Health

New study raises questions about tampon safety for women

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(NEW YORK) — A new study that detected variable levels of heavy metals, including lead, in tampons currently on the market is being reviewed by the U.S. Food and Drug Administration, a spokesperson for the agency told ABC News.

The study published in Environmental International by researchers at the University of California, Berkeley, evaluated the levels of 16 types of metals, including lead as well as mercury, arsenic and iron, in 30 tampons from 14 different brands obtained in the U.S., Greece and England.

Differing levels of metals were found on materials of all 30 tampons, which included both organic and non-organic brands, according to the study, published July 3.

The study’s authors noted that it is not clear whether the metal levels found in the tampons would contribute any negative health effects to users but called for more research to be done.

“Despite this large potential for public health concern, very little research has been done to measure chemicals in tampons,” the study’s lead author, Jenni A. Shearston, a postdoctoral scholar at the UC Berkeley School of Public Health and UC Berkeley’s Department of Environmental Science, Policy, & Management, said in a statement. “To our knowledge, this is the first paper to measure metals in tampons.”

Shearston added, “I really hope that manufacturers are required to test their products for metals, especially for toxic metals. It would be exciting to see the public call for this, or to ask for better labeling on tampons and other menstrual products.”

The FDA noted in a statement that the study has “limitations” but said the agency is reviewing its findings.

“The FDA is reviewing the study. All studies have limitations. While the chemical method used indicates these metals are present in the tampons tested in the laboratory, the study does not assess whether any metals are released from tampons when used in the body,” the agency said in a statement Tuesday. “It also does not address whether any metal, if released, can be absorbed into the vaginal lining or, subsequently into the bloodstream.”

The statement continued, “We plan to evaluate the study closely, and take any action warranted to safeguard the health of consumers who use these products.”

In their findings, the study’s authors acknowledged that the types of metals detected are commonly found in the environment and could come in contact with tampon materials in a variety of ways. Possibilities include through water, air or soil, by nearby contamination or during the manufacturing process but more research is needed to understand exactly how this is happening.

Experts say it is important to note that the study only measured the levels of metals in materials of the tampons. It did not measure any levels of these metals in the blood to correlate with human health.

Dr. Stephanie Widmer, an emergency medicine physician and medical toxicologist, echoed the study’s authors in saying more research needs to be done.

“We have no understanding of the absorption, if there is any, or if this has any impact on human health,” Widmer, who was not involved with the study, told ABC News. “More research needs to be done and this study fails to provide any evidence that women who use tampons are walking around with higher than normal, or even higher levels of heavy metals in their blood than women who do not use tampons.”

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Health

Colorado public health officials confirm human plague case in the state

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(NEW YORK) — Colorado public health officials have confirmed a human case of plague in a Pueblo County resident, according to the Pueblo Department of Public Health and Environment.

Plague is very rare, with an average of seven human plague cases reported annually in the U.S., according to the Centers for Disease Control and Prevention.

While the disease killed millions of people in Europe during the Middle Ages, nowadays, it is a rare cause of illness in rural areas of the southwestern U.S., particularly in New Mexico, Arizona and Colorado, the agency said.

Certain regions of Africa and Asia have also reported cases over the past few years.

A potentially life-threatening disease, plague is caused by the bacterium Yersinia pestis. It is usually passed to humans through the bite of an infected rodent flea or by handling an infected animal, according to the Pueblo Department of Public Health.

Symptoms can include sudden fever, chills, severe headache, muscle aches, swollen lymph nodes, nausea and vomiting, per the CDC.

Plague can be cured with antibiotics, but they must be administered promptly to prevent serious illness or death.

Health officials urged anyone who develops symptoms of plague to seek medical care immediately.

In order to avoid infection, health officials suggest people take precautions, including avoiding contact with dead animals, regularly treating pets for fleas and eliminating places in and around the home where rodents can breed.

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Health

Where COVID cases are increasing in the US amid summer ‘bump’

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(NEW YORK) — COVID-19 cases are rising in several regions of the United States as summer gets underway.

For the week ending June 29, the latest date for which data is available, COVID test positivity was 9% across the U.S., an increase of 0.8% from the previous week, according to data from the Centers for Disease Control and Prevention. This is higher than levels seen during early May 2024 but lower than several points during the pandemic.

Test positivity was highest in the Southwest and western U.S. with 15.7% positivity in the region comprised of Arizona, California and Nevada, CDC data showed.

Additionally, wastewater data from the CDC shows that COVID viral activity is low nationally but has been steadily rising over the last month-and-a-half. For the week ending June 22, levels were classified as “high” in the West and “moderate” in the South.

Wastewater tracking is often used as an early detection tool for monitoring potential future upticks, although it can be inconsistent.

Dr. William Schaffner, a professor of preventive medicine at Vanderbilt University Medical Center, said the country has traditionally seen increases in COVID every summer, so a “bump” at this point in the year was to be expected, as experts had predicted.

“We had anticipated that there would be something of a summer bump because we have seen that in the past … COVID hangs around during the summer and even gets a little more active, unlike influenza, which virtually disappears during the summertime,” he told ABC News. “Now this bump will go down, and then, of course, we’ll get the conventional winter surge later.”

Weekly hospitalizations are still near record lows but have been ticking up over the past few weeks, according to CDC data. The highest rates are among those aged 65 and older with a rate of 7.7 per 100,000 for the week ending June 15, the latest date for which data is complete.

Comparatively, adults between ages 18 to 49 and children aged 4 and under have a rate of 0.5 per 100,000, the data showed.

Schaffner said the groups making up hospitalizations are those with chronic illnesses — such as heart disease or lung disease — or those who are immunocompromised.

“Particularly older people … with chronic illnesses, the immune-compromised, particularly if they are not up to date in their vaccination, that’s the population we see now contributing to that bump in hospitalizations,” he said.

Meanwhile, deaths have been steadily dropping since January of this year and continue to remain low, CDC data indicate. For the week ending June 8 — the latest date for which complete data is available because deaths are subject to reporting delays — just 283 COVID deaths were reported, which is a record low.

Currently, KP.2 and KP.3, offshoots of the omicron variant, are the dominant COVID-19 variants in the U.S. making up nearly half of all cases.

CDC officials told ABC News in a statement on Monday that there is “no evidence that KP.2, KP.3, or any other recent variant, causes more severe disease.”

The CDC added that it is tracking all variants and recommended vaccination as the most effective way to prevent severe illness from COVID-19.

Schaffner agreed that the best way to prevent severe illness is to be up to date on vaccinations. High-risk groups that haven’t received a COVID-19 vaccine since last fall are currently eligible for another dose to carry them through the summer.

“Be sure this fall, when we have yet another updated vaccine, to get that vaccine along with your influenza vaccine,” he said. “We update both of them now on an annual basis, and that should be certainly a fall routine for all of us, but especially people in high-risk groups.”

He recommended those in high-risk groups, or people who will be around high-risk groups, to consider masking in indoor crowded areas, and — if they test positive — to receive early treatment with antiviral medication such as Paxlovid.

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Health

What’s better for weight loss, Mounjaro or Ozempic? New study provides answer

Jakub Porzycki/NurPhoto via Getty Images

(NEW YORK) — As the popularity of drugs used for weight loss continues to explode, a new study is shedding light on which drug is most effective for weight loss.

Mounjaro, a drug with the main active ingredient tirzepatide, was found to be more helpful in helping people lose weight and maintain their weight loss, according to a study published Monday in JAMA Internal Medicine.

Individuals taking Mounjaro were three times as likely to lose 15% or more of total body weight, 2.5 times as likely to experience 10% or more weight loss, and 1.8 times as likely to experience 5% or more weight loss compared to those taking semaglutide, the active ingredient found in Ozempic.

This finding was sustained at 12 months of follow-up, according to the study, which analyzed more than 18,000 patients with obesity, both with and without Type 2 diabetes.

The study found that patients without diabetes lost more weight than patients with diabetes.

According to the study’s authors, more research is needed to understand why Mounjaro, with the active ingredient tirzepatide, was found to be more effective for weight loss.

Tirzepatide targets both the GLP 1 and the GIP receptor agonist, while semaglutide mimics only the GLP-1 receptor agonist, a type of hormone in the body that impacts everything from the brain to muscle to the pancreas, stomach and liver.

Both Ozempic and Mounjaro are approved by the U.S. Food and Drug Administration to treat Type 2 diabetes, but some doctors prescribe the medication “off-label” for weight loss, as is permissible by the FDA.

When these drugs are used “off-label,” it is usually not covered by insurance and can be costly, running as much as $1,000 per month.

There are also now two drugs on the market that are FDA-approved for weight loss — Wegovy, a medication that contains the same main ingredient, semaglutide, as Ozempic, and Zepbound, a medication that contains the same main ingredient, tirzepatide, as Mounjaro.

The drugs, typically taken once weekly as injections, work by helping the pancreas increase the production of insulin to move sugar from the blood into body tissues.

They also slow down the movement of food through the stomach and curb appetite, thereby causing weight loss.

Past clinical studies have shown users of the medications can lose between 5% and 20% of their body weight on the medications over time.

Medical specialists point out that using medication to lose weight also requires cardio and strength training and changing your diet to one that includes proteins and less processed foods with added sugars.

The most commonly reported side effects of medications used for weight loss are nausea and constipation, but gallbladder and pancreatic disease are also reported. Makers of these drugs recommend having a conversation about the side effect profile and personalized risks with a healthcare professional before starting.

Barbra Streisand publicly asks Melissa McCarthy about Ozempic, sparking debate on weight and shaming
The study found there was no difference in the number of adverse gastrointestinal effects between people with and without Type 2 diabetes in the study.

Prapti Chatterjee-Murphy, M.D., a member of the ABC News Medical Unit, contributed to this report.

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Health

Yale releases report critical of UK transgender youth care research study

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(NEW HAVEN, Conn.) — A new report released by Yale Law School and Yale School of Medicine criticizes the often-cited Cass Review on gender-affirming care for transgender youth, commissioned by the National Health Service (NHS) in the United Kingdom.

The review, released in April, was performed by Dr. Hillary Cass, a former president of the Royal College of Pediatrics and Child Health, amid a rise in referrals to NHS’ gender services. Her review – which calls for more research, more support, and more caution around gender-affirming care – has been cited in the NHS decision to restrict the prescribing of puberty-pausing medications, also known as puberty blockers, to children and young people under 18 years old in the U.K.

In the U.S., gender-affirming care remains a hot-button issue in the political and medical arenas. At least 25 states have enacted restrictions on care for transgender youth since 2022, according to the Human Rights Campaign.

The Cass review was cited in recent, successful legislative efforts in Indiana to uphold a 2023 law that prohibited physicians from providing “gender transition procedures” to anyone younger than 18 years old, with certain medical exceptions.

The Yale report – which states it was authored by a team of researchers and clinicians that has “86 years of experience working with 4,800 transgender youth,” and “has published 278 peer-reviewed studies, 168 of which are related to gender-affirming care” – takes issue with several aspects of the Cass Review in their critique, saying that it “obscures key findings, misrepresents its own data, and is rife with misapplications of the scientific method.” It also accuses the Review of speculating about data on transgender patients, and criticizes certain statements made in the Review about concern over gender care referrals, early medical intervention, and more.

Yet despite being cited in the NHS decision to restrict prescribing puberty blockers to minors, the Yale report notes that the Cass Review does not recommend a ban on trans youth care. It also notes that it consistently makes recommendations that are in line with international gender-affirming medical care guidelines by the World Professional Association for Transgender Health (WPATH) and the Endocrine Society, a professional medical organization that is “dedicated to providing the field of endocrinology with timely, evidence-based recommendations for clinical care and practice,” according to its website.

In response to an ABC News request for comment, the team that authored the Cass Review said in a statement that the research that “underpins” the Review’s findings “looked at 237 papers from 18 countries, providing information on a total of 113,269 children and adolescents,” and was subject to peer review.

“In making her recommendations, Dr. Cass had to rely on the currently available evidence and think about how the NHS can respond safely, effectively, and compassionately,” the Review team told ABC News.

The statement continued, “The body of research on gender care for children and young people was strikingly poor compared to other areas of child and adolescent healthcare where life changing interventions are given, meaning there is not a reliable evidence base upon which to make clinical decisions, or for children and their families to make informed choices.”

Spike in gender service referrals

The Cass Review repeatedly claims that the increase of referrals for gender-affirming care in the U.K. was “exponential,” and that social acceptance of transgender identities is unlikely to be the sole explanation for the rise.

“While it certainly seems to be the case that there is much greater acceptance of trans identities, particularly among younger generations, which may account for some of the increase in numbers, the exponential change in referrals over a particularly short five-year timeframe is very much faster than would be expected for normal evolution of acceptance of a minority group,” Cass states.

In their report, Yale researchers counter that the increase in referrals to the U.K.’s Gender Identity Service is not exponential, and points to Cass’s own data on referrals, which they say actually shows the number of referrals plateaued, and then decreased starting in 2017. A graph included in the Cass Review that shows a spike from 2021 to 2022 in child and adolescent referrals for gender dysphoria is accompanied by a note that states there is “a strong possibility that there was double counting” of referrals during the time period.

“While there certainly is an increase in referrals, describing this increase as ‘exponential’ is a serious error that fuels concern that the Review is too often more interested in subjective polemics than in scientific accuracy,” the Yale report says.

Research quality on gender-affirming care

The Cass Review also criticized the evidence supporting the need for gender-affirming care. It concluded that “while a considerable amount of research has been published in this field, systematic evidence reviews demonstrated the poor quality of the published studies, meaning there is not a reliable evidence base upon which to make clinical decisions, or for children and their families to make informed choices.”

Yale experts counter in their report that the Cass Review’s “recommendations are informed by a flawed concept of evidence.” It says the Review “fails to recognize the nuances of evidence quality measures”; that it “does not follow established standards for evaluating evidence and evidence quality”; that it “casually discusses evidence quality and does not define it, contravening standard practice in scientific evaluations of medical research”; and that it “fails to contextualize the evidence for gender-affirming care with the evidence base for other areas of pediatric medicine.”

“If high-quality evidence were a prerequisite for medical care, we would all be worse off,” the Yale report further states. “Moderate, low, and very low-quality evidence,” as defined by what the report says is “one of the most widely accepted frameworks for determining evidence quality,” and “informs necessary, high-value care at every stage of life.”

The Cass Review team states in an online FAQ that “the approach to the assessment of study quality was the same as would be applied to other areas of clinical practice – the bar was not set higher for this Review.”

A subsequent clarification in the FAQ further states: “The same level of rigor should be expected when looking at the best treatment approaches for this population as for any other population so as not to perpetuate the disadvantaged position this group have been placed in when looking for information on treatment options.”

Early intervention concerns

The Yale report also takes issue with what it calls “unfounded speculation” in the Cass Review that “social transition and puberty-pausing medications may cause harm by putting youth onto a medical path.” It further notes instances in which they assert the Cass Review “expresses concern that early supportive interventions, such as social transition and puberty-pausing medications, lock young people into irreversible care.”

For example, while stating that for some young patients, the “best outcome” will be gender transitioning, the Review also argues that “those who had socially transitioned at an earlier age and/or prior to being seen in clinic were more likely to proceed to a medical pathway,” and that “the vast majority of people started on puberty blockers proceed from puberty blockers to masculinizing/feminizing hormones” – an “altered trajectory, culminating in medical intervention which will have life-long implications.”

The Cass Review also cautions that young people who transition before they experience life as the gender with which they do not identify “may have no frame of reference to cause them to regret or detransition, but at the same time they may have had a different outcome without medical intervention and would not have needed to take life-long hormones.”

“It is completely unscientific and inappropriate to expect a young person, regardless of their gender identity, to ‘try out’ life as a gender they do not identify with – as the Review supposes transgender youth should,” the Yale report states. It further says that “The Review’s own data show that most referred patients are never subsequently referred to pediatric endocrinology and even fewer receive medical interventions.”

The Yale report argues that continuing care isn’t necessarily cause for alarm or concern, and that “The Review does not consider the most likely explanation for why most youth who receive early, supportive interventions continue onto gender-affirming hormone therapy: that they are indeed transgender.”

“It is not social transition and puberty-pausing medications that drive a persistent transgender identity,” the Yale report asserts. “It is a transgender identity that drives social transition and subsequent medical interventions.”

Detransitioning and regret

The Cass Review asserts that “the percentage of people treated with hormones who subsequently detransition remains unknown due to the lack of long-term follow-up studies, although there is suggestion that numbers are increasing.”

However, in the Review’s audit of 3,306 patients who were discharged from the U.K. Gender Identity Service (GIDS), fewer than 10 patients transitioned back to their birth-registered gender – which Yale researchers note is “a ‘detransition’ date of 0.3%.”

The Yale report also states that it is “exceedingly rare that an individual would later determine that they are not transgender” after receiving clinical transgender care and support. “A person who regrets receiving care may continue to identify as transgender; another who stops medications may not experience regret, and one who stops identifying as transgender may not regret receiving medical care,” the report says.

A report in JAMA Pediatrics noted by the Yale report found that 1% of youth who received gender-affirming medications in the study re-identified with their assigned sex at birth.

In another study noted in the Yale report, this one in the LGBT Health journal, 82.5% of those surveyed “reported familial pressure, social pressure, employment difficulty, inability to access care, and financial reasons” as the reason they presented themselves as their sex assigned at birth.

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Health

What to know about new study showing weight loss drugs can lower cancer risk

In this photo illustration, boxes of the diabetes drug Ozempic rest on a pharmacy counter on April 17, 2023 in Los Angeles. (Mario Tama/Getty Images, FILE)

(NEW YORK) — GLP-1 medications such as Ozempic and Wegovy have exploded in popularity for their weight loss benefits and now new research is showing the medications may help with another condition, cancer.

People with Type 2 diabetes who were treated with GLP-1 medications were found to be less likely to be diagnosed with obesity-associated cancers than people treated with insulin or metformin, according to a new study published July 5 in the medical journal JAMA Network Open.

Here are four questions answered about what the study’s findings mean for the future of obesity, cancer and GLP-1 medications:

1. What types of cancer did the GLP-1 medications affect in the study?

The study, which analyzed over one decade of data from more than 1.5 million patients with Type 2 diabetes, looked at 13 types of cancer associated with obesity, including esophageal, breast, colorectal, endometrial, gallbladder, stomach, kidney, ovarian, pancreatic, and thyroid cancer as well as hepatocellular carcinoma, meningioma, and multiple myeloma.

The study found that for patients treated with GLP-1 drugs, the risk of gallbladder cancer, meningioma, pancreatic cancer, and hepatocellular carcinoma, a type of liver cancer, was cut approximately in half.

The risk for ovarian, colorectal cancer, multiple myeloma, esophageal, endometrial and kidney cancers was also significantly reduced for patients taking GLP-1s.

In addition, the study found that people taking GLP-1 drugs did not have a higher risk for being diagnosed with cancer.

2. What are GLP-1 medications and how do they work?

GLP-1 drugs help people produce insulin to lower the amount of sugar in their blood.

The class of drugs, which include Ozempic and Wegovy, work by mimicking the effects of GLP-1, a type of hormone in the body that impacts everything from the brain to muscle to the pancreas, stomach and liver.

The drugs, made from a compound called semaglutide, work by slowing down movement of food through the stomach and curbing appetite, thereby causing weight loss. They are typically taken via a once-weekly injection.

Ozempic is approved by the U.S. Food and Drug Administration to treat Type 2 diabetes, but some doctors prescribe the medication “off-label” for weight loss, as is permissible by the FDA.

Wegovy, a medication that contains the same main ingredient, semaglutide, as Ozempic, is FDA-approved for weight loss.

Clinical studies show users of the medications can lose between 5% and 20% of their body weight over time.

3. Why are the drugs being found to help reduce the risk of cancer?

The study authors wrote that more research is needed to determine exactly how and why GLP-1 drugs may contribute to a lower risk of obesity-associated cancers.

ABC News’ medical correspondent Dr. Darien Sutton, a board-certified emergency medicine physician, noted the study does not show precisely whether the GLP-1 drugs reduce the risk of cancer, or whether the weight loss they cause may lead to the lower risk.

“We’re looking at a study that shows an association, not necessarily a cause and effect, and you have to take a step back and understand what is that connection,” Sutton said. “The main theories include things like hormone disruption and obesity, [and] factors like growth factor and insulin increase the risk of cancer, also, immune system dysregulation.”

He continued, “The question is, how did these medications fit into that puzzle and reduce these risks?”

4. For what other conditions have GLP-1 drugs been studied?

Experts have theorized that the way in which semaglutide interacts with the brain to stop overeating also helps with other addictive behaviors, including alcohol use.

One small case study published last year found that six people who screened positive for alcohol use disorder saw a clinically significant decrease in symptoms while using semaglutide, the active ingredient in Ozempic and another medication, Wegovy, for weight loss.

While this small case study doesn’t provide strong scientific evidence that these drugs can also be used to treat alcohol use disorder, experts say it does reinforce the need for larger, randomized clinical trials that are in early stages.

Other research has shown that GLP-1 drugs can help reduce the risk of kidney disease and can help reduce the risk of anxiety, according to Sutton.

Sutton said that along with the benefits of GLP-1 drugs, people have to consider the risks as well.

Among all medications used for weight loss, the most commonly reported side effects are nausea and constipation, but gallbladder and pancreatic disease are also reported. Makers of these drugs recommend having a conversation about the side effect profile and personalized risks with a healthcare professional before starting.

“It just reminds us that when we’re trying to make a decision whether or not to use these, you have to have a formal understanding of what these risks are,” Sutton said. “Because just like weight loss, it can be different from person to person.”

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Health

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.”

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Health

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.

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Health

The effect of weight loss drugs on muscle mass

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(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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Health

Arizona abortion rights group submits signatures needed for ballot measure

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(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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