health

the-dangers-of-sneezing—from-ejected-bowels-to-torn-windpipes

The dangers of sneezing—from ejected bowels to torn windpipes

health, Science, sneeze, sneezing, syndication / /

Autosomal Dominant Compelling Helioopthalmic Outburst (achoo) —

The benefits of a good sneeze can sometimes come with a greater risk of injury.

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Picture shows a woman about to sneeze holding a handkerchief in her hand.

If you were to envision the kind of accident that would cause a person’s bowels to explode out of their body, you might imagine some sort of gruesome stabbing or grisly car accident. You’d probably never imagine that something as commonplace and harmless as a sneeze would cause this kind of ghastly injury—but that’s exactly what happened to a Florida man earlier this month.

The man had recently had abdominal surgery and was suffering from wound dehiscence—where his surgical scar wasn’t healing properly. While eating breakfast, the man first sneezed, then began coughing. He noticed pain and a wet sensation on his lower abdomen—only to discover several loops of his bowel had burst through his unhealed wound.

The man was rushed to hospital for emergency surgery where his bowels were returned to his abdomen.

Sneezing is normally a protective mechanism that keeps potentially harmful things—such as dust, bacteria and viruses – out of our respiratory system. The process is controlled by the so-called “sneezing center” in the brain’s medulla (which governs autonomic functions, including breathing). It’s activated by the presence of irritants in the lining of the nose and airways, which send impulses to the center.

The response is a closing of your eyes, throat and mouth while your chest muscles contract—compressing your lungs and driving air out of your respiratory system. This forces whatever triggered the response “out” of your system at an impressive speed—up to 15.9m/s (35mph) in some cases.

But despite the benefits of a good sneeze, it can sometimes come with a greater risk of injury than many might realize.

For instance, violent sneezing can cause the lung to herniate through the intercostal muscles between the ribs—usually at a point of weakness. This is typically a result of morbid obesity, chronic obstructive pulmonary disease, diabetes or smoking.

There are also cases of sneezing tearing the delicate tissues of the lungs. This happens when the higher pressure air deep in the lungs escapes into the space between the chest and the lung, causing this air to compress the lung on one or both sides of the chest.

The lungs aren’t the only thing that can tear. There are reports of people tearing the delicate lining of the brain from sneezing—leading to a subarachnoid haemorrhage (a type of stroke) which can be fatal if not diagnosed and treated promptly.

Even if you don’t tear this delicate lining, a sneeze can still affect the brain—with reports of people suffering weakness on one side of the body or visual disturbances following a sneeze.

Sneezing raises blood pressure which can cause other serious injuries to the blood vessels. There are cases of aortic dissection from sneezing, where the force of the sneeze tears the layers of the aorta (the major artery that carries oxygenated blood around the body) and causes blood to burst between the layers. If not treated, it has a 50 percent mortality rate within 48 hours of happening.

While it’s pretty common to injure your back while sneezing, this isn’t the only musculoskeletal injury that can happen. There are case reports of people fracturing the bones around their eye from sneezing. This type of fracture, called a blow-out fracture, is typically caused by blunt force trauma—often from a golf, tennis or baseball to the eye.

The small bones of the ear can fracture following a sneeze, which can cause hearing loss. Dental implants have been known to dislodge themselves into other parts of the face from a forceful sneeze.

The increased pressure caused by sneezing can cause fluid to escape from the body, particularly urine from the bladder. This is typically seen in people with weak pelvic floor muscles—usually caused by pregnancy, childbirth, obesity, menopause, and physical trauma or nerve damage.

Don’t hold it in

Given all the potential injuries a sneeze can cause, you might think it’s better to hold them in.

But even that isn’t safe to do. In 2023, a Scottish man held in a sneeze by closing his mouth and holding his nose. This resulted in him tearing his windpipe. By closing off his airways, this allowed the pressure generated by the sneeze to build up inside the respiratory system—which can sometimes be up to 20 times the pressure normally seen in the respiratory system. But this energy has to go somewhere, so is typically absorbed by the tissues.

Others have fractured bones of their face holding in sneezes, damaged their larynx (voice box), and torn the tissues in their chest that protect the lungs.

Thankfully, there is one injury that would be impossible for a sneeze to cause. Ever been told that if you sneeze with your eyes open, it’ll cause them to pop out? Thankfully, that’s just a tall tale. This is because your eyes are held in place by muscles and a nerve that anchors it in place. Not to mention that the airways in our respiratory system have no connection to your eyeballs or eye sockets.

Our body is well adapted to sneeze, so you probably don’t need to worry about suffering any injuries as many of these harms only happen in very rare circumstances. Though if you’re someone like Donna Griffiths (who has the longest recorded sneezing fit, lasting a nose-clearing 976 days) or Yi Yang (who has the loudest recorded sneeze at 176 decibels, the equivalent of a rocket taking flight), you may be at greater risk of harm.The Conversation

Adam Taylor, Professor and Director of the Clinical Anatomy Learning Centre, Lancaster University. This article is republished from The Conversation under a Creative Commons license. Read the original article.

The dangers of sneezing—from ejected bowels to torn windpipes Read More »

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Soda additive “no longer considered safe,” gets long-awaited FDA ban

brominated vegetable oil, BVO, fda, food additives, health, Mountain Dew, Science, Sun drop / /

Decades coming —

Brominated vegetable oil (BVO) is used in citrus sodas but has largely been phased out.

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Tops of citrus sodas at a manufacturing plant.

Enlarge / Tops of citrus sodas at a manufacturing plant.

After more than five decades of limbo, the Food and Drug Administration on Wednesday revoked the authorization of brominated vegetable oil (BVO) in food, banning an additive long known to have toxic effects that is already banned in Europe, Japan, Australia, New Zealand, and California.

BVO—simply vegetable oil that is modified with bromine—has been used in foods since the 1920s. It has often been used as a stabilizer for fruit flavorings, particularly in citrusy beverages, including sodas, to keep the citrus flavoring from separating and floating to the top. The FDA authorized the use of BVO just after gaining the authority to regulate food additives in 1958. By the early 1960s, the FDA had put BVO on its first inventory of food additives it deemed generally safe—designated “generally recognized as safe” or GRAS. But safety concerns quickly surfaced, and by the late 1960s, the FDA had already limited its use to a flavoring stabilizer and capped the amount that could be used to 15 parts per million.

That 15-ppm limit was authorized on an “interim basis,” pending more safety studies. In 1970, the FDA revoked the GRAS designation for BVO, but continued to allow the 15-ppm limit—on an interim basis—given that safety studies “did not indicate an immediate health threat from the limited use.”

“Disgraceful”

The interim safety limit stayed in place until now, as the FDA was waiting for more safety data. In the mid-2010s, following bans in Europe and Japan, the agency began to review BVO and commissioned its own studies. A resulting rat study, which the agency published in 2022, found that when rats were fed BVO at levels that mimicked humans’ exposure at the 15-ppm limit, the animals developed abnormalities in their thyroids, alterations in their hormone signaling, and accumulation of brominated fatty acids in their hearts, livers, and fat.

The FDA proposed its ban in November 2023. At the time, the FDA’s Deputy Commissioner for Human Foods, James Jones, hinted at the agency’s inactions by noting that the proposed restructuring at the agency was intended to “develop a faster and more nimble process for evaluating chemicals in the food supply.”

By then, most major soda makers had already phased BVO out of their citrusy sodas and other drinks amid public pressure. Coca-Cola pledged to remove BVO from its drinks in 2014, and PepsiCo confirmed in 2020 that it had removed it from its drinks, including Mountain Dew and Gatorade. The FDA reports that only a few beverages in the US still use the additive. Among the lingering users is Sun Drop, according to its product page.

Manufacturers have one year to reformulate their products, the FDA notes.

Consumer advocates chided the FDA while celebrating the ban. “The FDA’s decision to ban brominated vegetable oil in food is a victory for public health,” Scott Faber, senior vice president of government affairs at the Environmental Working Group, said in a statement. “But it’s disgraceful that it took decades of regulatory inaction to protect consumers from this dangerous chemical.”

Soda additive “no longer considered safe,” gets long-awaited FDA ban Read More »

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Alzheimer’s scientist indicted for allegedly falsifying data in $16M scheme

Alzheimer's, Cassava, CUNY, fraud, health, Hoau-Yan Wang, NIH, NIH grant, research, research funding, research misconduct, Science, Simufilam, Western blots / /

Funding Scheme —

The work underpinned an Alzheimer’s drug by Cassava, now in a Phase III trial.

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Alzheimer’s scientist indicted for allegedly falsifying data in $16M scheme

A federal grand jury has indicted an embattled Alzheimer’s researcher for allegedly falsifying data to fraudulently obtain $16 million in federal research funding from the National Institutes of Health for the development of a controversial Alzheimer’s drug and diagnostic test.

Hoau-Yan Wang, 67, a medical professor at the City University of New York, was a paid collaborator with the Austin, Texas-based pharmaceutical company Cassava Sciences. Wang’s research and publications provided scientific underpinnings for Cassava’s Alzheimer’s treatment, Simufilam, which is now in Phase III trials.

Simufilam is a small-molecule drug that Cassava claims can restore the structure and function of a scaffolding protein in the brain of people with Alzheimer’s, leading to slowed cognitive decline. But outside researchers have long expressed doubts and concerns about the research.

In 2023, Science magazine obtained a 50-page report from an internal investigation at CUNY that looked into 31 misconduct allegations made against Wang in 2021. According to the report, the investigating committee “found evidence highly suggestive of deliberate scientific misconduct by Wang for 14 of the 31 allegations,” the report states. The allegations largely centered around doctored and fabricated images from Western blotting, an analytical technique used to separate and detect proteins. However, the committee couldn’t conclusively prove the images were falsified “due to the failure of Dr. Wang to provide underlying, original data or research records and the low quality of the published images that had to be examined in their place.”

In all, the investigation “revealed long-standing and egregious misconduct in data management and record keeping by Dr. Wang,” and concluded that “the integrity of Dr. Wang’s work remains highly questionable.” The committee also concluded that Cassava’s lead scientist on its Alzheimer’s disease program, Lindsay Burns, who was a frequent co-author with Wang, also likely bears some responsibility for the misconduct.

In March 2022, five of Wang’s articles published in the journal PLOS One were retracted over integrity concerns with images in the papers. Other papers by Wang have also been retracted or had statements of concern attached to them. Further, in September 2022, the Food and Drug Administration conducted an inspection of the analytical work and techniques used by Wang to analyze blood and cerebrospinal fluid from patients in a simufilam trial. The investigation found a slew of egregious problems, which were laid out in a “damning” report obtained by Science.

In the indictment last week, federal authorities were explicit about the allegations, claiming that Wang falsified the results of his scientific research to NIH “by, among other things, manipulating data and images of Western blots to artificially add bands [which represent proteins], subtract bands, and change their relative thickness and/or darkness, and then drawing conclusions” based on those false results.

Wang is charged with one count of major fraud against the United States, two counts of wire fraud, and one count of false statements. If convicted, he faces a maximum penalty of 10 years in prison for the major fraud charge, 20 years in prison for each count of wire fraud, and five years in prison for the count of false statements, the Department of Justice said in an announcement.

In a statement posted to its website, Cassava acknowledged Wang’s indictment, calling him a “former” scientific adviser. The company also said that the grants central to the indictment were “related to the early development phases of the Company’s drug candidate and diagnostic test and how these were intended to work.” However, Cassava said that Wang “had no involvement in the Company’s Phase 3 clinical trials of simufilam.”

Those ongoing trials, which some have called to be halted, are estimated to include over 1,800 patients across several countries.

Alzheimer’s scientist indicted for allegedly falsifying data in $16M scheme Read More »

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Microdosing candies finally recalled after psychoactive muscimol found

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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 »

surgeons-remove-pig-kidney-transplant-from-woman

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.

Surgeons remove pig kidney transplant from woman Read More »