Potentially dangerous doses of melatonin and CBD found in gummies sold for sleep | CNN



CNN
 — 

Testing of over two dozen melatonin “gummies” sold as sleep aids found some had potentially dangerous amounts of the hormone that helps regulate sleep, according to a new study.

“One product contained 347% more melatonin than what was actual listed on the label of the gummies,” said study coauthor Dr. Pieter Cohen, an associate professor of medicine at the Cambridge Health Alliance in Somerville, Massachusetts.

A jar of gummies might also contain ingredients you didn’t count on, Cohen said: “One of the products that listed melatonin contained no melatonin at all. It was just cannabidiol, or CBD.”

According to the US Food and Drug Administration, “it is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement.” Yet several of the tested products containing CBD in the study openly advertised the addition of that compound to their melatonin product, Cohen said.

“Four of the tested products contained levels of CBD that were between 4% and 18% higher than on the label,” Cohen said.

The use of CBD in over-the-counter aids is particularly concerning because parents might purchase gummy products to give to their children to help them sleep, said Dr. Cora Collette Breuner, a professor of pediatrics at Seattle Children’s Hospital at the University of Washington.

“There’s no data that supports the use of CBD in children,” said Breuner, who was not involved in the study. “It’s currently only recommended for a very specific use in children over 1 with intractable seizure disorders.”

Aside from CBD, consuming a gummy that unknowingly contains extremely high levels of melatonin — well over the daily 0.5 to 1 milligram per night that has been shown to induce sleep in kids — is also dangerous, said Breuner, who serves on the integrative medicine committee of the American Academy of Pediatrics, which is currently writing new guidelines on supplements in children.

Side effects of melatonin use in children can include drowsiness, headaches, agitation, and increased bed-wetting or urination in the evening. There is also the potential for harmful interactions with medications and allergic reactions to the melatonin, according to the National Center for Complementary and Integrative Health, a department of the National Institutes of Health.

The agency also warns supplements could affect hormonal development, “including puberty, menstrual cycles, and overproduction of the hormone prolactin,” which causes breast and milk development in women.

In the study, published Tuesday in the journal JAMA, researchers sent 25 products labeled as melatonin gummies to an outside lab that tested for levels of melatonin and other substances.

However, the research team didn’t pick products “willy-nilly” off the internet, Cohen said. The scientists carefully chose the first 25 gummy melatonin products displayed on the National Institutes of Health database, which the public can check to see labels of dietary supplements sold in the United States.

“We choose gummies over other products because we thought parents would chose edibles to give to their children,” Cohen said. “”We also wanted to take a closer look at those products after last year’s report that poison centers have had over a quarter million calls about pediatric ingestion, thousands of hospitalizations, ICU visits, even some deaths.”

A 2022 report by the US Centers of Disease Control and Prevention found calls to poison control about melatonin ingestion by children rose 530% between 2012 to 2021. The largest spike in calls — 38% — occurred between 2019 and 2020, the report said.

Most of the calls were about children younger than 5 years old who had accidentally eaten gummies caregivers had not properly locked away.

“Gummies are enticing to young children, who see them as candy,” Cohen said. “We wondered if there was something going on with the products that might be contributing to the calls to the poison control centers.”

The new study found 88% of the gummies were inaccurately labeled, and only three contained a quantity of melatonin that was within 10% of what was listed on the label, said Cohen, who has studied invalid labeling of supplements for years.

“The regulatory framework for supplements is broken,” he said, “The manufacturers are not complying with the law, and the FDA is not enforcing the law. So what that means is that we have a lot of poor-quality products out there.”

A spokesperson for the FDA told CNN the agency would review the findings of the study, adding that the FDA generally doesn’t comment on specific studies, but “evaluates them as part of the body of evidence to further our understanding about a particular issue.”

“It’s important to underscore that under current law, the FDA does not have the authority to approve dietary supplements before they are marketed, and firms have the primary responsibility to make sure their products are not adulterated or misbranded before they are distributed,” the spokesperson said via email.

Steve Mister, president and CEO of the Council for Responsible Nutrition, a trade association for the dietary supplement industry, released a statement saying that manufacturers may add additional melatonin to be sure the product remains at the levels on the label as degradation naturally occurs over time.

“While there may be some variability in overages as companies adhere to the FDA’s requirements regarding shelf life and potency, it does not mean there is a risk in taking these products as intended,” Mister said.

People often view melatonin as an herbal supplement or vitamin, experts say. Instead, melatonin is a hormone that is made by the pineal gland, located deep within the brain, and released into the bloodstream to regulate the body’s sleep cycles.

Studies have found that while using melatonin can be helpful in inducing sleep if used correctly — taking a small amount at least two hours before bed — but the actual benefit is small, Breuner said.

In six randomized controlled trials on melatonin treatment in the pediatric population, she said, melatonin decreased the time it took to fall asleep, ranging from 11 minutes to 51 minutes.

“However, these were very small studies with widely variable results,” Breuner said. “So I say to the parents, ‘You’re really looking at as little as 11 minutes in decreasing the amount of time it takes your child to fall asleep.’”

Anyone considering melatonin should be sure that the bottle has the stamp of the United States Pharmacopeia (USP), which manufacturers hire to test and verify products.

“If it has a USP stamp on the label, you can be sure the product is accurately labeled,” Cohen said. “However, that doesn’t mean melatonin products are going to work or they’re a good idea to take.

“That’s not what the USP is about,” he said. “But at least the verification of the label should eliminate the problems we’re seeing here in our study.”

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These women ran an underground abortion network in the 1960s. Here’s what they fear might happen today | CNN



CNN
 — 

The voice on the phone in 1966 was gruff and abrupt: “Do you want the Chevy, the Cadillac or the Rolls Royce?”

A Chevy abortion would cost about $200, cash in hand, the voice explained. A Cadillac was around $500, and the Rolls Royce was $1,000.

“You can’t afford more than the Chevy? Fine,” the voice growled. “Go to this address at this time. Don’t be late and don’t forget the cash.” The voice disappeared.

Dorie Barron told CNN she recalls staring blankly at the phone in her hand, startled by the sudden empty tone. Then it hit her: She had just arranged an illegal abortion with the Chicago Mafia.

The motel Barron was sent to was in an unfamiliar part of Chicago, a scary “middle of nowhere,” she said. She was told to go to a specific room, sit on the bed and wait. Suddenly three men and a woman came in the door.

“I was petrified. They spoke all of three sentences to me the entire time: ‘Where’s the money?’ ‘Lie back and do as I tell you.’ And finally ‘Get in the bathroom,’” when the abortion was over, Barron said. “Then all of a sudden they were gone.”

Bleeding profusely, Barron managed to find a cab to take her home. When the bleeding didn’t stop, her bed-ridden mother made her go to the hospital.

At 24, Barron was taking care of her ailing mother and her 2-year-old daughter when she discovered she was pregnant. Her boyfriend, who had no job and lived with his parents, “freaked,” said Barron, who appears in a recent HBO documentary. The boyfriend suggested she get an abortion. She had never considered that option.

“But what was I to do? My mom was taking care of my daughter from her bed while I worked — they would read and play games until I got home,” Barron said.”How was either of us going to cope with a baby?

“Looking back, I realize I was taking my life in my hands,” said Barron, now an 81-year-old grandmother. “To this day it gives me chills. If I had died, what in God’s green earth would have happened to my mom and daughter?”

Women in the 1960s endured restrictions relatively unknown to women today. The so-called “fairer sex” could not serve on juries and often could not get an Ivy League education. Women earned about half as much as a man doing the same job and were seldom promoted.

Women could not get a credit card unless they were married — and then only if their husband co-signed. The same applied to birth control — only the married need apply. More experienced women shared a workaround with the uninitiated: “Go to Woolworth, buy a cheap wedding-type ring and wear it to your doctor’s appointment. And don’t forget to smile.”

Marital rape wasn’t legally considered rape. And, of course, women had no legal right to terminate a pregnancy until four states — Alaska, Hawaii, New York and Washington — legalized abortion in 1970, three years before Roe v. Wade became the law of the land.

Illinois had no such protection, said Heather Booth, a lifelong feminist activist and political strategist: “Three people discussing having an abortion in Chicago in 1965 was a conspiracy to commit felony murder.”

Despite that danger, a courageous band of young women — most in their 20’s, some in college, some married with children — banded together in Chicago to create an underground abortion network. The group was officially created in 1969 as the “Abortion Counseling Service of Women’s Liberation.”

But after running ads in an underground newspaper: “Pregnant? Don’t want to be? Call Jane,” each member of the group answered the phone as “Jane.”

Despite their youth, members of Jane managed to run an illegal abortion service dedicated to each woman's needs.
From left: Martha Scott, Jeanne Galatzer-Levy, Abby Pariser, Sheila Smith and Madeline Schwenk.

“We were co-conspirators with the women who called us,” said 75-year-old Laura Kaplan, who published a book about the service in 1997 entitled “The Story of Jane: The Legendary Underground Feminist Abortion Service.”

“We’ll protect you; we hope you’ll protect us,” Kaplan said. “We’ll take care of you; we hope you’ll take care of us.”

What started as referrals to legitimate abortion providers changed to personalized service when some members of Jane learned to safely do the abortions themselves. Between the late 1960s and 1973, the year that the Supreme Court decided Roe v. Wade, Jane had arranged or performed over 11,000 abortions.

“Our culture is always searching for heroes,” said Kaplan. “But you don’t have to be a hero to do extraordinary things. Jane was just ordinary people working together — and look what we could accomplish, which is amazing, right?”

Even after several members were caught and arrested, the group continued to provide abortions for women too poor to travel to states where abortion had been legalized.

“I prayed a lot. I didn’t want to go to jail,” said 80-year-old Marie Learner, who allowed the Janes to perform abortions at her apartment.

“Some of us had little children. Some were the sole breadwinners in their home,” Learner said. “It was fearlessness in the face of overwhelming odds.”

Marie Learner opened her home to women undergoing abortions. Her neighbors knew, she said, but did not tell police.

The story of Jane has been immortalized in Kaplan’s book, numerous print articles, a 2022 movie, “Call Jane,” starring Elizabeth Banks and Sigourney Weaver, and a documentary on HBO (which, like CNN, is owned by Warner Bros. Discovery).

Today the historical tale of Jane has taken on a new significance. After the 2022 Supreme Court reversal of Roe v. Wade and the mid-term takeover of the US House of Representatives by Republicans, emboldened conservative lawmakers and judges have acted on their anti-abortion beliefs.

Currently more than a dozen states have banned or imposed severe restrictions on abortion. Georgia has banned abortions after six weeks, even though women are typically unaware they are pregnant at that stage. In mid-April, Florida Governor Ron DeSantis signed a bill that would ban most abortions after six weeks. It won’t go into effect until the state Supreme Court overturns its previous precedent on abortion. Several other states are considering similar legislation. In other states, judicial battles are underway to protect abortion access.

“It’s a horrific situation right now. People will be harmed, some may even die,” said Booth, who helped birth the Jane movement while in college.

“Women without family support, without the information they need, may be isolated and either harm themselves looking to end an unwanted pregnancy or will be harmed because they went to an unscrupulous and illegal provider,” said Booth, now 77.

A key difference between the 60s and today is medication abortion, which 54% of people in the United States used to end a pregnancy in 2022. Available via prescription and through the mail, use of the drugs is two-fold: A person takes a first pill, mifepristone, to block the hormone needed for a pregnancy to continue.  A day or two later, the patient takes a second drug, misoprostol, which causes the uterus to contract, creating the cramping and bleeding of labor.

In early April a Texas judge, US District Judge Matthew Kacsmaryk – a Trump appointee who has been vocal about his anti-abortion stance — suspended the US Food and Drug Administration’s approval of mifepristone despite 23 years of data showing the drug is safe to use, safer even than penicillin or Viagra.

On Friday, the Supreme Court froze the ruling and a subsequent decision by the Fifth US Circuit Court of Appeals at the request of the Justice Department and the drug manufacturer. The action allows access to mifepristone in states where it’s legal until appeals play out over the months to come.

However, 15 states currently restrict access to medication abortion, even by mail.

The actions of anti-abortion activists, who have been accused of “judge shopping” to get the decisions they want, is “an unprecedented attack on democracy meant to undermine the will of the vast majority of Americans who want this pill — mifepristone — to remain legal and available,” Heather Booth told CNN.

“This is a further weaponization of the courts to brazenly advance the end goal of banning abortion entirely,” she added.

If women in her day could have had access to medications that could be used safely in their homes, they would not have been forced to risk their lives, said Dorie Barron, thinking back to her own terrifying abortion in a sketchy Chicago motel.

“I’m depressed as hell, watching stupid, indifferent men control and destroy women’s lives all over again,” she said. “I really fear getting an abortion could soon be like 1965.”

Chicago college student Heather Booth had just finished a summer working with civil rights activists in Mississippi when she was asked to help with a different kind of injustice.

Heather Booth, 18, with civil rights heroine Fannie Lou Hamer during

A girl in another dorm was considering suicide because she was pregnant. Booth, who excelled at both organization and chutzpah, found a local doctor and negotiated an abortion for the girl. Word spread quickly.

“There were about 100 women a week calling for help, much more than one person could handle,” Booth said. “I recruited about 12 other people and began training them how to do the counseling.”

Counseling was a key part of the new service. This was a time when people “barely spoke about sex, how women’s bodies functioned or even how people got pregnant,” Booth said. To help each woman understand what was going to happen to them, Booth quizzed the abortion provider about every aspect of the procedure.

“What do you do in advance? Will it be painful? How painful? Can you walk afterwards? Do you need someone to be with you to take you home?” The questions continued: “What amount of bleeding is expected, and can a woman handle it on their own? If there’s a problem is there an urgent number they can call?”

Armed with details few if any physicians provided, the counselors at Jane could fully inform each caller about the abortion experience. The group even published a flyer describing the procedure, long before the groundbreaking 1970 book “Our Bodies, Ourselves” began to educate women about their sexuality and health.

“I don’t particularly like doctors because I always feel dissatisfied with the experience,” said Marie Learner, who spoke to many of the women who underwent an abortion at her home.

“But after their abortion at Jane, women told me, ‘Wow, that was the best experience I’ve ever had with people helping me with a medical issue.’”

Eileen Smith, now 73, was one of those women. “Jane made you feel like you were part of this bigger picture, like we were all in this together,” she said. “They helped me do this illegal thing and then they’re calling to make sure I’m OK? Wow!

“For me, it helped battle the feeling that I was a bad person, that ‘What’s wrong with me? Why did I get pregnant? I should know better’ voice in my head,” said Smith. “It was priceless.”

Like many young women in the 60s, Heather Booth often protested for civil and women's rights.

Many of the women who joined Jane had never experienced an abortion. Some viewed the work as political, a part of the burgeoning feminist movement. Others considered the service as simply humanitarian health care. All saw the work as an opportunity to respect each woman’s choice.

“I was a stay-at-home mom with four kids,” said Martha Scott, who is now in her 80s. “We knew the woman needed to feel as though she was in control of what was happening to her. We were making it happen for her, but it was not about us. It was about her.”

Some volunteers, like Dorie Barron, experienced the Jane difference firsthand when she found herself pregnant a few years after her abortion at the hands of the Mafia.

“It was a 100% total reversal — I had never experienced such kindness,” Barron said. Not only did a Jane hold each woman’s hand and explain every step of the process, “they gave each of us a giant supply of maternity sanitary pads, and a nice big handful of antibiotics,” she said. “And for the next week, I got a phone call every other day to see how I was.”

Barron soon began volunteering for Jane by providing pregnancy testing for women in the back of a church in Chicago’s Hyde Park.

“It wasn’t just abortion,” Barron explained. “We also said, ‘You could consider adoption,’ and gave adoption referrals. And if the woman wanted to continue with her pregnancy, we said, ‘Fine, please by all that is holy make sure you get prenatal care, take your vitamins, and eat as best you can.’ It was women helping women with whatever they needed.”

Most of the women who contacted Jane were unable to support themselves, in unhealthy relationships, or already had children at home, so the service was a way of “helping them get back on track,” said Smith, who, like Barron, had begun working for Jane after her abortion.

“We were telling them ‘This isn’t the end of the world. You can continue to leave your boyfriend or your husband or continue to just take care of those kids you have.’ We were there to help them get through this,” said Smith, who later became a homecare nurse.

From left: Eileen Smith, Diane Stevens and Benita Greenfield were three of the dozens of women who volunteered for Jane.

Diane Stevens says she came to work for Jane after experiencing an abortion in 1968 at the age of 19. She was living in California at the time, which provided “therapeutic abortions” if approved in advance by physicians.

“I’d had a birth control failure, and I was coached by Planned Parenthood on how to do this,” said Stevens, now 74. “I had to see two psychiatrists and one doctor and tell them I was not able to go through with the pregnancy because it would a danger to both my physical and mental health.

“I was admitted to the psychiatric ward, although I didn’t really know that — I thought I was just in a hospital bed. But oh no, ‘I was mentally ill,’ so that’s where they put me,” said Stevens, who later went to nursing school with Smith. “Then they wheeled me off for the abortion. I had general anesthesia, was there for two days, and then I was discharged. Isn’t that crazy?”

Sakinah Ahad Shannon, now 75, was one of the few Black women who volunteered as a counselor at Jane. She joined after accompanying a friend who was charged a mere $50 for her abortion. At that time, Jane’s fee was between $1 and $100, based on what the woman could afford to pay, Shannon said.

“When I walked in, I said, ‘Oh my God, here we go again. It’s a room of White women, archangels who are going to save the world,’” said Shannon, a social worker and member of the Congress of Racial Equality, an interracial group of non-violent activists who pioneered “Freedom Rides” and helped organize the March on Washington in 1963.

What she heard and saw at her friend’s counseling session was so impressive it “changed my life,” Shannon said. She and her family later opened and operated three Chicago abortion clinics for over 25 years, all using the Jane philosophy of communication and respect.

“It was a profoundly amazing experience for me,” she said. “I call the Janes my sisters. The color line didn’t matter. We were all taking the same risk.”

Sakinah Ahad Shannon and her daughters went on to open and run three abortion clinics in Chicago.

It wasn’t long before the women discovered a “doctor” performing abortions for Jane had been lying about his credentials. There was no medical degree — in the HBO documentary, he admitted he had honed his skills by assisting an abortion provider.

The group imploded. A number of members quit in horror and dismay. For the women who stayed, it was an epiphany, said Martha Scott. Like her, several of the Janes had been assisting this fake doctor for years, learning the procedures step by step.

“You’d learn how to insert a speculum, then how to swap out the vagina with an antiseptic, then how to give numbing shots around the cervix and then how to dilate the cervix. You learned and mastered each step before you moved on to the next,” said Laura Kaplan, who chronicled the procedure in her book.

By now, several of the Janes were quite experienced and willing to do the work. Why not perform the abortions themselves?

“Clearly, this was an intense responsibility,” said Judith Acana, a 27-year-old high school teacher who joined Jane in 1970. She started her training by helping “long terms,” women who were four or five months along in the pregnancy.

“Remember, abortion was illegal (in Illinois) so it could take weeks for a woman to find help,” said Arcana, now 80. “Frequently women who wanted an abortion at 8 or 10 weeks wound up being 16 or 18 weeks or more by the time they found Jane.”

The miscarriage could happen quickly, but it rarely did, she said. It usually took anywhere from one to two days.

“Women who had no one to help them would come back when contractions started,” Arcana said. “One of my strongest memories is of a teenage girl who had an appointment to have her miscarriage on my living room floor.”

The group also paid two Janes to live in an apartment and be on call 24/7 to assist women who had no one to help them miscarry at home, said Arcana, a lifelong educator, author and poet. “But many women took care of it on their own, in very amazing and impressive and powerful ways,” she said.

Judith Arcana learned how to do abortions herself and wrote about the Jane experience in poems, stories, essays and books.

Any woman who had concerns or questions while miscarrying alone could always call Jane for advice any time of the day or night.

“People would call in a panic: ‘The bleeding won’t stop,’” Smith recalled. “I would tell them, ‘Get some ice, put it on your stomach, elevate your legs, relax.’ And they would say ‘Oh my gosh, thank you!’ because they were so scared.”

For women who were in their first trimester, Jane offered traditional D&C abortions — the same dilation and curettage used by hospitals then and today, said Scott, who performed many of the abortions for Jane. Later the group used vacuum aspiration, which was over in a mere five to 10 minutes.

“Vacuum aspiration was much easier to do, and I think it’s less difficult for the woman,” Scott said. “Abortion is exactly like any other medical procedure. It’s the decision that’s an issue — the doing is very straightforward. This was something a competent, trained person could do.”

It was May 3, 1972. Judith Arcana was the driver that day, responsible for relocating women waiting at what was called “the front” to a separate apartment or house where the abortions were done, known as “the place.”

On this day, a Wednesday, the “place” was a South Shore high-rise apartment. Arcana was escorting a woman who had completed her abortion when they were stopped by police at the elevator.

“They asked us, ‘Which apartment did you come out of?’ And the poor woman burst into tears and blurted out the apartment number,” Arcana said. “They took me downstairs, put cuffs on me and hooked me to a steel hook inside of the police van.”

Inside the apartment on the 11th floor, Martha Scott said she was setting up the bedroom for the next abortion when she heard a knock at the door, followed by screaming: “You can’t come in!”

“I shut the bedroom door and locked it,” Scott said, then hid the instruments and sat on the bed to wait. It wasn’t long until a cop kicked the door in and made her join the other women in the living room.

“We tell this joke about how the cops came in, saw all these women and said, ‘Where’s the abortionist?’ You know, assuming that it would be a man,” Scott said.

By day’s end, seven members of Jane were behind bars: Martha Scott, Diane Stevens, Judy Arcana, Jeanne Galatzer-Levy, Abby Pariser, Sheila Smith and Madeleine Schwenk. Suddenly what had been an underground effort for years was front page headlines.

“Had we not gotten arrested, I think no one would ever have known about Jane other than the women we served,” Scott said.

Top: Sheila Smith and Martha Scott.
Bottom: Diane Stevens and Judith Arcana.

An emergency meeting of Jane was called. The turnout was massive — even women who had not been active in months showed up, anxious to know the extent of the police probe, according to the women with whom CNN spoke.

Despite widespread fear and worry, the group immediately began making alternate plans for women scheduled for abortions at Jane in the next few days to weeks. The group even paid for transportation to other cities where abortion had already been legalized, they said.

News reports over the next few days gave further details of the bust: There was no widespread investigation by the police. It was a single incident, triggered by a call from a sister-in-law who was upset with her relative’s decision to have an abortion, they said.

“It wasn’t long after I was arrested that I came back and worked for quite a few months,” said Scott, one of the few fully trained to do abortions.

“I like to think I was a good soldier,” Scott said. “I like to think what did made a difference not only to a whole bunch of people, but also to ourselves. It gave us a sense of empowerment that comes when you do something that is hard to do and also right.”

As paranoia eased, women began to come back to work at Jane, determined to carry on.

“After the bust, we had a meeting and were told ‘Everybody needs to start assisting and learn how to do abortions.’ I was like, ‘Whoa, whoa, whoa!’” said Eileen Smith, who had not been arrested. “But you felt like you really didn’t have much of a choice. We had to keep the service running.”

Laura Kaplan volunteered for the Janes, later immortalizing the group in her book,

The preliminary hearing for the arrested seven was in August. Several of the women in the apartment waiting for abortions the day of the arrest suddenly developed amnesia and refused to testify. According to Kaplan’s book, one of the women later said, “The cops tried to push me around, but f**k them. I wasn’t going to tell on you.”

It didn’t matter. Each Jane was charged with 11 counts of abortion and conspiracy to commit abortion, with a possible sentence of up to 110 years in prison.

As they waited for trial, the lawyer for the seven, Jo-Anne Wolfson, adopted delaying tactics, Kaplan said. A case representing a Texas woman, cited as “Jane Roe” to protect her privacy, was being considered by the US Supreme Court. If the Court ruled in Roe’s favor, the case against the Jane’s might be thrown out.

That’s exactly what happened. On March 9, 1973, three months after the Supreme Court had legalized abortion in the US, the case against the seven women was dropped and their arrest records were expunged.

Later that spring, a majority of Janes, burned out by the intensity of the work over the last few years, voted to close shop. An end of Jane party was held on May 20. According to Kaplan’s book, the invitation read:

“You are cordially invited to attend The First, Last and Only Curette Caper; the Grand Finale of the Abortion Counseling Service. RSVP: Call Jane.”

Today, most of the surviving members of Jane are in their 70s and 80s, shocked but somehow not surprised by the actions of abortion opponents.

“This is a country of ill-educated politicos who know nothing about women’s bodies, nor do they care,” said Dorie Barron. “It will take generations to even begin to undo the devastating harm to women’s rights.”

In the meantime, women should research all available options, keep that information confidential, seek support from groups working for abortion rights, and “share your education with as many women as you can,” Barron added.

As more and more reproductive freedoms have been rolled back over the past year, many of the Janes are angry and fearful for the future.

Abortion rights demonstrators walk across the Brooklyn Bridge in New York nearly two weeks after the leak of a draft Supreme Court opinion that would overturn Roe v. Wade.

“This is about the most intimate decision of our lives — when, whether and with whom we have a child. Everyone should have the ability to make decisions about our own lives, bodies, and futures without political interference,” said Heather Booth, who has spent her life after leaving Jane fighting for civil and women’s rights.

“We need to organize, raise our voices and our votes, and overturn this attack on our freedom and our lives. I have seen that when we take action and organize we can change the world.”

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End of data sharing could make Covid-19 harder to control, experts and high-risk patients warn | CNN



KFF Health News
 — 

Joel Wakefield isn’t just an armchair epidemiologist. His interest in tracking the spread of covid is personal.

The 58-year-old lawyer who lives in Phoenix has an immunodeficiency disease that increases his risk of severe outcomes from covid-19 and other infections. He has spent lots of time since 2020 checking state, federal, and private sector covid trackers for data to inform his daily decisions.

“I’m assessing ‘When am I going to see my grandkids? When am I going to let my own kids come into my house?’ ” he said.

Many Americans have moved on from the pandemic, but for the millions who are immunocompromised or otherwise more vulnerable to covid, reliable data remains important in assessing safety.

“I don’t have that luxury to completely shrug it off,” Wakefield said.

The federal government’s public health emergency that’s been in effect since January 2020 expires May 11. The emergency declaration allowed for sweeping changes in the U.S. health care system, like requiring state and local health departments, hospitals, and commercial labs to regularly share data with federal officials.

But some shared data requirements will come to an end and the federal government will lose access to key metrics as a skeptical Congress seems unlikely to grant agencies additional powers. And private projects, like those from The New York Times and Johns Hopkins University, which made covid data understandable and useful for everyday people, stopped collecting data in March.

Public health legal scholars, data experts, former and current federal officials, and patients at high risk of severe covid outcomes worry the scaling back of data access could make it harder to control covid.

There have been improvements in recent years, such as major investments in public health infrastructure and updated data reporting requirements in some states. But concerns remain that the overall shambolic state of U.S. public health data infrastructure could hobble the response to any future threats.

“We’re all less safe when there’s not the national amassing of this information in a timely and coherent way,” said Anne Schuchat, former principal deputy director of the Centers for Disease Control and Prevention.

A lack of data in the early days of the pandemic left federal officials, like Schuchat, with an unclear picture of the rapidly spreading coronavirus. And even as the public health emergency opened the door for data-sharing, the CDC labored for months to expand its authority.

Eventually, more than a year into the pandemic, the CDC gained access to data from private health care settings, such as hospitals and nursing homes, commercial labs, and state and local health departments.

CDC officials have been working to retain its authority over some information, such as vaccination records, said Director Rochelle Walensky.

Walensky told the U.S. House in February that expanding the CDC’s ability to collect public health data is critical to its ability to respond to threats.

“The public expects that we will jump on things before they become public health emergencies,” she later told KFF Health News. “We can’t do that if we don’t have access to data.”

The agency is negotiating information-sharing agreements with dozens of state and local governments, Walensky said, as well as partnering with the Centers for Medicare & Medicaid Services. It is also lobbying for the legal power to access data from both public and private parts of the health care system. The hospital data reporting requirement was decoupled from the health emergency and is set to expire next year.

But it’s an uphill battle.

“Some of those data points we may not have anymore,” Walensky said, noting how access to covid test results from labs will disappear. That data became a less precise indicator as people turned to at-home testing.

Moving forward, Walensky said, the CDC’s covid tracking will resemble its seasonal flu surveillance, which uses information from sample sites to establish broad trends. It’ll offer a less granular view of how covid is spreading, which experts worry could make it harder to notice troubling new viral variants early.

Overall, federal courts — including the U.S. Supreme Court — have not been supportive of expanded public health powers in recent years. Some issued rulings to block mask mandates, pause mandatory covid vaccination requirements, and end the nationwide eviction moratorium.

Such power limits leave the CDC with its “utterly dysfunctional, antiquated” data collection system, said Lawrence Gostin, director of the O’Neill Institute for National and Global Health Law at Georgetown University. It’s like a “mosaic,” he said, in which states and territories collect data their own way and decide how much to share with federal officials.

Although covid numbers are trending down, the CDC still counts thousands of new infections and hundreds of new deaths each week. More than 1,000 Americans are also hospitalized with covid complications daily.

“When we stop looking, it makes it all more invisible,” Gostin said. “Covid knowledge and awareness is going to melt into the background.”

State and local public health officials are generally willing to share data with federal agencies, but they often run into legal hurdles that prevent them from doing so, said Marcus Plescia, chief medical officer of the Association of State and Territorial Health Officials.

It will take a lot of work to loosen state restrictions on public health data. And the political will may be lacking, considering many jurisdictions have rolled back public health powers in recent years. Until rules change, the CDC’s power to help states is limited, Plescia said.

“Their hands are tied a little bit in how much they can do,” he said.

Public health officials rely on data to target interventions and track how well they’re working. A lack of information can create blind spots that exacerbate poor outcomes for high-risk populations, said Denise Chrysler, a senior adviser for the Network for Public Health Law.

“If you don’t have the data, you can’t locate who you’re failing to serve. They’re going to fall between the cracks,” she said.

The lack of covid data broken down by race and ethnicity in the early days of the pandemic obscured the outsize impact covid had on marginalized groups, such as Black and Hispanic people, Chrysler said. Some states, like New Jersey and Arizona, issued rules to mandate the collection of race and ethnicity data for covid, but they were temporary and tied to state emergency declarations, she said.

Inconsistent local data precipitated the end of privately run projects that supplemented government resources.

The available data researchers could pull from “was just terrible,” said Beth Blauer, associate vice provost for public sector innovation at Johns Hopkins, who helped launch its dashboard. The decision to end the program was practical.

“We were relying on publicly available data sources, and the quality had rapidly eroded in the last year,” she said.

The fast collapse of the data network also raises questions about state and local agencies’ long-term investments in tracking covid and other threats.

“I wish that we had a set of data that would help us guide personal decision-making,” Blauer said. “Because I’m still fearful of a pandemic that we don’t really know a ton about.”

To Schuchat, formerly of the CDC, there’s a lot of ground to regain after years of underinvestment in public health, long before the covid pandemic — and high stakes in ensuring good data systems.

The CDC’s detection of a vaping-related lung illness in 2019 was recognized after case reports from a hospital in Wisconsin, she said. And she attributed the nation’s slow reaction to the opioid crisis on poor access to emergency room data showing a troubling trend in overdoses.

“We’re much better when we detect things before there’s an emergency,” Schuchat said. “We can prevent major emergencies from happening.”

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The cost of senior care is rising while caregivers are ‘drowning’ without help | CNN



CNN
 — 

For most of her life, Tammy La Barbera has been taking care of someone other than herself. First, it was her two children. Then, it was her brother and father, who both died after being diagnosed with cancer. Now, Tammy is taking care of her 90-year-old mother, Ada, who was diagnosed with dementia five years ago.

In recent months, Ada’s condition deteriorated so quickly that Tammy resigned from her job as an event manager to become a full-time caregiver.

“I don’t have help here, and I know it’s going to get worse,” she said.

Tammy, 53, struggles to provide her mother with the care she needs and would like to place her in a memory care facility equipped to handle the mood swings and outbursts that her mother has due to her condition. But Tammy says she doesn’t expect to ever have enough money to pay for that care.

Recently, she said, she looked into an assisted living facility near her home in Murrieta, California. She says placing her mother at the facility – or others like it – would cost between $7,000 and $10,000 a month out-of-pocket.

Across the country, millions of caregivers like Tammy are looking after a loved one – a relative or a friend. About 53 million US adults are caregivers, according to a 2020 report from AARP.

Sixty-three percent of US caregivers who look after adults said the person they were looking after needed care because of “long-term physical conditions,” the report says.

Since her mother’s diagnosis, Tammy’s life has been turned upside-down.

Ada cannot bathe herself or cook for herself. Most days, she doesn’t even remember who her daughter is.

“All her daily duties are done by me,” Tammy said, caring for her mother all day is like being a prisoner in her own home.

Sooner or later, she said, she will have to move her mother to a long-term care facility and do whatever she can to pay for it.

“I know that I’m reaching a crossroads with my mom’s care, and I’m trying to do this as long as I can,” Tammy said. “But I know the way things are going, and if she’s progressing pretty rapidly, I’m not going to have a choice.”

Ada La Barbera was a teacher for 20 years, so she gets a pension check each month. Tammy puts that money, along with her mother’s monthly Social Security checks, toward bills.

It’s just over $3,300 a month, and along with Tammy’s dwindling savings, it’s barely enough to keep them afloat, Tammy says. She can barely afford her rent.

It’s because of her financial struggles that Tammy has been putting off long-term care for her mother.

Where Tammy and Ada live in California, a home health aide would cost about $137 for one hour of care, according to an online calculator from AARP.

“When you’re on a fixed income, you can’t afford that,” Tammy said. “So I don’t have the luxury to do that.”

A long-term care facility is even more expensive. On average, it costs $10,830 a month to stay at a nursing home and $5,806 per month for an assisted living facility, according to the nonprofit National Investment Center for Senior Housing and Care.

Then there is memory care, where Tammy says her mother belongs.

Memory care facilities are the fastest-growing sector of the senior housing market, according to the National Investment Center. On average, memory care costs just over $7,500 a month, center COO Chuck Harry says.

These facilities offer more hands-on care for people with dementia. They can include special features like locked units that prevent wandering patients from leaving the facility unattended and enclosed outdoor spaces where patients can move about safely.

A nurse comes to see Ada at home every other week. During that 40-minute visit, Ada’s vitals are checked, and her medications are adjusted. Those visits are covered by Medicare, Tammy says.

Medicare is a medical health insurance program that is for people 65 years or older. But Medicare does not cover the cost of a long-term care facility.

And although Ada and Tammy are on a fixed income, Ada doesn’t qualify for other federal safety net programs like Medicaid because Tammy says they are not considered low-income.

For middle-income families, Medicaid goes into effect only after a family has gone through the process of “spending down” their assets until they qualify for the program.

“That is usually the path of anyone going into a nursing home for the long term: spending your own money – which is all out of pocket – and then reaching a Medicaid level of eligibility,” said Susan Reinhard, senior vice president and director of the AARP Public Policy Institute, noting that each state has its own Medicaid program and process.

Until a family qualifies for Medicaid, the program will only cover the medical costs of a stay at a long-term facility, not room and board.

Caroline Pearson, the lead author of a landmark 2019 demographic study called “The Forgotten Middle,” says most middle-income Americans find themselves in a position where they are too “wealthy” to receive Medicaid coverage for long-term care services but too “poor” to afford the out-of-pocket costs of that care.

So why does putting a loved one in a nursing home or an assisted living facility cost so much? Providing long-term care services is expensive, Pearson says, adding that the senior housing industry requires a large workforce of nurses and staff to support it. That is also expensive.

Additionally, as seniors sell their homes and move into these facilities, long-term care facilitators are essentially providing housing, she said. And housing is not cheap.

The senior housing industry also caters to a high-income population, according to Pearson, who is now executive director of the Peterson Center on Healthcare.

“The fit and finish at the buildings … [residents] expect to be really high-end. The amount of amenities and services that are part of that senior housing property … they expect to be high-end,” she said. “The market has seen good returns and then replicated that model.”

And the demand for high-quality, long-term care is only expected to go up as the baby boomer generation continues to age, according to Pearson.

“Most people don’t begin to need long-term care services until between 75 and 85. And so as the baby boomers hit those ages, that is where we’re going to see that demand really explode,” she said.

According to the US Census Bureau, baby boomers – people born from 1946 to 1964 – will all be over the age of 65 by 2030. The oldest members of that generation will be 84 at that point.

In 2019, there were about 8 million middle-income seniors – people 75 and older – living in the United States, Pearson says in her study.

She projects that there will be 14.4 million middle-income seniors in the US by 2029, with 60% expected to have mobility limitations and 20% expected to have “high health care and functional needs.”

“We are going to [have] double the number of middle-income seniors when the baby boomers age,” Pearson said. “Fewer of those baby boomers are going to have spouses or children who live nearby to provide unpaid caregiving support.”

Most family caregivers are spouses or middle-age daughters, the study notes.

At the end of the day, Pearson says, many Americans don’t think about aging until it’s staring them in the face.

“People [think] that they will live healthy and independently until they die, and sadly, that’s just statistically very unlikely for most people,” she said.

Tammy, with her parents and brother, says her family thought they were prepared for the future.

Tammy says her family thought they were prepared for the future.

In 1965, Ada married Tammy’s father, Peter “Jazz” La Barbera, an accountant.

“My dad was a very, very good saver, and he did have a little bit of savings,” Tammy said. “He was set just for the future, not for anything unexpected.”

In 1970, Tammy was born in Queens. She and her older brother, Peter Jr., grew up an hour outside New York City.

“We had a small house, and we lived in that house our whole lives, and … we were the perfect family,” Tammy said.

She eventually moved to California, where she had two kids. Her parents followed, along with her brother and his wife.

Tammy says the physical and mental toll of caring for her husband and son kickstarted Ada's health problems.

But soon after the move, Peter Jr. was diagnosed with cancer, and he died a year later. Two years after that, Tammy’s father received a cancer diagnosis and died within seven weeks.

Tammy believes that the physical and financial toll of taking care of her son and husband kickstarted her mother’s health problems. Shortly after her husband died, Ada had a minor stroke and was diagnosed with dementia.

“It’s almost like her grief was so overwhelming. Especially losing her son. I don’t think her brain had the capacity to deal with anything else anymore,” Tammy said.

The stress associated with taking care of a loved one full-time, or even part-time, can have negative consequences, research has shown.

Some of the physical symptoms associated with taking care of someone with dementia include higher levels of depression and anxiety, worse self-reported physical health, compromised immune function and increased risk of early death, the US Centers for Disease Control and Prevention reports.

Over half (53%) of caregivers indicate that a decline in their health compromises their ability to provide care, according to the CDC.

“I have sacrificed 10 years of my life being a caretaker, and I don’t have a life,” Tammy said. “It’s an honor to take care of my mother. But doing this every single day … it’s a lot.”

Tammy is preparing for her own future by taking part in genetic testing that will tell her whether she is more likely to develop dementia like her mother.

“I would like to prepare as much as I can, whether it’s medication or adjusting my life,” she said. “I just don’t want to put my kids through this.”

She would also like to see changes to the system.

Pearson says the solution to the cost issue is not simple and will probably be resolved only through a combination of incremental Medicaid expansion, changes to the senior housing industry and federal subsidies.

AARP’s Reinhard says tax credits for family caregivers could help people like Tammy get a break. Employers could also help by supporting workers who need to stop working to care for a family member or friend.

In September, the US Department of Health and Human Services, through its Administration for Community Living, announced a national strategy aimed at supporting family caregivers, highlighting nearly 350 actions the federal government will take.

The strategy also includes 150 actions that it says local governments, communities and private businesses can adopt to help build a more supportive system.

“Supporting family caregivers is an urgent public health issue, exacerbated by the long-term effects of the COVID-19 pandemic,” HHS Secretary Xavier Becerra said in a news release. “This national strategy recognizes the critical role family caregivers play in a loved one’s life.”

Gal Wettstein, a senior research economist for the Center for Retirement Research at Boston College, says it would be beneficial for middle-income Americans to speak to a financial adviser as early as possible and transfer assets to a family member if they think they might need to enter a long-term care facility in the near future.

This way, if their only option is to spend down their assets to become eligible for Medicaid, they hit that eligibility sooner.

Long-term care insurance is another option, but experts say it’s rarely sold anymore because it is typically more expensive than other kinds of insurance.

Pearson says Americans can plan ahead by investing in long-term care insurance in their 40s for it to benefit them when they will most likely need it, in their 80s.

Wettstein also recommends long-term care insurance.

“[Long-term care insurance] plans are getting harder and harder to sign, but they do still exist. Some insurers will still sell them,” he said.

Ultimately, covering the cost of senior care comes down to families and how much they save for the future, until changes are made by senior housing providers and policy makers.

“We are so far away from having any sort of swift and universal solution,” Pearson said.

For now, Ada is on a waitlist for a spot at a skilled-nursing home about an hour from where they live. If she moves there, her cost of living might be partially covered through a Medicaid program.

Tammy was told that Ada is one of more than 2,000 people waiting for a spot.

“We’re drowning. We’re care workers, and we’re drowning,” Tammy said. “We don’t have help.”

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A quarter of Americans live with polluted air, with people of color and those in Western states disproportionately affected, report says | CNN



CNN
 — 

About 1 in 4 people in the United States – more than 119 million residents – live with air pollution that can hurt their health and shorten their lives, according to a new report from the American Lung Association. People of color are disproportionately affected, as are residents of Western cities.

Since President Richard Nixon signed the Clean Air Act in 1970, emissions of outdoor air pollutants have fallen 78%, according to the US Environmental Protection Agency. But Wednesday’s 2023 State of the Air report, which focuses on ozone and particle pollution, shows that millions put their health on the line every time they step outside.

To capture pollution levels at the county level, researchers analyzed data collected by the EPA’s Air Quality System, a repository of ambient air quality data from more than 10,000 monitors. They characterized the hourly average ozone concentration and the 24-hour average particle pollution concentration for 2019-21 at each monitoring site and factored in year-round pollution information from the EPA.

There were significant improvements in some areas. Generally, 17.6 million fewer people were breathing unhealthy air than in last year’s report, due largely to falling levels of ozone in some regions.

Ozone pollution is the main ingredient in smog. It comes from cars, power plants and refineries. Exposure to ozone can immediately exacerbate asthma symptoms, and people with long-term exposure to higher levels face a significantly higher risk of death from respiratory diseases than those who live with cleaner air.

Around 25% more counties got an A grade in the report for lower levels of ozone pollution. Some of that improvement can be attributed to the Clean Air Act, according to Katherine Pruitt, author of the report and the American Lung Association’s national senior director for policy.

Emission controls have helped, she said, as has the country’s continuing move away from its reliance on coal for its energy needs. Even something simple as the increase in the number of people who work from home has played a role.

“The Biden administration has set themselves a good, strong to do list of things that will help with environmental justice and climate protection,” Pruitt said. “They’re moving kind of slow, though. So we’d like them to pick up the pace.”

Despite the progress, not everyone was lucky enough to live in a county with good ozone levels. More than 100 million people live in counties that get an F for ozone smog, the report says.

Western and Southwestern cities are the most ozone-polluted, with 10 of the 25 most-polluted cities in California. New York, Chicago and Hartford, Connecticut, were the only three on that list east of the Mississippi River.

The five metropolitan areas with the worst ozone pollution are Los Angeles-Long Beach, California; Visalia, California; Bakersfield, California; Fresno-Madera-Hanford, California; and Phoenix-Mesa, Arizona.

Particle pollution, the other form of pollution tracked in the report, still seems to be a significant issue for the US.

Often hard to see, particle pollution is a mix of solid and liquid droplets that may come in the form of dirt, dust, soot or smoke. Coal- and natural gas-fired power plants create it, as do cars, agriculture, unpaved roads, construction sites and wildfires.

Particle pollution is so tiny – 1/20th of a width of a human hair – that it can travel past your body’s usual defenses.

Instead of being carried out when you exhale, it can get stuck in your lungs or go into your bloodstream. The particles cause irritation and inflammation and may lead to respiratory problems. Exposure can cause cancer, stroke or heart attack; it could also aggravate asthma, and it has even been associated with a higher risk of depression and anxiety, studies show.

The new report says the number of people living in counties with failing grades for daily spikes of particle pollution was the highest it has been in a decade. Nearly 64 million live with these kind of unhealthy spikes in counties that get failing grades.

One driver of the high amounts of particle pollution are the wildfires that have consumed hundreds of thousands of acres. In 2021 alone, there were 14,407 fires, many in the West, according to the National Interagency Fire Center. There used to be a wildfire season, experts say, but now they happen year-round.

Those fires are why the regions with the highest concentrations of air pollution are largely in the West.

When the American Lung Association started producing its report in 2004, 106 counties in 30 states got failing grades for daily spikes in particle pollution. Fewer than half were in eight states west of the Rocky Mountains. Today, 111 counties in 19 states got Fs for spikes in particle pollution, and all but eight counties are in the West, the report says.

Urban centers in the Rust Belt and the industrialized East had gotten the most failing grades in the early 2000s, but many have cleaned up and now get passing grades.

Bakersfield, California, displaced Fresno as the metropolitan area with the worst short-term particle pollution, but Fresno did not suddenly develop cleaner air. That city still had the most-polluted label for year-round particle pollution, tied with Visalia, in the agricultural San Joaquin Valley.

Los Angeles is still the city with the worst ozone pollution, according to the report, as it has been for all but one of the years included in the report.

California has some of the more progressive environmental legislation in the country, but the climate crisis has not been kind to the state, said Tarik Benmarhnia, an air pollution and wildfire researcher at the University of California, San Diego, who did not work on the new report.

“All these cities like Bakersfield and Visalia are in a valley near the forests that are seeing big fires. There’s also intense agricultural and industrial work there, so they unfortunately have all the worst conditions for air pollution,” Benmarhnia said.

There are some newcomers to the list of the 25 areas with the most particle pollution, including Denver and Fargo, North Dakota. Reno, Nevada; Yakima and Spokane, Washington; and Boise, Idaho; all made the worst list this year.

San Luis Obispo, California; Portland, Oregon; and Seattle and Bellingham, Washington; all moved off the list of worst 25 cities.

Residents in the cities ranked worst for particle pollution are living with more of it, the report says. In the top 25 cities with the worst air, the average number of days residents were exposed to high levels of fine particle pollution increased to a weighted average of 18.3, up from 16.5 in last year’s report.

East of the Mississippi, Pittsburgh and Lancaster, Pennsylvania, were the two worst metropolitan areas in the country, posting more days high in fine particle pollution in this year’s report.

Not everyone experiences pollution the same way in the US. Regardless of the region, communities of color bear the brunt of the problem.

Specifically, although people of color make up 41% of the overall US population, they are 54% of the nearly 120 million people living in counties with at least one failing grade for unhealthy air. And in the counties with the worst air quality, 72% of the 18 million residents are people of color, the report said.

Other research has also shown this trend. On maps that lay out areas with high levels of air pollution and where communities were redlined – areas where Black people were forced to live – they line up perfectly, Pruitt said.

“Then, the other aspect is, when you have a community of color that is a voluntary community, people aren’t forced to live there, those are communities that tend to have less of a voice, so decision makers place polluting sources in those communities because there’s not as much howling by people with power when they do. So those communities get the highways; they get the landfills; they get the fence lines,” she said.

There’s a myth that only poor communities live with disproportionate pollution levels, says Chris Tessum, a professor in the Civil and Environmental Engineering Department of the University of Illinois. Tessum, who was not involved in the new report, says race really is the determining factor.

“The thinking is that people with more money will buy better property, which has lower air pollution and that’s just the way of the world or whatever, but that’s just kind of emphatically not, not true,” he said.

Communities need to play a key role in making decisions to help clean air, Tessum said.

“People that have the power will use that power to benefit themselves and not the people that have been historically overburdened,” he said.

The new report says government and residents can make a difference. One suggestion is to leverage Inflation Reduction Act funding to help reduce emissions at ports and to invest in zero-emission heavy-duty vehicles and in infrastructure that would improve air quality monitoring.

States can also use the Clean Air Act authority to adopt the California zero-emissions standards for cars and trucks, the report says.

At the federal level, agencies must finalize stronger limits on air pollution to truly protect public health and advance environmental justice, the report says, including standards to move the country toward zero-emissions vehicles. The EPA also has to set stronger national standards for particle pollution and ozone, the researchers say.

Pruitt said she knows firsthand how better policies can work. She said growing up before the Clean Air Act, pollution was so high that she could see it every time she stepped outside. Today, the pollution is not nearly as visible.

“I’m in my mid-60s, and of course, air pollution was very tangible when I was young, but these days, thank goodness it isn’t. Most people don’t see it,” she said. Unless a person has a lung condition, they may not even feel it.

But just because you can’t see it or feel it doesn’t mean it’s not there. Pruitt encourages people to remember that no level of pollution is safe. The World Health Organization estimates that the combined effects of ambient air pollution and household air pollution are associated with 6.7 million premature deaths annually.

“People don’t really recognize that what they’re breathing is impacting their health,” Pruitt said.

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To protect kids from tobacco, pediatricians say, focus should be on quitting — or never starting | CNN



CNN
 — 

Although smoking rates for adults in the US are at their lowest recorded levels, more must be done to stop children from using tobacco, according to a new set of policy statements from the American Academy of Pediatrics.

The statements, published Monday, are the association’s first tobacco policy update since 2015. They’re based on newer science and better reflect how many children now use e-cigarettes as more kid-friendly products have flooded the market.

AAP policy statements are created by expert pediatricians to help leaders craft more effective public health policy and to guide physicians on how to keep kids safe – in this case, from tobacco.

Researchers have been telling Americans for generations that tobacco products are bad for them, yet nearly 200 US children take up smoking every day, according to the US Centers for Disease Control and Prevention.

Tobacco use is the No. 1 cause of preventable death in the United States, the CDC says.

The rates of kids who use e-cigarettes are high, the AAP says, and the use of hookahs and cigars has not declined. However, the pediatricians note, traditional cigarette smoking has declined over the years.

Specifically, in 2022, nearly 5% of middle school and about 17% of high school students reported some form of current tobacco use, according to the CDC. In 2021, about 11% of middle schoolers and 34% of high schoolers said they had ever tried tobacco.

These “try rates” are important because most adult smokers started at young ages, according to the CDC.

And in smoking rates remain disproportionately high in certain communities, including those who are Black, Hispanic, Native American, Alaska Native or LGBTQ+.

In its updated policy statements, the AAP continues to encourage pediatricians to screen for tobacco use as part of a child’s regular checkup. A talk about tobacco should start no later than age 11 or 12, the report says.

For kids who want to quit tobacco, pediatricians should refer them to behavioral interventions like counseling or prescribe nicotine replacement therapy, which has been shown to be effective with children who have moderate or severe tobacco addiction.

That practice has shifted over the years, according to Dr. Susan Walley, co-author of the new policy statements. In medical school, she said, her professors didn’t talk much about smoking except to tell people to quit.

“Now, we know it’s an addiction and a chronic medical disease. Telling someone just to quit would be like telling somebody who’s diabetic, ‘you just need to think about making your blood sugar better.’ We’ve learned so much,” said Walley, a pediatrician at Children’s National in Washington, D.C.

The new report notes that children who smoke cigarettes should not be encouraged to use e-cigarettes as an alternative. Some experts have argued that e-cigarettes are a good smoking cessation tool, but the AAP says evidence is lacking.

At the checkup, pediatricians should also ask caregivers about their tobacco habits and make recommendations. Nearly 40% of kids are regularly exposed to secondhand smoke, the AAP says, and caregiver use is the biggest reason children are exposed to secondhand smoke.

In children, secondhand smoke can lead to respiratory and ear infections and asthma attacks. Since 1964, more than 2.5 million nonsmokers who didn’t smoke have died from health problems caused by exposure to secondhand smoke, according to the CDC.

The AAP is urging the US Food and Drug Administration to better regulate all tobacco and nicotine products and the federal government to fund child-specific tobacco prevention, screening and treatment programs.

Despite getting nearly $27 billion from a tobacco settlement and tobacco taxes this year, states shortchange programs designed to prevent kids from using tobacco products and help people quit, according to the Campaign for Tobacco-Free Kids.

The AAP recommends raising the prices on tobacco products, as higher prices can act as a deterrent for young users.

Taxes are also considered one of the most effective ways to reduce smoking, particularly among children, studies have found. However, Congress hasn’t raised federal tobacco taxes in 14 years. The federal cigarette tax remains $1.01 per pack, and taxes vary for other tobacco products. No state increased its cigarette taxes in 2022, either.

The AAP policy statements on tobacco recommend a total flavor ban, including menthol.

In April, the FDA proposed eliminating two tobacco products popular with children: flavored cigars and menthol cigarettes. But it could be years before that becomes a reality, as even if that rule is finalized this year, manufacturers will probably sue to keep it from going into effect.

Tobacco companies have long used menthol to mask the unpleasant flavors of their products. Studies show that it makes the products more attractive to new users and makes it harder for people to quit.

Tobacco companies are also frequently introducing flavored products in child-friendly disposable vapes in flavors like blue raspberry and sour apple.

“Sadly, they also have very, very high levels of nicotine. Just the tobacco products themselves, they have really exploded. Part of it is the lack of regulation, and then on top of that, there’s these new oral nicotine products that are unfortunately gaining a lot of popularity from our youth,” Walley said.

Walley is optimistic that more children can quit tobacco or not start in the first place, but she knows that pediatricians have their work cut out for them, based on what her sons tell her about school.

“I’m a parent of three boys, and when I hear from my boys [that] they don’t want to go to the bathroom because people will be vaping in there, it just breaks my heart that they’re not having a bathroom break all day because of that,” she said. “That kids are so addicted that they have to sneak away to the bathroom, or they are vaping in class using some covert pieces of clothing, shows this really is a public health crisis.

“We at the AAP want to make sure that people remember, this is one of the most modifiable things in terms of social determinants of health,” Walley said. “A lot of the social determinants of health, we really can’t control, but whether you use tobacco or whether you start using tobacco is something that we can do something about.”

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Texas abortion drug ruling could create ‘slippery slope’ for FDA approvals, drug research and patients, experts say | CNN



CNN
 — 

What happened in one judge’s courtroom in Texas could have drastic effects for the United States’ entire drug approval process, experts warn.

US District Judge Matthew Kacsmaryk’s ruling that suspended the US Food and Drug Administration’s approval of the medication abortion drug mifepristone was an unprecedented one, the first time a court has bypassed the federal system set up to determine what drugs should be allowed on the market.

Regardless of whether the ruling – or a part of it – is ultimately allowed to stand, legal scholars, scientists and drugmakers are concerned that the decision could start a trend of drugs being targeted in courts, creating a chilling effect on drug development in the US and hurting patients in the process.

Vaccines, including the Covid-19 shots, antidepressants and psychotropic medicines could be at risk, some said.

“Well, one does not want to be Chicken Little,” former FDA Commissioner Dr. Jane Henney said Wednesday, but “I can’t imagine that it wouldn’t have implications for other products.

“The approval process will be at risk, and it’s not just an approval process that patients rely on and providers rely on, it’s one that has been considered the gold standard, really, for the world,” said Henney, who was the head of the FDA when mifepristone was approved.

Since the dawn of the 20th century, the FDA has had the sole authority in the United States to regulate drugs. In 1906, the federal government created the agency to enforce the Pure Food and Drug Act, which was instituted to ensure that medicine, food and cosmetics were safe.

Over the years, that authority became more defined.

After elixir of sulfanilamide, a drug used to treat streptococcal infections, killed 107 people in 1937, Congress created the Food, Drug, and Cosmetic Act. Signed into law in 1938 by President Franklin D. Roosevelt, it required manufacturers to conduct pharmacological studies to prove that their drugs were safe before they could be sold or advertised. In 1962, drug manufacturers were also required to prove to the FDA that their products were effective.

Modern drug approval in the US is a careful and conscientious process. Before any drug goes to market, there are countless hours of research, the work and expertise of multiple scientists, and several layers of oversight for approval.

Until now, the courts have been deferential to the FDA’s process and have never overturned an FDA decision on the grounds that the agency misjudged the science, said William Schultz, a former deputy commissioner at the FDA and former general counsel for the Department of Health and Human Services.

“Any FDA drug approval involves hundreds of judgments by the agency. And if a court feels free just to kind of take a fresh look at each of those, there’s a chance that a court will find one of those FDA judgments wrong,” Schultz said in an online discussion Monday about the impact of the Texas court’s ruling that was hosted by Protect Our Care, an organization that advocates for equitable and affordable health care.

Hundreds of well-known biotech and pharmaceutical company leaders, concerned about the effects of Kacsmaryk’s ruling on other drug approvals, signed an open letter Monday in support of the FDA’s authority “to approve and regulate safe, effective medicines for every American.”

The letter also advocated a reversal of the mifepristone decision from a judge with “no scientific training,” saying it “set a precedent for diminishing FDA’s authority over drug approvals, and in so doing, creates uncertainty for the entire biopharma industry.”

In a separate statement, the biotech industry group BIO’s interim president and CEO, Rachel King, emphasized the “dangerous precedent” the decision sets.

“The preliminary ruling by a federal judge in Texas is an assault on science and the FDA’s long-standing role as the authority to make decisions on the safety and efficacy of medicines. For a court to invalidate the approval of a drug that was reviewed and approved more than two decades ago is without precedent. As legal scholars have noted, the courts do not have the medical expertise to make these types of scientific determinations,” King said.

The main lobbying group for the pharmaceutical industry, PhRMA, criticized Kacsmaryk’s ruling as undermining the regulatory process.

“PhRMA has serious concerns with any court substituting its opinion for the FDA’s expert approval decision-making,” said James C. Stansel, the association’s executive vice president, general counsel and corporate secretary. Stansel added that such a decision could have a “chilling effect on the research and development ecosystem.”

The pharmacutical sector is a huge part of the American economy. Of the world’s 25 largest phamacutical companies, 10 are based in the US, and most of the others have a large base of operations in the country.

Often, the US market is the first to get access to new drugs, but that could change if lawsuits undermine the regulatory integrity of the FDA process, said Susan Lee, partner in the law firm Goodwin’s Life Sciences group and Life Sciences Regulatory & Compliance practice, who works with companies to get drugs approved by the FDA.

“If there do tend to be more lawsuits like this, I wonder if there might be a little bit of a tendency to not always look at the US as the first market,” Lee said. “Some manufacturers may say ‘we’d rather go to Europe, where we’re not going to be sued on a jurisdiction-by-jurisdiction basis.’ “

Lee also wonders whether manufacturers will abandon efforts to develop drugs that could be considered unappealing to some, such as those that help women’s health or work to prevent HIV.

“I think there are just certain sectors that are already kind of thinking about whether they might also have a target on their back. I’ve definitely heard that discussed,” Lee said.

The groups at the heart of the Texas case have not disclosed any further plans regarding lawsuits over medications, but experts say they are already hearing concern.

“I’ve already been getting questions from lawmakers and other people about ‘could the Covid vaccine be next?’ or other things that may have stigma around it,” said Dr. Kristyn Brandi, an ob/gyn and abortion provider in New Jersey and a spokesperson for the American College of Obstetricians and Gynecologists.

The Covid-19 vaccines have been thoroughly tested and found to be safe and effective, but they’re the subject of conspiracy theories and misunderstanding about how mRNA vaccines were tested. Beliefs that the vaccines were tested on recently harvested aborted fetal cells made some people decidedly anti-vaccine.

Dr. Lynn R. Goldman, professor and dean of the Milken Institute School of Public Health at George Washington University, is also concerned that mRNA vaccines could be targeted soon.

“There might be people who disagree with some of the technologies that are used by vaccine makers, like the mRNA vaccines, but feeling uncomfortable about a technology is not the same thing as identifying that there is risk,” she said in the Protect Our Care conversation.

Members of the LGBTQ+ community may also be vulnerable, experts say, as activists could target puberty blockers or hormones used in gender-affirming therapy.

“I don’t like to do slippery slope, but I’m also very worried about things like gender-affirming care, since there’s already been so many laws about that recently in other states,” Brandi said.

There is political pressure against other vaccines, antidepressants and psychotropic medicines, among others, former FDA Commissioner Margaret Hamburg and former Principal Deputy Commissioner Joshua Sharfstein wrote in an editorial published Thursday in the journal Science.

“If judges begin to dictate the terms of medication access, then others will seek to use ideology and influence to advance their agendas,” they warn.

Goldman said that any legal decision that could undermine the FDA drug approval process would ultimately hurt the doctors who prescribe them and the people who use them.

Doctors don’t have time to vet all the studies used to prove that a drug is safe and effective, so they rely on the FDA for this work, she said. Court interference could confuse this process.

“I think that this is, for doctors, an incredibly serious moment, because up to now, we have been able to trust that an approval by the FDA is a science-based decision and that we can say that if the FDA has approved a drug, that it is safe for us to use,” Goldman said.

A lack of confidence in the drug approval process will ultimately hurt people far beyond the most recent decision, Protect Our Care Chair Leslie Dach says.

“Confidence that the FDA can do its work is essential for clinicians and patients who depend on it in its decision-making for matters of life and death,” Dach said.

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Biden administration declares fentanyl laced with xylazine ‘an emerging threat’ in the US | CNN



CNN
 — 

The White House has declared that the powerful synthetic opioid fentanyl combined with xylazine – an animal tranquilizer that’s increasingly being used in illicit drugs – is an “emerging threat” facing the United States due to its role in the ongoing opioid crisis.

Administration officials call the threat FAAX, for fentanyl-adulterated or -associated xylazine.

The move, announced Wednesday, marks the first time in history that any administration has declared a substance to be an emerging threat to the country, said Dr. Rahul Gupta, director of the Office of National Drug Control Policy. The SUPPORT Act of 2018 established that the office has authority to declare such “emerging threats,” and no administration has used it until now. Last year, Congress declared methamphetamine an emerging drug threat but none have been declared by an administration previously. Under other agencies or in separate circumstances, concerns such as bioterrorism, infectious diseases or climate change may be identified as “emerging threats.”

“This drug, which is an animal sedative, is being mixed with fentanyl and is being found in almost all 50 states now,” Gupta said Tuesday. “It’s become an important part for us to make sure that we’re declaring it an emerging threat.”

Now that the administration has declared fentanyl combined with xylazine an emerging threat, it has 90 days to coordinate a national response. “We are working quickly to develop and implement a whole of government nationwide plan, with real deliverable action, that will save lives and will be published within 90 days of this designation,” Gupta said.

Xylazine, also known as tranq or tranq dope, has been linked to an increasing number of overdose deaths in the United States due to its rising illicit use. Between 2020 and 2021, overdose deaths involving xylazine increased more than 1,000% in the South, 750% in the West and about 500% in the Midwest, according to an intelligence report released last year by the US Drug Enforcement Administration.

And in some cases, people might not even know that xylazine was in the drug they used.

Just last month, authorities at the DEA issued a public safety alert about the “widespread threat” of fentanyl mixed with xylazine, reporting that in 2022 approximately 23% of fentanyl powder and 7% of fentanyl pills seized by the DEA contained xylazine.

Fentanyl, which has been driving the opioid crisis, is a fast-acting opioid, and people who use it illicitly say that adding xylazine can extend the duration of the high the drug provides.

Xylazine is not an opioid. It is approved by the US Food and Drug Administration for use as a tranquilizer in veterinary medicine, typically in horses, but it is not approved for use in humans. And xylazine can do major damage to the human body, including leaving drug users with severe skin ulcers, soft-tissue wounds and necrosis – sometimes described as rotting skin – that can lead to amputation.

“Xylazine is one of the contaminants in fentanyl, but there could be others,” Gupta said. “So, I think with the declaration of an emerging threat, we’re sending a clear message to producers and traffickers of illicit xylazine and illicit fentanyl that we’re going to respond quicker, we’re going to match the challenge of evolution of these drugs supply, and that we’re going to protect lives first and foremost.”

Now that xylazine has been declared an emerging threat, some of President Biden’s $46 billion drug budget request to Congress can be used to respond.

This year, the Biden administration announced that the President has called on Congress to invest $46.1 billion for agencies overseen by the Office of National Drug Control Policy to tackle the nation’s illicit drug crisis.

If the budget request is not approved, there could be the option to reallocate money within the Office of National Drug Control Policy, but “we don’t want to be in a position where moneys that are being utilized for some other important aspect of saving lives has to be moved away for this purpose,” Gupta said Tuesday. “That is the reason we are asking Congress to act.”

Such funds could be used to test drugs on the street for xylazine, collect data on FAAX, invest in care for people exposed to FAAX and develop potential treatments for a xylazine-related overdose.

The medication naloxone, also known as Narcan, is an antidote for an opioid overdose, but people who have overdosed on a combination of opioids and xylazine may not immediately wake up after taking naloxone, as it may not reverse the effects of xylazine in the same way it does opioids.

“We need to recognize, first of all, that there is a shift that is occurring from organic compounds and substances like heroin and cocaine to more synthetics,” Gupta said of the state of the nation’s illicit drug crisis.

“Both the types of drugs have changed – from predominantly organic to predominantly synthetics – but the way drugs are bought and sold have also changed,” he said. “Now, all you need is a phone in the palm of your hand and a social media app to order and buy some of the most dangerous substances on planet Earth.”

Xylazine is just one of the many adulterants – or substances that are typically added to others – found in the nation’s illicit drug supply.

“All of a sudden, you can synthesize hundreds of compounds and kind of mix them together and see what does the best in the market,” Joseph Friedman, a researcher at the University of California, Los Angeles, told CNN in March. “People are synthesizing new benzodiazepines, new stimulants, new cannabinoids constantly and adding them into the drug supply. So people have no idea what they’re buying and what they’re consuming.”

Some of these adulterants may be as simple as sugar or artificial sweeteners added for taste or additives or fillers that bulk up the drug. Sometimes, they may be contaminants left over from the manufacturing process.

Addicted? How to get help

  • If you’re addicted to prescription drugs, help is available. You can call the Substance Abuse Mental Health Services Administration 24/7 hotline at 1-800-662-HELP(4357) or visit their website.
  • But all of these things can carry real-life health harms, says Naburan Dasgupta, an epidemiologist and senior scientist at the Gillings School of Global Public Health at the University of North Carolina, Chapel Hill.

    Like an opioid, xylazine can depress the respiratory system, so the risk of overdose multiplies when it’s combined with heroin or fentanyl.

    Also, “in the veterinary literature, we know that it causes a really bad severe form of anemia. And so when people are injecting heroin that’s contaminated with xylazine, they can end up with a near-fatal form of blood iron deficiency,” Dasgupta said in March. “We had one person here who ended up going to the hospital needing multiple blood transfusions. And it was all because of the xylazine.”

    US lawmakers are moving to classify xylazine as a controlled substance.

    In March, bipartisan legislation – the Combating Illicit Xylazine Act – was introduced in the House and Senate. It describes illicit xylazine as an “urgent threat to public health and safety” and calls for it to be a Schedule III drug under the Controlled Substances Act, a category on the five-level system for substances with moderate to low potential for physical or psychological dependence. Xylazine would be one level below opioids like fentanyl.

    “Our bipartisan bill would take important steps to combat the abuse of xylazine by giving law enforcement more authority to crack down on the illicit distribution of this drug, including by putting stiffer penalties on criminals who are spreading this drug to our communities,” Sen. Maggie Hassan, D-N.H., said in a statement in March.

    The bill would also require manufacturers to send reports on production and distribution to the DEA so the agency can ensure that the product is not being diverted to the black market.

    “This bill recognizes the dangers posed by the increasing abuse of animal tranquilizers by drug traffickers, and provides new tools to combat this deadly trend,” Sen. Chuck Grassley, R-Iowa, said in the statement.

    “It also ensures that folks like veterinarians, ranchers and cattlemen can continue to access these drugs for bona fide animal treatment.”

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    EPA proposes new regulations on toxic gas used to sterilize spices and medical equipment | CNN



    CNN
     — 

    The US Environmental Protection Agency on Tuesday proposed a set of new restrictions on facilities that use the cancer-causing chemical ethylene oxide, a colorless, odorless gas that is used to sterilize medical devices and spices.

    The agency said the new rules, which have not been finalized, would help to reduce ethylene oxide gas that these facilities release by 80%, bringing emissions below a Clean Air Act standard for elevated cancer risk.

    Communities exposed to ethylene oxide gas have been pushing the EPA to put tighter controls on plants that use ethylene oxide gas.

    In 2018, an EPA report found that dozens of communities across the nation faced elevated cancer risks because of trace of amounts of ethylene oxide released into air as part of the sterilization process.

    The EPA issued the report on the new risks without issuing a news release, as it had done for the same report in years past. Some affected communities learned of the risk through a health assessment conducted by the Agency for Toxic Substances and Disease Registry, a division of the US Centers for Disease Control and Prevention, and media reports. A report from the EPA’s Office of the Inspector General found that some communities weren’t alerted to their risk by EPA at all.

    The elevated risk became apparent after a two-decade long review of the toxicity of ethylene oxide by scientists in EPA’s Integrated Risk Information System (IRIS) program.

    While the EPA acknowledged that ethylene oxide was more dangerous that had been previously understood, it continued to use an older set of rules to regulate facilities that released ethylene oxide as well as companies that manufacture it.

    The proposed rules aim to better align regulations on the producers and users of ethylene oxide with the cancer risk posed by the chemical. They follow a set of proposed rules issued by EPA last week that would put new controls on facilities that manufacture ethylene oxide.

    Taken together, the two sets of rules would remove 77 tons of ethylene oxide emissions a year, an 84% reduction compared with 2020 levels, EPA Deputy Administrator Janet McCabe said in a call with reporters on Tuesday.

    Environmental watchdog groups applauded the proposed restrictions, but noted that they don’t go far enough to protect vulnerable communities, where residents are often low-income and disproportionately people of color.

    “These regulations are long overdue, by almost a decade. I’m relieved and pleased that the EPA has finally issued proposed standards that are based on their own scientists’ recommendations on an updated, higher cancer risk value. If enacted, these updated regulations would reduce emissions in fenceline communities,” said Darya Minovi, a senior researcher scientist at the Union of Concerned Scientists.

    “When the EPA issues the final rule, they should throw the net wider. The standard should cover a larger range of facilities to include off-site warehouses that often store recently sterilized equipment that continue to release ethylene oxide, but aren’t regulated for their air emissions.”

    Minovi also said the EPA should require fenceline monitors – devices that constantly read the air outside of facilities to make sure that toxic gas isn’t drifting into neighborhoods.

    Jaime Rukstales, a member of the Illinois grassroots advocacy group Stop EtO in Lake County – one of the communities impacted by ethylene oxide pollution – says the EPA needs to impose tougher restrictions on “all types of facilities that impact the health of our communities … including sterilizers, manufacturers and warehouses near our homes, schools and businesses.”

    Some off-site warehouses used to store newly sterilized products have registered high levels of ethylene oxide due to off-gassing of the products.

    Meanwhile, chemical manufacturers sued the EPA in February over its updated hazard assessment for ethylene oxide. The industry wants the agency to use a less protective standard developed by the Texas Commission on Environmental Quality.

    AdvaMed, a group that lobbies for the interests of medical device manufacturers, warned that more regulations could pose problems for patients.

    “If new EPA regulations force sterilization facilities to close, patients could face treatment delays as sterile technology supplies, such as pacemakers and surgical equipment, fall short,” Scott Whitaker, president and CEO of AdvaMed, said in a comment posted on the group’s website.

    The EPA said some commercial sterilizers have already made the planned changes.

    “Many sterilization and health care facilities are already taking the steps outlined in the proposal and have seen emissions drop significantly,” McCabe said.

    Most facilities have taken action to control ethylene oxide blown out of sterilization chambers through exhaust vents known as “back vents” but only 25% to 33% of sterilizers are controlling so-called fugitive emissions, ethylene oxide that escapes or leaks into room air, said Jonathan Witt, an environmental engineer and technical lead on EPA’s review of the National Emissions Standards for Hazardous Air Pollutants.

    “So we think it’s a good sizable chunk of the industry, but still a little ways to go,” Witt said on a call with reporters.

    If the rules go into effect, sterilizers would have 18 months to make the changes, which the EPA said is an accelerated time frame under the Clean Air Act.

    AdvaMed’s Whitaker says that’s not enough time.

    “It could take many months for abatement equipment to arrive. Supply chains and manufacturing are still recovering from the pandemic,” he noted in the statement.

    In issuing the proposed rules, the EPA said it aimed to strike a balance between lowing cancer risks for impacted communities and workers who use ethylene oxide while preserving “critical sterilization capabilities.”

    The proposed rules would apply to 86 commercial sterilization facilities in the United States that use ethylene oxide gas to fumigate spices and medical devices.

    The EPA says 20 billion medical devices – mostly single-use, disposable items used in health care such as catheters, gloves and surgical gowns – are sterilized using ethylene oxide.

    The US Food and Drug Administration is actively exploring alternatives to the use of the gas, the EPA said on Tuesday, but some devices still can’t be sterilized any other way.

    In proposing the new rules, EPA said its new analysis found that exposure to ethylene oxide, or EtO, on the job significantly increased cancer risks for workers in sterilization facilities and those who apply ethylene oxide in health care facilities.

    “Now, a new EPA analysis shows that there may also be significant risks to workers who handle [ethylene oxide] and people who live, work or go to school near places where EtO is used in sterilization. And failing to take action to address these risks is simply unacceptable,” EPA Administrator Janet McCabe said on a call with reporters.

    The additional lifetime cancer risk for a worker exposed to ethylene oxide for eight hours a day, 240 days a year for 35 years was between 1 in 10 and 1 in 36 for workers in sterilization facilities; and between 1 in 12 and 1 in 25 for workers exposed to ethylene oxide in health care facilities.

    To help lower those risks, the proposed rules require greater use of personal protective equipment for workers and new controls to decrease the amount of ethylene oxide in indoor air.

    Whitaker from AdvaMed, the medical device industry group, said the cancer risk for employees exposed to ethylene oxide on the job is overstated and disregards “the strong employee protections already in practice.”

    Companies will also be required to use new real-time monitoring methods to confirm that these pollution controls are working inside facilities. These controls can measure ethylene oxide in indoor air down to 10 parts per billion. If ethylene oxide levels climb above this threshold, everyone in the workplace would be required to wear protective equipment.

    They will also lower the amount of ethylene oxide that can be used for each sterilization cycle. The EPA is proposing to limit the application rate for ethylene oxide to no more than 500 milligrams per liter of air.

    The rules would eliminate some niche uses of ethylene oxide where alternatives exist, including its use in museums, archival settings, beekeeping, some cosmetics, and in musical instruments.

    The EPA will take public comment on the new rules for 60 days. The agency will also host a virtual public webinar on May 1 to discuss its proposed rules and new risk assessment.

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    How safe is the abortion pill compared with other common drugs | CNN



    CNN
     — 

    A federal judge in Texas ruled on Friday to suspend the Food and Drug Administration’s approval of mifepristone, the first drug in the medication abortion process, nationwide by the end of this week.

    The judge sided with the coalition of anti-abortion national medical associations that filed the lawsuit. He argued that the FDA failed to adequately consider risks associated with the drug, including “the intense psychological trauma and post-traumatic stress women often experience from chemical abortion.”

    However, data analyzed by CNN shows mifepristone is even safer than some common, low-risk prescription drugs, including penicillin and Viagra. There were five deaths associated with mifepristone use for every 1 million people in the US who have used the drug since its approval in 2000, according to the US Food and Drug Administration as of last summer. That’s a death rate of 0.0005%.

    Comparatively, the risk of death by penicillin — a common antibiotic used to treat bacterial infections like pneumonia — is four times greater than it is for mifepristone, according to a study on life-threatening allergic reactions. Risk of death by taking Viagra — used to treat erectile dysfunction — is nearly 10 times greater, according to a study cited in the amicus brief filed by the FDA.

    “[Mifepristone] has been used for over 20 years by over five million people with the capacity to become pregnant,” said Ushma Upadhyay, an associate professor in the department of obstetrics, gynecology and reproductive science at the University of California, San Francisco. “Its safety is very well established.”

    The Justice Department, the FDA, and Danco — a manufacturer of mifepristone that intervened in the case — have already appealed the ruling.

    Within hours of the decision in Texas, a federal judge in Washington state issued a conflicting ruling that the federal government must keep mifepristone available in the 17 Democrat-led states and the District of Columbia that had sued in a separate lawsuit.

    If the Texas ruling is allowed to take effect this week, 40 million more women of reproductive age would lose access to medication abortion care around the country, according to data from abortion rights advocacy group NARAL Pro-Choice America. That’s in addition to the 24.5 million women of reproductive age living in states with abortion bans.

    “The court’s disregard for well-established scientific facts in favor of speculative allegations and ideological assertions will cause harm to our patients and undermines the health of the nation,” said Dr. Jack Resneck, Jr., president of the American Medical Association, in a statement. “By rejecting medical facts, the court has intruded into the exam room and has intervened in decisions that belong to patients and physicians.”

    Medication abortion has become the most common method for abortion, accounting for more than half of all US abortions in 2020, according to the Guttmacher Institute.

    The growing popularity of medication abortion is largely because of its accessibility, said Abigail Aiken, associate professor at the University of Texas at Austin who leads a research group on medication abortion.

    “It reduces the cost, it reduces barriers where people may not want to go to a clinic,” she said.

    It is also a safer option than both procedural abortion or childbirth. The rate of major complications — like hemorrhages or infections — for medication abortions is about one-third of a percent, according to a 2015 study conducted by Upadhyay. That means out of more than 11,000 cases, 35 experienced any major complications.

    The likelihood of serious complications via procedural abortion — performed second-trimester or later — is slightly higher than medication abortion at 0.41%, according to the same study. And childbirth by far comes with the highest risk, at 1.3%.

    If access to mifepristone is cut off, abortion clinics and telehealth organizations could pivot to misoprostol-only abortions, Aiken told CNN. Although misoprostol-only abortions are used around the world, they are less effective, associated with a higher risk of serious complications and often more painful than the mifepristone and misoprostol combination, she said.

    In the latest study of self-managed misoprostol-only medication abortions in the US, Johnson found misoprostol-only abortions to be a safe alternative, though less safe than using both pills. The study, published in February, analyzed data from online telehealth medication abortion provider Aid Access from 2020. Nearly 90% of 568 users reported completed abortions and 2% experienced serious complications using only misoprostol.

    Mifepristone and misoprostol together is still considered the gold standard, Aiken told CNN. People who used the two-pill combination were less likely to experience serious complications than those who went with the misoprostol-only regimen.

    “It’s clear people can use these medications, mifepristone and misoprostol, at home even without the help of a medical professional very safely,” said Aiken.

    Because misoprostol is used to treat multiple ailments including stomach ulcers, it’s readily stocked in pharmacies and unlikely to be taken off the market anytime soon, Johnson told CNN.

    However, a lesser-effective method means more people will likely have unsuccessful abortions.

    “It’s possible that it might not work for some people, and it will prolong their abortions,” said Upadhyay. “Then by the time they get back to the clinic, they’re seeking abortion later in pregnancy.”

    Before the ruling, 19 states already restricted telehealth abortion care, limiting access to medication abortion. Nearly half of US adults were unsure whether medication abortion was currently legal in their state as of late-January, according to a survey conducted by the Kaiser Family Foundation. Experts say that confusion will only be exacerbated.

    “People are not going to be sure mifepristone or misoprostol in fact, is available. I think it’s going to be confusing,” said Aiken. “As people look around for options or feel unsure about their options, they may end up delaying [care].”

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