‘Invisible’ heat wave risks need more attention as temperatures rise, expert says

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(NEW YORK) — Millions of people are dealing with extreme heat waves as climate change continues to raise temperatures to unhealthy levels.

Jeff Goodell, a climate journalist, published a new book The Heat Will Kill You First: Life and Death on a Scorched Planet, that examines how damaging the increased heat waves are for people’s health. Goodell warned that people need to be cautious about their activities during the high heat days.

He spoke with ABC News’ “Start Here” podcast Tuesday about the heat and what can be done to mitigate the damage.

START HERE: Thanks for being with us, Jeff. I’m wondering, like in your mind when we talk about climate change, is heat just by itself, heat the single most affecting part of that whole picture? That’s the thing that actually hits will hit the human race the hardest.

JEFF GOODELL: Well, I think it’s very clear that when it comes to your own health risk and to your own life, heat is by far the most dangerous impact of climate change. Heat kills far more people than drought and wildfires. My previous book was about sea level rise. And, sea level rise is really important because it impacts every coastal city in the world and it’s going to have huge impacts on real estate and flooding and things like that.

But nobody stands on Miami Beach and drowns because of sea level rise. It’s happening over a longer period of time. The thing about heat is that it can kill you very quickly.

But it’s also the larger warming of the planet that is causing the glaciers to melt, is causing the sea level rise that’s drying out the forests that are causing hotter, bigger wildfires. It’s changing the precipitation patterns because of the changes in the atmosphere.

So, it is the large scale driver of all these big changes, and it’s also the micro killer –invisible force that is most deadly to you as a person.

START HERE: Well, and so I’ve been wondering lately, is all temperature change relative? If you’re used to living in 60 degree weather and then at 70 degrees, you’re undergoing the same amount of change that somebody who lives in 95 degree weather and now it’s 105 [degrees] all the time. Is that the same difference or is there a level — is there a threshold at which the air temperature becomes profoundly more dangerous for people?

GOODELL: Well, I mean, there has been some speculation [and] some papers written about this, about what is the sort of human threshold for heat. And there’s the idea of what’s called a wet bulb temperature, which is a measurement kind of like a complicated heat index that was developed by the military that includes sunlight and wind speed and enclosure wearing and everything.

A wet bulb temperature of 95 degrees…you can basically think of it as a sunny, humid day at 95 degrees. If you are out in that for very long and do any kind of exercise or movement around your, you will rapidly head into heat stroke land.

In my book, I write about a farm worker in Oregon who died in the fields because he was afraid if he took shade and water breaks, he would be fired. The thing about these heat waves is that there’s a real kind of justice and equity issue involved here. Not just here in the United States, but there are billions of people on this planet who do not have access to air conditioning and will not have access to air conditioning anytime soon.

The last point about I’ll make about the air conditioning is that it’s a false sense of security because I’m here right now talking to you in Austin and it’s 106 degrees right now. If there were a power failure in Austin right now and that power failure lasted for very long, hundreds, if not thousands of people would die because they would lose air conditioning all of a sudden. We’ve built many of our houses without the ability to open windows.

They are all sealed up very tight, and they become like convection ovens without mechanical air conditioning. So, you know, there’s an inevitability that that kind of power failure is going to happen on a grid in a major American city during one of these heat waves.

START HERE: Well, and in fact, you’ve described your book is like it’s not just doomerism, it’s a survival guide for this new era that we’re all inhabiting right now. I mean, if we’re looking for survival tips. And I’m serious, are there practical things that we should be doing? Not just like write your congressmen and like try to get less CO2. Like, are there things we should be doing preparing ourselves for to get by in a much hotter, hotter world?

GOODELL: Well, again, just to stress the obvious and to repeat the obvious, cutting fossil fuel emissions as quickly as possible is the first order of business in any kind of thinking about what to do about extreme heat. But, on a more practical level, it’s, you know, getting smart about the risks of heat.

I didn’t understand the risk before I started writing this book, even though I have been writing about climate change for almost a decade. I was really dumb about it. I came close to having a heat stroke myself. I didn’t understand what was happening. People don’t understand how dangerous heat is and how and how to deal with it. For example, one of the myths is that if you drink enough water, you’ll be fine. That’s not true.

Water does not in itself cool you off or cools you off. Is it the sweat? And yes, you need to have water in you so you can continue sweating. And if you get dehydrated, you can’t sweat. But there are many stories and I write about them in my book of people who die of heat stroke and have plenty of water. It’s just that they’re in conditions where they’re exercising, hiking, walking, working, whatever, in hot conditions and their bodies overcome by heat.

START HERE: So literally thinking differently about exertion, where you live and what these heat extremes are doing now.

GOODELL: Exactly. And there’s a lot to be done with checking in on vulnerable people. A lot of heat deaths can be easily avoided by better education about heat, about ranking heat waves..so that we know the severity of them because they’re invisible. We don’t see them. They’re not like hurricanes where you can you see the trees bending in half. The risks are very visible. With heat, they’re not.

So we need to get a lot better about messaging about it than the media and government officials, public health officials. There are initiatives underway to try to name heat waves to make it more tangible to people’s imaginations and more identifiable. You know what the risks are. Simple things like, calling relatives, friends, people who you think might be vulnerable and saying, “Hey, it’s going to be really hot tomorrow. Are you set? Is your air conditioning working or if you don’t have air conditioning, do you know where to go?” There’s a lot of just simple things like that that can be done.

START HERE: It’s almost against speaking to your idea of like, these are just like storms, but they’re more invisible. My mom, like, gets like annoyingly, she calls me whenever she thinks there’s a snow flurry on the way. Yes. You want to do that for a huge heat wave. Like that’s the difference.

GOODELL: Right. And the media plays into this. Whenever there’s a heat warnings or whatever they show pictures of people at the beach and they show pictures of kids running through sprinklers and things like that. And there’s this notion that, you know, yeah, it’s going to be warm, but it’s not really dangerous. And, you know, just like put a hat on and put on sunscreen and drink plenty of water and you’ll be fine. Well, you won’t be fine. And it’s much more dangerous than that.

As these temperatures climb and climb and climb, these risks grow faster and faster and they become more urgent. And, I opened my book with the story of a family in California. They went for a hike on a warm day in the California foothills. And the next day they were all found dead on the trail, including their tragically, their one-year-old daughter, because they all had heatstroke.

They knew they were experienced hikers. They understood the risk, but they miscalculated. And those kinds of questions in this kind of education about this is just going to become more and more and more important as we get hotter and hotter and hotter.

START HERE: Yeah. And I keep going back to 95 degrees and humid, being like this moment where the cellularly your body starts to react differently. It was this past Friday that it was 95 degrees and muggy. I went out for what I thought was a healthy bike ride. I hydrated myself really well throughout the day, and yet hours and hours later, my wife is like, You don’t look well. Like, this was bad for your health. That’s the sort of decision making that you think will be changing, whether we like it or not.

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As 988 centers struggle with staffing, some peer supporters feel shut out

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(NEW YORK) — When Angelica Garcia’s high school crush, first love, and father of her two children died unexpectedly, she said, her life went into a free fall. The Los Angeles native said she struggled to cope; within months, she started using marijuana, then cocaine and methamphetamine.

“I didn’t have the tools to deal with my emotions,” Garcia told ABC News. “[So] I started self-medicating.”

Years later, after struggling with homelessness, depression, and addiction, Garcia said she found hope and help through an unlikely source: a peer support specialist.

A peer supporter is someone with the “lived experience” of recovery from mental illness, substance use disorder, or both, according to the Substance and Mental Health Services Administration (SAMHSA). These individuals undergo training and certification that varies by state, but hinges on education aimed at what SAMHSA calls “recovery-oriented” and “person-centered” approaches to care.

Since 2015, when SAMHSA released its initial guidance around mobilizing peer supporters, 49 states have developed peer certification programs; in 40 states, peer supporters – who typically work for independent behavioral health organizations that provide in-person as well as “warm-line” services over the phone – can be reimbursed by Medicaid, according to 2022 data from the Kaiser Family Foundation.

Peers have been shown to offer additional benefits compared with care relying solely on psychologists, psychiatrists, or social workers, SAMHSA says, including reduced rates of substance use and hospitalization. In May, the Biden administration highlighted expanding access to peer support as a key element of its mental health Unity Agenda.

Garcia has been a peer supporter with Project Return Peer Support Network for the past decade and a half. But Garcia says peer supporters like her have largely been excluded from the administration’s major overhaul of the national 988 crisis lifeline. In California, peers were often not included in planning discussions leading up to the hotline’s rollout, Garcia said. Likewise, in other states like Wisconsin, many credentialed peers have not been used to answer hotline calls, advocates say.

That’s coupled with the fact that many crisis centers across the country have struggled to hire enough staff to answer the calls coming in.

In part due to these staffing shortages, crisis centers nationally are missing tens of thousands of calls every month, advocates say. And—while other aspects of 988, such as the over 5 million calls, texts, and chats answered since the hotline’s launch in July 2022, have been a considerable success—the missed calls represent a problem that may lead to worse outcomes, Monica Johnson, 988 directors at SAMHSA, said.

That’s where peer supporters could come in, she said.

States need to “rethink and reimagine who can answer these calls,” Johnson said, “because it opens up a whole new group of people who can be really impactful in this work.”

The Secret Sauce

John Draper, who was the founding director of the pre-988 crisis lifeline, believes the “lived expertise” of peer supporters is their secret sauce.

“Empathy is foremost. That’s not something they teach in school,” Draper said.

According to SAMHSA, care provided by peer supporters leads to reduced rates of psychosis, substance use, depression, and hospitalization. Other federal agencies, like the Centers for Medicare and Medicaid Services and the Department of Justice, have advocated for their use in crisis response.

Some states, like Georgia, have fully leveraged peers, said Johnson.

Ever since, in 1999, the Supreme Court found the state liable for excessive use of psychiatric hospitalizations—and told the state to produce alternatives—peers were “weaved into all [Georgia’s mental health] services,” Johnson, who previously ran the state’s Department of Behavioral Health & Developmental Disabilities, said. This includes during the 988 rollouts, Johnson said: peers have assessed, triaged, and responded to crisis calls since the hotline’s launch.

Other states, though, have not meaningfully involved peers, Tim Saubers, board vice president of the National Association of Peer Supporters, said. For example, in Wisconsin—where Saubers founded the state’s peer support advocacy network—his colleagues have struggled for inclusion since the earliest days of 988, he said.

“From the beginning, [Wisconsin’s Department of Health Services] had no interest in hearing what the peer voice had to say,” Saubers said, referring to the community’s desire to be involved with the 988 response as well as potentially answering calls themselves.

“Peer specialists are incredibly important to our behavioral health continuum and their ideas have played a vital role in 988 planning and implementation,” Jennifer Miller, a spokesperson for the Wisconsin Department of Health Services, wrote in an email. Peers were represented at each of the state’s fifteen planning meetings for 988 between April 2021 and April 2023, she added.

Another barrier peer counselors say they often face is educational requirements. For example, Wisconsin—despite its 30% vacancy rate of 988 call operators—is just one of the states that requires a bachelor’s degree or higher, according to data reviewed by ABC News from state health departments. The bars to fill senior positions are even higher: in Connecticut and West Virginia, managers must have masters’ degrees, in addition to various clinical licenses.

As a result, peer supporters often do not qualify for many call center jobs, Hannah Wesolowski, chief advocacy officer at the National Alliance on Mental Illness (NAMI), said.

“Focusing just on the educational requirement distracts us from a huge part of the population who could fill this opportunity,” Wesolowski said.

Research shows that people with mental illnesses are twice as likely to drop out of high school and college as their peers.

“There’s mounting frustration and resignation that no matter how much we have to offer the existing system is not willing to take us up on it,” Saubers said.

‘We should be at the table’

In June, given that peer certification standards vary state by state, SAMHSA released guidance “to accelerate universal adoption, recognition, and integration of the peer workforce.”

The agency’s recommendations included loosening educational requirements and ensuring that past behaviors—like a history of substance use—don’t disqualify peer supporters.

The guidelines created “standardized ways to go about how to build, certify, and support the peer workforce,” Johnson said. “It feels like a game-changer.”

However, the guidance is not a mandate. So how—and whether—these standards will promote peer support for 988 state-by-state remains an open question, Saubers said.

That ambiguity leaves some people like Garcia frustrated.

California’s Department of Health Care Services “considers individuals with lived experienced [sic] to be a vital component of the behavioral health workforce,” Anthony Cava, a department spokesperson, said in an email. “We look forward to continuing to develop specific opportunities for peer support related to 988.”

For Garcia though, the time in between now and then represents a lost opportunity.

“We should be at the table because [without peers], there’s a big part missing,” Garcia said.

Despite some of the hotline’s challenges, if you or a loved one is struggling with a mental health crisis or considering suicide, call or text 988.

ABC News is looking into challenges and successes with implementation of the 988 Suicide and Crisis Lifeline. If you have had issues or successes with the line, please contact us here.

 

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Cannabis-related ED visits increased among young Americans during COVID pandemic: CDC

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(ATLANTA) — Emergency department visits involving cannabis increased for children, teens and young adults during the COVID-19 pandemic, new federal data suggests.

A report published Thursday from the Centers for Disease Control and Prevention looked at visits for Americans under 25 years old throughout the pandemic and compared the data to a 2019 baseline.

Researchers found the largest increases in visits were among children aged 10 and younger as well as adolescents between ages 11 and 14.

There was also an increase among older teens and young adults aged 15 to 24. However, cannabis is legal in several states for adults aged 21 and older.

The CDC analyzed data from a weekly average of nearly 1,700 emergency departments that report to the National Syndromic Surveillance Program as well as state and local health departments.

The team expanded its data by searching for other terms that indicated cannabis use such as “smoke weed” or “ingest hash” in the main complaints or discharge paperwork.

Among those aged 10 and under, the average number of weekly cannabis-related ED visits ranged from 30.4 per 10,000 visits to 71.5 per 10,000 visits. Prior to the pandemic, the average was between 18.7 and 23.2 visits.

This age group had their highest number of average visits during summer 2022, the report found. Visits declined during the second half of the 2020-21 school year before increasing thereafter.

For those between ages 11 and 14, the range was between 69.8 and 209.3 compared to a range of 90.5 and 138.5 before the pandemic.

Meanwhile, preteens and teens in this group saw their peak in weekly visits occur during the second half of the 2021–22 school year.

The team noted that the majority of visits during the study period were among 15-to-24-year-olds. Even though rates were elevated from 2020 to summer 2021, they returned to baseline.

However, this was the only age group that did not see statistically significant increases even before the pandemic, as was seen with children and younger teens.

The new report did not discuss why the number of visits went up, noting that there could be different drivers depending on the age group.

A separate report from the National Institute on Drug Abuse at the National Institutes of Health found that young people’s perception of the risk using of cannabis use has declined in recent years.

“Improving clinicians’ awareness of rising cannabis-involved ED visits might aid in early diagnosis of cannabis intoxication among young persons,” the authors wrote in their report. “Further, increasing adults’ knowledge regarding safe cannabis storage practices, strengthening youths’ coping and problem-solving skills through evidence-based prevention programs, and modifying cannabis packaging to decrease appeal to youths might help prevent intentional and unintentional cannabis use.”

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FDA approves first birth control pill for use without prescription

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(NEW YORK) — The Food and Drug Administration approved the first birth control pill in the United States that can be sold without a prescription Thursday.

The progestin-only pill, called Opill, is made by French drugmaker HRA Pharma and its parent company Perrigo and the approval is a first-of-its-kind move by federal regulators.

It comes after an independent advisory panel agreed this spring that the drug was safe for most patients. Doctors say progestin-only pills, also known as the “mini pill,” pose fewer medical risks than combination pills that rely on estrogen.

“Today’s approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States,” said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, in a statement. “When used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy.”

One concern raised by FDA advisers had been whether consumers, particularly young teens, will adequately screen themselves for potential medical risks.

But FDA advisers agreed those risks were minimal compared to the significant benefits in removing hurdles to prevent unwanted pregnancies, particularly for younger women or those facing financial or child care constraints.

More than a dozen states have already passed laws expanding access to hormonal birth control by allowing pharmacists to dispense the drugs themselves or rely on a standing order from a doctor.

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Why MIS-C cases are dropping dramatically across the US: Experts

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(NEW YORK) — During the early days of the COVID-19 pandemic, one of the most misunderstood complications children were experiencing was MIS-C.

MIS-C, or multisystem inflammatory syndrome in children, is a condition in which different body parts can become inflamed — such as the heart, lungs, brain and kidneys — and is often seen in children after they are diagnosed with COVID-19, according to the Centers for Disease Control and Prevention.

Over the course of the pandemic, there have been 9,499 reported cases of MIS-C and 79 deaths, CDC data shows. Cases especially skyrocketed during the first year of the pandemic.

Since then, however, MIS-C cases have dropped dramatically and have almost disappeared entirely. Experts told ABC News they are not sure why this is but there are probably multiple reasons, including more children being immune to COVID-19, as well as newer variants causing less severe complications.

“It is definitely a medical mystery,” Dr. Elizabeth Schlaudecker, medical director of Cincinnati Children’s division of infectious diseases, told ABC News. “We haven’t figured it out yet. We’re still working on it.”

What is MIS-C and how is it treated?

MIS-C is an inflammatory condition that is caused by infection with SARS-CoV-2, the virus that causes COVID-19. It typically occurs between two to six weeks after infection and presents a combination of symptoms, including inflammation of various parts of the body along with gastrointestinal symptoms, rash and fever.

Doctors are unclear about what causes some children to develop MIS-C but believe it may involve a genetic predisposition for inflammation in response to respiratory diseases.

Most children with MIS-C end up hospitalized and, if they are sick enough, can spend time in intensive care units.

“It’s reassuring that for the most part kids do much, much better than adults when it comes to SARS-CoV-2 infection,” Dr. Samuel Dominguez, associate professor of pediatrics at Children’s Hospital Colorado, told ABC News. “But there are a subset of kids who can have serious disease related to SARS-CoV-2, and probably the most severe for that is MIS-C.”

“These kids are gonna be very sick. Half of the kids that we saw ended up in our ICU and so I think that’s an important point that MIS-C definitely is not a benign disease,” Dr. Dominguez added.

There are several treatments for MIS-C including anti-inflammatory medications, as well as intravenous immunoglobulin, a therapy made up of antibodies to help fight infections and reduce inflammation.

Why MIS-C cases have gone up and down

During the first two years of the pandemic, doctors said cases of MIS-C were rising rapidly around the country. During the week of Jan. 21, 2021, there were 261 diagnosed MIS-C cases, CDC data shows.

As of the week ending Feb. 15, 2023 — the latest period for which data is available — there were just 10 cases across the U.S.

“We had a protocol and an algorithm that we followed at our hospital, like many other hospitals, and if there was concern that a patient had MIS-C, back in the early days from 2020 through 2021, we would get a phone call on our infectious disease service,” said Dr. Schlaudecker.

“And we were receiving many phone calls a week evaluating children’s MIS-C and treating children for MIS-C,” Dr. Schlaudecker continued. “And now, it’s almost unheard of. I can’t remember the last time we got a call with any concerns for of MIS-C. So, that’s really good news.”

Experts told ABC News that a combination of immunity from infection and vaccination has probably lowered the MIS-C risk among children.

“The majority of children at this point in the United States have some immunity to COVID-19,” Dr. Schlaudecker said. “Many have been infected and others have been vaccinated, and some have been infected and vaccinated and are therefore immune. So, I’m imagining that that has something to do with it.”

CDC data shows an estimated 91.9% of Americans between ages 6 months and 17 years have antibodies due to previous COVID-19 infection. From infection and vaccination, the percentage increases to 96.3%.

As of May 10, 61.8% of those aged 12 to 17 have completed a primary series of vaccinations in addition to 32.9% of those aged 5 to 11, 6.1% of those aged 2 to 4, and 4.7% of those under age 2, according to CDC data. No age group has surpassed 10% vaccinated when it comes to completing an updated bivalent booster.

Additionally, experts said the COVID-19 variants currently circulating in the U.S. may be causing less severe disease than the variants that were more prevalent in the earlier months of the pandemic.

“The delta variant surged in the summer of 2021 and continued into the early fall of 2021, [and] clearly contributed to more MIS-C cases than we saw with any other variants,” Dr. James Versalovic, pathologist-in-chief and chair of Texas Children’s Hospital’s department of pathology, told ABC News. “Many of us are convinced that there’s something regarding the immunogenicity, or the way the human immune system responded to different variants, that put more children at risk for MIS-C with the delta variant than we saw before the delta variant and since the delta variant waned in late 2021.”

He added that even though the omicron variant led to the biggest surge of cases seen in the United States since the pandemic began, it didn’t translate into more MIS-C cases.

“At our peak at this hospital we were seeing up to two to three cases per day in 2021 with delta and MIS-C,” Dr. Versalovic said. “With omicron, it was really never more than one case per day and often times it will be several days between a single case of MIS-C.”

“What we’ve seen is, as the omicron subvariants have shifted, we’ve even seen cases drop even further and now, it may be three or four months between cases, and we’ve seen little to no MIS-C in 2023,” he continued.

Vaccination is the best form of protection

However, the doctors who spoke with ABC News warned that just because MIS-C cases have dropped noticeably doesn’t mean that the threat is gone. Another highly infectious subvariant could lead to a surge in cases.

“Parents need to continue to remain vigilant…and we continue to strongly recommend bivalent COVID vaccine for children six months of age and above,” Dr. Versalovic said.

He also recommended that parents consider other interventions, including masking in places such as airplanes, to lower the risk of COVID-19.

Ultimately, it’s also important to recognize the signs of MIS-C and to seek medical care if necessary.

“If kids have prolonged fever, or with sort of any of these other symptoms – severe abdominal pain, red eyes, rash, red lips – those would be indications to seek medical attention to try to find out what’s going on,” Dr. Dominguez said.

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Formerly conjoined twins go home after 6-hour surgery to separate them

Texas Children’s Hospital

(NEW YORK) — Twin sisters who were born conjoined at the abdomen are now home, one month after a successful surgery to separate them.

Ella Grace and Eliza Faith Fuller were discharged on Tuesday from Texas Children’s Hospital, where they had been cared for in the neo-natal intensive care unit since their birth in March.

“It’s hard to explain in words exactly how excited we are,” the twins’ dad Jesse Fuller said in a video shared by Texas Children’s Hospital. “It’s been 134 days, so the feelings are overwhelming.”

The twins’ mom Sandy Fuller said she was “completely shocked” when she found out she was pregnant with twins. She described it as a “hard and difficult” time when she and her husband found out their twin daughters were conjoined.

“[When] we found out they were conjoined, it was hard and difficult, but we trusted that God was going to work in the entire journey, so it was OK,” she said.

Sandy Fuller gave birth to Ella and Eliza on March 1 at Texas Children’s Pavilion for Women. The girls each weighed 5 pounds, 10 ounces at birth.

In addition to sharing an abdomen, the sisters also shared liver tissues, according to the hospital.

As Ella and Eliza spent the next three months being cared for in the NICU, a team of 17 medical professionals, including seven surgeons and four anesthesiologists, prepared for their complex separation surgery.

“Our team began planning and preparing for this operation before these babies were even born,” Dr. Alice King, the lead surgeon on the operation and a pediatric surgeon at Texas Children’s Hospital, said in a statement. “From conducting simulations of the procedure, to collaborating extensively with our colleagues in anesthesiology, maternal-fetal medicine, neonatology and radiology, we have all been working together to achieve one common goal: the best outcome for Ella and Eliza.”

On June 14, Ella and Eliza were separated in a surgery that lasted around six hours, according to the hospital.

Three days after the surgery, Sandy and Jesse Fuller, who are also parents to an older daughter, were able to hold Ella and Eliza separately for the first time.

“I think you can look at them and just see God’s goodness and how kind he’s been to us, because they’re true miracles since day one,” said Sandy Fuller.

Conjoined twins occur once in every 50,000 to 60,000 births, according to the Children’s Hospital of Philadelphia.

The Fullers said the only way so far to tell their daughters’ apart is by a “small flat spot” that Ella has on one ear.

They added that even with all they’ve been through, they’ve also seen their daughters grow their own personalities over their first six months of life.

“We say Ella is just sassy with a little bit of drama,” said Sandy Fuller. “Eliza is just more laid-back, goes with the flow. But they’re both such sweet, happy babies”

The twins will continue their recovery at home. Doctors expect them to make a full recovery.

“I know it’s going to be another chaotic moment once we get home, but we’re excited about that chaotic moment,” Jesse Fuller said. “I’m kind of bracing myself because I know it’s going to be a wild house pretty soon, but I’m excited.”

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Regulators examine reports of self-harm, suicidal thoughts among people taking Ozempic, Saxenda

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(NEW YORK) — Regulators in Europe have launched a review after three people in Iceland experienced thoughts of suicide or self-harm after taking popular diabetes and weight loss drugs Ozempic and Saxenda.

The review is being led by the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee out of an abundance of caution.

The agency said Tuesday that its review will conclude by November 2023, and has expanded to review 150 cases.

At this point, it’s not clear if people experienced thoughts of suicide or self-harm due to an underlying mental health condition, or whether these thoughts were related to starting drugs like Ozempic and Saxenda, which are called GLP-1 receptor agonists.

“The presence of a signal does not necessarily mean that a medicine caused the adverse event in question,” the agency said in a statement.

Still, experts say it important for regulators to diligently review any new possible health concern related to approved drugs.

Suicide is not currently listed as a side effect of Ozempic, according to the U.S. Food and Drug Administration’s drug label. That means it is not a safety problem that emerged during the large clinical trials that were done to test for safety and effectiveness.

Ozempic, Saxenda and others are part of a class of drugs called GLP-1 RAs that help people produce insulin and lower the amount of sugar in the blood.

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.

Ozempic was approved by the FDA in 2017 to treat Type 2 diabetes, but some doctors prescribe it “off-label” for weight loss.

Saxenda and another drug, Wegovy, are both FDA approved for weight loss for people with obesity or who are overweight.

These drugs have not previously been associated with thoughts of self-harm.

However, prior weight loss medications have been associated with thoughts of self-harm. For that reason, Wegovy and Saxenda are not recommended for people with have previously had suicidal thoughts.

Known side effects of the drugs can include severe nausea and constipation.

Saxenda, Wegovy and Ozempic are all made by Novo Nordisk.

The pharmaceutical company told ABC News in a statement that it is “continuously performing surveillance” of the data and real-world uses of the drugs to ensure patient safety.

“Patient safety is a top priority for Novo Nordisk, and we take all reports about adverse events from use of our medicines very seriously. GLP-1 receptor agonists have been used to treat type 2 diabetes for more than 15 years and for treatment of obesity for 8 years, including Novo Nordisk products such as semaglutide and liraglutide that have been on the market for more than 10 years,” Novo Nordisk said in a statement. “In the US, FDA requires medications for chronic weight management that work on the central nervous system, including Wegovy® and Saxenda®, to carry a warning about suicidal behavior and ideation. This event had been reported in clinical trials with other weight management products.”

“Novo Nordisk is continuously performing surveillance of the data from ongoing clinical trials and real-world use of its products and collaborates closely with the authorities to ensure patient safety and adequate information to healthcare professionals,” the statement continued. “Novo Nordisk remains confident in the benefit risk profile of the products and remains committed to ensuring patient safety.”

The FDA also told ABC News it “routinely evaluates” approved drugs for safety.

The agency has so far not followed its European counterparts in announcing a review of GLP-1 RAs.

“The FDA routinely evaluates individual adverse event reports and adverse event reports from the published literature for all approved drugs,” the FDA said in a statement. “As a general matter, the FDA does not comment on third-party research or individual reports but may evaluate these as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health.”

“Clinical trials of Wegovy did not support an increased risk of suicidal behavior, suicidal ideation, or other psychiatric adverse events with Wegovy; however, suicidal behavior and ideation have been reported in clinical trials of other weight management drugs. For this reason, the US prescribing information for Wegovy contains a Warning and Precaution for suicidal behavior and ideation,” the statement continued. “The FDA monitors the safety of a drug throughout its life cycle, including post-approval. In addition, the FDA maintains a system of postmarketing surveillance and risk assessment programs and if newly identified safety signals are identified, the FDA will determine what actions are appropriate after a thorough review of the body of evidence.”

Doctors say anyone experiencing thoughts of self-harm for any reason should quickly reach out to a professional.

If you or someone you know is struggling with thoughts of suicide — free, confidential help is available 24 hours a day, 7 days a week. Call or text the national lifeline at 988. Even if you feel like it, you are not alone.

Copyright © 2023, ABC Audio. All rights reserved.

July has the highest number of drowning deaths. Here’s how to prevent them

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(NEW YORK) — The month of July has seen the highest number of unintentional drowning deaths since 2018, according to data from the Centers for Disease Control and Prevention.

Provisional data shows that nearly 800 people died in 2022 from an accidental drowning. According to the CDC, in 2020, during the peak of the coronavirus pandemic, it topped 839 accidental drownings. The U.S. sees over 4,000 deaths from drownings each year.

Drowning is also the leading cause of death for children between the ages of 1 and 4 and the second leading cause of death for kids between 5 and 14, according to the CDC.

The American Academy of Pediatrics released a statement in late June encouraging both parents and doctors to prioritize water safety, especially during the summer months when more families head to swimming pools, beaches and lakes.

“We have to look at swimming as a basic life skill, like learning to read. Because it is,” pediatrician Dr. Andrew Kiragu said in the statement. “Swimming is a skill that can save your life or the life of your child. It’s something everyone needs to learn.”

The National Drowning Prevention Alliance, a nonprofit founded in 2005, is dedicated to lowering the number of drownings and promoting water safety. Adam Katchmarchi, the group’s executive director, previously shared with ABC News’ Good Morning America the organization’s recommendations for staying safe near water.

“Oftentimes, parents think that they will see something or hear something when their child is drowning, and unfortunately, it’s very silent and very quick,” Katchmarchi said. “We recommend parents practice five simple layers of protection they can do to keep their child safe around the water.”

The National Drowning Prevention Alliance recommends these top five water safety tips:

Install and use alarms and fences

Barriers like proper fencing and alarms can “help restrict access to water and provide notification when someone enters the area where the water body is, such as a backyard pool,” Katchmarchi said.

Actively supervise swimmers and water activities

Katchmarchi emphasized the importance of active monitoring while swimming or recreating near water.

“We recommend that supervising adults do three things. We call them the three C’s: They are competent, capable and constant, so that they are capable of making a rescue and that supervision is constant at all times,” Katchmarchi said.

He added, “Part of the supervision element is … making sure that you can actively supervise your child anytime they’re around or in the water, and one of those ways is to make sure that they have a bright colored swimsuit.”

Learn how to swim

“We also recommend swimming lessons, making sure a child — and even adults — are water competent and have basic survival skills in the water,” Katchmarchi said.

Use life jackets

In addition, the National Drowning Prevention Alliance urges the use of U.S. Coast Guard-approved life jackets in, near or around bodies of water and while boating.

“Life jackets should be sized appropriately for the wearer. When other layers of protection may break down, life jackets can help prevent unintentional drowning,” the organization states on its website.

Prepare for any emergencies

“No one intends for these incidents to happen, but [by] taking simple steps, we can reduce the risk,” Katchmarchi said.

He added that, oftentimes, the difference between life and death is “only a few seconds,” and ensuring parents are able to “recognize that situation and provide care appropriately” is crucial.

Emergency preparedness also includes calling 911 if the situation calls for it, learning and practicing CPR, and learning how to use water safety and rescue equipment.

Copyright © 2023, ABC Audio. All rights reserved.

Regulators examine 3 reports of self-harm, suicidal thoughts among people taking Ozempic, Saxenda

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(NEW YORK) — Regulators in Europe have launched a review after three people in Iceland experienced thoughts of suicide or self-harm after taking popular diabetes and weight loss drugs Ozempic and Saxenda.

The review is being led by the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee out of an abundance of caution.

At this point, it’s not clear if the three people in Iceland experienced thoughts of suicide or self-harm due to an underlying mental health condition, or whether these thoughts were related to starting drugs like Ozempic and Saxenda, which are called GLP-1 receptor agonists.

“There is a ‘background rate’ of suicidality that, of course, can then include people taking any drug,” said ABC Chief Medical Correspondent Dr. Jennifer Ashton. “When more people take GLP1 agonists, there will therefore be crossover to some of those people exhibiting suicidality. As we always say, observation [does not mean] causality.”

Still, experts say it important for regulators to diligently review any new possible health concern related to approved drugs.

Suicide is not currently listed as a side effect of Ozempic, according to the U.S. Food and Drug Administration’s drug label. That means it is not a safety problem that emerged during the large clinical trials that were done to test for safety and effectiveness.

Ozempic, Saxenda and others are part of a class of drugs called GLP-1 RAs that help people produce insulin and lower the amount of sugar in the blood.

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.

Ozempic was approved by the FDA in 2017 to treat Type 2 diabetes, but some doctors prescribe it “off-label” for weight loss.

Saxenda and another drug, Wegovy, are both FDA approved for weight loss for people with obesity or who are overweight.

These drugs have not previously been associated with thoughts of self-harm.

However, prior weight loss medications have been associated with thoughts of self-harm. For that reason, Wegovy and Saxenda are not recommended for people with have previously had suicidal thoughts.

Known side effects of the drugs can include severe nausea and constipation.

Saxenda, Wegovy and Ozempic are all made by Novo Nordisk.

The pharmaceutical company told ABC News in a statement that it is “continuously performing surveillance” of the data and real-world uses of the drugs to ensure patient safety.

“Patient safety is a top priority for Novo Nordisk, and we take all reports about adverse events from use of our medicines very seriously. GLP-1 receptor agonists have been used to treat type 2 diabetes for more than 15 years and for treatment of obesity for 8 years, including Novo Nordisk products such as semaglutide and liraglutide that have been on the market for more than 10 years,” Novo Nordisk said in a statement. “In the US, FDA requires medications for chronic weight management that work on the central nervous system, including Wegovy® and Saxenda®, to carry a warning about suicidal behavior and ideation. This event had been reported in clinical trials with other weight management products.”

“Novo Nordisk is continuously performing surveillance of the data from ongoing clinical trials and real-world use of its products and collaborates closely with the authorities to ensure patient safety and adequate information to healthcare professionals,” the statement continued. “Novo Nordisk remains confident in the benefit risk profile of the products and remains committed to ensuring patient safety.”

The FDA also told ABC News it “routinely evaluates” approved drugs for safety.

The agency has so far not followed its European counterparts in announcing a review of GLP-1 RAs.

“The FDA routinely evaluates individual adverse event reports and adverse event reports from the published literature for all approved drugs,” the FDA said in a statement. “As a general matter, the FDA does not comment on third-party research or individual reports but may evaluate these as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health.”

“Clinical trials of Wegovy did not support an increased risk of suicidal behavior, suicidal ideation, or other psychiatric adverse events with Wegovy; however, suicidal behavior and ideation have been reported in clinical trials of other weight management drugs. For this reason, the US prescribing information for Wegovy contains a Warning and Precaution for suicidal behavior and ideation,” the statement continued. “The FDA monitors the safety of a drug throughout its life cycle, including post-approval. In addition, the FDA maintains a system of postmarketing surveillance and risk assessment programs and if newly identified safety signals are identified, the FDA will determine what actions are appropriate after a thorough review of the body of evidence.”

Doctors say anyone experiencing thoughts of self-harm for any reason should quickly reach out to a professional.

If you or someone you know is struggling with thoughts of suicide — free, confidential help is available 24 hours a day, 7 days a week. Call or text the national lifeline at 988. Even if you feel like it, you are not alone.

Copyright © 2023, ABC Audio. All rights reserved.

Dozens of beaches across Northeast closed for swimming due to high levels of bacteria in water

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(NEW YORK) — Beaches in several states across the Northeast have recently been closed to swimmers due to high levels of bacteria in the water.

Numerous beaches in Massachusetts, New Hampshire and Rhode Island were closed by public health officials due to unsafe water quality.

“When the water quality is unsafe, the beach is required to be ‘posted’ with a sign that indicates swimming is unsafe and may cause illness,” the Massachusetts Department of Public Health wrote on its website.

More than 60 beaches were closed for swimming in Massachusetts after high levels of fecal bacteria were detected in the water, according to the department.

Heavy rainfall from recent storms that hit the Northeastern states may be one reason behind the high levels of human waste, experts said.

A large amount of water from rain or snow can run off the land and carry fecal matter into water at beaches, officials said. Additionally, it can lead to sewage systems overflowing, which can cause untreated sewage to reach nearby bodies of water.

“Water from rain or snowmelt can cause certain types of sewers to overflow if their capacity is exceeded,” the Environmental Protection Agency states on its website. “Discharges from combined sewer overflows (CSOs) and sanitary sewer overflows (SSOs) contain a mixture of raw sewage, industrial wastewater and storm water, and have resulted in beach closings.”

In Rhode Island, officials have been testing levels of enterococci bacteria, which live in the intestinal tracts of humans and are a sign of water contamination by fecal waste, according to the EPA.

Eight beaches across Rhode Island have closed over the past month after levels of these bacteria exceeded more than 60 colony forming units — the number of bacteria cells viable to form a small colony — per 100 milliliters in saltwater and freshwater.

Three beaches remain closed in Rhode Island as of Monday. The state Department of Health said it plans to monitor all beaches through Labor Day.

Additionally, nine beaches in Massachusetts are being monitored for high levels of cyanobacteria.

Cyanobacteria, often referred to as blue-green algae, are a type of bacteria often found in freshwater but can appear in salt water or brackish water, according to the Centers for Disease Control and Prevention.

The bacteria itself doesn’t infect people but can produce toxins that make people sick.

The contaminated water 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.

Meanwhile, in New Hampshire, seven beaches were closed on Thursday due to “elevated bacteria levels” according to separate statements from the Wareham Board of Health and the town of Rye.

Health officials have not revealed what bacteria has contaminated the water or how widespread the contamination is.

As of Monday, three of the beaches have reopened but the others will remain closed with officials saying, “we want to ensure that the water quality is back to its pristine condition before we welcome you back.”

 

Copyright © 2023, ABC Audio. All rights reserved.