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Research monkeys still having a ball days after busting out of lab, police say

By: Beth Mole
8 November 2024 at 22:51

If you need any inspiration for cutting loose and relaxing this weekend, look no further than a free-wheeling troop of monkeys that broke out of their South Carolina research facility Wednesday and, as of noon Friday, were still "playfully exploring" with their newfound freedom.

In an update Friday, the police department of Yemassee, SC said that the 43 young, female rhesus macaque monkeys are still staying around the perimeter of the Alpha Genesis Primate Research Facility. "The primates are exhibiting calm and playful behavior, which is a positive indication," the department noted.

The fun-loving furballs got free after a caretaker "failed to secure doors" at the facility.

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After decades, FDA finally moves to pull ineffective decongestant off shelves

By: Beth Mole
7 November 2024 at 23:27

In a long-sought move, the Food and Drug Administration on Thursday formally began the process of abandoning oral doses of a common over-the-counter decongestant, which the agency concluded last year is not effective at relieving stuffy noses.

Specifically, the FDA issued a proposed order to remove oral phenylephrine from the list of drugs that drugmakers can include in over-the-counter products—also known as the OTC monograph. Once removed, drug makers will no longer be able to include phenylephrine in products for the temporary relief of nasal congestion.

"It is the FDA’s role to ensure that drugs are safe and effective," Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. "Based on our review of available data and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant."

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For fame or a death wish? Kids’ TikTok challenge injuries stump psychiatrists

By: Beth Mole
6 November 2024 at 22:19

Kids and teens can make some pretty hairbrained choices sometimes. But when a kid's choice is to engage in a TikTok challenge that threatens their life, psychiatrists can struggle to understand if it was just an exasperating poor choice born out of impulsivity and immaturity or something darker—an actual suicide attempt.

In a Viewpoint published today in JAMA Psychiatry, two psychiatrists from the University of Tennessee Health Science Center at Memphis raise the alarm about the dangers and complexities of TikTok challenges. They're an "emerging public health concern" for kids, the psychiatrists write, and they're blurring the lines between unintentional injuries and suicide attempts in children and teens.

The child and adolescent psychiatrists Onomeasike Ataga and Valerie Arnold say that their psychiatry team first saw injuries from TikTok challenges during the COVID-19 pandemic, but the trend has continued since the pandemic eased. Over recent years, they've seen children and teens hospitalized from a variety of challenges, including the "blackout challenge," in which participants attempt to choke themselves until they pass out; the "Benadryl challenge," in which participants ingest a large amount of the allergy medicine to get high and hallucinate; and the "fire challenge," in which participants pour a flammable liquid on their body and light it on fire. In these cases, the psychiatry team is sometimes called in to help assess whether the children and teens had an intent to self-harm. It's often hard to determine—and thus hard to decide on treatment recommendations.

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“Havard”-trained spa owner injected clients with bogus Botox, prosecutors say

By: Beth Mole
6 November 2024 at 00:05

A Massachusetts spa owner has been arrested for what prosecutors describe as a blundering scheme in which she conspicuously smuggled counterfeit Botox and skin fillers into the US, then peddled them to clients by falsely claiming to be a nurse with a degree from "Havard" [sic] and a license from the state's "Estate Board."

Nevertheless, the woman—Rebecca Fadanelli, 38, of Stoughton—allegedly performed over 2,700 illegal injections between 2021 and 2024, raking in over $900,000 with the scam.

According to an affidavit from a special agent with the Food and Drug Administration, Fadanelli was smuggling in counterfeit Botox and fillers from China and Brazil. Between November 2023 and March 2024, Customs and Border Protection (CBP) seized at least six parcels from China addressed to Fadanelli or her employees. The packages included various counterfeit injectable drugs, including products labeled as Botox and skin fillers Sculptra and Juvederm.

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Drugmaker shut down after black schmutz found in injectable weight-loss drug

By: Beth Mole
4 November 2024 at 23:05

The Food and Drug Administration is warning consumers not to use any drugs made by a compounding pharmacy in California after regulators realized the pharmacy was making drugs that need to be sterile—particularly injectable drugs—without using sterile ingredients or any sterilization steps.

The products made by the pharmacy, Fullerton Wellness LLC, in Ontario, California, include semaglutide, which is intended to mimic brand-name weight-loss and diabetes drugs Wegovy and Ozempic. Fullerton also made tirzepatide, which is intended to mimic weight-loss and diabetes drugs Zepbound and Mounjaro.

The FDA became aware of the problem after a patient submitted a complaint to the regulator that a vial of semaglutide from Fullerton Wellness had an unidentified "black particulate" floating in it. Semaglutide, like tirzepatide, is injected under the skin and is intended to be sterile.

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As hospitals struggle with IV fluid shortage, NC plant restarts production

By: Beth Mole
1 November 2024 at 21:42

The western North Carolina plant that makes 60 percent of the country's intravenous fluid supply has restarted its highest-producing manufacturing line after being ravaged by flooding brought by Hurricane Helene last month.

While it's an encouraging sign of recovery as hospitals nationwide struggle with shortages of fluids, supply is still likely to remain tight for the coming weeks.

IV fluid-maker Baxter Inc, which runs the Marion plant inundated by Helene, said Thursday that the restarted production line could produce, at peak, 25 percent of the plant's total production and about 50 percent of the plant's production of one-liter IV solutions, the product most commonly used by hospitals and clinics.

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Idaho health district abandons COVID shots amid flood of anti-vaccine nonsense

By: Beth Mole
31 October 2024 at 20:42

Residents in the Southwest District Health in Idaho are no longer able to get COVID-19 vaccines from public health clinics after the district's board of directors voted 4–3 recently to stop administering the shot.

The vote came during a hearing swamped by misinformation and conspiracy theories about the lifesaving vaccines. It's a chilling reminder of how dangerous anti-vaccine sentiment and misinformation have infested communities nationwide, causing vaccination rates to slip across the country and making way for deadly outbreaks of preventable diseases.

Safety net

In a hearing last week, Perry Jansen, the health district’s medical director, gave the only presentation that favored keeping COVID-19 vaccines available through district clinics. He echoed the points that all health experts and major health organizations, including the Centers for Disease Control and Prevention, have pointed out for years: that COVID-19 vaccines have proven to be safe, lifesaving immunizations that are recommended for everyone ages 6 months and up.

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Slivered onions are likely cause of McDonald’s E. coli outbreak, CDC says

By: Beth Mole
30 October 2024 at 21:40

Slivered onions are the likely source of the multi-state E. coli outbreak linked to McDonald's Quarter Pounder burgers that continues to grow, the Centers for Disease Control and Prevention announced Wednesday.

Onions were one of two primary suspects when the CDC announced the outbreak on October 22, with the other being the beef patties used on the burgers. But onions quickly became the leading suspect. The day after the CDC's announcement, McDonald's onion supplier, Taylor Farms, recalled peeled and diced yellow onion products, and several other fast food chains took onions off the menu as a precaution. (No other restaurants have been linked to the outbreak to date.)

According to the CDC, traceback information and epidemiological data collected since then have all pointed to the onions, and, according to McDonald's, state and federal testing of the beef patties has all come back negative.

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Person accidentally poisoned 46 coworkers with toxin-loaded homemade lunch

By: Beth Mole
30 October 2024 at 20:52

For some, microwaving fish in the employee lunch room is the ultimate work faux pas. But for one (likely mortified) employee of a seafood distribution plant in Maryland, it's probably causing a mass poisoning with the homemade noodle dish they brought to share for lunch. The dish sickened 46 employees, spurring their employer to hastily release a statement assuring customers that it wasn't the company's food that caused the illnesses.

On October 21, first responders and paramedics arrived at the NAFCO Wholesale Fish Distribution Facility in Jessup, where dozens of employees had abruptly fallen ill about three hours after lunch. Helicopter footage of the event captured images of workers around picnic tables outside the plant, some doubled over and with their heads down.

Ultimately, 46 people were sickened, and at least 26 were treated at an area hospital with symptoms of food poisoning, according to The Baltimore Banner. They all recovered.

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Pizza place accidentally spiked dough with THC, sickening dozens

By: Beth Mole
28 October 2024 at 19:15

Dozens of people in Wisconsin have been sickened and at least five needed emergency medical services after inadvertently eating pizza tainted with Delta-9-tetrahydrocannabinol (THC), the principal psychoactive compound in cannabis, officials of Public Health Madison & Dane County reported late Friday.

The contamination, which health officials called "unintentional," occurred at Famous Yeti’s Pizza in Stoughton between October 22 and October 24. In a news release, the local health department advised customers to throw away any pizza they had from the restaurant during that time period.

"We want to be sure anyone who has this pizza on hand throws it away so they don't get sick," Bonnie Armstrong, director of Environmental Health at Public Health Madison & Dane County, said in the release. "If you ate the pizza and are experiencing THC-related symptoms, please contact your health care provider or call 911 if your symptoms worsen."

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Ars Live: What else can GLP-1 drugs do? Join us today for a discussion.

By: Beth Mole
29 October 2024 at 14:22

News and talk of GLP-1 drugs are everywhere these days—from their smash success in treating Type 2 diabetes and obesity to their astronomical pricing, drug shortages, compounding disputes, and what sometimes seems like an ever-growing list of other conditions the drugs could potentially treat. There are new headlines every day.

Although the drugs have abruptly stolen the spotlight in recent years, researchers have been toiling away at developing and understanding them for decades, stretching back to the 1970s. Despite all the time and effort, the drugs still hold mysteries and unknowns. For instance, researchers thought for years that they worked directly in the gut to decrease blood sugar levels and make people feel full. After all, the drugs mimic an incretin hormone, glucagon-like peptide-1, that does exactly that. But, instead, studies have since found that they work in the brain.

In fact, the molecular receptors for GLP-1 are sprinkled in many places around the body. They're found in the central nervous system, the heart, blood vessels, liver, and kidney. Their presence in the brain even plays a role in inflammation. As such, research on GLP-1 continues to flourish as scientists work to understand the role it could play in treating a range of other chronic conditions.

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Taco Bell, KFC, Pizza Hut, Burger King pull onions amid McDonald’s outbreak

By: Beth Mole
24 October 2024 at 21:21

Big-name fast food chains, including Taco Bell, KFC, Pizza Hut, and Burger King, are reportedly pulling onions off their menus in certain locations amid a deadly, multistate outbreak of E. coli O157:H7 linked to McDonald's Quarter Pounders.

Though the source of the outbreak bacteria has not been confirmed by the Centers for Disease Control and Prevention, the leading suspects are the beef patties and the sliced onions used on the popular burger.

On Wednesday, McDonald's onion supplier Taylor Farms recalled peeled and diced yellow onion products, according to a notice from US Foods, a supplier of food service operations.

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Bird flu hit a dead end in Missouri, but it’s running rampant in California

By: Beth Mole
24 October 2024 at 19:23

As H5N1 bird flu continues to spread wildly among California dairy herds and farmworkers, federal health officials on Thursday offered some relatively good news about Missouri: The wily avian influenza virus does not appear to have spread from the state's sole human case, which otherwise remains a mystery.

On September 6, the Missouri Health department announced that a person with underlying health conditions tested positive for bird flu, and later testing indicated that it was an H5N1 strain related to the one currently circulating among US dairy cows. But, state and federal health officials were—and still are—stumped as to how that person became infected. The person had no known contact with infected animals and no contact with any obviously suspect animal products. No dairy herds in Missouri have tested positive, and no poultry farms had reported recent outbreaks, either. To date, all other human cases of H5N1 have been among farmworkers who had contact with H5N1-infected animals.

But aside from the puzzle, attention turned to the possibility that the unexplained Missouri case had passed on the infection to those around them. A household contact had symptoms at the same time as the person—aka the index case—and at least six health care workers developed illnesses after interacting with the person. One of the six had tested negative for bird flu around the time of their illness, but questions remained about the other five.

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McDonald’s deadly Quarter Pounder E. coli outbreak is likely bigger than we know

By: Beth Mole
23 October 2024 at 15:33

One person is dead and 48 others across 10 states have been sickened in an E. coli O157:H7 outbreak that appears to be linked to McDonald's Quarter Pounders and the slivered onions used on the burgers, according to the Centers for Disease Control and Prevention.

McDonald's has paused distribution of the slivered onions and removed Quarter Pounders from the menus of restaurants in areas known to be affected. As of now, those areas include Colorado, Kansas, Utah, and Wyoming, as well as portions of Idaho, Iowa, Missouri, Montana, Nebraska, Nevada, New Mexico, and Oklahoma.

However, the CDC was quick to note that the size and span of the outbreak are likely larger than is currently known. "This outbreak may not be limited to the states with known illnesses, and the true number of sick people is likely much higher than the number reported," the agency said in its outbreak notice posted Tuesday afternoon.

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Shady drugmaker used code words to sell knockoff weight-loss drug: Lawsuit

By: Beth Mole
22 October 2024 at 22:31

Amid ongoing legal battles over coveted GLP-1 therapies, a drug vendor in Washington state is accused of running an outlandish scheme to sell do-it-yourself kits to make illicit knockoff versions of weight-loss and diabetes drugs, Zepbound and Mounjaro.

For the alleged scheme, vendor Pivotal Peptides has customers buy a set of ingredients they have to mix together to create their own injectable versions of the drugs. Customers don't need a prescription or even a medical consultation to order the kit, even though the brand-name drugs are prescription-only. That may not be surprising, though, since the dubious white powder customers receive is stated to be "a research chemical for lab research and veterinary purposes only." Once purchased, the kit's instructions recommend users disinfect their home work surface before beginning and stress the importance of using the sterile water included in the kit to dissolve the powder to the desired concentration. The instructions then explain how to inject oneself with the homemade mixture using a 30-gauge syringe.

That's all according to a lawsuit filed Monday by pharmaceutical giant Eli Lilly, maker of tirzepatide-based Zepbound and Mounjaro, which are sold as ready-to-use medicines in single-dose pens or vials. The lawsuit against Pivotal Peptides is one of three that Lilly filed this week, all accusing questionable drugmakers of unlawfully selling knockoff versions of its tirzepatide drugs that have not been tested or approved. But the one against Pivotal Peptides stands out for the scheme the owners allegedly used to sell their knockoff version.

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US vaccinations fall again as more parents refuse lifesaving shots for kids

By: Beth Mole
17 October 2024 at 20:40

Measles, whooping cough, polio, tetanus—devastating and sometimes deadly diseases await comebacks in the US as more and more parents are declining routine childhood vaccines that have proved safe and effective.

The vaccination rates among kindergartners have fallen once again, dipping into the range of 92 percent in the 2023–2024 school year, down from about 93 percent the previous school year and 95 percent in 2019–2020. That's according to an analysis of the latest vaccination data published today by the Centers for Disease Control and Prevention.

The analysis also found that vaccination exemptions rose to an all-time high of 3.3 percent, up from 3 percent in the previous school year. The rise in exemptions is nearly entirely driven by non-medical exemptions—in other words, religious or philosophical exemptions. Only 0.2 percent of all vaccination exemptions are medically justified.

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There’s another massive meat recall over Listeria—and it’s a doozy

By: Beth Mole
16 October 2024 at 19:24

Another nationwide meat recall is underway over Listeria contamination—and it's far more formidable than the last.

As of October 15, meat supplier BrucePac, of Durant, Oklahoma, is recalling 11.8 million pounds of ready-to-eat meat and poultry products after routine federal safety testing found Listeria monocytogenes, a potentially deadly bacterium, in samples of the company's poultry. The finding triggered an immediate recall, which was first issued on October 9. But, officials are still working to understand the extent of the contamination—and struggling to identify the hundreds of potentially contaminated products.

"Because we sell to other companies who resell, repackage, or use our products as ingredients in other foods, we do not have a list of retail products that contain our recalled items," BrucePac said in a statement updated October 15.

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Drugmakers can keep making off-brand weight-loss drugs as FDA backpedals

By: Beth Mole
15 October 2024 at 21:53

Facing a lawsuit, the Food and Drug Administration has decided to reconsider its decision to take popular weight-loss and diabetes drugs off of the national shortage list, which will allow compounding pharmacies to continue selling cheaper copycat versions—at least for now.

A trade organization representing compounding pharmacies sued the agency last week over its October 2 announcement that there was no longer a shortage of tirzepatide drugs, branded as Mounjaro for diabetes and Zepbound for weight loss. The products, members of the extremely popular and effective class of GLP-1 drugs, had been on the shortage list since December 2022.

Being on the list meant that compounding pharmacies were legally allowed to make "essentially copies" of the products; the only time these pharmacies—also called outsourcing facilities—can make imitation versions of approved drugs, such as tirzepatide, is when the products appear on the shortage list. So, with the FDA's announcement, compounders were immediately barred from making any more of the lucrative drugs and had 60 days to fulfill existing orders.

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Routine dental X-rays are not backed by evidence—experts want it to stop

By: Beth Mole
14 October 2024 at 19:11

Has your dentist ever told you that it's recommended to get routine dental X-rays every year? My (former) dentist's office did this year—in writing, even. And they claimed that the recommendation came from the American Dental Association.

It's a common refrain from dentists, but it's false. The American Dental Association does not recommend annual routine X-rays. And this is not new; it's been that way for well over a decade.

The association's guidelines from 2012 recommended that adults who don't have an increased risk of dental caries (myself included) need only bitewing X-rays of the back teeth every two to three years. Even people with a higher risk of caries can go as long as 18 months between bitewings. The guidelines also note that X-rays should not be preemptively used to look for problems: "Radiographic screening for the purpose of detecting disease before clinical examination should not be performed," the guidelines read. In other words, dentists are supposed to examine your teeth before they take any X-rays.

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