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cdc-ditches-5-day-covid-isolation,-argues-covid-is-becoming-flu-like

CDC ditches 5-day COVID isolation, argues COVID is becoming flu-like

5-day isolation, CDC, COVID-19, COVID-19 vaccination, flu shots, health, infectious idease, influenza, isolation, respiratory virus, RSV, Science, vaccines / /

New phase —

The agency released a unified “practical” guidance for respiratory viruses.

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A view of the Centers for Disease Control and Prevention headquarters in Atlanta.

Enlarge / A view of the Centers for Disease Control and Prevention headquarters in Atlanta.

COVID-19 is becoming more like the flu and, as such, no longer requires its own virus-specific health rules, the Centers for Disease Control and Prevention said Friday alongside the release of a unified “respiratory virus guide.”

In a lengthy background document, the agency laid out its rationale for consolidating COVID-19 guidance into general guidance for respiratory viruses—including influenza, RSV, adenoviruses, rhinoviruses, enteroviruses, and others, though specifically not measles. The agency also noted the guidance does not apply to health care settings and outbreak scenarios.

“COVID-19 remains an important public health threat, but it is no longer the emergency that it once was, and its health impacts increasingly resemble those of other respiratory viral illnesses, including influenza and RSV,” the agency wrote.

The most notable change in the new guidance is the previously reported decision to no longer recommend a minimum five-day isolation period for those infected with the pandemic coronavirus, SARS-CoV-2. Instead, the new isolation guidance is based on symptoms, which matches long-standing isolation guidance for other respiratory viruses, including influenza.

“The updated Respiratory Virus Guidance recommends people with respiratory virus symptoms that are not better explained by another cause stay home and away from others until at least 24 hours after both resolution of fever AND overall symptom are getting better,” the document states. “This recommendation addresses the period of greatest infectiousness and highest viral load for most people, which is typically in the first few days of illness and when symptoms, including fever, are worst.”

“Residual risk”

The CDC acknowledged that the eased isolation guidance will create “residual risk of SARS-CoV-2 transmission,” and that most people are no longer infectious only after 8 to 10 days. As such, the agency urged people to follow additional interventions—including masking, testing, distancing, hygiene, and improving air quality—for five additional days after their isolation period.

“Today’s announcement reflects the progress we have made in protecting against severe illness from COVID-19,” CDC Director Dr. Mandy Cohen said in a statement. “However, we still must use the commonsense solutions we know work to protect ourselves and others from serious illness from respiratory viruses—this includes vaccination, treatment, and staying home when we get sick.”

Overall, the agency argued that a shorter isolation period would be inconsequential. Other countries and states that have similarly abandoned fixed isolation times did not see jumps in COVID-19 emergency department visits or hospitalizations, the CDC pointed out. And most people who have COVID-19 don’t know they have it anyway, making COVID-19-specific guidance moot, the agency argued. In a recent CDC survey, less than half of people said they would test for SARS-CoV-2 if they had a cough or cold symptoms, and less than 10 percent said they would go to a pharmacy or health care provider to get tested. Meanwhile, “The overall sensitivity of COVID-19 antigen tests is relatively low and even lower in individuals with only mild symptoms,” the agency said.

The CDC also raised practical concerns for isolation, including a lack of paid sick leave for many, social isolation, and “societal costs.”

The points are likely to land poorly with critics.

“The CDC is again prioritizing short-term business interests over our health by caving to employer pressure on COVID guidelines. This is a pattern we’ve seen throughout the pandemic,” Lara Jirmanus, Clinical Instructor of Medicine at Harvard Medical School, said in a press release last month after the news first broke of the CDC’s planned isolation update. Jirmanus is a member of the People’s CDC, a group that advocates for more aggressive COVID-19 policies, which put out the press release.

Another member of the group, Sam Friedman, a professor of population health at NYU Grossman School of Medicine, also blasted the CDC’s stance last month. The guidance will “make workplaces and public spaces even more unsafe for everyone, particularly for people who are high-risk for COVID complications,” he said.

COVID and flu

But, the CDC argues that the threat of COVID-19 is fading. Hospitalizations, deaths, prevalence of long COVID, and COVID-19 complications in children (MIS-C) are all down. COVID-19 vaccines are safe and effective at preventing severe disease, death, and to some extent, long COVID—we just need more people to get them. Over 95 percent of adults hospitalized with COVID-19 in the 2023–2024 respiratory season had no record of receiving the seasonal booster dose, the agency noted. Only 22 percent of adults got the latest shot, including only 42 percent of people ages 65 and older. In contrast, 48 percent of adults got the latest flu shot, including 73 percent of people ages 65 and older.

But even with the crummy vaccination rates for COVID-19, a mix of past infection and shots have led to a substantial protection in the overall population. The CDC even went as far as arguing that COVID-19 deaths have fallen to a level that is similar to what’s seen with flu.

“Reported deaths involving COVID-19 are several-fold greater than those reported to involve influenza and RSV. However, influenza and likely RSV are often underreported as causes of death,” the CDC said. In the 2022–2023 respiratory virus season, there were nearly 90,000 reported COVID-19 deaths. For flu, there were 9,559 reported deaths, but the CDC estimates the true number to be between 18,000 and 97,000. In the current season, there have been 32,949 reported COVID-19 deaths to date and 5,854 reported flu deaths, but the agency estimates the real flu deaths are between 17,000 and 50,000.

“Total COVID-19 deaths, accounting for underreporting, are likely to be higher than, but of the same order of magnitude as, total influenza deaths,” the agency concluded.

In all, the CDC was ready to fold SARS-CoV-2 into the gang of common seasonal respiratory viruses, with most cases mild and undiagnosed. “Viruses cause most acute respiratory illnesses, but it is rarely possible to determine the type of virus without testing, and oftentimes testing does not change clinical management,” the agency wrote.

CDC ditches 5-day COVID isolation, argues COVID is becoming flu-like Read More »

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Gastrointestinal disease explodes in Ala. elementary school; 773 kids out

Alabama, elementary school, gastrointestinal, health, Infectious disease, Norovirus, outbreak, school, Science, students / /

no, no, no —

Highly contagious norovirus is the leading suspect; four other area schools affected.

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An electron micrograph of norovirus.

Enlarge / An electron micrograph of norovirus.

Officials in Alabama have shut down an elementary school for the rest of the week and are conducting a deep clean after 773 of the school’s 974 students were absent Wednesday amid an explosive outbreak of gastrointestinal illness.

Local media reported that only 29 students were absent from Fairhope West Elementary School on Tuesday. However, the situation escalated quickly on Wednesday as word spread of a stomach bug going around the Gulf Coast school. A spokesperson for the county school district told AL.com that 773 students and 50 staff were absent Wednesday. It’s unclear how many of the absences were due to sickness or precaution.

Health officials are now investigating the cause of the gastrointestinal outbreak, collecting specimens for testing. So far, officials are working under the assumption that it is norovirus, a highly infectious gastrointestinal bug that can survive hand sanitizer and transmit easily from surfaces, food, and water. The symptoms of the unidentified illness align with norovirus: vomiting, diarrhea, abdominal cramps, and nausea.

On Wednesday, Baldwin County Schools Superintendent Eddie Tyler sent a message to parents saying that the county had decided to shut the school down for the rest of the week. “Due to the amount of staff and students who are absent, the number who are experiencing symptoms, and in an effort to help contain the contagion, we unfortunately need to shut the building down,” Tyler wrote. “While out, we will be conducting a deep cleaning of the school so when students return next week, it will be sanitized to the fullest extent.”

But local outlet WKRG reported Thursday that the outbreak has already spread beyond Fairhope West. On Thursday, 1,231 students from four other area schools were also absent, including 721 students at Fairhope East Elementary School, 136 at a third elementary school, 170 at a middle school, and 204 at a high school. These are in addition to the 974 students at Fairhope West who are out of school while it is shut down.

Norovirus activity is high across the country, with the northeastern region seeing the largest surge, according to surveillance by the Centers for Disease Control and Prevention. The agency notes that outbreaks are commonly linked to health care settings, restaurants or catered events, cruise ships, as well as schools and childcare centers. “Close quarters, shared spaces, and high-touch surfaces make it easy for norovirus to spread in schools,” the CDC points out.

In 2022, the COVID-19 pandemic flipped the script on standard norovirus outbreaks. People who were hoping to avoid close contact and share indoor air with strangers headed to the great outdoors, which led to a large outbreak of norovirus in the Grand Canyon.

Gastrointestinal disease explodes in Ala. elementary school; 773 kids out Read More »

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Study finds link between marijuana use and cardiovascular disease

cannibis, cardiovascular disease, health, heart attack, marijuana, Science, stroke / /

Association —

Researchers call for more studies to understand why they’re linked.

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A cannabis flower is seen at East End Flower Farm, in Mattituck, New York, on November 16, 2023.

Enlarge / A cannabis flower is seen at East End Flower Farm, in Mattituck, New York, on November 16, 2023.

Survey data collected from more than 430,000 US adults over multiple years suggests a strong, statistically significant link between the use of cannabis and an increased risk of cardiovascular disease, specifically heart attack and stroke.

The open-access study, published this week in Journal of the American Heart Association, found that people who used cannabis every day had 25 percent higher odds of having a heart attack and 42 percent higher odds of having a stroke compared with those who did not use cannabis at all.

But, the national survey data—collected between 2016 and 2020—also contained data on people who used cannabis less frequently than daily. Survey respondents were asked how many days in the past 30 days they used cannabis, which allowed researchers to estimate the odds of cardiovascular disease along the whole spectrum of cannabis use. And they found near-linear dose-responses, with more days of use per month associated with higher risk.

This isn’t the first time that researchers have found an association between cannabis use and cardiovascular disease, but the study is among the largest to date—with a sample size between three and 17 times larger than previous studies. Its size not only added weight to the link but also allowed the researchers to drill down into other risk factors for cardiovascular disease.

Clear link

One common complicating factor is that people who use cannabis also often use tobacco products, which carry their own increased risk for cardiovascular disease. In the new study, led by Abra Jeffers of Massachusetts General Hospital, researchers were able to do two additional analyses: one that looked at cardiovascular disease risk in people who use cannabis but had never used tobacco products and a second one that looked at people who used cannabis but had never used tobacco products or e-cigarettes. Without tobacco use, the higher odds of heart attack and stroke persisted for people who used cannabis. For those without tobacco or e-cigarette use, only the higher odds of stroke remained.

The researchers also looked at age, another complicating factor. Heart disease can take years or decades to develop, but people who use cannabis tend to skew younger. The 434,104 people who took the survey ranged from age 18 to 74, and the analyses adjusted for other health factors, including alcohol use, diabetes, body mass index, and physical activity. When the researchers looked at just the adults who would be considered on the young side for developing cardiovascular disease (less than 55 for men and less than 65 for women), they found that cannabis use also increased the odds of premature cardiovascular disease—and again the link was independent of tobacco and e-cigarette use.

In all, the researchers concluded that “these data suggest that cannabis use may be a risk factor for cardiovascular disease and may be a risk factor for premature cardiovascular disease,” they wrote. This is particularly concerning, they add, because of the growing acceptance and use of cannabis in the US and a decline in perceived health risks.

Limitations

But, the study has limitations that preclude a firm conclusion that cannabis is causing cardiovascular disease. The study relies on self-reported data on both cardiovascular health and cannabis use—both of which can be unreliable. It also relied on data collected at a specific point in time. It’s possible that some people turned to cannabis use after developing cardiovascular disease rather than before, for instance. The survey data can’t make that distinction; it’s only making an association. The authors note that cardiovascular disease, heart attack, and stroke have not previously been identified as major reasons that people use cannabis. This lessens the reverse concern that cardiovascular disease is increasing the odds of cannabis use. But, the researchers do note that many studies have linked the use of cannabis to chronic pain, insomnia, and anxiety—all of which have also been associated with cardiovascular disease. Last, the survey data does not include data on people’s actual cardiovascular health, such as blood pressure and lipid profiles.

Another wrinkle to the study is the route of cannabis use and how it may play a role in the link to cardiovascular disease. About 74 percent of cannabis users in the study reported smoking cannabis, which could potentially increase the risk of cardiovascular disease much the same way tobacco cigarettes do—a result of inhaling particulate matter into the lungs. It’s unclear if edible cannabis products would weaken the association seen in the study.

But, the authors note that there is a biologically plausible link between cannabis and cardiovascular disease. Cell signaling receptors that detect components of cannabis (endocannabinoid receptors) are ubiquitous throughout the cardiovascular system, the researchers note. And the key psychoactive substance in cannabis, Tetrahydrocannabinol (THC), can increase blood pressure and heart rate during use.

Study finds link between marijuana use and cardiovascular disease Read More »

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CDC recommends spring COVID booster for people 65 and up

65 and up, booster dose, CDC, COVID-19, COVID-19 vaccine, health, hospitalization, Science, spring booster / /

More protection —

The shot should be taken at least four months since the last COVID vaccination.

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The Moderna Spikevax COVID-19 vaccine is shown at a CVS in 2023.

Enlarge / The Moderna Spikevax COVID-19 vaccine is shown at a CVS in 2023.

People ages 65 and up should get another dose of a COVID-19 vaccine this spring, given the age group’s higher risk of severe disease and death from the pandemic virus, the Centers for Disease Control and Prevention announced Wednesday.

Earlier today, an advisory committee for the CDC voted overwhelmingly in favor of recommending the spring booster dose. And late this afternoon, CDC Director Mandy Cohen signed off on the recommendation, allowing boosting to begin.

“Today’s recommendation allows older adults to receive an additional dose of this season’s COVID-19 vaccine to provide added protection,” Cohen said in a statement. “Most COVID-19 deaths and hospitalizations last year were among people 65 years and older. An additional vaccine dose can provide added protection that may have decreased over time for those at highest risk.”

The spring booster will be an additional shot of the 2023–2024 COVID-19 vaccines made by Pfizer-BioNTech, Moderna, and Novavax. The booster dose should be taken after at least four months have passed since a previous COVID-19 vaccination. However, as FDA representative David Kaslow noted in today’s advisory committee meeting, the FDA will likely approve a 2024–2025 version of COVID-19 vaccines for this coming fall. Given that, it’s best for people to get their spring booster dose by the end of June, so they can be ready for another booster before the winter when COVID-19 has generally peaked.

A report published earlier this month by the CDC found that the 2023–2024 COVID-19 vaccine was about 54 percent effective at preventing symptomatic COVID-19 when compared against people who had not received the latest vaccine. However, the CDC estimates that only about 22 percent of adults in the US have gotten a COVID-19 booster this season, and just over 40 percent of people ages 65 and up have gotten the shot.

People over age 65 made up 67 percent of COVID-19 hospitalizations between October 2023 and January 2024, according to CDC data presented at today’s advisory committee meeting. In early January, COVID-19 hospitalizations hit a seasonal high of about 35,000 weekly new admissions per week and nearly 2,500 weekly deaths.

The advisers debated how to word their recommendation for a spring booster and whether getting a booster should require consulting with a health care provider. But, ultimately, the committee decided on a more permissive recommendation, allowing anyone in the age group who wants a booster to be able to freely get one, including at convenient locations, such as local pharmacies.

“Data continues to show the importance of vaccination to protect those most at risk for severe outcomes of COVID-19,” the CDC said in its announcement of the recommendation. “An additional dose of the updated COVID-19 vaccine may restore protection that has waned since a fall vaccine dose, providing increased protection to adults ages 65 years and older.”

The CDC noted that its previous recommendations allow people who are immunocompromised to get additional doses of the COVID-19 vaccines.

CDC recommends spring COVID booster for people 65 and up Read More »

surprising-link-found-between-niacin-and-risk-of-heart-attack-and-stroke

Surprising link found between niacin and risk of heart attack and stroke

cardiovascular disease, cleveland clinic, Genetics, health, heart attack, inflammation, metabolites, niacin, Science, stroke, vitamin b3 / /

Unexpected —

Breakdown products of niacin, aka Vitamin B3, may spur vascular inflammation.

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A shopper looks at a meat display on June 20, 2022, at the Market 32 Supermarket in South Burlington, Vermont. Niacin can be found in foods such as red meat, poultry, fish, fortified cereals and breads, brown rice, nuts, legumes, and bananas.

Enlarge / A shopper looks at a meat display on June 20, 2022, at the Market 32 Supermarket in South Burlington, Vermont. Niacin can be found in foods such as red meat, poultry, fish, fortified cereals and breads, brown rice, nuts, legumes, and bananas.

In the early 20th century, the deadliest nutrient-related disease in US history ravaged the American South. Pellagra, a disease caused by a deficiency in niacin and/or tryptophan, is marked by the four “D’s”: diarrhea, dermatitis that leads to gruesome skin plaques, dementia, and death. At its peak during the Great Depression, pellagra killed nearly 7,000 Southerners a year. Between 1906 and 1940, researchers estimate that the epidemic struck roughly 3 million Americans, killing around 100,000.

The deadly epidemic led to voluntary—and eventually mandatory—fortification of wheat and other cereals with niacin (aka Vitamin B3). By the middle of the century, pellagra nearly vanished from the US. But, decades later, the public health triumph may be backfiring. With Americans’ diets more reliant than ever on processed, niacin-fortified foods, the average niacin intake in the US is now nearing what’s considered the tolerable upper limit of the nutrient, according to a federal health survey. And an extensive study recently published in Nature Medicine suggests that those excess amounts of niacin may be exacerbating cardiovascular disease, increasing risks of heart attacks, strokes, and death.

The study, led by Stanley Hazen, chair of Cardiovascular and Metabolic Sciences at Cleveland Clinic’s Lerner Research Institute, connected high blood levels of a breakdown product of niacin—and to a lesser extent, tryptophan—to an elevated risk of major adverse cardiovascular events (MACE). And this elevated risk appears to be independent of known risk factors for those events, such as high cholesterol.

“What’s exciting about these results is that this pathway appears to be a previously unrecognized yet significant contributor to the development of cardiovascular disease,” Hazen said in an announcement of the study. It can be measured, he added, and one day could be a new avenue for treatment and prevention.

Metabolite fishing

Hazen and his colleagues didn’t start out suspecting niacin could be a culprit in cardiovascular disease. They arrived at that point after fishing through patients’ blood plasma. The researchers were carefully inventorying metabolites in the fasting plasma of 1,162 patients who had been evaluated for cardiovascular disease. They were looking for anything that might be linked to a heightened risk of heart attack, stroke, or death in a three-year period that couldn’t entirely be explained by other risk factors. Despite advances in identifying and treating cardiovascular disease, researchers have noted that some patients continue to be at risk of serious cardiovascular events despite having their traditional risk factors treated and controlled. Hazen and his colleagues wanted to know why.

The metabolomic trawling came up with an unknown metabolite (signature C7H9O2N2) that was significantly linked to having a MACE in the three-year period. People who had higher levels of this metabolite circulating in their systems were within the top 75th percentile for relative MACE risk in the cohort. Further work identified the metabolite as actually being two related molecules: 2PY (N1-methyl-2-pyridone-5-carboxamide) and 4PY (N1-methyl-4-pyridone -3-carboxamide)—both the final breakdown products of niacin.

Surprising link found between niacin and risk of heart attack and stroke Read More »

unvaccinated-florida-kids-exposed-to-measles-can-skip-quarantine,-officials-say

Unvaccinated Florida kids exposed to measles can skip quarantine, officials say

anti-vaccine, Florida, health, Ladapo, measles, MMR, Science, vaccines / /

Bad idea —

On Tuesday, nearly 20 percent of the school’s 1,067 students were reportedly absent.

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Florida Surgeon General Dr. Joseph Ladapo speaks during a press conference at Neo City Academy in Kissimmee, Florida.

Enlarge / Florida Surgeon General Dr. Joseph Ladapo speaks during a press conference at Neo City Academy in Kissimmee, Florida.

Paul Hennessy/SOPA Images/LightRocket via Getty Images

A sixth student at Florida’s Manatee Bay Elementary School outside of Fort Lauderdale has a confirmed case of measles, health officials announced late Tuesday. However, health officials are not telling unvaccinated students who were potentially exposed to quarantine.

The school has a low vaccination rate, suggesting that the extremely contagious virus could spark a yet larger outbreak. But in a letter sent to parents late Tuesday, Florida Surgeon General Joseph Ladapo—known for spreading anti-vaccine rhetoric and vaccine misinformation—indicated that unvaccinated students can skip the normally recommended quarantine period.

The letter, signed by Ladapo, noted that people with measles can be contagious from four days before the rash develops through four days after the rash appears. And while symptoms often develop between 8 to 14 days after exposure, the disease can take 21 days to appear. As such, the normal quarantine period for exposed and unvaccinated people, who are highly susceptible to measles, is 21 days.

“Because of the high likelihood of infection, it is normally recommended that children stay home until the end of the infectious period, which is currently March 7, 2024,” Ladapo’s letter states, adding that the date could change as the situation develops. “However, due to the high immunity rate in the community, as well as the burden on families and educational costs of healthy children missing school, [the health department] is deferring to parents or guardians to make decisions about school attendance.”

Local media outlets reported that, on Tuesday, more than 200 of the school’s 1,067 students were absent.

The measles cluster began Friday when a third grader, who had not recently traveled, was diagnosed with the vaccine-preventable illness. Over the weekend, three additional cases were identified, leading the local health department to release a health advisory. Two additional cases were identified this week. It’s unclear if all six children are unvaccinated.

According to a county vaccine study, only 89.31 percent of the school’s students were vaccinated in the 2023/2024 school year, suggesting that around 114 students are susceptible due to their vaccination status.

The measles virus spreads easily through respiratory transmission and can linger in air space for up to two hours after an infected person has been in an area. Among people susceptible to the virus—those who are unvaccinated or have compromised immune systems—up to 90 percent will become infected upon exposure. People who are fully vaccinated, meanwhile, are considered protected. Two doses of the Measles, Mumps, and Rubella (MMR) vaccine are 97 percent effective at preventing the disease.

Measles symptoms include high fever, runny nose, red and watery eyes, and a cough, as well as a telltale rash that develops after initial symptoms. About 1 in 5 unvaccinated people with measles are hospitalized, according to the Centers for Disease Control and Prevention, while 1 in 20 infected children develop pneumonia and up to 3 in 1,000 children die of the infection.

Unvaccinated Florida kids exposed to measles can skip quarantine, officials say Read More »

ala.-hospital-halts-ivf-after-state’s-high-court-ruled-embryos-are-“children”

Ala. hospital halts IVF after state’s high court ruled embryos are “children”

Alabama, assisted reproductive technology, children, embryo, fertility, frozen embryo, health, IVF, Science / /

Consequences —

Anger and uncertainty spread in wake of Friday’s ruling by the state’s Supreme Court.

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Nitrogen tanks holding tens of thousands of frozen embryos and eggs sit in the embryology lab at New Hope Fertility Center in New York City on December 20, 2017.

Enlarge / Nitrogen tanks holding tens of thousands of frozen embryos and eggs sit in the embryology lab at New Hope Fertility Center in New York City on December 20, 2017.

The University of Alabama at Birmingham (UAB) health system is halting in vitro fertilization treatment in the wake of a ruling by the state’s Supreme Court on Friday that deemed frozen embryos to be “children,” The ruling opens up anyone who destroys embryos to liability in a wrongful death lawsuit, according to multiple media reports.

The announcement—the first facility to report halting IVF services—is the much-feared outcome of Friday’s ruling, which was widely decried by reproductive health advocates.

“We are saddened that this will impact our patients’ attempt to have a baby through IVF, but we must evaluate the potential that our patients and our physicians could be prosecuted criminally or face punitive damages for following the standard of care for IVF treatments,” UAB said a statement to media. The statement noted that egg retrieval would continue but that egg fertilization and embryo development are now paused.

Ars has reached out to UAB for further comment and will update this story with any additional information.

Production of extra embryos is a normal part of IVF treatment for several reasons. Most notably, not all embryos will be viable, implant in a uterus, and lead to a live birth. So, creating as many embryos as possible is a common strategy to ensure that people who wish to conceive have the best chance of doing so. Embryos can also be screened for genetic conditions, allowing only the healthiest to be implanted, while those with debilitating or fatal abnormalities can be discarded.

In 2021, approximately 238,126 patients in the US had 413,776 rounds of IVF, resulting in 97,128 live-born infants, according to the Centers for Disease Control and Prevention. The percentage of egg retrievals that lead to a live birth ranges from 54 percent to 9 percent, depending on a patient’s age.

But, the standard practices of IVF used for hundreds of thousands of patients each year were thrown into question and upheaval Friday when the Alabama Supreme Court ruled that all embryos, even those outside of a uterus or frozen in storage, are “children” under state law. Anyone who destroys them is liable under the state’s Wrongful Death of a Minor Act, the court concluded. Chief Justice Tom Parker cited his religious beliefs and quoted the Bible to support the stance.

Reproductive health experts quickly speculated that the ruling would roll back IVF treatment in the state. Some facilities, such as the case of UAB, may halt treatment entirely. While others may choose to fertilize eggs conservatively, adding cost and time to the already arduous process of IVF. Genetic screening of embryos from couples who carry debilitating or fatal mutations may no longer be possible. Doctors could be sued if an embryonic ball of a few cells does not survive the treatment. Insurance rates for fertility clinics could skyrocket. Patients, meanwhile, may have to keep unneeded embryos frozen indefinitely.

On Tuesday, The Washington Post reported that the ruling had created a wave of anger, shock, and confusion across the state. Patients are considering moving frozen embryos—some leftover from IVF rounds, some purposely banked for future use—to storage facilities out of the state. Lawyers cautioned that divorce settlements that stipulate frozen embryos must be destroyed may now be void.

But the fear and confusion don’t end there. Health advocates worry more states will follow Alabama’s lead. And, if small clumps of cells gain personhood rights in more states, liability could spread to contraceptive use and people who suffer a miscarriage.

Ala. hospital halts IVF after state’s high court ruled embryos are “children” Read More »

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Musk claims Neuralink patient doing OK with implant, can move mouse with brain

elon musk neuralink, health, Neuralink, Policy / /

Neuralink brain implant —

Medical ethicists alarmed by Musk being “sole source of information” on patient.

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A person's hand holidng a brain implant device that is about the size of a coin.

Enlarge / A Neuralink implant.

Neuralink

Neuralink co-founder Elon Musk said the first human to be implanted with the company’s brain chip is now able to move a mouse cursor just by thinking.

“Progress is good, and the patient seems to have made a full recovery, with no ill effects that we are aware of. Patient is able to move a mouse around the screen by just thinking,” Musk said Monday during an X Spaces event, according to Reuters.

Musk’s update came a few weeks after he announced that Neuralink implanted a chip into the human. The previous update was also made on X, the Musk-owned social network formerly named Twitter.

Musk reportedly said during yesterday’s chat, “We’re trying to get as many button presses as possible from thinking. So that’s what we’re currently working on is: can you get left mouse, right mouse, mouse down, mouse up… We want to have more than just two buttons.”

Neuralink itself doesn’t seem to have issued any statement on the patient’s progress. We contacted the company today and will update this article if we get a response.

“Basic ethical standards” not met

Neuralink’s method of releasing information was criticized last week by Arthur Caplan, a bioethics professor and head of the Division of Medical Ethics at NYU Grossman School of Medicine, and Jonathan Moreno, a University of Pennsylvania medical ethics professor.

“Science by press release, while increasingly common, is not science,” Caplan and Moreno wrote in an essay published by the nonprofit Hastings Center. “When the person paying for a human experiment with a huge financial stake in the outcome is the sole source of information, basic ethical standards have not been met.”

Caplan and Moreno acknowledged that Neuralink and Musk seem to be “in the clear” legally:

Assuming that some brain-computer interface device was indeed implanted in some patient with severe paralysis by some surgeons somewhere, it would be reasonable to expect some formal reporting about the details of an unprecedented experiment involving a vulnerable person. But unlike drug studies in which there are phases that must be registered in a public database, the Food and Drug Administration does not require reporting of early feasibility studies of devices. From a legal standpoint Musk’s company is in the clear, a fact that surely did not escape the tactical notice of his company’s lawyers.

But they argue that opening “the brain of a living human being to insert a device” should have been accompanied with more public detail. There is an ethical obligation “to avoid the risk of giving false hope to countless thousands of people with serious neurological disabilities,” they wrote.

A brain implant could have complications that leave a patient in worse condition, the ethics professors noted. “We are not even told what plans there are to remove the device if things go wrong or the subject simply wants to stop,” Caplan and Moreno wrote. “Nor do we know the findings of animal research that justified beginning a first-in-human experiment at this time, especially since it is not lifesaving research.”

Clinical trial still to come

Neuralink has been criticized for alleged mistreatment of animals in research and was reportedly fined $2,480 for violating US Department of Transportation rules on the movement of hazardous materials after inspections of company facilities last year.

People “should continue to be skeptical of the safety and functionality of any device produced by Neuralink,” the nonprofit Physicians Committee for Responsible Medicine said after last month’s announcement of the first implant.

“The Physicians Committee continues to urge Elon Musk and Neuralink to shift to developing a noninvasive brain-computer interface,” the group said. “Researchers elsewhere have already made progress to improve patient health using such noninvasive methods, which do not come with the risk of surgical complications, infections, or additional operations to repair malfunctioning implants.”

In May 2023, Neuralink said it obtained Food and Drug Administration approval for clinical trials. The company’s previous attempt to gain approval was reportedly denied by the FDA over safety concerns and other “deficiencies.”

In September, the company said it was recruiting volunteers, specifically people with quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis. Neuralink said the first human clinical trial for PRIME (Precise Robotically Implanted Brain-Computer Interface) will evaluate the safety of its implant and surgical robot, “and assess the initial functionality of our BCI [brain-computer interface] for enabling people with paralysis to control external devices with their thoughts.”

Musk claims Neuralink patient doing OK with implant, can move mouse with brain Read More »

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Measles erupts in Florida school where 11% of kids are unvaccinated

CDC, Florida, health, Infectious disease, measles, Science, Transmission, vaccination rate, virus / /

outbreak potential —

Over 100 children at the school are susceptible to virus.

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A child with measles.

Enlarge / A child with measles.

Florida health officials on Sunday announced an investigation into a cluster of measles cases at an elementary school in the Fort Lauderdale area with a low vaccination rate, a scenario health experts fear will become more and more common amid slipping vaccination rates nationwide.

On Friday, Broward County Public School reported a confirmed case of measles in a student at Manatee Bay Elementary School in the city of Weston. A local CBS affiliate reported that the case was in a third-grade student who had not recently traveled. On Saturday, the school system announced that three additional cases at the same school had been reported, bringing the current reported total to four cases.

On Sunday, the Florida Department of Health in Broward County (DOH-Broward) released a health advisory about the cases and announced it was opening an investigation to track contacts at risk of infection.

At Manatee Bay Elementary School, the number of children at risk could be over 100 students. According to a Broward County vaccine study reported by the local CBS outlet, only 89.31 percent of students at Manatee Bay Elementary School were fully immunized in the 2023/2024 school year, which is significantly lower than the target vaccination coverage of 95 percent. The school currently has 1,067 students enrolled, suggesting that up to 114 students are vulnerable to the infection based on their vaccination status.

Measles is one of the most contagious viruses known. It spreads via respiratory and airborne transmission. The virus can linger in air space for up to two hours after an infected person has been in an area. People who are not vaccinated or have compromised immune systems are susceptible, and up to 90 percent of susceptible people exposed to the virus will become infected. Measles symptoms typically begin around eight to 14 days after exposure, but the disease can incubate for up to 21 days. The symptoms begin as a high fever, runny nose, red and watery eyes, and a cough before the telltale rash develops. Infected people can be contagious from four days before the rash develops through four days after the rash appears, according to the Centers for Disease Control and Prevention. About 1 in 5 unvaccinated people with measles is hospitalized, the CDC adds, while 1 in 20 infected children develop pneumonia and up to 3 in 1,000 children die of the infection.

Those who are not immunocompromised and are fully vaccinated against measles (who have received two doses of the Measles, Mumps, and Rubella (MMR) vaccine) are generally not considered at risk. The two doses are about 97 percent effective at preventing measles and protection is considered to be life-long.

The DOH-Broward said it is now “identifying susceptible contacts that may be candidates for post-exposure prophylaxis through MMR or immunoglobulin.”

While the risk of measles is generally low in the US—the country declared it eliminated in 2000—the threat of large outbreaks is growing as vaccination rates slip. Many cases in the US are linked to travel from countries where the virus still circulates. But, if a travel-related case lands in a pocket with low vaccination coverage, the virus can take off. Such was the case in 2019, when the country tallied 1,274 measles cases and nearly lost its elimination status.

Health officials typically consider vaccination coverage of 95 percent or greater to protect from ongoing transmission. In the years since the COVID-19 pandemic began, vaccination rates among US kindergartners have slipped to 93 percent, and vaccination exemptions reached an all-time high in the latest data from the 2022-2023 school year. There are now at least 10 states that have vaccination exemption rates above 5 percent, meaning that even if every non-exempt child is vaccinated, those states will not have enough coverage to reach the 95 percent target.

The CDC has tallied 20 measles cases in the US so far this year. But that is the tally as of February 15; it does not include any of the Florida cases reported since Friday. In 2023, there were 58 measles cases reported to the CDC.

This story was updated to include additional information about measles infection outcomes.

Measles erupts in Florida school where 11% of kids are unvaccinated Read More »

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

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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 »

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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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CDC to update its COVID isolation guidance, ditching 5-day rule: Report

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update —

The agency is reportedly moving from the fixed time to a symptom-based isolation period.

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CDC to update its COVID isolation guidance, ditching 5-day rule: Report

The Centers for Disease Control and Prevention is preparing to update its COVID-19 isolation guidance, moving from a minimum five-day isolation period to one that is solely determined by symptoms, according to a report from The Washington Post.

Currently, CDC isolation guidance states that people who test positive for COVID-19 should stay home for at least five days, at which point people can end their isolation as long as their symptoms are improving and they have been fever-free for 24 hours.

According to three unnamed officials who spoke with the Post, the CDC will update its guidance to remove the five-day minimum, recommending more simply that people can end their isolation any time after being fever-free for 24 hours without the aid of medication, as long as any other remaining symptoms are mild and improving. The change, which is expected to be released in April, would be the first to loosen the guidance since the end of 2021.

In an email to Ars, a CDC spokesperson did not confirm or deny the report, saying only that, “There are no updates to COVID guidelines to announce at this time. We will continue to make decisions based on the best evidence and science to keep communities healthy and safe.”

The Post notes that the proposed update to the guidance matches updated guidance from California and Oregon, as well as other countries.

The officials who spoke with the outlet noted that the loosened guidelines reflect that most people in the US have developed some level of immunity to the pandemic coronavirus from prior infections and vaccinations.

A report earlier this month found that the 2023–2024 COVID-19 vaccine was about 54 percent effective at preventing symptomatic COVID-19 when compared against people who had not received the latest vaccine. However, the CDC estimates that only about 22 percent of adults have received the updated shot.

Currently, the CDC recommends that people wear a mask for 10 days after testing positive unless they have two negative tests 48 hours apart. The Post reported that it’s unclear if the CDC will update its mask recommendation.

CDC to update its COVID isolation guidance, ditching 5-day rule: Report Read More »