fda

apple’s-airpods-pro-could-be-getting-a-“hearing-aid-mode”-later-this-year

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 »

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

Abortion, fda, health, mifepristone, retraction, Science, Scientific publishing, Supreme Court / /

retracted —

A large number of other, non-retracted studies find mifepristone to be very safe.

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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.

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.

Mifepristone, considered safe and effective by the FDA and medical experts, is used in over half of abortions in the US.

Criticism

Amid the legal dispute, the now-retracted studies drew immediate criticism from experts, who pointed out flaws. Of the three, the most influential and heavily criticized is the 2021 study titled “A Longitudinal Cohort Study of Emergency Room Utilization Following Mifepristone Chemical and Surgical Abortions, 1999–2015” (PDF). The study suggested that up to 35 percent of women on Medicaid who had a medication abortion between 2001 and 2015 visited an emergency department within 30 days afterward. Its main claim was that medication abortions led to a higher rate of emergency department visits than surgical abortions.

Critics noted a number of problems: The study looked at all emergency department visits, not only visits related to abortion. This could capture medical care beyond abortion-related conditions, because people on Medicaid often lack primary care and resort to going to emergency departments for routine care. When the researchers tried to narrow down the visits to just those related to abortion, they included medical codes that were not related to abortion, such as codes for ectopic pregnancy, and they didn’t capture the seriousness of the condition that prompted the visit. Medication abortions can cause bleeding, and women can go to the emergency department if they don’t know what amount of bleeding is normal. The study also counted multiple visits from the same individual patient as multiple visits, likely inflating the numbers. Last, the study did not put the data in context of emergency department use by Medicaid beneficiaries in general over the time period.

In contrast to Studnicki’s study, the American College of Obstetricians and Gynecologists notes that studies looking at tens of thousands of medication abortions have concluded that “Serious side effects occur in less than 1 percent of patients, and major adverse events—significant infection, blood loss, or hospitalization—occur in less than 0.3 percent of patients. The risk of death is almost non-existent.”

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

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

aducanumab, Aduhelm, Alzheimer's, Biogen, clinical trial, fda, health, Science / /
Multistory glass office building.

Enlarge / The exterior of the headquarters of biotechnology company Biogen in Cambridge, Massachusetts.

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.

In the announcement, Biogen noted it took a financial hit of $60 million in the fourth quarter of 2023 to close out its work on Aduhelm, which the company at one point reportedly estimated would bring in as much as $18 billion in revenue per year.

The saga

But the data never appeared to support such lofty aspirations. The drug is intended to work against the clumps of misfolded beta-amyloid protein that accumulate in the brains of people with Alzheimer’s. Though a small, early clinical trial showed the drug could reduce plaques in the brains of people with Alzheimer’s, it initially failed two identically designed Phase 3 trials. The trials, which collectively enrolled nearly 3,300 patients, intended to evaluate if the drug could slow the progression of Alzheimer’s in its early stages.

In March 2019, the company announced that it was ending both trials after a futility analysis indicated that the drug wasn’t working. But later that year, Biogen stunningly reversed course, saying that additional data had rolled in from the trials after the March announcement. A new analysis of the data from one of the two trials indicated that a subset of patients given the highest dose showed a small benefit on cognitive tests—though the patients in the other trial still saw no benefit. The data also found that 40 percent of patients given the high dose developed brain swelling.

Biogen boldly submitted its data to the FDA for approval. In November 2020, a panel of independent advisors for the FDA voted resoundingly against Aduhelm’s approval. Ten of 11 committee members voted against the drug while the remaining member voted “uncertain.” After voting no, one member commented on the “incongruity” of Biogen’s presentation of the drug and the actual data. “It just feels to me like the audio and the video on the TV are out of sync, and there are literally a dozen red threads that suggests concerns about the consistency of evidence—a dozen,” the member said. The FDA, too, in its own statistical analysis of the data, concluded that “there is no compelling substantial evidence of treatment effect or disease slowing.”

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

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

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

65+, adults, blood clot, CDC, COVID-19, fda, health, heart attack, Science, stroke, vaccine / /

stay up to date —

Data provides more evidence older people should stay up to date on COVID vaccines.

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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.

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.”

But, the statistical blip could potentially cause lingering concerns. While clinicians had noted lower rates of thromboembolic events among vaccinated people, the authors of the new study noted that, until now, there were no rigorous estimates of how effective COVID-19 vaccines are at preventing those events.

For their analysis, they primarily looked at two groups of patients: A group of 12.7 million Medicare beneficiaries ages 65 and older and a group of around 78,600 Medicare beneficiaries ages 18 and older with end-stage renal disease (ESRD) on dialysis, a condition that increases their risk for thromboembolic events, including COVID-19-related thromboembolic events. Using medical claims records from September 2022 to March 2023, the researchers compared rates of thromboembolic events among the people in those groups that had gotten a bivalent COVID-19 booster dose and those who had only gotten the original monovalent COVID-19 vaccine in the past. To be considered a COVID-related thromboembolic event, the event had to occur within a week of or a month after a COVID-19 diagnosis.

Protective effect

In the group of 12.7 million patients ages 65 and older, about 5.7 million (45 percent) had gotten the bivalent booster, making them up to date on their COVID-19 vaccinations at the time. The remaining 7 million (55 percent) had only gotten the original vaccine.

During the study period, 17,746 patients who were not up to date on their COVID shots got COVID-19 and experienced a COVID-related thromboembolic event. Of the bivalent boosted patients, there were 4,255 COVID-related thromboembolic events. The researchers adjusted for confounding factors, such as age, race, and time of vaccination, and estimated that the bivalent booster was overall 47 percent effective at preventing COVID-related thromboembolic events, which again include strokes, blood clots, and heart attacks.

A sub-analysis including the time since vaccination indicated that the estimated effectiveness waned about two months after receipt of the vaccine, dropping early effectiveness of 54 percent down to 42 percent at 60 days or more.

Among the 78,600 patients ages 18 and up with ESRD, 23,229 (29.5 percent) received a bivalent dose and thus were up to date on their COVID-19 vaccines. The remaining patients (70.5 percent) had only received an original vaccine, and of those, 917 experienced a COVID-19-related thromboembolic event after getting the pandemic virus. Among the up-to-date patients, there were only 123 events. After adjustments, the researchers estimated that the vaccines’ effectiveness against thromboembolic events was 51 percent in this group, which also waned slightly over time.

The study has limitations, such as that it can’t account for previous COVID-19 infections, which could alter people’s risk of developing complications from COVID-19, including thromboembolic events. It relied on medical claims, which have limitations, and it’s possible there are other confounding factors, such as the use of Paxlovid and behavioral differences. Last, Medicare beneficiaries are not representative of the whole population.

But, given the data available, the study authors concluded that it appears the bivalent vaccine dose “helped provide protection against COVID-19–related thromboembolic events compared with more distant receipt of original monovalent doses alone.” The authors recommend that, “to prevent COVID-19–related complications, including thromboembolic events, adults should stay up to date with recommended COVID-19 vaccination.”

The CDC currently estimates that only 21 percent of adults ages 18 and up have received the latest COVID-19 booster dose, including 41.5 percent of adults ages 65 and up.

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

chromium-found-in-lead-tainted-fruit-pouches-may-explain-contamination

Chromium found in lead-tainted fruit pouches may explain contamination

adulteration, CDC, children, chromium, cinnamon, cinnamon applesauce, contamination, fda, fruit pouches, health, lead, lead chromate, lead poisoning, Science, spices, WanaBana / /

Nightmare —

Lead chromate, an artificial coloring, has been used in other spices to conceal poor quality.

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The three recalled pouches linked to lead poisonings.

Enlarge / The three recalled pouches linked to lead poisonings.

The Food and Drug Administration has discovered a second metal contaminant—chromium—in the recalled cinnamon applesauce pouches found to contain cinnamon contaminated with extremely high levels of lead. The products have now poisoned nearly 300 young children in 37 states.

The health implications of the additional contaminant are not clear. There is no antidote for chromium exposure, and the Centers for Disease Control and Prevention recommends supportive care. But the finding does hint at the possible motivation behind the tragic poisonings.

In the FDA’s announcement, the agency noted that “The lead-to-chromium ratio in the cinnamon apple puree sample is consistent with that of lead chromate (PbCrO4).” This is a notorious adulterant of spices used to artificially bolster their color and weight.

Lead chromate is a vibrant yellow substance that has frequently turned up in turmeric sourced from India and Bangladesh. In a 2017 study by public health researchers at Boston University, 16 of 32 turmeric products bought in markets in the Boston area had lead levels over the FDA’s allowable lead level for candy (the FDA does not have guidelines for lead levels in spices, specifically). Two samples, the only two samples sourced from Bangladesh, exceeded the allowable lead level by two orders of magnitude. The researchers had conducted the study after a string of lead poisoning cases in US children were linked to contaminated spices, including turmeric. Other studies have also identified spices as a source of lead exposure in US children.

The 2017 study highlighted the reason that lead chromate is used as an adulterant. A media outlet in Bangladesh quoted one turmeric trader’s explanation: “Traders use the artificial color [lead chromate] to hide the marks of pest attacks and other spots on raw turmeric. It is used during boiling and polishing to make the spice look brighter to attract big buyers, including spice processing firms.”

The FDA’s testing does not definitively conclude that lead chromate was in the contaminated cinnamon, which was sourced from an Austrofoods manufacturing facility in Ecuador and used in the recalled applesauce pouches. But it does bolster the FDA’s suspicion that the poisonings were the result of “economically motivated adulteration,” a specific category of food fraud defined by the FDA.

Jim Jones, FDA’s deputy commissioner for human foods, told Politico in December that the agency believed then that the contamination was economically motivated. “My instinct is they didn’t think this product was going to end up in a country with a robust regulatory process,” Jones said. “They thought it was going to end up in places that did not have the ability to detect something like this.”

Health effects

For the hundreds of US children poisoned by the applesauce pouches, the finding of chromium adds yet more nightmarish uncertainty of possible long-term health effects. Lead is a potent neurotoxic metal that can damage the brain and nervous system. In developing toddlers and younger children, the effects of the acute exposures could manifest as learning and behavior problems, as well as hearing and speech problems in the years to come.

The effects of chromium exposure are less clear. Chromium is a naturally occurring metal and an essential trace nutrient. But there are two notable forms: chromium III and the more toxic chromium VI. The FDA’s testing couldn’t identify which form of chromium was present in the cinnamon applesauce pouches, but the more toxic chromium VI is what’s present in lead chromate. Chromium VI is considered a carcinogen, and chronic, prolonged inhalation and skin exposure is associated with chronic lung disease and ulceration of skin and mucous membranes, the CDC notes. But the effects of eating chromium VI are not well studied or understood beyond the immediate, nonspecific effects of an acute exposure—which might include abdominal pain, nausea, vomiting, diarrhea, anemia, and kidney and liver dysfunction.

The CDC and the FDA note that it’s possible that even if chromium VI contaminated the applesauce pouches, the acidity of the applesauce and the stomach may have converted the chromium VI to chromium III.

The FDA recommends that the families of children exposed to the recalled pouches—especially those with elevated blood lead levels—should inform their health care providers of potential chromium exposure. The CDC provided clinical guidance for doctors on how to test and care for children with exposure.

The recalled cinnamon applesauce pouches include WanaBana apple cinnamon fruit puree pouches (sold nationally and through multiple retailers, including Amazon and Dollar Tree), Schnucks-brand cinnamon-flavored applesauce pouches and variety packs (sold at Schnucks and Eatwell Markets grocery stores), and Weis-brand cinnamon applesauce pouches (sold at Weis grocery stores).

According to the CDC’s latest numbers, which, as of the time of publication, were last updated on December 29, there have been a total of 287 cases identified across 37 states.

Chromium found in lead-tainted fruit pouches may explain contamination Read More »

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FDA would like to stop finding Viagra in supplements sold on Amazon

Amazon, cialis, drugs, fda, health, Policy, supplements, Viagra / /

Well, that’s one kind of energy —

“Big Guys Male Energy Supplement” turns out to be a vehicle for prescription drugs.

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Image of a pile of blue pills that forms the shape of a male symbol.

If you were to search for a product called “Mens Maximum Energy Supplement” on Amazon, you’d be bombarded with everything from caffeine pills to amino acid supplements to the latest herb craze. But at some point last year, the FDA had purchased a specific product by that name from Amazon and sent it off to one of its labs to find out if the self-proclaimed “dietary supplement” contained anything that would actually boost energy.

In August, the FDA announced that the supposed supplement was actually a vehicle for a prescription drug that offered a very specific type of energy boost. It contained sildenafil, a drug much better known by its brand name: Viagra.

Four months later, the FDA is finally getting around to issuing a warning letter to Amazon, giving it 15 days to not only address Mens Maximum Energy Supplement and a handful of similar vehicles for prescription erection boosters, but also asking for an explanation of how the company is going to keep similarly mislabelled prescription drugs from being hawked on its site in the future.

Prescription energy

Mens Maximum Energy Supplement was just one of seven products that the FDA found for sale on Amazon that contained either Sildenafil or Tadalafil (marketed as Cialis). The product names ranged from the jokey (WeFun and Genergy) to the vaguely suggestive (Round 2) to the verbose (Big Guys Male Energy Supplement and X Max Triple Shot Energy Honey). All of them were marketed as supplements and contained no indication of their active ingredients.

And that, as the FDA explains to Amazon in detail, means selling those products violates a whole host of laws and regulations. They’re being marketed as dietary supplements, but don’t fit the operative legal definition of these supplements. They’re offering prescription drugs without providing directions for their intended and safe use. They contain no warnings about unsafe doses or how long they can be used safely.

The FDA points out that these rules exist for very good reasons. Both of the drugs found in these supplements inhibit an enzyme called a type-5 phosphodiesterase which, among other things, influences the circulatory system. One potential side effect is a dangerous drop in blood pressure. Both Sildenafil and Tadalafil can also have dangerous interactions with a specific class of drugs often taken by those with diabetes, high blood pressure, or heart disease.

Legal remedies

The FDA’s letter makes it clear that the highlighted supplements aren’t intended to be an exhaustive list of the products that Amazon offers in violation of federal law. And it is very explicit about the fact that it is Amazon’s responsibility (and not the FDA’s) to ensure compliance: “You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.”

And Amazon clearly has its work cut out for it. None of the products cited by the FDA’s letter appear to still be for sale under the same name at Amazon—a company spokesperson told Ars that it pulled them in response to the original FDA findings. But searches for them at Amazon brought up a number of similar products, many of which included pills with the blue color that Viagra was marketed with.

So, the FDA wants to see a plan that describes how Amazon will not only deal with the products at issue in this letter, but prevent all similar violations in the future: “Include an explanation of each step being taken to prevent the recurrence of violations, including steps you will take to ensure that Amazon will no longer introduce or deliver for introduction into interstate commerce unapproved new drugs and/or misbranded products with undeclared drug ingredients, as well as copies of related documentation.”

Amazon is being given 15 days to respond to the warning letter. Failure to adequately address these violations, the FDA warns, will result in legal action.

FDA would like to stop finding Viagra in supplements sold on Amazon Read More »

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MDMA—aka ecstasy—submitted to FDA as part of PTSD therapy

fda, health, maps, mdma, psychedelics, PTSD, Science, therapy / /

Groovy —

If FDA approved, it would require the DEA to reclassify MDMA.

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Girl with an ecstasy tablet on her tongue.

Enlarge / Girl with an ecstasy tablet on her tongue.

A corporation dedicated to studying the benefits of psychedelic drugs filed an application with the Food and Drug Administration this week for approval to use MDMA—aka ecstasy or molly—in combination with talk therapy to treat post-traumatic stress disorder.

If approved, it would be the first-of-its-kind combination treatment—a psychedelic-assisted therapy. An approval would also require the Drug Enforcement Administration to reclassify MDMA, which is currently in the DEA’s most restricted category, Schedule I, which is defined as drugs “with no currently accepted medical use and a high potential for abuse.” The category also includes LSD, heroin, and marijuana.

The public benefit corporation (PBC) that filed the FDA application was created by MAPS, The Multidisciplinary Association for Psychedelic Studies, which has been supporting this type of work since 1986. The application is based on positive data from two randomized, double-blind, placebo-controlled Phase III studies, which were funded and organized by MAPS and MAPS PBC.

The first study, published in Nature Medicine in 2021, involved a total of 90 participants with moderate PTSD. It found that MDMA-assisted talk therapy (aka psychotherapy) significantly improved Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) scores compared with participants who were given talk therapy with a placebo. In the second study, published in September in Nature Medicine, the finding held up among 104 participants with moderate or severe PTSD (73 percent had severe PTSD).

In both trials, participants took 80 to 180 mg doses of MDMA or a placebo at the start of three eight-hour sessions, which were spaced around a month apart. Between those experimental treatment sessions, participants also had three 90-minute sessions for participants to process the experimental experience.

MDMA—3,4-methylenedioxymethamphetamine—affects neurotransmitters in the brain, increasing the activity of serotonin, dopamine, and norepinephrine, to be specific. This leads people who take the drug to experience euphoria, hallucinations, sharpened sensory perception, and sociability, but it can also induce confusion, depression, and paranoia. Its use in psychotherapy has been explored for decades.

In a statement this week, MAPS PBC CEO Amy Emerson celebrated the FDA submission. “The filing of our [new drug application] is the culmination of more than 30 years of clinical research, advocacy, collaboration, and dedication to bring a potential new option to adults living with PTSD, a patient group that has experienced little innovation in decades,” she said.

MAPS founder and President Rick Doblin also celebrated the submission this week, saying in a statement: “When I started MAPS in 1986, the FDA was still blocking all research with psychedelics. … By breaking that barrier, we have opened doors for others to conduct their own promising research into psychedelic-assisted therapies with psilocybin, ayahuasca, ketamine, and more. The novel approaches undertaken in psychedelic-assisted therapy research have led to fundamental shifts in our understanding of how these devastating mental health conditions can be treated.”

So far, the MDMA-assisted therapy has drawn criticism for its expected inaccessibility. The treatment outlined in the two MDMA trials involves lengthy—and likely pricey—therapy sessions with highly trained therapists. The Washington Post published an estimated price of between $13,000 to $15,000 per treatment round, and it’s unclear for now whether it would be covered by health insurance if approved by the FDA. “Most people in the world won’t be able to afford these clinics,” Allen Frances, a Duke University professor emeritus of psychiatry, told the Post.

Now that the NDA is submitted, the FDA has 60 days to determine whether it will be accepted for review and whether it will be a priority or standard review (six months or ten months, respectively), MAPS PBS noted. MAPS is seeking a priority review. In 2017, the FDA granted MDMA “Breakthrough Therapy,” designed to help hasten the development and review of drugs for serious conditions when evidence indicates they may substantially improve upon current therapies.

The only psychedelic with FDA approval to date is esketamine, a variation of ketamine, which was approved in 2019 to treat treatment-resistant depression.

MDMA—aka ecstasy—submitted to FDA as part of PTSD therapy Read More »

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Every homeopathic eye drop should be pulled off the market, FDA says

eye drops, fda, health, homeopathic, infection, Science, Vision / /

don’t risk it —

Eye drops are uniquely risky because the eye is an immune-privileged site.

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Young man applying eye drops.

This year has been marked by many terrifying things, but perhaps the most surprising of the 2023 horrors was … eye drops.

The seemingly innocuous teeny squeeze bottle made for alarming headlines numerous times during our current revolution around the sun, with lengthy lists of recalls, startling factory inspections, and ghastly reports of people developing near-untreatable bacterial infections, losing their eyes and vision, and dying.

Recapping this unexpected threat to health, the Food and Drug Administration on Tuesday released an advisory titled “What You Should Know about Eye Drops” in hopes of keeping the dangers of this year from leaking into the next. Among the notable points from the regulator was this stark pronouncement: No one should ever use any homeopathic ophthalmic products, and every single such product should be pulled off the market.

The point is unexpected, given that none of the high-profile infections and recalls this year involved homeopathic products. But, it should be welcomed by any advocates of evidence-based medicine.

Homeopathy is an 18th century pseudoscience that produces bogus remedies that work no better than a placebo and, if prepared improperly, can be toxic, even deadly. The practice relies on two false principles: the  “law of similars,” aka “like cures like,” meaning a substance that causes a specific symptom in a healthy person can treat conditions and diseases that involve that same symptom, and the “law of infinitesimals,” which states that diluting the substance renders it more potent. As such, homeopathic products begin with toxic substances that are then extremely diluted—often into oblivion—in a ritualistic procedure. Some homeopaths hold that water molecules can have “memory.”

Clear risks

In the US, these products are marketed as legitimate treatments and sold alongside evidence-based treatments (though consumer advocates are trying to change that). The reason this is allowed for now is because of a regulatory quirk: Based on the 1938 Food, Drug, and Cosmetic Act, homeopathic products are generally considered exempt from pre-market FDA safety and efficacy reviews as long as the active ingredient in the product is included in the Homeopathic Pharmacopoeia, a list of substances approved by homeopaths.

In recent years, the FDA and the Federal Trade Commission have cracked down on homeopathic products, though. And it seems from today’s advisory that the FDA is not holding back on homeopathic products for the eyes. The regulator notes that any products meant for the eye “pose a heightened risk of harm” because the eyes are an immune-privileged site in the body. That is, innate immune responses are restrained in the eye to prevent damaging inflammation, which could threaten vision. “Any drug used in the eyes must be sterile to reduce the risk of infection,” the FDA said.

But whether or not homeopathic eye drops are labeled as sterile doesn’t seem to matter to the FDA. The regulator cautions: “Do not use ophthalmic products that: Are labeled as homeopathic, as these products should not be marketed.” Their lack of pre-market safety and efficacy reviews appears to be enough to warrant avoidance.

The FDA also cautions consumers not to use any over-the-counter eye drop product that claims to treat glaucoma, cataracts, retinopathy, or macular degeneration because there are simply no actual over-the-actual treatments for these conditions. If a non-prescription product claims this, you can assume it’s bogus and avoid it. Consumers should also avoid anything that includes Methylsulfonylmethane (MSM), which is illegally sold in the US, and anything with silver sulfate or argentum because these can permanently change the white color of your eyes.

Every homeopathic eye drop should be pulled off the market, FDA says Read More »