health

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

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

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

promising but pricey —

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

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

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

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

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

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

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

Devastating disease

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

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

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

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

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

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

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

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

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Health experts plead for unvaxxed Americans to get measles shot as cases rise

American Medical Association, CDC, children, health, health advisory, infectious diseases, measles, Science, travel, vaccination, vaccines / /

MMR is safe and effective —

The US hit last year’s total in under 12 weeks, suggesting we’re in for a bad time.

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A view from a hospital as children receiving medical treatment, in capital Kabul, Afghanistan on April 18, 2022. More than 130 children have died from the measles in Afghanistan since the beginning of this year.

Enlarge / A view from a hospital as children receiving medical treatment, in capital Kabul, Afghanistan on April 18, 2022. More than 130 children have died from the measles in Afghanistan since the beginning of this year.

The Centers for Disease Control and Prevention and the American Medical Association sent out separate but similar pleas on Monday for unvaccinated Americans to get vaccinated against the extremely contagious measles virus as vaccination rates have slipped, cases are rising globally and nationally, and the spring-break travel period is beginning.

In the first 12 weeks of 2024, US measles cases have already matched and likely exceeded the case total for all of 2023. According to the CDC, there were 58 measles cases reported from 17 states as of March 14. But media tallies indicate there have been more cases since then, with at least 60 cases now in total, according to CBS News. In 2023, there were 58 cases in 20 states.

“As evident from the confirmed measles cases reported in 17 states so far this year, when individuals are not immunized as a matter of personal preference or misinformation, they put themselves and others at risk of disease—including children too young to be vaccinated, cancer patients, and other immunocompromised people,” AMA President Jesse Ehrenfeld said in a statement urging vaccination Monday.

The latest data indicates that vaccination rates among US kindergarteners have slipped to 93 percent nationally, below the 95 percent target to prevent the spread of the disease. And vaccine exemptions for non-medical reasons have reached an all-time high.

The CDC released a health advisory on Monday also urging measles vaccination. The CDC drove home the point that unvaccinated Americans are largely responsible for importing the virus, and pockets of unvaccinated children in local communities spread it once it’s here. The 58 measles infections that have been reported to the agency so far include cases from seven outbreaks in seven states. Most of the cases are in vaccine-eligible children aged 12 months and older who are unvaccinated. Of the 58 cases, 54 (93 percent) are linked to international travel, and most measles importations are by unvaccinated US residents who travel abroad and bring measles home with them, the CDC flagged.

The situation is likely to worsen as Americans begin spring travel, the CDC suggested. “Many countries, including travel destinations such as Austria, the Philippines, Romania, and the United Kingdom, are experiencing measles outbreaks,” the CDC said. “To prevent measles infection and reduce the risk of community transmission from importation, all US residents traveling internationally, regardless of destination, should be current on their [measles-mumps-rubella (MMR)] vaccinations.” The agency added in a recommendation to parents that “even if not traveling, ensure that children receive all recommended doses of MMR vaccine. Two doses of MMR vaccine provide better protection (97 percent) against measles than one dose (93 percent). Getting MMR vaccine is much safer than getting measles, mumps, or rubella.”

For Americans who are already vaccinated and communities with high vaccination coverage, the risk is low, the CDC noted. “However, pockets of low coverage leave some communities at higher risk for outbreaks.” This, in turn, threatens wider, continuous spread that could overturn the country’s status of having eliminated measles, which was declared in 2000. The US was close to losing its elimination status in 2019 when outbreaks among unvaccinated children drove 1,247 cases across 31 states. Vaccination rates have only fallen since then.

“The reduction in measles vaccination threatens to erase many years of progress as this previously eliminated vaccine-preventable disease returns,” the AMA’s Ehrenfeld warned.

As Ars has reported previously, measles is among the most contagious viruses known and can linger in airspace for up to two hours. Up to 90 percent of unvaccinated people exposed will contract it. Symptoms can include high fever, runny nose, red and watery eyes, and a cough, as well as the hallmark rash. About 1 in 5 unvaccinated people with measles are hospitalized, while 1 in 20 infected children develop pneumonia, and up to 3 in 1,000 children die of the infection. Brain swelling (encephalitis) can occur in 1 in 1,000 children, which can lead to hearing loss and intellectual disabilities. The virus can also destroy immune responses to previous infections—a phenomenon known as “immune amnesia”—which can leave children vulnerable to various other infections for years afterward.

Health experts plead for unvaxxed Americans to get measles shot as cases rise Read More »

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Deadly morel mushroom outbreak highlights big gaps in fungi knowledge

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

This fungi’s not fun, guys —

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

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

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

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

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

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

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

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

Mysterious poison

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

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

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

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

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

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

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Amid paralyzing ransomware attack, feds probe UnitedHealth’s HIPAA compliance

Change Healthcare, cyberattack, health, HHS, HIPAA, Policy, ransomware, Science, unitedhealth / /

most significant and consequential incident —

UnitedHealth said it will cooperate with the probe as it works to restore services.

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Multistory glass-and-brick building with UnitedHealthcare logo on exterior.

As health systems around the US are still grappling with an unprecedented ransomware attack on the country’s largest health care payment processor, the US Department of Health and Human Services is opening an investigation into whether that processor and its parent company, UnitedHealthcare Group, complied with federal rules to protect private patient data.

The attack targeted Change Healthcare, a unit of UnitedHealthcare Group (UHG) that provides financial services to tens of thousands of health care providers around the country, including doctors, dentists, hospitals, and pharmacies. According to an antitrust lawsuit brought against UHG by the Department of Justice in 2022, 50 percent of all medical claims in the US pass through Change Healthcare’s electronic data interchange clearinghouse. (The DOJ lost its case to prevent UHG’s acquisition of Change Healthcare and last year abandoned plans for an appeal.)

As Ars reported previously, the attack was disclosed on February 21 by UHG’s subsidiary, Optum, which now runs Change Healthcare. On February 29, UHG accused the notorious Russian-speaking ransomware gang known both as AlphV and BlackCat of being responsible. According to The Washington Post, the attack involved stealing patient data, encrypting company files, and demanding money to unlock them. The result is a paralysis of claims processing and payments, causing hospitals to run out of cash for payroll and services and preventing patients from getting care and prescriptions. Additionally, the attack is believed to have exposed the health data of millions of US patients.

Earlier this month, Rick Pollack, the president and CEO of the American Hospital Association, called the ransomware attack on Change Healthcare “the most significant and consequential incident of its kind against the US health care system in history.”

Now, three weeks into the attack, many health systems are still struggling. On Tuesday, members of the Biden administration met with UHG CEO Andrew Witty and other health industry leaders at the White House to demand they do more to stabilize the situation for health care providers and services and provide financial assistance. Some improvements may be in sight; on Wednesday, UHG posted an update saying that “all major pharmacy and payment systems are up and more than 99 percent of pre-incident claim volume is flowing.”

HIPAA compliance

Still, the data breach leaves big questions about the extent of the damage to patient privacy, and the adequacy of protections moving forward. In an additional development Wednesday, the health department’s Office for Civil Rights (OCR) announced that it is opening an investigation into UHG and Change Healthcare over the incident. It noted that such an investigation was warranted “given the unprecedented magnitude of this cyberattack, and in the best interest of patients and health care providers.”

In a “Dear Colleague” letter dated Wednesday, the OCR explained that the investigation “will focus on whether a breach of protected health information occurred and Change Healthcare’s and UHG’s compliance with the HIPAA Rules.” HIPAA is the Health Insurance Portability and Accountability Act, which establishes privacy and security requirements for protected health information, as well as breach notification requirements.

In a statement to the press, UHG said it would cooperate with the investigation. “Our immediate focus is to restore our systems, protect data and support those whose data may have been impacted,” the statement read. “We are working with law enforcement to investigate the extent of impacted data.”

The Post notes that the federal government does have a history of investigating and penalizing health care organizations for failing to implement adequate safeguards to prevent data breaches. For instance, health insurance provider Anthem paid a $16 million settlement in 2020 over a 2015 data breach that exposed the private data of almost 79 million people. The exposed data included names, Social Security numbers, medical identification numbers, addresses, dates of birth, email addresses, and employment information. The OCR investigation into the breach discovered that the attack began with spear phishing emails that at least one employee of an Anthem subsidiary fell for, opening the door to further intrusions that went undetected between December 2, 2014, and January 27, 2015.

“Unfortunately, Anthem failed to implement appropriate measures for detecting hackers who had gained access to their system to harvest passwords and steal people’s private information,” OCR Director Roger Severino said at the time. “We know that large health care entities are attractive targets for hackers, which is why they are expected to have strong password policies and to monitor and respond to security incidents in a timely fashion or risk enforcement by OCR.”

Amid paralyzing ransomware attack, feds probe UnitedHealth’s HIPAA compliance Read More »

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 »

study-finds-link-between-marijuana-use-and-cardiovascular-disease

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 »

cdc-recommends-spring-covid-booster-for-people-65-and-up

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 »

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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 »

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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 »

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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 »