awareness of the need to urinate, peeing at random times and appearing startled whenever it happened. Clearly, the pons served as an important command center for urinary function, telling the bladder when to release urine.

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FDA’s review of MDMA for PTSD highlights study bias and safety concerns

bias, clinical trial, fda, health, mdma, PTSD, Science / /

Complicated —

FDA advisors will meet June 4 to discuss and vote on the therapy’s effectiveness.

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MDMA is now in the FDA's hands.

Enlarge / MDMA is now in the FDA’s hands.

The safety and efficacy data on the use of MDMA (aka ecstasy) for post-traumatic stress disorder therapy is “challenging to interpret,” the Food and Drug Administration said in a briefing document posted Friday. The agency noted significant flaws in the design of the underlying clinical trials as well as safety concerns for the drug, particularly cardiovascular harms.

On Tuesday, June 4, the FDA will convene an advisory committee that will review the evidence and vote on MDMA’s efficacy and whether its benefits outweigh its risks. The FDA does not have to follow the committee’s recommendations, but it often does. If the FDA subsequently approves MDMA as part of treatment for PTSD, it would mark a significant shift in the federal government’s stance on MDMA, as well as psychedelics, generally. Currently, the US Drug Enforcement Administration considers MDMA a Schedule I drug, defined as one with “no currently accepted medical use and a high potential for abuse.” It would also offer a new treatment option for patients with PTSD, a disabling psychiatric condition with few treatment options currently.

As Ars has reported previously, the submission of MDMA for approval is based on two clinical trials. The first trial, published in Nature Medicine in 2021, involved 90 participants with moderate PTSD and found that MDMA-assisted psychotherapy significantly improved Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) scores compared with participants who were given psychotherapy along with a placebo. In the second study, published in September in Nature Medicine, the finding held up among 104 participants with moderate or severe PTSD (73 percent had severe PTSD).

In the briefing documents released Friday, the FDA highlighted that there was a high potential for bias to have crept into those results. Though the trials were designed to be double-blind (meaning that therapists and trial participants were not told who received MDMA), the FDA noted that MDMA “produces profound alterations in mood, sensation, suggestibility, and cognition.” Blinding is “nearly impossible,” the FDA wrote.  And indeed, approximately 90 percent of those assigned to take MDMA and 75 percent of those assigned to a placebo were able to accurately guess their treatment assignment, the FDA notes. As such, it is “reasonable to assume” that bias and “expectation bias” affected the results of the trials, the FDA concluded.

The agency also noted concerns that MDMA caused “significant increases in blood pressure and pulse,” which could trigger cardiac events, such as heart attacks. However, the trial data was limited for assessing the risks of these adverse events.

The FDA also dinged the studies for not including data on whether participants experienced effects such as “euphoria” after taking MDMA—an anticipated effect that could indicate the drug’s potential for abuse.

In all, the FDA’s review presented a complicated picture of MDMA’s risk-benefit assessment, one that should make for an interesting discussion Tuesday. The FDA’s criticisms follows an even more critical report released earlier this month by the Institute for Clinical and Economic Review (ICER), which identified “substantial concerns about the validity of the results” from the clinical trials.

Like the FDA, ICER found the trials to be “essentially unblinded.” However, ICER went further, having conducted a number of interviews with trial participants and others involved, finding that the trials largely pulled from an existing community of psychedelic advocates and supporters, introducing significant bias. “Concerns have been raised by some that therapists encouraged favorable reports by patients and discouraged negative reports by patients including discouraging reports of substantial harms, potentially biasing the recording of benefits and harms,” the report said. MDMA is known to induce confusion, depression, and paranoia in some. One participant reported feeling “relentlessly suicidal” after the trial, as a result of participating in it, but that result was not reflected in the trial’s reported results.

Various people told ICER that the community involved in the trials regarded psychedelics “more like a religious movement than like pharmaceutical products.” Some participants felt as though “they could be shunned if they reported bad outcomes or that it could lead to future patients being denied the benefits of MDMA-AP.”

In all, ICER concluded that the evidence available to assess for MDMA treatment is “insufficient.”

Editor’s Note: This story was corrected to report that the participant’s suicidal thoughts occurred after the trial, as a result of participation, not during the trial.

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Modern lives are messing up menstrual cycles—earlier starts, more irregularity

Apple, health, IPhone, JAMA, menstrual cycles, obesity, period, puberty, Science / /

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Earlier and irregular periods are both linked to poor health outcomes.

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Panty liners, hygienic tampons, and sanitary pads.

Enlarge / Panty liners, hygienic tampons, and sanitary pads.

People in the US are starting their menstrual cycles earlier and experiencing more irregularities, both of which raise the risk of a host of health problems later in life, according to an Apple women’s health study looking at data from over 70,000 menstruating iPhone users born between 1950 and 2005.

The mean age of people’s first period fell from 12.5 years in participants born between 1950 and 1969 to 11.9 years in participants born between 2000 and 2005, with a steady decline in between, the study found. There were also notable changes in the extremes—between 1950 and 2005, the percentage of people who started their periods before age 11 rose from 8.6 percent to 15.5 percent. And the percentage of people who started their periods late (at age 16 or above) dropped from 5.5 percent to 1.7 percent.

In addition to periods shifting to earlier starting ages, menstrual cycles also appeared to become more irregular. For this, researchers looked at how quickly people settled into a regular cycle after the start of their period. Between 1950 and 2005, the percentage of people obtaining regularity within two years fell from 76.3 percent to 56 percent.

The study, published by researchers at Apple and Harvard in the journal JAMA Network Open, notes that both of these findings bode poorly for long-term health. Early starting age of menstrual cycles is linked to adverse health outcomes, including cardiovascular diseases, cancers, spontaneous abortion, and premature death, the researchers write. And a longer time to regularity is linked to fertility problems, longer menstrual cycles, and an increased risk of metabolic conditions and all-cause mortality.

Looking across race and ethnicity categories, researchers found that the trends affected all groups. However, Black and Hispanic participants had consistently earlier menstrual starting ages than white and Asian participants. Black participants also saw a larger magnitude shift toward earlier starting ages compared with white participants.

It’s unclear what’s driving the menstrual changes, but the authors speculate that there could be a multitude of factors. The most prominent potential factor is childhood obesity, which has increased in the US over the course of the study period and is known to be linked to earlier puberty. However, the authors note that obesity doesn’t explain the totality of the shifts—an exploratory analysis indicated that obesity only accounted for 46 percent of the trends seen in the study. And other studies have indicated that the shift toward earlier menstrual cycles began before the upward trend of obesity in the US.

The authors of the current study point to various potential environmental factors, including endocrine-disrupting chemicals, metals, air pollutants, dietary patterns, psychosocial stress, and adverse childhood experiences.

The study has limitations, of course, including that it relied on self-reported data and was limited to people who own iPhones, who generally skew toward higher socioeconomic status. Thus, the findings may not be generalizable to the population overall. Still, the data fits with other studies, and the researchers called for more awareness among health care practitioners and more studies to look at trends and health outcomes.

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