Mushroom chocolates, gummies recalled across multiple states linked to hospitalizations, illness

FDA

(NEW YORK) — A California company has recalled its mushroom-infused chocolates and sweets containing a chemical not approved for food by the U.S. Food and Drug Administration.

Consumption of the recalled Prophet Premium Blends Diamond Shruumz products has been associated with “a series of illnesses” across more than 20 states and one possible related death, according to the FDA.

The agency announced last week that as of July 1, a total of 48 illnesses had been reported from 24 states.

“At Prophet Premium Blends, we prioritize the health and safety of our consumers above all else,” the Santa Ana-based company wrote in a statement on its website. “Recently, we have been made aware of reported incidents involving our product, Diamond Shruumz. Due to consumers becoming ill after consuming the entire chocolate bar and some products containing higher levels of Muscimol than normal, it is crucial that all of our consumers refrain from ingesting this product while we, alongside the FDA, continue our investigation as to what is the cause of the serious adverse effects.”

As of time of publication, the company had ceased production and distribution of all Diamond Shruumz products.

What is muscimol?

According to the National Library of Medicine, muscimol is “a member of the class of isoxazoles that … has been isolated from mushrooms of the genus Amanita.”

Details of mushroom chocolate, gummies recall

Prophet Premium Blends first announced a recall on June 27 for all flavors of its Diamond Shruumz products, including its Infused Cones, Microdosing Chocolate Bars, and both Micro- and Mega-Dose/Extreme Gummies, because they contain muscimol, which the company and government agency said could be the potential cause of related illnesses reported by consumers.

“Muscimol could be a potential cause of symptoms consistent with those observed in persons who became ill after eating Diamond Shruumz products,” the recall announcement, which was posted on the FDA’s website, stated. “Reported symptoms have included those linked to seizures, agitation, involuntary muscle contractions, loss of consciousness, confusion, sleepiness, nausea and vomiting, abnormal heart rates, and hyper/hypotension.”

ABC News medical correspondent Dr. Darien Sutton explained that the chemical, derived from some mushrooms, “can be incredibly toxic” at certain doses.

“The problem is that the dosage is not exact and so many people are exposed to these toxic levels and just don’t know,” Sutton said. “These supplements have little to no FDA regulation.”

Where recalled mushroom chocolates, gummies were sold

According to the FDA investigation into the foodborne illness, which began earlier in June, the products were previously available online and in person at a variety of retail locations nationwide including at smoke and vape shops, as well as retailers that sell hemp-derived products such as cannabidiol or delta-8 THC.

“Consumers should not eat, sell, or serve any flavor of Diamond Shruumz-brand Chocolate Bars, Cones, or Gummies. Consumers should check their homes and discard these products or return them to the company for a refund,” the FDA stated last week.

Prophet Premium Blends added on its website that “retailers and wholesalers should discontinue use, stop distribution, quarantine the product immediately and contact their sales representative to initiate the return and refund.”

“Consumers who have purchased Diamond Shruumz products are urged to stop using the product and return it to 1019 Arlington St., Orlando, FL 32805, for a full refund,” the company stated.

Customers with additional questions can call the company directly at (209) 314-0881 between 8:30 a.m. and 4:30 p.m. PDT.

Illnesses tied to mushroom chocolate, gummies recall in 24 states

As of July 1, illnesses associated with consumption of the recalled products were reported in two dozen states, according to the FDA.

Alabama, California, Colorado, Florida, Maryland, Minnesota, Missouri, Montana, Nevada, New Jersey, New York, North Dakota, Oklahoma and South Dakota all reported one illness each. Tennessee, Pennsylvania and Ohio each reported two illnesses apiece.

Georgia, Iowa, Kentucky and North Carolina reported three illnesses each, while South Carolina reported four illnesses, Indiana reported five, and Arizona reported six.

Forty-six of the 48 people reported seeking medical care, and 27 have been hospitalized, according to the FDA. The FDA said there is one potentially associated death under investigation, but the agency has yet to share any additional information on the individual.

What to know about muscimol present in some mushroom chocolates

According to research published in the American Journal of Preventative Medicine last month, psilocybin-containing mushrooms like the type used in the Diamond Shruumz products “have potent pharmacological properties including Amanita muscaria mushrooms, which contain the compound muscimol. Muscimol is psychotropic — i.e., can produce acute changes in perception, mood, cognition, and behavior. [It is] highly toxic and can be fatal at high enough doses.”

According to those researchers, there has been significant growing interest in psilocybin-containing mushrooms among U.S. adults since 2021.

“12.3% of U.S. adults report[ed using] psilocybin-containing mushrooms in 2022, up significantly from 11.4% in 2021,” they wrote. “This makes psilocybin-containing mushrooms the most commonly used hallucinogenic substance.”

Copyright © 2024, ABC Audio. All rights reserved.

Nutrition companies, parents clash in court over cause of infant intestinal disease

ABC News

(NEW YORK) — Chance Dean was alive for just 25 days.

Yet his tragic story has reverberated in hospitals around the country, impacted the stock price of two multinational corporations, and ignited a high-stakes legal clash over a pernicious disease that kills hundreds of babies a year in the United States.

Born two months early and weighing less than four pounds, Chance spent all his days under close medical supervision in neonatal intensive care units (NICUs) near his family’s home in Southern Illinois.

His mother, Jasmine Watson, was unable to produce enough breast milk to fully nourish Chance and his fraternal twin brother, Chase. She initially opted to have her sons fed with a combination of her own milk and human breast milk from donor banks.

As Chance and his brother were being prepared for transfer to a hospital where donor milk was unavailable, doctors began transitioning them on Day 12 to a formula designed specifically for premature, low-birthweight infants, in addition to Watson’s breast milk, which was fortified to adequately support their nutrition.

On Day 22, Chance took a sudden turn for the worse.

“He just seemed like he just didn’t feel good,” Watson, 25, said in an interview. “It seemed like he was uncomfortable.”

Doctors diagnosed Chance with necrotizing enterocolitis (NEC, pronounced “neck”), a devastating illness of the intestines that primarily affects premature infants. The disease led to three urgent surgeries in an unsuccessful effort to save his life.

At 9:43 p.m. on March 28, 2020, Chance died in the arms of his mother.

“In that moment, I felt like the only thing that I could do for him was be there,” Watson said. “I held him the entire time until his heart stopped beating.”

Chance’s twin, who received the same formula at the same time, did not develop NEC.

Four years later, a photograph of Chance — in a tiny blue knit cap — was displayed for jurors as “Plaintiff’s Exhibit 887” at the St. Clair County Courthouse in Belleville, Illinois. Watson alleged in a civil lawsuit that Chance’s NEC developed because of the switch from donor breast milk to a cow’s milk-based formula made by Mead Johnson, a global pediatric nutrition company.

“The reason we’re here in this courtroom is because Chance Dean never made it out of the hospital,” Watson’s lawyer Sean Grimsley said in his opening statement. “He died because he was given formula manufactured and sold by defendant Mead Johnson.”

Phyllis Jones, a defense attorney for Mead Johnson, stepped up to tell jurors that Watson’s lawyers were unjustifiably pinning the blame for Chance’s death on the formula. “It’s an easy answer, but it’s not the right answer.” Jones said. “It’s not the answer that the evidence will ultimately support in this case.”

“Four different neonatologists at two different hospitals made the decision that preterm infant formula … was the right option for Chance Dean to keep him growing, to keep him developing,” Jones said.

After a three-week trial, the jury decided that the company was negligent and had failed to adequately warn Watson that the incidence of NEC is higher in formula-fed premature babies. The jury awarded Watson $60 million to compensate for her loss and for the suffering Chance endured.

“For good reason, we believe this is the largest compensatory damages award ever in St. Clair County and stands as one of the most substantial in Illinois state history,” Watson’s lawyers wrote in a press release following the verdict.

Mead Johnson , in a statement from its UK-based parent company Reckitt Benckiser, said it was “surprised and deeply disappointed with the verdict” and vowed to “pursue all options” to have it overturned.

“It is important to note that this is a single verdict in a single case and should not be extrapolated,” the statement said. “We continue to believe that the allegations from the plaintiff’s lawyers in this case were not supported by the science or experts in the medical community.”

The company told ABC News that the verdict “sets a dangerous precedent that interferes with the practice of medicine and the patient-doctor relationship.”

‘Warning moms’

The Watson case, which concluded in March, was the first of its kind to go to trial. Interest in the proceedings was so expansive that an overflow courtroom was opened to accommodate all the lawyers from around the country who came to observe.

That’s because there are more than a thousand similar lawsuits in the U.S., involving over 7,000 families whose premature babies died or suffered serious injuries from NEC — with the first NEC case against formula-maker Abbott, Mead Johnson’s chief rival, scheduled to go to trial Monday in St. Louis.

The lawsuits allege the cow’s milk-based preterm infant formulas made by Mead Johnson and Abbott cause or substantially increase the risk of premature infants contracting NEC, when compared to babies who are fed a diet of their mother’s own milk or donated breast milk.

“Our allegation is that these formula manufacturers should be, at minimum, warning moms, doctors, dietitians, nurses, and hospitals of the risk of this horrendous disease that comes with switching preterm infants from a human milk to a cow’s milk-based formula,” said Ben Whiting, a partner at Keller Postman, a national law firm that represents Watson and hundreds of other plaintiffs suing the companies.

Over the past three years, claims against one or both formula-makers have been filed in state courts from Connecticut to California. Hundreds more are pending in federal court. Plaintiffs argue that the companies have long been aware of the risks but have failed to provide adequate warnings to parents and their medical providers.

“We were never given any information about additional risk with formula,” said Brent Rheinecker, whose premature baby daughter Willa died from NEC four years ago. Brent and his wife Elizabeth filed suit against the formula makers in Madison County, Illinois. Their case has not yet been set for trial.

“We never want another family to go through what we did. We never want another child to go through what our baby did. Her life was so short,” Elizabeth Rheinecker said.

In their legal complaints, lawyers for the families suing Mead Johnson and Abbott cite several scientific studies spanning three decades that have reported a higher occurrence of NEC in formula-fed preemies. The magnitude of the risk, however, varies widely in the scientific literature — from no significant difference to as much as three to ten times greater. Still, no study to date has shown that formula causes NEC.

Recent research, published in January in the Journal of the American Medical Association, followed 483 extremely preterm infants and found that babies in a preterm formula group gained weight more rapidly than those fed only with nutrient-fortified human donor milk — but that over twice as many formula-fed babies (9.0% compared to 4.2%) developed NEC compared to those fed only with donor milk. Health care providers say this is not enough to show a conclusive cause, but enough for scientists to continue to study the association. At the same time, some premature babies who were never given formula went on to develop NEC, suggesting that human milk is not completely protective.

“What we’re trying to do is to make sure that moms and doctors have the complete information that they need in order to make the best decision possible that they can for their preterm babies,” Whiting said. “The pain and suffering that these babies go through with this NEC is absolutely enormous. The way that it tears families apart — even if you’re a strong mom like Jasmine Watson — is significant.”

The lawsuits targeting the preterm formulas do not allege that the products are contaminated. The litigation is unrelated to Abbott’s baby formula recalls in 2022, which led to nationwide shortages.

‘An essential part of the medical toolkit’

Mead Johnson and Abbott, direct competitors in business, have been largely aligned in defending their respective preterm formulas, which they describe as “essential, safe, life-saving nutrition products” that have been successfully administered in NICUs for decades, according to court filings. The companies contend the mass litigation is itself “causing fear among parents” and “endangering the relationships” between parents and their physicians.

“No published study has ever concluded that defendants’ products cause NEC,” attorneys for the companies wrote in a joint filing in federal court. “Despite plaintiffs’ recent campaign against these products, NICU medical teams — including in the world’s best hospitals — continue to administer them as an essential part of the medical toolkit for treating these most fragile of patients.”

Amy Gates, a pediatric nutrition specialist who serves as Mead Johnson’s medical director, said in an interview after the Watson verdict that plaintiffs’ attorneys are “taking advantage” of the emotional impact that comes with the loss of a child.

“My fear is that we lose sight of the science and we allow emotion to win. And if that happens, there will be thousands of preemies who will be at risk,” Gates said. “Not every baby can sustain himself on just breast milk. And loss of access to these life-saving products would be a tragedy.”

The two companies have also argued that because their preterm formulas are used almost exclusively under medical supervision in hospital settings, they should therefore be considered by courts in the same manner as prescription medications and medical devices, where a legal principle known as the “learned intermediary doctrine” often applies. The logic of the doctrine is that medical professionals — the learned intermediaries — are best positioned to know the risks and benefits of a particular treatment and to communicate that to patients.

Three courts, however, have rejected that argument, declining to apply the doctrine to preterm infant formula, because – as one judge wrote – “it is not a recognized prescription medication or medical device.”

“At the end of the day, it’s the formula manufacturer — it’s their product. And so they are the ones that actually know the risks of using their own product,” Whiting said.

The presiding judge in the Watson case, in a pretrial ruling, rejected the learned intermediary defense and later instructed the jury — over Mead Johnson’s objections — that the company had a duty to warn “the consumer, like Jasmine Watson, about the dangers of its products,” according to court records.

Mead Johnson contends that jury instruction severely undercut their defense. The company argued at trial that it had no legal obligation to warn Watson or other patients, because the doctors who administer preterm formula already know about the risks of NEC.

“These patients are cared for by highly trained neonatologists and dietitians and clinical staff that know what they’re doing,” Gates said. “They fully understand the risks and benefits of everything they do for these patients.”

But Watson’s lawyers argued that testimony from doctors at trial indicated they did not fully appreciate the degree of risk allegedly associated with preterm formula.

“The doctors in this case talked about how there was a slight increased risk of NEC by switching to the formula, when in fact it’s a significant risk,” Whiting said. “And the doctors, they are not omnipotent. They don’t know everything there is to know about everything that’s out there. And that’s why at the end of the day, the legal duty on the manufacturers is to make sure to do everything that they can to make sure that the mom knows about the risk. And one of the ways they can do that is by giving a better warning to the doctors.”

‘A tragic disease’

NEC is a life-threatening intestinal disease predominantly impacting young neonates born prematurely, though it affects older and full-term babies in less common instances. Many infants recover, but the condition can lead to death or lifelong medical issues in the most severe cases.

“Babies who are born preterm, particularly those that are born with a birth weight less than three pounds, or who are very low birthweight, are at risk of a number of complications related to prematurity. That doesn’t just include NEC. It can also include their lungs and their brain,” said Dr. Ravi Patel, a neonatologist at Children’s Healthcare of Atlanta.

Patel, an assistant professor of pediatrics at Emory University, has been studying NEC for 14 years.

“It involves the sudden development of intestinal inflammation, and in severe cases, it can go on to where the tissue dies, and babies need surgery,” Patel said. “NEC is a tragic disease. But most people have never heard of NEC and don’t know what it is, even though it is a major contributor to neonatal mortality.”

The exact number of infants who have had NEC is unknown, but research shows the incidence of NEC has declined over the last 20 years. One recent study published in the Journal of Pediatric Surgery found that on average, there were about 3,000 cases a year from 2006 to 2017. Despite similar declines in mortality rates, data from the Centers for Disease Control and Prevention (CDC) shows that from 2017-2021, over 300 infants died from the disease each year, on average.

The cause of NEC is unknown, though it is believed to be a combination of multiple risk factors, the most important being premature birth and very low birthweight. Other possible factors include “the makeup of bacteria in the intestines, not enough blood flow or oxygen to the intestines, and an infant’s diet,” according to the American Academy of Pediatrics (AAP).

“NEC is a multifactorial disease. It’s not just any single factor we can pinpoint to why babies develop NEC,” Patel said. “We know that babies who only get breast milk are still at risk.”

Though a definitive cause of NEC has not been determined, it has been shown that the use of breast milk can be protective.

“One of the best ways to prevent necrotizing enterocolitis is by breastfeeding,” said Patel, who is not involved in any of the litigation related to NEC. “Our goal is to always provide mother’s own milk, but when that’s not possible, the feeding choices involve donor milk as an option. And donor milk has been shown, particularly in recent studies, to lower the risk of NEC.”

An AAP policy statement in 2012 noted that “feeding preterm infants human milk is associated with a significant reduction (58%) in the incidence of necrotizing enterocolitis” and recommended that “all preterm infants should receive human milk.” When mother’s own milk is unavailable “pasteurized donor milk, appropriately fortified, should be used,” the statement said.

Donor milk comes from mothers who have pumped more breast milk than they need. That milk is then collected and processed by networks of volunteers. Donor milk and maternal breast milk are typically fortified with extra calories and nutrients to meet the unique needs of premature infants in NICUs. Studies have also indicated that the pasteurization process — which kills bacteria and viruses that might be in the donor milk — may reduce many of the protective components of human milk.

“Overall, pasteurized donor milk is nutritionally suboptimal to a mother’s own milk,” according to an AAP clinical report published in 2021.

The Human Milk Banking Association of North America and its 33 milk banks dispensed nearly 10 million ounces of donor milk to 1,500 hospitals in 2023, the organization announced in February, but added that “the need for donor human milk continues to grow.”

An analysis by the CDC found that donor milk was unavailable for very-low-birthweight infants at 13% of advanced care NICUs, based on data from 2020. “Availability of donor milk at hospitals might be affected by supply from milk banks, cost, and reimbursement, which can vary by state and payment source,” the report said.

“Because donors’ milk is a limited resource, some babies do need formula to provide adequate nutrition,” Patel said. “We want to provide nourishment to babies, to make sure that they grow, that they get bigger, and ideally, that they can go home with their families.

“And those nutrition decisions are made at the bedside between clinicians and families, taking in the context of the unique circumstances of each baby,” he added.

‘Can’t be replicated’

Attorneys for Mead Johnson argued during Watson’s trial that the reason for differences in NEC rates is “not because formula is harmful. It’s because formula doesn’t protect in the same way that breast milk does. It doesn’t include the same protective factors.”

“We at Mead Johnson acknowledge that mother’s breast milk, in particular, is unique in its biologic protections that can’t be replicated,” Gates said. “Not every baby has access to breast milk. And there are many reasons why babies need alternatives and supplements. And we believe that access to safe and nutritious formula is extremely important. And loss of that access could put thousands of preemies at risk.”

The verdict in Watson’s lawsuit propelled the burgeoning legal dispute into international headlines and jolted the companies’ stock prices. Reckitt lost billions in market value following the jury’s decision in March, while Abbott shares dipped about 4% over two days.

Reckitt’s CEO, Kris Licht, told analysts during an earnings call in April that the company had “no plans to stop providing the product, as that would be detrimental to the care of preterm babies and their families.”

“I can tell you that we are spending a lot of time thinking about how to best navigate the litigation; how to prevail in the litigation,” Licht said.

The trial’s outcome also prompted a cautionary public statement from the NEC Society, a nonprofit patient-led advocacy group, urging against abrupt changes to neonatal care based on a single jury’s findings.

“Neonatal feeding decisions should be made at patients’ bedsides, not in courtrooms,” the organization said. “Verdicts like the Watson case may prompt ICUs to reconsider their approaches to feeding neonatal patients, but not necessarily in a way that better protects infants from NEC.”

Peter Pitts, a former U.S. Food and Drug Administration official, in an opinion article published in the Washington Times, argued that the litigation presents “a direct threat to the lives of America’s preterm infants.”

“Once again, tort lawyers, sensing a big payday, have put greed before civic duty by putting at risk one of our most at-risk populations – premature infants,” wrote Pitts, the founder of the nonprofit Center for Medicine in the Public Interest.

‘I would have made a different decision’

Watson said that she could not recall anyone talking to her about an elevated risk of NEC before her two sons were transitioned to formula and transferred to the hospital that did not use any donor breast milk.

“If I had known the risk of giving my children this formula, absolutely, I would have made a different decision,” she said. “I don’t want any other parents to ever have to go through that. I want them to know that you can ask questions. Make sure you understand.”

Two months after the conclusion of Watson’s case, Mead Johnson filed a motion for a new trial, arguing that the judge erred by precluding the company from presenting evidence of potential contributing causes of Chance Dean’s death, including an alleged accidental laceration or abrasion of his liver during the second of his three surgeries. The company also contends the jury instructions “erased the important role of physicians in making decisions for premature infants in the neonatal intensive care unit.”

Watson’s attorneys argue in response that the company’s motion is “unfounded, and should be quickly denied so Mead Johnson can be finally held accountable for its actions, and so Chance Dean’s family can finally get the justice and closure they deserve,” according to court records.

“Despite the lengthy adversarial process and the resulting lawful jury instructions, Mead Johnson wants to lay blame for the jury’s verdict at the feet of this Court and not its own negligence or its own failure to warn,” Watson’s lawyers wrote.

The court has set a hearing on Mead Johnson’s post-trial motion for later this month.

Meanwhile, the first NEC case against Abbott is scheduled to go to trial on Monday, with the plaintiff, Margo Gill, alleging that her daughter suffered long-term health consequences from NEC, which she blames on the company’s preterm infant formula. Abbott has denied the allegations.

“These cases seek to advance a theory promoted by plaintiffs’ lawyers that has no basis in science and is not supported by the medical community. The allegations are without merit,” said Scott Stoffel, a vice president of public affairs for the company.

Copyright © 2024, ABC Audio. All rights reserved.

The effect of weight loss drugs on muscle mass

bymuratdeniz/Getty Images

(NEW YORK) — Prescription drugs like Ozempic, Wegovy, Mounjaro and Zepbound have grown in popularity among patients looking to lose weight. But could they also affect someone’s muscle mass?

ABC News’ Becky Worley appeared on Good Morning America Thursday to discuss what effects these drugs may have on muscle mass:

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Arizona abortion rights group submits signatures needed for ballot measure

Rebecca Noble/Getty Images

(PHOENIX) — An Arizona abortion rights group turned in a petition on Wednesday morning for a ballot measure that would enshrine the right to an abortion in the state’s constitution.

Arizona for Abortion Access, the organization behind the petition, said it collected 823,685 voter signatures — more than double the 383,923 signatures required from registered voters to qualify for the November 2024 election.

The proposed amendment, which is being called the “Arizona Abortion Access Act,” would allow abortions up until fetal viability, usually around 24 to 26 weeks gestation, with exceptions after that period “if a treating healthcare provider determines an abortion is needed to protect the life or physical or mental health of the patient.”

During a press conference Wednesday morning at the Arizona State Capitol, Dawn Penich, the ballot committee’s spokesperson, said it is the “most signatures ever submitted” by a citizen-led ballot initiative.

“To put that into context, that means one out of every five Arizona voters signed this petition,” she said.

County officials will have until late August to verify if there are enough valid signatures on the petition, which is then certified by the Arizona secretary of state’s office.

If the petition is approved, Arizona will join four other states — Colorado, Florida, Maryland and Nevada — that have a measure on the ballot to establish the right to an abortion in the state’s constitution.

Since the Supreme Court overturned Roe v. Wade, four states — California, Michigan, Ohio and Vermont — voted to enshrine abortion rights in their constitutions.

Meanwhile, Kansas voters rejected a measure to remove the right to an abortion from its state constitution while voters in Kentucky and Montana voted against further restricting rights to abortion services.

On the national level, President Joe Biden has vowed to defend women’s reproductive rights and fight for legal access to abortion.

Arizona for Abortion Access did not immediately return ABC News’ request for comment.

Earlier this year, the Arizona Supreme Court reinstated an 1864 near-total abortion ban, which was set to go into effect on Sept. 27.

Lawmakers, however, quickly passed a bill repealing the long dormant ban, which was signed by Gov. Katie Hobbs. The repeal takes effect on Sept. 14, which is 90 days after the end of the legislative sessions, meaning the Civil War-era ban will not go into effect.

Instead, Arizona will keep its current laws in place, which ban abortion at 15 weeks gestation or later. Women are required to make two trips 24 hours apart, one for an in-person consultation and another for the procedure.

Additionally, women must receive an ultrasound even if medically unnecessary and receive a medication abortion in person because state laws ban the use of telehealth.

Dr. Paul Isaacson, an OB/GYN who has practiced abortion care in Arizona for the last 20 years, called the current law “unacceptable” during Wednesday’s news conference.

“Fifteen weeks is a completely arbitrary point that doesn’t relate to any specific milestone in fetal development,” Isaacson said. “Many of the medical complications that can lead to the need for an abortion don’t occur or might not be discovered before 15 weeks.”

He added, “Current Arizona law puts health care professionals and patients in countless unacceptable and dangerous situations. Current law makes no exception for rape, for incest or countless health complications.”

ABC News’ Irving Last and Michael Pappano contributed to this report.

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4th human case of bird flu linked to dairy cow outbreak: CDC

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(ATLANTA) — The fourth human case of bird flu linked to the current dairy cow outbreak was confirmed on Wednesday in a dairy worker in Colorado, according to the Centers for Disease Control and Prevention.

Previously, one human case had been reported in Texas and two human cases reported in Michigan.

As with the previous cases, the patient is a dairy farm worker who came into contact with cows that tested positive for the H5N1 strain of bird flu, or avian influenza.

The worker was previously being monitored because of their exposure to infected cattle and reported symptoms to state health officials.

Testing results were inconclusive at the state level, but specimens forwarded to the CDC for additional testing were positive for influenza A, the federal health agency said.

The patient reported eye symptoms only. They received treatment with oseltamivir, an antiviral drug used to treat influenza, and has since recovered.

This is a developing story. Please check back for updates.

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What to know as clinical trial begins for ‘next generation’ nasal COVID-19 vaccine

NIAID Integrated Research Facility

(NEW YORK) — The first phase of human trials studying a possible nasal COVID-19 vaccine has opened, the National Institutes of Health (NIH) announced.

The clinical trial, sponsored by the federal health agency, is enrolling participants at three sites across the U.S.

Researchers believe the vaccine candidate may provide even better protection against emerging variants than the COVID vaccines given via injection.

“The concept is that we’re looking for next generation vaccines,” said Dr. John Brownstein, an epidemiologist and chief innovation officer at Boston Children’s Hospital and an ABC News contributor. “Throughout the pandemic, we had the incredible scientific breakthrough of COVID vaccines that happened, that got into production incredibly quickly and were safe and effective. But of course, we also recognize that there are challenges of the existing vaccines.”

Here’s what you need to know about the nasal COVID-19 vaccine clinical trial now underway:

What is the new vaccine candidate?

The candidate, MPV/S-2P, uses a live-weakened version of a virus called murine pneumonia virus (MPV), which does not cause disease in humans.

MPV will deliver a stabilized version of the spike protein, which the SARS-CoV-2 virus, that causes COVID-19, uses to attach and infect human cells. This will teach the body to recognize the protein and train immune cells to attack if a person is infected.

Pre-clinical trials in non-human primates found MPV/S-2P to be safe and well-tolerated and that it produced a robust immune response, both in SARS-CoV-2 antibodies and in the epithelial cells that line the nose and respiratory tract.

“Viruses like SARS-CoV-2 come into the body through the nose, into the lungs and then gets integrated into our bloodstream and disseminated through the body,” Dr. Reynold Panettieri, a professor of medicine at the Robert Wood Johnson Medical School at Rutgers University, told ABC News.

“What we realized is that systemic vaccination — when we inject it and it goes through the body to build up immunity — is not as effective as generating a mucosal, or lining cell, immunity in the nose or in the lungs,” he said. “And so, when people can inhale the protein, in this case, the spike protein … it actually builds up an immune response that’s much more robust than that when it is injected.”

Challenges with the current vaccine

In December 2021, the U.S. Food and Drug Administration (FDA) authorized two new messenger RNA (mRNA) COVID-19 vaccines, from Pfizer-BioNTech and from Moderna, to target the original variant.

While most vaccines use a weakened or inactivated virus to stimulate an immune response, mRNA vaccines teach the body how to make proteins that can trigger an immune response and fight off an infection.

Because researchers can design mRNA vaccines more quickly than they can produce the live or weakened pathogens needed for a traditional vaccine, mRNA vaccines against COVID-19 were quickly developed, tested, mass produced and delivered to the general population, preventing millions of hospitalizations and deaths, according to analyses.

Both have been updated over time to target new variants including in September 2022 to target both the original variant and BA.4 and BA.5 – offshoots of the omicron variant — and in September 2023 to target the XBB offshoot of the omicron variant. Only the latter is currently in use.

“The current vaccines have diminished efficacy over time,” Brownstein said. “These vaccines were highly protective against severe COVID hospitalizations and deaths, [but] it wasn’t as effective at slowing cases and preventing transmission.”

Additionally, mRNA vaccines require a multi-step process to manufacture as well as ultra-cold storage, which can present logistical challenges. Further, some people may not want to receive mRNA vaccines because they are averse to needles.

“Nasal spray is often more often more accepted by a population, so if it’s a less concerning mode of delivery, plus it offers better protection, plus it offers potentially better storage and distribution potential, it highlights that this could be a really important new step in controlling this virus,” Brownstein said.

How will the trial work?

The clinical trial will enroll 60 healthy adult participants between ages 18 and 64 who received at least three doses of an MRNA COVID-19 vaccine approved or authorized by the FDA.

There will be several trial sites including at Baylor College of Medicine in Houston Texas; The Hope Clinic of Emory University in Decatur, Georgia; and New York University Grossman Long Island School of Medicine in Long Island.

Participants will be split into three groups, each receiving different dosages. Researchers will follow-up with the volunteers seven times over the course of a year and measure if the vaccine is safe and if it produces an immune response in the nose and in the blood.

Because clinical trials take time to produce data and require at least three phases before being submitted for FDA authorization, experts say it’s unlikely these vaccines will be available in fall 2024.

“Early in the pandemic, we were moving quicker than usual to get a get a vaccine out there,” Panettieri said. “Not that any steps were skipped, but we needed to save lives.”

Because a COVID-19 infection now results in mild symptoms for most healthy people, “we do have time to actually go through the typical process the FDA takes to approve a new therapy,” he added. “That is going to help everyone. It’s going to be making sure it’s safe and effective.”

Dr. John Beigel, associate director for clinical research in the National Institute of Allergy and Infectious Diseases’ (NIAID) division of microbiology and infectious diseases, told ABC News that MPV/S-2P falls under Project NextGen.

The project, led by the Biomedical Advanced Research and Development Authority (BARDA) and the NIAID, plans to support 15 next generation vaccines into Phase 1 clinical trials, of which MPV/S-2P is the first.

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Top migraine medication effective for preventing migraines, treating drug-induced headaches is hard to access

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(NEW YORK) — A new study shows that FDA-approved oral migraine drug atogepant is effective for relieving difficult-to-treat “medication overuse headaches” that are the result of using too much of other pain relieving medications. However, patients often have to jump through hoops to get it covered by their insurance company.

Migraines affect nearly one in eight adults in the U.S. Migraines are also the leading cause of disability in adults under 50 years of age in the United States. This high number underscores the need for better treatments for people with migraines.

Atogepant, marketed under the brand Qulipta by the company AbbVie, is part of a new class of migraine medications known as CGRP inhibitors, so named because they block a protein called calcitonin gene-related peptide (CGRP), which has been found to be a cause of migraines.

Qulipta is one of only two FDA-approved CGRP inhibitors taken as a pill for the prevention of migraine headaches, the other being rimegepant, marketed as Nurtec by Pfizer. All other drugs in this class used for migraine prevention are injectables.

The American Headache Society’s (AHS) recently released a position statement that says that CGRP inhibitors should be the first treatment a doctor prescribes for migraines. But insurance companies often require patients to go through a process known as “step therapy” where they have to try less expensive interventions before they can get access to Qulipta or one of the other CGRP inhibitors.

“CGRP-targeting therapies, unlike most other migraine treatments that were ‘borrowed’ from other indications like antidepressants, blood pressure medications or seizure medications, were developed specifically to treat migraines based upon a solid foundation of evidence,” according to Dr. Andrew Charles, professor of Neurology at UCLA and lead author of the American Headache Society’s position statement.

Step therapy requires patients to try a series of cheaper drugs first, even if they are less efficient and cause more side effects, before they are approved to receive one of the newer treatments. The goal of step therapy is to control costs, but it can also end up delaying proper treatment and patients often find it frustrating and time-consuming because they must needlessly go through several medications before they can get ones that work.

“Step therapy, or fail first requirement, is a no-win situation for people like me living with migraines. For me, using medications that were known to be less effective delayed necessary treatment, and led to worsening disability and chronification of my migraine disease,” says Nancy Harris Bonk, a migraine patient and advocate.

Congress has proposed a bill potentially banning step therapy when it is unsafe, which its often the case for migraine patients.

“It is no surprise that medication costs are a barrier for patients to access these treatments despite this position paper, and a major goal for all of us is to reduce drug costs for patients and the system,” Dr. Matthew Robbins, associate professor of neurology at Weill Cornell and president-elect of the AHS, told ABC News. “However, our primary goal is always to get the right treatments to the right patients, so we are hopeful that the position statement will move along insurance companies, pharmacy benefit managers, and other systems of care to improve access in addition to cost reductions for these medications.”

For example, AbbVie offers a program to help with the expense of the Qulipta by providing a savings card and patient assistance program that can reduce out-of-pocket costs for eligible patients, including those on Medicare and Medicaid.

Pfizer, the makers of Nurtec, offer a similar savings and assistance program but only for those on private insurance plans. People on Medicare and other government-funded insurance may wind up paying high out-of-pocket costs.

“Many patients and healthcare providers are not aware of the patient assistance program offered by Abbvie or other companies. Additionally, pharmacies often do not accept co-pay cards or coupons offered by the manufacturer, which leaves many patients without access to necessary medications,” said Dr. Hida Nierenburg, a board-certified neurologist and headache specialist at Nuvance Health.

“Although they are expensive, some insurers are now acknowledging that the overwhelming evidence supporting their efficacy, tolerability, and safety warrants consideration as a first line treatment for the prevention of migraine” says, Dr. Charles.

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High levels of bacteria in water lead to multiple beach closures across the US

CDC

(NEW YORK) — Beaches in several states across the country have been closed to swimmers over the last few days due to harmful levels of bacteria in the water.

In Massachusetts, at least 37 beaches were closed as of Monday afternoon due to “bacterial exceedance,” according to the state’s Department of Public Health (MDPH). Many of the beaches tested positive for high levels of a type of fecal bacteria, and beachgoers were warned not to swim or enter the water in those locations to avoid risk of illness, according to the health agency.

Additionally, at least three beaches in Coronado, California – located on a peninsula in San Diego Bay – have been closed since June 26 because “[b]acteria levels exceed health standards.” San Diego County’s Department of Environmental Health and Quality said such closures are usually due to sewage or chemical spills.

Further, New York’s Suffolk County last week issued an advisory against bathing at 63 beaches due to increased bacteria levels caused by heavy rainfall and stormwater runoff.

Although health officials did not elaborate on what types of bacteria were found in California or New York, officials in Massachusetts identified the bacteria as enterococci. The bacteria are typically found in the intestinal tracts of warm-blooded animals, including humans, according to the U.S. Environmental Protection Agency (EPA), and may “indicate possible contamination of streams and rivers by fecal waste.”

Enterococci bacteria commonly cause urinary tract infections, and can also cause blood infections and endocarditis, an inflammation of the lining of the heart’s values and chambers, according to the National Institutes of Health.

Heavy rains after long periods of drought can pick up animal or human excrement, which can then be carried by runoff into nearby bodies of water, including oceans. Heavy rains can also cause sewage systems to overflow, causing untreated sewage to likewise contaminate bodies of water.

Additionally, two beaches in Massachusetts were closed due to high levels of cyanobacteria, according to the MDPH. Often referred to as blue-green algae, cyanobacteria are often found in freshwater but can appear in saltwater or brackish water, according to the Centers for Disease Control and Prevention (CDC) . The bacteria itself doesn’t infect humans but can produce toxins that make people sick.

Ingestion of water that contains cyanobacteria can cause symptoms including headaches, stomach pain, dizziness, vomiting, and diarrhea. It can also cause irritation of the skin, eyes, nose, throat and lungs.

Cyanobacteria can multiply quickly in warm waters that become rich in nutrients, including from fertilizers and septic tank overflows, the CDC said.

Four beaches in Michigan also were closed on Monday due to high levels of Escherichia coli (E. coli), bacteria, according to the Michigan Department of Environment, Great Lakes and Energy.

E. coli is another bacterium that lives in the intestinal tract of warm-blooded animals. Most types of E. coli are harmless, but many strains can cause severe illness, including diarrhea, stomach cramps and vomiting, according to the CDC.

The CDC recommends staying out of bodies of water – including oceans, lakes and rivers – if the water looks cloudier than usual, is discolored, or smells bad. Swimmers are also cautioned to stay out of the water if they see pipes draining into or around the water, of if they themselves have diarrhea.

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Fermented hair care hits shampoo aisle: What to know and is it worth the hype?

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(NEW YORK) — Since the pandemic, concerns over personal health have been at the forefront of consumers’ minds. One of the concerns that took flight was gut health and the microbiome, with a rise in sales for products like probiotics, greens powder, and digestive sodas (like Poppi and Olipop).

But conversations around microbiome health aren’t exclusive to just the gut. The same interest has moved into beauty, with brands touting the importance of maintaining a healthy skin microbiome to prevent premature aging and acne. The Rootist, a new hair-care line launched in April, is introducing fermented ingredients as the next wave of innovation in the shampoo aisle with promises of “anchored, active roots, a hydrated, balanced scalp, and strong, healthy hair.”

Clare Hennigan, principal analyst – Beauty & Personal Care at Mintel, says these brands have already piqued consumer interest.

“In hair care from 2022 to 2023, the number of products that feature microbiome in the product description have actually increased 52.3%,” Hennigan told ABC News. “We really see, especially in hair care, the momentum stirring and the demand growing for microbiome hair care solutions.”

But what are these fermented ingredients, how do brands claim they work and are they worth the hype?

What are fermented ingredients and how can they help maintain and balance the microbiome?

Very simply put, fermented ingredients are bacteria, says Dr. Mona Gohara, MD, a board-certified dermatologist and associate clinical professor at Yale School of Medicine.

“If you leave something out long enough, things kind of grow out of it. One of the things that grows is bacteria,” Gohara told ABC News.

Not all bacteria are bad, however, think of yogurt and kombucha for instance, which are made through fermentation.

The Rootist says that it’s this fermenting process that makes their products “easily recognized and received by roots, scalp, and hair.” Just like skin and the gut, the scalp has its own bacteria and types of fungi which together create its microbiome. According to Gohara, the presumption here is that the fermented ingredients in products like that of The Rootist help feed the bacteria on our scalps which in turn supports the health of our pre-existing scalp microbiome.

And maintaining a balanced scalp microbiome is crucial to keeping hair healthy, says Dr. Jeannette Graf, MD, a board-certified dermatologist and assistant clinical professor of dermatology at the Mount Sinai School of Medicine. Conditions like dandruff or acne can be influenced by the microbiome.

“If we have an imbalance of our microbiome or a microbiome is not working correctly, we need to create an environment on the skin of the scalp, on the skin of face, where they can exist,” Graf told ABC News.

“Think of it like a garden, and the soil is the scalp. If the soil is healthy, the plants and the flowers are going to blossom,” explained Gohara. “If the scalp is compromised or inflamed or irritated, it’s less healthy soil, right? And that, and then leads to less healthy, bountiful garden.”

Are they worth the hype?

While in theory fermented hair care ingredients may be beneficial to the scalp microbiome, the bottom line is that there is that there’s still more research that needs to be done.

“Within the personal care industry – there are many new ingredient technologies being developed,” Graf said. “So studies are done by these biotech companies- and good ones. But that is where most of the research and literature is published.”

“It’s safe to say that at a minimum, the product will support a healthy scalp microbiome,” Gohara added, who draws a line at claiming these products will lead to increased hair growth. “It means that in me, whatever my biological potential as a 48-year-old woman at this point, if I use this, it’ll make my hair grow as optimally as it would biologically at this point.”

And while experts say there is still research to be done, Hennigan says the industry is all in on fermented hair.

“This signals broader industry trends overall, where we’ll see how we can really personalize our products specific to even perhaps our own personal microbiomes, to better target and pinpoint our specific needs,” Hennigan said.

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LGBTQ people say their mental health is positively impacted when states have protective laws

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(NEW YORK) — Growing up in the 1990s and early 2000s just outside of Akron, Ohio, Shane Stahl felt it was taboo to talk about being part of the LGBTQ+ community or about LGBTQ+ experiences.

Stahl, 40, who identifies as a gay man, said that although he grew up in an accepting and supporting family, he didn’t feel like it was possible to openly express himself and feared he would be ostracized from his community if he did so.

As lawmakers in Ohio began to introduce — and sometimes pass — more anti-LGBTQ+ legislation, at both the local and the state level, Stahl said it took a toll on his mental health.

“It made me want to leave if I could,” he told ABC News. “It makes you feel very isolated, and I don’t know that this is everybody’s experience, but my experience always kind of was like, ‘Well, what does that person think about me? Do they have an inclination that maybe I’m gay? And if they do, are they going to treat me any differently? Are they going to say something to somebody that can have an effect on my job or my ability to rent an apartment or get a car, or any of those things that we all need to do to survive?’ So, yeah, it was definitely very isolating and scary.”

About a year-and-a-half ago, Stahl got a new job for Equality California — a nonprofit civil rights organization advocating for LGBTQ+ Californians — and moved to West Hollywood. He said being able to live in an accepting community made him feel welcome and improved his mental health.

Seeing the increase in anti-LGBTQ+ legislation “definitely was part of the motivation to leave Ohio and come to a place where I knew that there were strong laws on the books, that I knew I would be protected as a gay person,” he said. “Coming from a very suburban northeastern Ohio experience, it feels there’s a sense of peace I have now about my life that I didn’t necessarily have before.”

While anti-LGBTQ+ legislation can have a harmful effect on mental health, experts and LGBTQ+ rights advocates say legislation that strengthens protections for LGBTQ+ people can do just the opposite as well as bring a sense of acceptance and belonging.

LGBTQ+ people at higher risk of mental health struggles

Research has shown that LGBTQ+ people are more likely to experience mental health struggles than those who are heterosexual or cisgender.

LGBTQ+ individuals are 2.5 times more likely to have depression and anxiety or to misuse substances compared with heterosexual individuals, according to the American Psychiatric Association.

Additionally, LGBTQ+ youth are at increased risk of suicidal thoughts and ideations as well as attempted suicide.

However, experts say there is nothing that intrinsically puts LGBTQ+ people at higher risk of mental health challenges or suicide, and that it’s largely brought on by stigma, biases and discrimination.

“LGBTQ people are not at higher risk for suicide or other mental health challenges because of anything inherent in who we are. It’s about how we’re treated,” Casey Pick, director of law and policy for the Trevor Project, a nonprofit focusing on suicide prevention efforts among LGBTQ+ youth.

These biases and discrimination can take shape as anti-LGBTQ+ legislation including forced outing in schools, school sports bans, banning gender-affirming care for minors, criminalizing drag performances, book bans and limiting the ability of LGBTQ+ people to foster or adopt children.

In 2023, a FiveThirtyEight analysis found more than 100 anti-LGBTQ+ laws have passed in the last five years with more than half of them passing last year.

More than 500 anti-LGBTQ+ bills have been introduced throughout the 2024 legislative session, according to the American Civil Liberties Union (ACLU). Such policies can have a negative impact on mental health.

Pick, who identifies as lesbian, said she remembers when the U.S. was debating marriage equality. In California, in 2008, lawmakers were debating Proposition 8, which was a ballot measure that would have added a state constitutional amendment banning same-sex marriage.

“I remember being in my early 20s when California was actively debating Proposition 8, and so the constant onslaught of negative ads that would portray people like me, gay people, just trying to have a family as being a threat to children, a threat to family was just a constant negative grind on my mental health,” she said.

As anti-LGBTQ+ laws and policies have been enacted, many people — and some in cases their families — have left their home states to move to more protective states.

“Nobody should feel that they can’t live and call the place they want to call home because of who they are or who they love,” Stahl said. “The goal should not be to relocate these people; the goal should be let’s make their communities inclusive and welcoming.”

Pro-LGBTQ+ legislation positive for mental health

While more research is needed to better understand the full effects that protective legislation can have for LGBTQ+ people, studies have shown pro-LGBTQ+ legislation can have a positive impact on mental health.

One 2018 study found that sexual minority men were more likely to report poor/fair health in states with limited protections compared with heterosexual counterparts. But in this study protective state laws made no difference among sexual minority women who were more likely to report poor/fair self-rated health compared to their heterosexual counterparts in states with both comprehensive and limited protections.

A 2016 study of transgender veterans found those living in states with employment nondiscrimination protections were 26% less likely to have mood disorders and 43% less likely to practice self-harm.

“We know that living in a community that is safe, affirming and accepting of who you are, directly correlates to lower rates of suicide to better mental health outcomes,” Pick said. “That looks like safe schools; that looks like access to necessary health care; that looks like just basic equality in day-to-day life.”

Pick said she was heartened when the conversation around same-sex marriage in the U.S. started shifting in a positive direction.

She contrasted her feelings in 2008 “to just how good it felt, when we started seeing in 2012, those ballot measures going the other way. It was still exhausting to be part of a political campaign that I didn’t ask for, but on the days that we saw that we won those elections, that people were accepting us, that were welcoming LGBTQ people in the community, that made a difference.”

Stahl said he often jokes that moving to a state like California, with its wider slate of LGBTQ+ protections, felt “like a different planet.”

“I walk around my city, and I see businesses that have gay pride flags and pride flags in their windows,” he said. “I see people catering specifically to the LGBTQ+ community; I see a wealth of resources; I see a local and a state government that wants the best for me in my community and is actively working to improve the quality of our lives and let us know that we are welcome and we belong.”

Pick and Stahl recommend that people contact their state lawmakers to push back against anti-LGBTQ+ legislation and advocate for protective legislation.

They add that it is also important to create safe, accepting and supportive communities for LGBTQ+ people.

“Something as simple as be the house where not just your child, but maybe your child’s LGBTQ friends can come over feel safe, get cookies after school, be the place where they know that they can just let down and relax and where they won’t be confronted with the kind of hostility that is all too common out there today,” Pick said.

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