health

long-covid-rates-have-declined,-especially-among-the-vaccinated,-study-finds

Long COVID rates have declined, especially among the vaccinated, study finds

covid-10 vaccines, COVID-19, Delta, health, long COVID, omicron, SARS-CoV-2, Science, vaccinated, variants / /

Good news —

In large study, rates of long COVID fell from 10% to 3.5% for the vaccinated.

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Long covid activists attend the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies hearing on the

Enlarge / Long covid activists attend the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies hearing on the “Fiscal Year 2025 Budget Request for the National Institutes of Health,” in Dirksen building on May 23, 2024.

As a summer wave of COVID-19 infections swells once again, a study published this week in the New England Journal of Medicine offers some positive news about the pandemic disease: Rates of long COVID have declined since the beginning of the health crisis, with rates falling from a high of 10.4 percent before vaccines were available to a low of 3.5 percent for those vaccinated during the omicron era, according to the new analysis.

The study, led by Ziyad Al-Aly, chief of research at the VA Saint Louis Health Care System, used data from a wealth of health records in the Department of Veterans Affairs. The researchers ultimately included data from over 440,000 veterans who contracted COVID-19 sometime between March 1, 2020, and January 31, 2022, as well as over 4.7 million uninfected veterans who acted as controls.

Al-Aly and colleagues divided the population into eight groups. People who were infected during the study period were divided into five groupings by the dates of their first infection and their vaccination status. The first group included those infected in the pre-delta era before vaccines were available (March 1, 2020, to June 18, 2021). Then there were vaccinated and unvaccinated groups who were infected in the delta era (June 19, 2021, to December 18, 2021) and the omicron era (December 19, 2021, and January 31, 2022). The uninfected controls made up the final three of eight groups, with the controls assigned to one of the three eras.

On the decline

In the pre-delta/pre-vaccine era, 10.42 out of 100 unvaccinated people infected developed long COVID in the year after their infection, which the researchers referred to as PASC, or postacute sequelae of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. In the delta era, the rate of long COVID among the unvaccinated fell slightly to 9.51 out of 100. But for the vaccinated, the rate fell much further, to 5.35 out of 100. A similar pattern was seen in the omicron era. For the unvaccinated, the rate of long COVID again fell slightly to 7.76 per 100 people, while the vaccinated saw their rate fall to 3.5 per 100.

In a secondary statistical analysis, called a decomposition analysis, the researchers found that vaccines could explain about 72 percent of the cumulative decline in long COVID rates across the eras, while era-related factors explained about 28 percent. Those era-related factors could include differences in the virus, improved treatments, and use of anti-viral medications.

Further, looking at data on the disease categories related to long COVID cases, the researchers also did an analysis finding a shift in symptoms over the eras. The researchers looked at over 10 disease categories: cardiovascular, coagulation and hematologic, fatigue, gastrointestinal, kidney, mental health, metabolic, musculoskeletal, neurologic, and pulmonary. Compared to the two earlier eras, the researchers noted an increase in gastrointestinal, metabolic, and musculoskeletal diseases involved in long COVID cases in the omicron era.

Overall, the study points to a welcomed decline in the rates of long COVID among the infected, particularly for those who are vaccinated. But, it also makes clear that long COVID isn’t a thing of the past: “a substantial residual risk of PASC remains among vaccinated persons who had SARS-CoV-2 infection during the omicron era,” Al-Aly and his colleagues conclude.

The study also has some limitations, leaving lingering questions for further study. One is whether the type or number of vaccines affect the risk of long COVID—that was not included in the study. The study also didn’t allow researchers to assess whether repeat infections increase the burden of long COVID.

Long COVID rates have declined, especially among the vaccinated, study finds Read More »

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Illegal drug found in Diamond Shruumz candies linked to severe illnesses

diamond shruumz, hallucinogenic, health, muscimol, Mushroom, poison, psilocin, psilocybin, psychedelics, Science / /

More drugs —

New testing finds psilocin, related to psilocybin, in gummies purchased in 2023.

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Illegal drug found in Diamond Shruumz candies linked to severe illnesses

Newly released testing data of Diamond Shruumz-brand gummies purchased in 2023 identified the presence of psilocin, a hallucinogenic drug closely related to the magic-mushroom drug psilocybin that is classified as a Schedule I drug, alongside psilocybin, heroin, and LSD.

The finding comes as Diamond Shruumz’s current line of gummies, chocolates, and candy cones is being recalled and are under active investigation in connection to a nationwide rash of severe illnesses, which have involved seizures, intubation, and intensive care. As of the latest update on July 15, 69 people in 28 states have been sickened after eating a Diamond Shruumz product. Sixty of the 69 sought medical care, 36 were hospitalized, and there is one potentially associated death under investigation.

The new finding of psilocin in the products, published by researchers at the University of Virginia, adds to growing concern about psychedelic mushroom candies generally. Although the candies are marketed as being legal, they have often been found to contain various undisclosed illegal drugs, gray market synthetic versions of drugs, as well as dangerous adulterants and contaminants.

In the ongoing investigation of Diamond Shruumz candies—led by the Food and Drug Administration and the Centers for Disease Control and Prevention, with the help of America’s Poison Centers and state and local partners—researchers have not identified psilocin in products linked to the illnesses. Instead, they have found a closely related synthetic hallucinogenic compound called 4-acetoxy-N,N-dimethyltryptamine, also known as psilacetin or 4-AcO-DMT. Psilacetin is thought to be metabolized into psilocin in the body and is said to have similar effects as taking magic mushrooms or psilocybin. The different testing results between the FDA-led investigation and the new UVA study may be due to possible formulation changes between 2023 and 2024 or simply differences in the products or batches of candies tested so far.

The UVA researchers, who published their findings in the CDC’s Morbidity and Mortality Weekly Report, looked into the mushroom candies after four adults reported illnesses to a local poison control center between September and November 2023. The people went to the emergency department with tachycardia, confusion, anxiety or somnolence, and nausea after eating gummy candies labeled as containing Amanita muscaria mushrooms. Amid their investigation into those cases, a 3-year-old also fell ill in June 2024 after accidentally eating two gummies sold as containing A. muscaria. All of the adults and the toddler recovered from their illnesses quickly, though the toddler was hospitalized for a day for observation.

Not legal or safe

A. muscaria is a legal hallucinogenic mushroom that contains psychoactive compounds ibotenic acid and muscimol. These resemble neurotransmitters in the brain and can cause gastrointestinal symptoms, agitation, and seizures.

The UVA researchers couldn’t track down the specific brands or products the sickened adults took, but they collected six similar products from nearby gas stations and smoke shops. Those six products included two Diamond Shruumz products, which were not sold as containing A. muscaria. Using liquid chromatography-mass spectrometry, the researchers found that the two Diamond Shruumz gummy products (Sour Peach Apple and Rainbow flavors) contained psilocin. The Rainbow flavor also contained caffeine.

In addition, a product labeled as “Wonderland Legal Psychedelics Cherry Nirvana” contained psilocin, the synthetic hallucinogen N,N-dimethyltryptamine, a compound found in kratom called mitragynine, and caffeine.  A product labeled as “Urb Magic Amanita Mushroom Watermelon” contained psilocybin, psilocin, and the stimulant 2-phenethylamine. A product called “Psilly’s Legal Psychedelic Mushrooms Fruit Punch” contained the stimulant ephedrine, and the product “Tryp mushroom gummies” wasn’t found to contain any concerning compounds.

The UVA study was not able to test for ibotenic acid or muscimol. In Diamond Shruumz’s recall notice, the company said it had found higher than normal levels of muscimol in its products. FDA testing has not identified muscimol in product testing, according to results released so far.

“People tend to equate ‘legal’ with ‘safe,’ which is not necessarily the case. These products are not regulated and can contain any number of unlabeled substances which, when consumed, can cause undesired symptoms,” lead author of the UVA study Avery Michienzi said in a statement. “Some packages will have QR codes showing that the products were tested in a lab and contain only what they are labeled to contain. These have been found to be inaccurate.”

The FDA this week warned that even though all of Diamond Shruumz’s products have been recalled, they remain on the shelves of stores nationwide. The agency said it is reaching out to industry partners to raise awareness of the recall and monitoring the effectiveness of Diamond Shruumz’s recall efforts.

Illegal drug found in Diamond Shruumz candies linked to severe illnesses Read More »

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Five people infected as bird flu appears to go from cows to chickens to humans

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Cows and chickens and humans, oh my! —

High temperatures made it hard for workers to use protective gear during culling.

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Five people infected as bird flu appears to go from cows to chickens to humans

The highly pathogenic avian influenza H5N1 virus that spilled from wild birds into US dairy cows late last year may have recently seeped from a dairy farm in Colorado to a nearby poultry farm, where it then infected five workers tasked with culling the infected chickens

In a press briefing Tuesday, federal officials reported that four of the avian influenza cases have been confirmed by the Centers for Disease Control and Prevention, while the fifth remains a presumptive positive awaiting CDC confirmation.

All five people have shown mild illnesses, though they experienced variable symptoms. Some of the cases involved conjunctivitis, as was seen in other human cases linked to the H5N1 outbreak in dairy cows. Others in the cluster of five had respiratory and typical flu-like symptoms, including fever, chills, sore throat, runny nose, and cough. None of the five cases required hospitalization.

The virus infecting the five people is closely related to the virus infecting the chickens on the poultry farm, which, in turn, is closely related to virus seen in infected dairy herds and in other human cases that have been linked to the dairy outbreak. The affected poultry farm is in Colorado’s northern county of Weld, which has also reported about two dozen outbreaks of avian influenza in dairy herds.

Dairy to poultry hypothesis

In one fell swoop, Colorado’s poultry farm outbreak has more than doubled the number of human avian influenza cases linked to the dairy cow spillover, bringing the previous tally of four cases to nine. While officials have previously noted instances where it appeared that H5N1 on dairy farms had moved to nearby poultry farms, this appears to be the first time such spread has led to documented human infections.

The link between the poultry farm cases and neighboring dairy farms is still just a hypothesis, however, Nirav Shah, the principal deputy director at the CDC, emphasized to reporters Tuesday. “It is a hypothesis that needs and requires a full investigation. But that is a hypothesis at this point,” he said of the link between the dairy farms and the poultry farm. So far, there is no direct evidence of a specific source of the poultry farm’s infection, and the route of infection is also unclear.

Throughout the outbreak of H5N1 on dairy farms, officials have noted that the primary way the virus appears to spread to new farms is via the movement of cows, people, and machinery between those facilities. There remains no evidence of human-to-human transmission. But milk from infected cows has been found to be brimming with high levels of infectious virus, and milk-contaminated equipment is a prime suspect in the spread.

In the press briefing Tuesday, Eric Deeble, acting senior advisor for H5N1 response with the US Department of Agriculture, noted the poultry are very susceptible to avian influenza and are easily infected. “It does not take much to introduce this into a flock,” Deeble said. The USDA is now working on a “trace-back” investigation on how the Colorado poultry farm was infected.

Searing spread

As for how the farm workers specifically became infected with the virus, health officials pointed to high temperatures that prevented workers from donning protective gear. The poultry farm is a commercial egg layer operation with around 1.8 million birds. Given the presence of bird flu on the premises, all 1.8 million birds need to be culled, aka “depopulated.” This is being carried out using mobile carts with carbon dioxide gas chambers, a common culling method. Workers are tasked with placing the birds in the chambers, which only hold a few dozen birds at a time. In all, the method requires workers to have a high degree of contact with the infected birds, going from bird to bird and batch to batch with the carts.

Amid this grim task, temperatures in the area reached over 100° Fahrenheit, and massive industrial fans were turned on in the facility to try to cool things down. Between the heat and the fans, the approximately 160 people involved in the culling struggled to use personal protective equipment (PPE). The required PPE for the depopulation involves a full Tyvek suit, boots, gloves, goggles, and an N95 respirator.

“The difficulty with wearing all that gear in that kind of heat, you can imagine,” said Julie Gauthier, executive director for field operations at the USDA’s Animal and Plant Health Inspection Service (APHIS). The industrial fans blowing large amounts of air made it yet more difficult for workers to keep goggles and respirators on their faces, she said.

The CDC and the USDA are both involved in further investigations of the poultry farm outbreak. CDC’s Shah noted that the team the agency deployed to Colorado included an industrial hygienist, who can work on strategies to prevent further transmission.

To date, at least 161 herds in 13 states have tested positive for avian influenza since the dairy outbreak was confirmed in March. Since January 2022, when US birds first tested positive for the H5N1 virus, 99 million birds in the US have been affected in 48 states, which involved 1,165 individual outbreaks.

Five people infected as bird flu appears to go from cows to chickens to humans Read More »

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What we know about microdosing candy illnesses as death investigation underway

cases, diamond shruumz, health, microdosing, muscimol, mushrooms, psychedelics, Science, seizures, Toxicology / /
The Birthday Cake flavored bar.

Enlarge / The Birthday Cake flavored bar.

One person may have died from eating Diamond Shruumz microdosing candies, which were recalled last week amid a rash of severe illnesses involving seizures, intubation, and intensive care stays.

According to an update this week from the Food and Drug Administration, the cluster of cases continues to increase across the country. To date, 48 people across 24 states have fallen ill after eating the candies, which include chocolate bars, gummies, and candy cones that were sold online and in retail locations, such as smoke and vape shops. Of the 48 people sickened, 46 were ill enough to seek medical care, and 27 were admitted to a hospital.

For now, the death noted in the FDA’s latest update is only “potentially associated” with the candies and is still under investigation. No other information is yet available.

But in an interview with Ars, medical toxicologist Michael Moss was not surprised that the candies may have turned deadly. Moss, who is the medical director of the Utah Poison Control Center, cared for one of the first people reported to be sickened in the cluster.

An early case

The person was sickened in Nevada and transferred to a hospital in Utah, where Moss was a member of his care team. After the person came out of intensive care, Moss sat down with him and tried to piece together what happened. According to Moss, the person had bought a Birthday Cake-flavored chocolate bar at a local store. The bars are sold as “microdosing” candies, suggesting they contain psychedelic compounds, but the exact components and dosages aren’t listed.

Though the person told Moss he had some experience with psychedelics before, it was only with actual mushrooms. This was the first time he had eaten such a bar. And the bar’s packaging had only vague instructions of how much to eat at one time to achieve certain effects. For instance, eating nine or more squares of the bar was described with an image of an eye with lots of rainbow colors.

“What does that dose mean? And how many milligrams of what is that? Nobody knows,” Moss said. “So, he decided, ‘It’s a chocolate bar.’ So why wouldn’t you just eat the chocolate bar? Pretty reasonable thing to do.”

But, within minutes of eating the bar, the person felt nauseated and very dizzy and tired. He went to lie down and doesn’t remember much after that. Fortunately, a family member came home soon after and found him. The family member saw that he had vomited and was possibly aspirating or choking. By the time paramedics arrived, he was having a seizure. He had another in the emergency room. Doctors gave him anti-seizure medications and a breathing tube and put him on ventilation before transferring him to the hospital in Utah.

What we know about microdosing candy illnesses as death investigation underway Read More »

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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 »