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      Deadly morel mushroom outbreak highlights big gaps in fungi knowledge

      news.movim.eu / ArsTechnica · Friday, 15 March - 16:51 · 1 minute

    Mature morel mushrooms in a greenhouse at an agriculture garden in Zhenbeibu Town of Xixia District of Yinchuan, northwest China's Ningxia Hui Autonomous Region.

    Enlarge / Mature morel mushrooms in a greenhouse at an agriculture garden in Zhenbeibu Town of Xixia District of Yinchuan, northwest China's Ningxia Hui Autonomous Region. (credit: Getty | Xinhua/Wang Peng )

    True morel mushrooms are widely considered a prized delicacy, often pricey and surely safe to eat. But these spongey, earthy forest gems have a mysterious dark side—one that, on occasion, can turn deadly, highlighting just how little we know about morels and fungi generally.

    On Thursday, Montana health officials published an outbreak analysis of poisonings linked to the honeycombed fungi in March and April of last year. The outbreak sickened 51 people who ate at the same restaurant, sending four to the emergency department. Three were hospitalized and two died. Though the health officials didn't name the restaurant in their report, state and local health departments at the time identified it as Dave’s Sushi in Bozeman . The report is published in the Centers for Disease Control and Prevention's Morbidity and Mortality Weekly Report.

    The outbreak coincided with the sushi restaurant introducing a new item: a "special sushi roll" that contained salmon and morel mushrooms. The morels were a new menu ingredient for Dave's. They were served two ways: On April 8, the morels were served partially cooked, with a hot, boiled sauce poured over the raw mushrooms and left to marinate for 75 minutes; and on April 17, they were served uncooked and cold-marinated.

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      Apple’s AirPods Pro could be getting a “hearing aid mode” later this year

      news.movim.eu / ArsTechnica · Tuesday, 12 March - 17:42

    AirPods arranged at an Apple Store

    Enlarge / Apple AirPods on display at the company's Fifth Avenue store in New York in Feb. 2024. (credit: Bing Guan/Bloomberg via Getty Images)

    Apple's AirPods Pro are getting closer to becoming fully fledged hearing aids and marketed as such, according to Bloomberg's Mark Gurman . The move could have a large impact on the hearing aid market, which has already been recently shaken up by over-the-counter models.

    Gurman writes that AirPods Pro are due to receive a hearing-aid function in iOS 18, arriving this fall and likely to be announced and outlined at a Worldwide Developers Conference in June. The Wall Street Journal reported in the fall of 2021 that Apple was working toward a future AirPods Pro model that functioned as a hearing aid and would also be able to monitor body posture and even body temperature.

    It was not clear from Gurman or the Journal's reporting whether the hearing aid function would be available only in a new model of AirPods Pro or offered as a software update on prior models. Since the Journal's report, Apple has released both a second-generation model of AirPods Pro and a refresh of that model with a USB-C port.

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      Don’t use these six cinnamon products, FDA warns after concerning lead tests

      news.movim.eu / ArsTechnica · Thursday, 7 March - 16:29 · 1 minute

    Cinnamon (Photo by Hoberman Collection/Universal Images Group via Getty Images)

    Enlarge / Cinnamon (Photo by Hoberman Collection/Universal Images Group via Getty Images) (credit: Getty | Hoberman Collection )

    Six different ground cinnamon products sold at retailers including Save A Lot, Dollar Tree, and Family Dollar contain elevated levels of lead and should be recalled and thrown away immediately, the US Food and Drug Administration announced Wednesday.

    The brands are La Fiesta, Marcum, MK, Swad, Supreme Tradition, and El Chilar, and the products are sold in plastic spice bottles or in bags at various retailers. The FDA has contacted the manufacturers to urge them to issue voluntary recalls, though it has not been able to reach one of the firms, MTCI, which distributes the MK-branded cinnamon.

    The announcement comes amid a nationwide outbreak of lead poisoning in young children linked to cinnamon applesauce pouches contaminated with lead and chromium. In that case, it's believed that a spice grinder in Ecuador intentionally added extreme levels of lead chromate to cinnamon imported from Sri Lanka, likely to improve its weight and/or appearance. Food manufacturer Austrofoods then added the heavily contaminated cinnamon, without any testing, to cinnamon applesauce pouches marketed to toddlers and young children across the US. In the latest update , the Centers for Disease Control and Prevention has identified 468 cases of lead poisoning that have been linked to the cinnamon applesauce pouches. The cases span 44 states and are mostly in very young children.

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      New FDA-approved drug makes severe food allergies less life-threatening

      news.movim.eu / ArsTechnica · Friday, 16 February - 22:41 · 1 minute

    Peanuts

    Enlarge / Peanuts (credit: Getty | CFOTO/Future Publishing )

    Living with food allergies can be a fraught existence. There is no cure, and the standard management is to be ever vigilant of everything you eat and have an emergency shot of epinephrine constantly handy in case an accidental ingestion leads to a swift, life-threatening reaction. But, for the millions of people in the US who live with such allergies, a new drug may dull the threat.

    On Friday, the Food and Drug Administration approved the antibody drug omalizumab (brand name Xolair) as an injection to lessen allergic reactions to foods in people ages 1 and up. In a trial of 168 children and adults with multiple food allergies, participants who received shots of omalizumab for 16 to 20 weeks were much more likely to tolerate a test dose of allergy-inducing foods at the end than those who received a placebo.

    Omalizumab—which was previously approved to treat asthma, hives, and nasal polyps—works by binding to a class of antibodies in the body called immunoglobulin E (IgE) that are specifically involved in allergic responses. The monoclonal antibody drug binds IgE, blocking it from binding to its target receptor, thus preventing it from triggering the immune responses that lead to allergy symptoms.

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      Can you sanitize the inside of your nose to prevent COVID? Nope, FDA says.

      news.movim.eu / ArsTechnica · Wednesday, 14 February - 23:37 · 1 minute

    Can you sanitize the inside of your nose to prevent COVID? Nope, FDA says.

    Enlarge (credit: Nozin.com )

    More than four years after SARS-CoV-2 made its global debut, the US Food and Drug Administration is still working to clear out the bogus and unproven products that flooded the market, claiming to prevent, treat, and cure COVID-19.

    The latest example is an alcohol-based sanitizer meant to be smeared inside the nostrils. According to its maker, the rub can protect you from becoming infected with SARS-CoV-2 and other nasty germs, like MRSA, and that protection lasts up to 12 hours after each swabbing. That all sounds great, but according to the FDA, none of it is proven. In a warning letter released Tuesday, the agency determined the sanitizer, called Nozin, is an unapproved new drug and misbranded.

    While ethyl alcohol is used in common topical antiseptics, like hand sanitizers, the FDA does not generally consider it safe for inside the nostrils—and the agency is unaware of any high-quality clinical data showing the Nozin is safe, let alone effective. The FDA also noted that, for general over-the-counter topical antiseptics, calling out specific pathogens it can fight off—like SARS-CoV-2 and MRSA—is not allowed under agency rules without further FDA review. Making claims about protection duration is also not allowed.

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      We may now know who’s behind the lead-tainted cinnamon in toddler fruit pouches

      news.movim.eu / ArsTechnica · Wednesday, 7 February - 22:42

    The three recalled pouches linked to lead poisonings.

    Enlarge / The three recalled pouches linked to lead poisonings. (credit: FDA )

    A spice grinder named Carlos Aguilera of Ecuador is the likely source of contaminated cinnamon containing extremely high levels of lead and chromium, which made its way into the apple cinnamon fruit pouches of US toddlers, according to an announcement by the Food and Drug Administration this week .

    To date, there have been 413 cases of poisoning across 43 US states , according to the Centers for Disease Control and Prevention.

    The FDA said Ecuadorian officials at the Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA) identified Aguilera as the cinnamon processor and reported to the FDA that his business is no longer operating. Aquilera received raw cinnamon sticks sourced from Sri Lanka, which, according to raw sample testing conducted by ARCSA, had no lead contamination upon their arrival. After Aguilera processed the cinnamon, it was supplied by a company called Negasmart to Austrofoods, the manufacturer of the apple cinnamon pouches.

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      Anti-abortion group’s studies retracted before Supreme Court mifepristone case

      news.movim.eu / ArsTechnica · Wednesday, 7 February - 00:07 · 1 minute

    Mifepristone (Mifeprex) and Misoprostol, the two drugs used in a medication abortion, are seen at the Women's Reproductive Clinic, which provides legal medication abortion services, in Santa Teresa, New Mexico, on June 17, 2022.

    Enlarge / Mifepristone (Mifeprex) and Misoprostol, the two drugs used in a medication abortion, are seen at the Women's Reproductive Clinic, which provides legal medication abortion services, in Santa Teresa, New Mexico, on June 17, 2022. (credit: Getty | Robyn Beck )

    Scientific journal publisher Sage has retracted key abortion studies cited by anti-abortion groups in a legal case aiming to revoke regulatory approval of the abortion and miscarriage medication, mifepristone—a case that has reached the US Supreme Court , with a hearing scheduled for March 26.

    On Monday, Sage announced the retraction of three studies, all published in the journal Health Services Research and Managerial Epidemiology. All three were led by James Studnicki, who works for The Charlotte Lozier Institute, a research arm of Susan B. Anthony Pro-Life America. The publisher said the retractions were based on various problems related to the studies' methods, analyses, and presentation, as well as undisclosed conflicts of interest.

    Two of the studies were cited by anti-abortion groups in their lawsuit against the Food and Drug Administration ( Alliance for Hippocratic Medicine v. FDA ), which claimed the regulator's approval and regulation of mifepristone was unlawful. The two studies were also cited by District Judge Matthew Kacsmaryk in Texas, who issued a preliminary injunction last April to revoke the FDA's 2000 approval of mifepristone. A conservative panel of judges for the 5th Circuit Court of Appeals in New Orleans partially reversed that ruling months later , but the Supreme Court froze the lower court's order until the appeals process had concluded.

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      Biogen dumps dubious Alzheimer’s drug after profit-killing FDA scandal

      news.movim.eu / ArsTechnica · Thursday, 1 February - 00:17

    Multistory glass office building.

    Enlarge / The exterior of the headquarters of biotechnology company Biogen in Cambridge, Massachusetts. (credit: Getty | Boston Globe )

    Biotechnology company Biogen is abandoning Aduhelm , its questionable Alzheimer's drug that has floundered on the market since its scandal-plagued regulatory approval in 2021 and brow-raising pricing.

    On Wednesday, the company announced it had terminated its license for Aduhelm (aducanumab) and will stop all development and commercialization activities. The rights to Aduhelm will revert back to the Neurimmune, the Swiss biopharmaceutical company that discovered it.

    Biogen will also end the Phase 4 clinical trial, ENVISION, that was required by the Food and Drug Administration to prove Biogen's claims that Aduhelm is effective at slowing progression of Alzheimer's in its early stages—something two Phase 3 trials failed to do with certainty.

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      COVID shots protect against COVID-related strokes, heart attacks, study finds

      news.movim.eu / ArsTechnica · Friday, 12 January - 21:10 · 1 minute

    A vial of the updated 2023-2024 formula of Pfizer's COVID-19 vaccine at a CVS Pharmacy in Eagle Rock, California, on September 14, 2023.

    Enlarge / A vial of the updated 2023-2024 formula of Pfizer's COVID-19 vaccine at a CVS Pharmacy in Eagle Rock, California, on September 14, 2023. (credit: Getty | Irfan Khan )

    Staying up to date on COVID-19 vaccines can cut the risk of COVID-related strokes, blood clots, and heart attacks by around 50 percent in people ages 65 years or older and in those with a condition that makes them more vulnerable to those events, according to a new study from the Centers for Disease Control and Prevention .

    The finding, published this week in the CDC's Morbidity and Mortality Weekly Report, should help ease concerns that the shots may conversely increase the risk of those events—collectively called thromboembolic events. In January 2023, the CDC and the Food and Drug Administration jointly reported a preliminary safety signal from their vaccine-monitoring systems that indicated mRNA COVID-19 vaccines may increase the risk of strokes in the 21 days after vaccination of people ages 65 and older. Since that initial report, that signal decreased, becoming statistically insignificant. Other vaccine monitoring systems, including international systems, have not picked up such a signal. Further studies ( summarized here ) have not produced clear or consistent data pointing to a link to strokes.

    In May, the FDA concluded that the evidence does not support any safety concern and reported that "scientists believe factors other than vaccination might have contributed to the initial finding."

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