fda

fragments-of-bird-flu-virus-genome-found-in-pasteurized-milk,-fda-says

Fragments of bird flu virus genome found in pasteurized milk, FDA says

avian influenza, bird flu, CDC, cows, dairy cows, fda, flu, H5N1, Infectious disease, influenza, milk, pasteurization, Science, Uncategorized / /

Milk testing —

The test cannot tell if the virus is live. The FDA still assess milk supply as safe.

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Cows being milked

Enlarge / Cows being milked

The Food and Drug Administration on Tuesday announced that genetic fragments from the highly-pathogenic avian influenza virus H5N1 have been detected in the pasteurized, commercial milk supply. However, the testing completed so far—using quantitative polymerase chain reaction (qPCR)—only detects the presence of viral genetic material and cannot tell whether the genetic material is from live and infectious viral particles or merely remnants of dead ones killed by the pasteurization process.

Testing is now ongoing to see if viable, infectious H5N1 can be identified in milk samples.

So far, the FDA still believes that the milk supply is safe. “To date, we have seen nothing that would change our assessment that the commercial milk supply is safe,” the agency said in a lengthy explanation of the finding and ongoing testing.

H5N1 made its startling jump to US dairy cows recently, with the first ever documented cases in a Texas herd confirmed on March 25. It has spread widely since then with at least 32 herds in eight states now known to be infected. The unexpected spread to bovines has raised fears that the virus is evolving to infect mammals more efficiently, and so poses a heightened risk of spread to and among humans.

But amid the alarming outbreak among the country’s dairy herds, federal agencies have appeared confident that the virus poses little risk to no risk to the safety of the milk supply.

“At this time, there continues to be no concern that this circumstance poses a risk to consumer health, or that it affects the safety of the interstate commercial milk supply because products are pasteurized before entering the market” the FDA wrote in an FAQ published Friday. “Pasteurization has continually proven to inactivate bacteria and viruses, like influenza, in milk.”

In the announcement Tuesday, the FDA also highlighted that multiple studies have shown that the pasteurization process for eggs, which uses lower temperatures than what is used for milk, is effective at inactivating H5N1.

Nevertheless, the FDA, along with the Centers for Disease Control and Prevention and the US Department of Agriculture, have continued to investigate potential risks, including establishing whether pasteurization can inactivate this specific virus. The FDA noted in its announcement Tuesday that, while pasteurization is expected to kill the virus, pasteurization is “different than complete sterilization.”

As such, it carried out the qPCR tests, expecting it might find some genetic fragments in the pasteurized milk because virus has been detected in raw milk. “Based on available information, pasteurization is likely to inactivate the virus, however the process is not expected to remove the presence of viral particles,” the FDA explained. “Therefore, some of the samples collected have indicated the presence of HPAI [Highly Pathogenic Avian Influenza] using quantitative polymerase chain reaction (qPCR) testing.”

The FDA did not indicate how many samples it has tested, where the samples were collected from, or the level of viral genetic material the samples contained.

The agency is now working on assessing whether it can identify if any virus particles are infectious using egg inoculation tests, which are considered a gold-standard for determining viral viability. It added that it will release results from those tests and others in “the next few days to weeks.”

“[W]e take this current situation and the safety of the milk supply very seriously. We recognize the importance of releasing further, actionable information,” the FDA said.

Meanwhile, the agency reported that the CDC’s food safety group has been closely monitoring emergency department data and flu testing data for any unusual trends in flu-like illness, flu, or conjunctivitis, which could indicate spread of H5N1 to people. “To date, surveillance systems do not show any unusual trends or activity,” the FDA said.

Fragments of bird flu virus genome found in pasteurized milk, FDA says Read More »

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Concern grows as bird flu spreads further in US cows: 32 herds in 8 states

avian influenza, bird flu, CDC, cows, dairy cows, fda, H5N1, herds, infection, milk, outbreak, Science, USDA, virus / /

Rapidly evolving —

Experts say the US is not sharing as much data on the outbreak as it should.

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Greylag geese sit on a field and rest while a cow passes by in the background.

Enlarge / Greylag geese sit on a field and rest while a cow passes by in the background.

Researchers around the world are growing more uneasy with the spread of highly pathogenic avian influenza (H5N1) in US dairy cows as the virus continues to make its way into new herds and states. Several experts say the US is not sharing enough information from the federal investigation into the unexpected and growing outbreak, including genetic information from isolated viruses.

To date, the US Department of Agriculture has tallied 32 affected herds in eight states: Idaho, Kansas, Michigan, New Mexico, North Carolina, Ohio, South Dakota, and Texas. In some cases, the movement of cattle between herds can explain the spread of the virus. But the USDA has not publicly clarified if all the herds are linked in a single outbreak chain or if there is evidence that the virus has spilled over to cows multiple times. Early infections in Texas were linked to dead wild birds (pigeons, blackbirds, and grackles) found on dairy farms. But the USDA reportedly indicated to Stat News that the infections do not appear to be all linked to the Texas cases.

Spread of the virus via cattle movements indicates that there is cow-to-cow transmission occurring, the USDA said. But it’s unclear how the virus is spreading between cows. Given that even the most symptomatic cows show few respiratory symptoms, the USDA speculates that the most likely way it is spreading is via contaminated milking equipment.

Adding to the uncertainty of the virus’s spread, The New York Times on Friday reported that the one herd found infected with H5N1 in North Carolina showed no symptoms of the virus. This raises the possibility that the virus could be silently spreading in unknown numbers of other asymptomatic herds and states. In its most recent FAQ document, the USDA encouraged testing for H5N1 if herds show clinical symptoms, such as lethargy, fever, low milk production, and loose stools. But the Times noted that the agency has begun reimbursing farms for testing asymptomatic cows.

Meanwhile, the USDA also reported that it has evidence that H5N1 from dairy farms has spread back into birds in nearby poultry farms, but how this is happening is also unknown.

Data gaps

All the uncertainty and widespread transmission raises concern about how the virus is evolving to infect mammals and whether it is heading for humans. Last week, the chief scientist for the World Health Organization, Jeremy Farrar, told reporters in Geneva that the spread of the virus in US dairy cows is an “enormous concern,” according to CNN.  “The great concern, of course, is that in doing so and infecting ducks and chickens—but now increasingly mammals—that that virus now evolves and develops the ability to infect humans. And then critically, the ability to go from human-to-human transmission.”

In particular, experts are wary that the dairy cow outbreaks could spill over to nearby pig farms as it’s doing with nearby poultry farms. Pigs can be infected with both bird flu viruses and human flu viruses, making them potential melting pots for new recombinant flu strains.

So far, the USDA says that genetic sequences of H5N1 viruses infecting cows has not revealed any mutations that “would make it more transmissible to humans and between people.” But last Thursday, Stat reported that international experts have faulted the USDA for not sharing more genetic data from its investigation, among other information. Until this weekend, the agency had only shared a few genetic sequences in an international database of viral genome sequences (GISAID).

“A country with capacity like the United States should be able to generate this information within days,” Marion Koopmans, head of the department of viroscience at Erasmus Medical Center in the Dutch city of Rotterdam told Stat last week. “I would expect very fast, very transparent updates, and it’s somewhat amazing not to see that happening.”

On Sunday, facing mounting criticism, the USDA announced the release of 239 genetic sequences to GISAID. It noted it is also adding raw data to a US federal database “in the interest of public transparency and ensuring the scientific community has access to this information as quickly as possible.” The agency said it will continue to make such data available on a rolling basis.

Dr. Rosemary Sifford, the USDA’s chief veterinarian, told the Times, “Please recall that we’ve been engaged in this for less than a month. We are working very hard to generate more information,” she said.

Overall, the USDA and the US Centers for Disease Control and Prevention continue to consider the risk to the public to be low. Farmworkers and others who have direct contact with infected animals are encouraged to take precautions, however.

While deadly to birds, H5N1 in cows is relatively mild, rarely if ever causing deaths. Milk from sick animals contains high levels of virus, but it is being destroyed. Even if some infected milk makes its way into the milk supply, the Food and Drug Administration is confident that the virus would be killed in the pasteurization process. “Pasteurization has continually proven to inactivate bacteria and viruses, like influenza, in milk,” the agency said in an FAQ Friday. Some experts have called for data confirming this, though.

Concern grows as bird flu spreads further in US cows: 32 herds in 8 states Read More »

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US drug shortages reach record high with 323 meds now in short supply

adderall, ASHP, cancer drugs, DEA, drug shortages, fda, generic drugs, health, pharmacists, pharmacy, Science / /

Terrible —

The shortages affect everything from generic cancer drugs to ADHD medication.

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Takeda Pharmaceutical Co. Adderall XR brand medication arranged at a pharmacy in Provo, Utah, in November 2023.

Enlarge / Takeda Pharmaceutical Co. Adderall XR brand medication arranged at a pharmacy in Provo, Utah, in November 2023.

Drug shortages in the US have reached an all-time high, with 323 active and ongoing shortages already tallied this year, according to data collected by the American Society of Health-System Pharmacists (ASHP).

The current drug shortage total surpasses the previous record of 320, set in 2014, and is the highest recorded since ASHP began tracking shortages in 2001.

“All drug classes are vulnerable to shortages,” ASHP CEO Paul Abramowitz said in a statement Thursday. “Some of the most worrying shortages involve generic sterile injectable medications, including cancer chemotherapy drugs and emergency medications stored in hospital crash carts and procedural areas. Ongoing national shortages of therapies for attention-deficit/hyperactivity disorder [ADHD] also remain a serious challenge for clinicians and patients.”

Erin Fox, associate chief pharmacy officer of University of Utah Health, told CBS MoneyWatch, that most of the drugs in short supply are generic, older products, and around half are injectable drugs that require more stringent manufacturing processes.

There are myriad reasons for the hundreds of drug shortages now facing doctors and patients, many of which remain unclear. But, as Ars has reported before, the root cause of shortages of low-cost, off-patent generic drugs is well established. These drugs have razor-thin to non-existent profit margins, driven by middle managers who have, in recent years, pushed down wholesale prices to rock-bottom levels. In some cases, generic manufacturers lose money on the drugs, disincentivizing other players in the pharmaceutical industry from stepping in to bolster fragile supply chains. Several generic manufacturers have filed for bankruptcy recently.

For other drugs, the situation is more complicated. The ADHD drug Adderall, for instance, has been in critical shortage since October 2022, causing millions of patients around the country to struggle to fill their prescriptions. It began when a manufacturing delay for one manufacturer kicked off a shortfall. Although that problem has since been resolved, it came amid a significant increase in Adderall prescriptions, which spiked further during the pandemic when telehealth prescribing became more common. Additionally, because Adderall—made of amphetamine-mixed salts—is a controlled substance, the Drug Enforcement Administration sets limits or “quotas” on how much of it manufacturers can make. Such quotas can exacerbate shortages, ASHP said.

But, in a joint letter with the Food and Drug Administration last August, the DEA said that, by its data, manufacturers of amphetamine products (including Adderall) only sold approximately 70 percent of their allotted quotas in 2022. That meant that there were approximately 1 billion more doses that they could have produced but did not make or ship. At the time, the agencies said its 2023 data was trending in the same direction.

In 60 percent of cases, manufacturers do not know or do not provide reasons why their drugs fall into short supply, ASHP found.

The organization has put forth policy recommendations to prevent shortages and improve supply chains, advocating for federal and regulatory changes. “Much work remains to be done at the federal level to fix the root causes of drug shortages,” Abramowitz said. “ASHP will continue to engage with policymakers regularly as we guide efforts to draft and pass new legislation to address drug shortages and continue to strongly advocate on behalf of our members for solutions that work.”

US drug shortages reach record high with 323 meds now in short supply Read More »

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$158,000 ALS drug pulled from market after failing in large clinical trial

ALS, Amylyx, clinical trial, fda, health, Science / /

Off the market —

The drug is now unavailable to new patients; its maker to lay off 70% of employees.

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$158,000 ALS drug pulled from market after failing in large clinical trial

Amylyx, the maker of a new drug to treat ALS, is pulling that drug from the market and laying off 70 percent of its workers after a large clinical trial found that the drug did not help patients, according to an announcement from the company Thursday.

The drug, Relyvrio, won approval from the Food and Drug Administration in September 2022 to slow the progression of ALS (amyotrophic lateral sclerosis, or Lou Gehrig’s disease). However, the data behind the controversial decision was shaky at best; it was based on a study of just 137 patients that had several weaknesses and questionable statistical significance, and FDA advisors initially voted against approval. Still, given the severity of the neurogenerative disease and lack of effective treatments, the FDA ultimately granted approval under the condition that the company was working on a Phase III clinical trial to solidify its claimed benefits.

Relyvrio—a combination of two existing, generic drugs—went on the market with a list price of $158,000.

Last month, the company announced the top-line results from that 48-week, randomized, placebo-controlled trial involving 664 patients: Relyvrio failed to meet any of the trial’s goals. The drug did not improve patients’ physical functions, which were scored on a standardized ALS-specific test, nor did it improve quality of life, respiratory function, or overall survival. At that time, the co-CEOs of the company said they were “surprised and deeply disappointed” by the result, and the company acknowledged that it was considering voluntarily withdrawing the drug from the market.

In the announcement on Thursday, the company called Relyvrio’s market withdrawal a “difficult moment for the ALS community.” Patients already taking the medication who wish to continue taking it will be able to do so through a free drug program, the company said. It is no longer available to new patients, effective Thursday.

Amylyx is now “restructuring” to focus on two other drug candidates that treat different neurodegenerative disease. The change will include laying off 70 percent of its workforce, which, according to The Washington Post, includes more than 350 employees.

Relyvrio is part of a series of similarly controversial drugs for devastating neurodegenerative diseases that have gained FDA approval despite questionable data. In January, drug maker Biogen announced it was abandoning Aduhelm, a highly contentious Alzheimer’s drug that failed two large trials prior to its heavily criticized approval.

$158,000 ALS drug pulled from market after failing in large clinical trial Read More »

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SCOTUS mifepristone case: Justices focus on anti-abortion groups’ legal standing

Abortion, alito, barrett, clarence thomas, comstock, drug approval, fda, gorsuch, kagan, ketanji brown jackson, medication abortion, mifepristone, Policy, Science, SCOTUS / /
Demonstrators participate in an abortion-rights rally outside the Supreme Court as the justices of the court hear oral arguments in the case of the <em>US Food and Drug Administration v. Alliance for Hippocratic Medicine</em> on March 26, 2024 in Washington, DC.” src=”https://cdn.arstechnica.net/wp-content/uploads/2024/03/GettyImages-2115237711-800×533.jpeg”></img><figcaption> <p><a data-height=Enlarge / Demonstrators participate in an abortion-rights rally outside the Supreme Court as the justices of the court hear oral arguments in the case of the US Food and Drug Administration v. Alliance for Hippocratic Medicine on March 26, 2024 in Washington, DC.

The US Supreme Court on Tuesday heard arguments in a case seeking to limit access to the abortion and miscarriage drug mifepristone, with a majority of justices expressing skepticism that the anti-abortion groups that brought the case have the legal standing to do so.

The case threatens to dramatically alter access to a drug that has been safely used for decades and, according to the Guttmacher Institute, was used in 63 percent of abortions documented in the health care system in 2023. But, it also has sweeping implications for the Food and Drug Administration’s authority over drugs, marking the first time that courts have second-guessed the agency’s expert scientific analysis and moved to restrict access to an FDA-approved drug.

As such, the case has rattled health experts, reproductive health care advocates, the FDA, and the pharmaceutical industry alike. But, based on the line of questioning in today’s oral arguments, they have reason to breathe a sigh of relief.

Standing

The case was initially filed in 2022 by a group of anti-abortion organizations led by the Alliance for Hippocratic Medicine. They collectively claimed that the FDA’s approval of mifepristone in 2000 was unlawful, as were FDA actions in 2016 and 2021 that eased access to the drug, allowing for it to be prescribed via telemedicine and dispensed through the mail. The anti-abortion groups justified bringing the lawsuit by claiming that the doctors in their ranks are harmed by the FDA’s actions because they are forced to treat girls and women seeking emergency medical care after taking mifepristone and experiencing complications.

The FDA and numerous medical organizations have emphatically noted that mifepristone is extremely safe and the complications the lawsuit references are exceedingly rare. Serious side effects occur in less than 1 percent of patients, and major adverse events, including infection, blood loss, or hospitalization, occur in less than 0.3 percent, according to the American College of Obstetricians and Gynecologists. Deaths are almost non-existent.

Still, a conservative federal judge in Texas sided with the anti-abortion groups last year, revoking the FDA’s 2000 approval. A conservative panel of judges for the Court of Appeals for the 5th Circuit in New Orleans then partially overturned the ruling, undoing the lower court’s ruling on the 2000 approval, allowing the FDA’s approval to stand, but still finding the FDA’s 2016 and 2021 actions unlawful. The ruling was frozen until the Supreme Court weighed in.

Today, many of the Supreme Court Justices went back to the very beginning: the claimed scenario that the plaintiff doctors have been or will imminently be harmed by the FDA’s actions. At the outset of the hearings, Solicitor General Elizabeth Prelogar argued that the plaintiffs had not been harmed, and, even if they were, they already had federal protections and recourse. Any doctor who consciously objects to caring for a patient who has had an abortion already has federal protections that prevent them from being forced to provide that care, Prelogar argued. As such, hospitals have legal obligations and have set up contingency and staffing plans to prevent violating those doctors’ federal conscious objection protections.

SCOTUS mifepristone case: Justices focus on anti-abortion groups’ legal standing Read More »

lifesaving-gene-therapy-for-kids-is-world’s-priciest-drug-at-$4.25m

Lifesaving gene therapy for kids is world’s priciest drug at $4.25M

drug pricing, fda, gene therapy, health, metachromatic leukodystrophy, Orchard, rare genetic conditions, Science / /

promising but pricey —

It’s unclear if government and private insurance plans can cover the costs.

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A mother with her twin 6-year-old boys who have metachromatic leukodystrophy, a genetic disease that leaves them unable to move. Photo taken on September 3, 2004.

Enlarge / A mother with her twin 6-year-old boys who have metachromatic leukodystrophy, a genetic disease that leaves them unable to move. Photo taken on September 3, 2004.

In a medical triumph, US Food and Drug Administration on Monday approved a gene therapy that appears to trounce a rare, tragic disease that progressively steals children’s ability to talk, move, and think, leading to a vegetative state and death. For those who begin to slip away in infancy, many die by age 5. But, with the new therapy, 37 children in an initial trial were all still alive at age 6. Most could still talk, walk on their own, and perform normally on IQ tests, which was unseen in untreated children. Some of the earliest children treated have now been followed for up to 12 years—and they continue to do well.

But, the triumph turned bittersweet today, Wednesday, as the company behind the therapy, Lenmeldy, set the price for the US market at $4.25 million, making it the most expensive drug in the world. The price is $310,000 higher than what experts calculated to be the maximum fair price for the lifesaving drug; the nonprofit Institute for Clinical and Economic Review, or ICER, gave a range last October of between $2.29 million to $3.94 million.

The price raises questions about whether state, federal, and private health insurance plans will be able to shoulder the costs. “Unless states have allocated appropriately for it, and looked at the drug pipeline, they may not be prepared for what could be significant cost spikes,” Edwin Park, a research professor at the McCourt School of Public Health at Georgetown University, told CNN.

It’s also unclear whether the drug can reach the children who need it in time. Lenmeldy must be given before symptoms develop or early on in symptom development in children. However, diagnosis of the rare genetic condition can be slow, and many children treated so far were identified because older siblings, now too old for treatment, developed the condition first.

Devastating disease

Stat, for instance, spoke with the mother of an 8-year-old with the condition, who can no longer talk or move, has frequent seizures, and requires a feeding tube and 28 different medications. Meanwhile, her 3-year-old brother, who has the same genetic mutation, is a typical toddler—he was able to get the new treatment when he was six months old. To get it, the family flew him to Milan, Italy, where Lenmeldy was first developed. It was approved for use in Europe in 2021.

The condition Lenmeldy treats is called metachromatic leukodystrophy (MLD), which occurs in about 40 children in the US each year. MLD is caused by a mutation in the gene that codes for the enzyme arylsulfatase A (ARSA). Without this enzyme, the body can’t break down sulfatides, a fatty substance that then builds up to toxic levels in the brain and peripheral nervous system. Sulfatides are essential components of myelin, the fatty insulation on nerve cells critical for quick transmission of electrical impulses. But, too much sulfatides leads to a loss of myelin, which gradually destroys myelin producing cells and leads to nervous system damage.

Lenmeldy prevents that damage by giving the body a working copy of the ARSA gene. In a one-time infusion, patients are given a dose of their own blood stem cells that have been genetically engineered to contain a functional ARSA gene. Patients undergo chemotherapy to clear out their own stem cells from bone marrow so the genetically modified cells can replace them. The engineered stem cells then produce myeloid cells that travel around the body in the blood, producing ARSA enzyme that can halt progression of MLD.

It’s unknown how long the therapy lasts, but it’s clearly buying children time and giving them hope for a full, normal life.

“MLD is a devastating disease that profoundly affects the quality of life of patients and their families,” Nicole Verdun, director of the FDA’s Office of Therapeutic Products, said in a statement. “Advancements in treatment options offer hope for improved outcomes and the potential to positively influence the trajectory of disease progression.”

It “has the potential to stop or slow the progression of this devastating childhood disease with a single treatment, particularly when administered prior to the onset of symptoms,” Bobby Gaspar, CEO of Lenmeldy’s maker, Orchard Therapeutics, said in a statement Wednesday. “We are committed to enabling broad, expedient, and sustainable access to this important therapy for eligible patients with early-onset MLD in the US.”

The company is working on expanding newborn screening to include tests for MLD, to try to find children early, Orchard reported. Still, with such a rare condition, it’s unclear if the pricey drug will be a moneymaker for the company. Stat notes that Orchard has previously abandoned four therapies for other rare genetic conditions because of the difficulty in meeting regulatory standards for essentially custom therapies and questions about whether health plans will pay the steep, multimillion-dollar prices. In April of last year, Belgium, Ireland, and the Netherlands walked away from price negotiations with the company, saying they couldn’t come to an agreement on this “extremely expensive therapy.”

Lifesaving gene therapy for kids is world’s priciest drug at $4.25M Read More »

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Deadly morel mushroom outbreak highlights big gaps in fungi knowledge

CDC, fda, food poisoning, fungi, health, montana, morel mushrooms, outbreak, Science, sushi, toxin / /

This fungi’s not fun, guys —

Prized morels are unpredictably and puzzlingly deadly, outbreak report shows.

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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.

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.

The mystery poison worked fast. Symptoms began, on average, about an hour after eating at the restaurant. And it was brutal. “Vomiting and diarrhea were reportedly profuse,” the health officials wrote, “and hospitalized patients had clinical evidence of dehydration. The two patients who died had chronic underlying medical conditions that might have affected their ability to tolerate massive fluid loss.”

Of the 51 sickened, 46 were restaurant patrons and five were employees. Among them, 45 (88 percent) recalled eating morels. While that’s a high percentage for such an outbreak investigation, certainly enough to make the morels the prime suspect, the health officials went further. With support from the CDC, they set up a matched case-control study, having people complete a detailed questionnaire with demographic information, food items they ate at the restaurant, and symptoms.

Mysterious poison

Forty-one of the poisoned people filled out the questionnaire, as did 22 control patrons who ate at the restaurant but did not report subsequent illness. The analysis indicated that the odds of recalling eating the special sushi roll were nearly 16 times higher among the poisoned patrons than among the controls. The odds of reporting any morel consumption were nearly 11 times higher than controls.

The detailed consumption data also allowed the health officials to model a dose response, which suggested that with each additional piece of the special roll a person recalled eating, their odds of sickness increased nearly threefold compared with people who reported eating none. Those who ate four or more pieces of the roll had odds nearly 22.5 times higher. A small analysis focusing on the five employees sickened, which was not included in the published study but was noted by the Food and Drug Administration, echoed the dose-response finding, indicating that sickness was linked with larger amounts of morel consumption.

When the officials broke down the analysis by people who ate at the restaurant on April 17, when the morels were served uncooked, and those who ate at the restaurant on April 8, when the mushrooms were slightly cooked, the cooking method seemed to matter. People who ate the uncooked rather than the slightly cooked mushrooms had much higher odds of sickness.

This all strongly points to the morels being responsible. At the time, the state and local health officials engaged the FDA, as well as the CDC, to help tackle the outbreak investigation. But the FDA reported that “samples of morel mushrooms collected from the restaurant were screened for pesticides, heavy metals, toxins, and pathogens. No significant findings were identified.” In addition, the state and local health officials noted that DNA sequencing identified the morels used by the restaurant as Morchella sextelata, a species of true morel. This rules out the possibility that the mushrooms were look-alike morels, called “false morels,” which are known to contain a toxin called gyromitrin.

The health officials and the FDA tracked down the distributor of the mushrooms, finding they were cultivated and imported fresh from China. Records indicated that 12 other locations in California also received batches of the mushrooms. Six of those facilities responded to inquiries from the California health department and the FDA, and all six reported no illnesses. They also all reported cooking the morels or at least thoroughly heating them.

Deadly morel mushroom outbreak highlights big gaps in fungi knowledge Read More »

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

airpods, AirPods Pro, Apple, fda, fda approval, hearing, hearing aids, hearing impairment, ios 18, Tech / /

Cheaper hearing aids —

In development for some time, AirPods could finally get the FDA label this fall.

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AirPods arranged at an Apple Store

Enlarge / Apple AirPods on display at the company’s Fifth Avenue store in New York in Feb. 2024.

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.

“Hearing aid” may also not be technically accurate, depending on Apple’s aims. The US Food and Drug Administration in 2022 provided for a new category of “Personal sound amplification products,” or PSAPs, that do not need to meet the stricter requirements for an FDA-approved hearing aid. This new category offered huge cost savings to people with mild to moderate hearing loss and kicked off a generation of hearing aids that connected to a smartphone over Bluetooth for setup, tuning, and monitoring. These are distinct from over-the-counter hearing aids, which, while still notably cheaper than “professional fit” hearing aids, are still regulated by the FDA.

A study in late 2022 found that first-generation AirPods Pro, with their “Live Listen” feature activated, could meet four of the five PSAP standards and just barely missed a sound-pressure threshold. Notably, the AirPods Pro, tested in relatively quiet environments, helped people hear about as well as hearing aid models that cost up to $10,000, within the PSAP standards.

The next version of Apple’s mobile operating system, iOS 18, is rumored to contain a multitude of features beyond AirPods updates. MacRumors (leaning on Gurman’s subscriber-only newsletter reporting) suggests that generative AI features, RCS support for text messages, and revamps to many core Apple apps are due.

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

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

CDC, cinnamon, contamination, fda, lead, lead poisoning, Science / /

More lead —

The FDA is putting manufacturers on notice to do more to keep contaminants out.

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

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.

Products identified by the FDA as containing elevated lead levels.

Enlarge / Products identified by the FDA as containing elevated lead levels.

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.

The alarming contamination spurred the FDA to conduct more sampling of cinnamon products, focusing an initial survey on products from discount retail stores, the agency said. The FDA makes note that the elevated lead levels found in the six products announced this week are significantly lower than what was seen in the cinnamon added to the applesauce pouches. The six products contained lead at levels ranging from 2.03 to 3.4 parts per million (ppm), while samples of the cinnamon added to the applesauce had levels ranging from 2,270 ppm to 5,110 ppm in the cinnamon.

The FDA has previously reported that 2.5 ppm is the limit being considered for bark spices, which includes cinnamon, by the international standard-setting body, Codex Alimentarius Commission.

So the six newly identified products are right around or just over that potential threshold and do not pose the same level of risk as the applesauce pouches. But the FDA warned that the elevated levels in the ground cinnamon could cause elevated blood lead levels after prolonged use, which the agency defined as months to years. This, in turn, could contribute to harmful health effects, particularly in children who absorb lead more readily than adults and are still developing. Lead is a potent neurotoxic metal that can damage the brain and nervous system, which for young children can lead to learning, behavior, and developmental problems.

“Today’s actions serve as a signal to industry that more needs to be done to prevent elevated levels of contaminants from entering our food supply,” Jim Jones, the FDA’s Deputy Commissioner for Human Foods, said in a statement. “Food growers, manufacturers, importers, and retailers share a responsibility for ensuring the safety of the foods that reach store shelves. The levels of lead we found in some ground cinnamon products are too high and we must do better to protect those most vulnerable to the negative health outcomes of exposure to elevated levels of lead.”

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

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

fda, food allergies, health, omalizumab, peanut, Science, Xolair / /

Taking the edge off —

Injections over several months allowed people to tolerate larger doses of trigger foods.

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Peanuts

Enlarge / Peanuts

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.

“This newly approved use for Xolair will provide a treatment option to reduce the risk of harmful allergic reactions among certain patients with IgE-mediated food allergies,” Kelly Stone, associate director of the Division of Pulmonology, Allergy, and Critical Care in the FDA’s Center for Drug Evaluation and Research, said in today’s announcement. “While it will not eliminate food allergies or allow patients to consume food allergens freely, its repeated use will help reduce the health impact if accidental exposure occurs.”

The trial began in 2019 and was run by the National Institute of Allergy and Infectious Diseases and is still ongoing. But an interim analysis of early data was enough to convince the FDA of the drug’s benefit.

More tolerance

For the trial, researchers recruited people who had an allergy to peanuts, as well as at least two other food allergies, including milk, egg, wheat, cashew, hazelnut, or walnut. Those assigned to get omalizumab received shots every two to four weeks for 16 to 20 weeks. Afterward, researchers looked at whether participants could handle 600 milligrams or more of peanut protein, which is equivalent to eating about 2.5 or more peanuts. Of those who got the shot, 68 percent (75 of 110 subjects) handled the peanut doses without moderate to severe allergy symptoms, such as whole-body hives, persistent coughing, or vomiting. In the placebo group, only 6 percent (3 of 55 subjects) managed this.

As secondary tests, the researchers tried other allergy-triggering foods at the higher dose of 1,000 milligrams or more. For cashews, 42 percent (27 of 64) of participants who received omalizumab tolerated the challenge without moderate or severe allergic reactions, compared with 3 percent (1 of 30) in the placebo group. For milk, 66 percent (25 of 38 subjects) who received the drug tolerated the dairy, while only 11 percent (2 of 19) of the placebo group did so. For egg, 67 percent (31 of 46 subjects) on the drug tolerated the dose, compared to 0 percent of the 19 who received placebo.

The benefits of omalizumab were not universal. The FDA notes that 17 percent of the people who received the drug had no significant improvement in their sensitivity to allergy-triggering food. As such, the FDA cautions that even if people receive Xolair, they should still avoid the foods that trigger their allergies.

The trial is ongoing, and researchers plan to look at the longevity of the drug’s effectiveness and whether it can be paired with another strategy to ratchet down food allergies: oral immunotherapy (OIT), which uses small, daily doses of an allergen to build tolerance over time. For the look at longevity, some trial participants will get shots for an additional 24 weeks, followed by more food challenges to see if the drug remains useful at easing allergic responses over the prolonged time period. For the OIT part of the trial, participants will get another 16 weeks of injections and, halfway through that, some will undergo multi-allergen OIT. They will then be followed for 44 additional weeks.

The FDA says the most common side effects of omalizumab are injection site reactions and fever, but the agency also warns of the possibility of joint pain, rash, parasitic infections, malignancies, and abnormal laboratory tests.

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

can-you-sanitize-the-inside-of-your-nose-to-prevent-covid?-nope,-fda-says.

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

COVID-19, fda, health, nasal spray, SARS-CoV-2, Science, warning letter / /

doesn’t pass the sniff test —

There are a lot of COVID nasal sprays for sale, but little data to show they work.

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

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.

The FDA’s warning letter is nothing to sneeze at; the letter threatens seizure and injunction for failing to adequately respond.

Nozin’s maker, Maryland-based Global Life Technologies Corp., did not immediately respond to a request for comment from Ars. On its website, the company touts its product’s effectiveness with a link to a published study from 2014, indicating that use of Nozin lowered the colonization levels of S. aureus and other bacteria in the noses of 20 healthy health care workers. The study did not address protection from infection or carriage of any viruses. The company also lists unpublished studies indicating that the product can kill bacteria in laboratory conditions, does not irritate skin, and lowered bacterial growth in the noses of 30 people over a 12-hour period.

This is far from the first dubious, nasal-based COVID product the FDA has called out. There was the Corona-cure nasal spray of 2020, and the Halodine and the NanoBio Protect nasal antiseptics of 2021. That year, the Federal Trade Commission sued a company called Xlear over allegedly false claims that its nasal spray can prevent and treat COVID-19. At least two more nasal spray makers received FDA warning letters in 2022.

To date, the FDA has not approved any nasal sprays to prevent or treat COVID-19, and the scant data on their efficacy remains inconclusive. But there are still plenty of such products for sale online. Most, like Nozin, claim to work by killing bacteria and viruses directly. One product, a nitric oxide nasal spray called Sanotize, is currently in a Phase III clinical trial to test whether it can prevent SARS-CoV-2 infections. Others claim to work by coating the nasal passage with the gelling agent iota-carrageenan to provide a barrier to viral entry. A pilot clinical trial of 400 health care workers in Argentina published in 2021 found that the use of an iota-carrageenan nasal spray led to a 4 percent absolute risk reduction in SARS-CoV-2 infection.

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

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

apple cinnamon fruit pouches, apple sauce, chromium, cinnamon, ecuador, fda, lead, poisoning, Science, spices, WanaBana / /

Tragedy —

At least 413 people, mostly young children, in 43 states have been poisoned.

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The three recalled pouches linked to lead poisonings.

Enlarge / The three recalled pouches linked to lead poisonings.

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.

According to FDA inspection documents obtained by CBS News, Austrofoods never tested its product for heavy metals at any point in production and repeatedly failed to identify the cinnamon as a raw ingredient needing such testing. “[Y]ou did not sample and test the raw material or the finished product for heavy metals,” the FDA wrote in its inspection report. Testing by the FDA immediately identified high levels of lead in the finished apple cinnamon puree and in the ground cinnamon powder Austrofoods used for the purees. The regulator also observed problems with Austrofood’s pasteurization and sanitation procedures, and noted equipment in poor condition that could have allowed metal pieces to break loose and get into food products.

Austrofood’s apple cinnamon fruit puree pouches were sold under three brands, all of which have been recalled: WanaBana apple cinnamon fruit puree pouches, Schnucks brand cinnamon-flavored applesauce pouches, and Weis brand cinnamon applesauce pouches.

The FDA reported that ARCSA’s investigation and legal proceedings are still ongoing to determine the ultimate responsibility for the contamination. The FDA acknowledged that it has “limited authority over foreign ingredient suppliers who do not directly ship product to the US. This is because their food undergoes further manufacturing/processing prior to export. Thus, the FDA cannot take direct action with Negasmart or Carlos Aguilera.”

Testing by the FDA hints that the cinnamon was contaminated with lead chromate, a vibrant yellow substance often used to bolster a spice’s appearance and weight artificially. It’s frequently been found contaminating turmeric sourced from India and Bangladesh.

The children exposed to the purees face uncertain long-term health effects. The effects of ingesting chromium are unclear, and it’s also not clear what form of chromium the children ingested from the pouches. Lead, on the other hand, is a potent neurotoxic metal that can damage the brain and nervous system. In young children, the effects of acute exposures could manifest as learning and behavior problems, as well as hearing and speech problems in the years to come.

Last year, the CDC reported that exposed children had shown blood lead levels as high as 29 micrograms per deciliter (µg/dL), more than eight times the 3.5 µg/dL threshold the agency considers the cutoff for high exposure.

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