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  • Migrants are staying on school grounds, in hotels or at police stations in several states — and some residents are furious | CNN

    Migrants are staying on school grounds, in hotels or at police stations in several states — and some residents are furious | CNN

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    CNN
     — 

    In New York City, hundreds of migrants are staying in current or former school gymnasiums.

    In Chicago, dozens of migrants have been sleeping in a police station.

    And in Florida, where the Republican governor has sent migrants to Democratic-led cities across the country, the state has hired three companies to relocate migrants from the state.

    While the surge of new migrants after last week’s expiration of Title 42 was not as large as many expected, the scramble to place asylum seekers who trekked thousands of miles to flee violence or crushing poverty has yielded widespread tensions within and between states.

    And more parts of the US could suddenly find themselves with unexpected migrants.

    About 300 migrants have been placed in current and former school gyms in New York City, a source familiar with the planning process told CNN.

    As of Monday, 220 migrants were in the gym of a former school on Staten Island, the source said. Less than 80 migrants have been housed at a gym at PS 188 on Coney Island, and fewer than 30 have been placed at a gym at PS 17 in Williamsburg, the source said.

    The gyms are not physically connected to the schools, the source added.

    Some New York City parents were dismayed or bewildered to learn of the city’s plan to temporarily house migrants in 20 school gyms.

    “I would like other places to be considered,” Samantha Clark told CNN affiliate WABC. “Our school is tiny. We can barely fit in it as it is.”

    Aramis Rosa said he sympathizes with the migrants but also opposes the plan to house them in school gyms.

    “We’re not against them,” Rosa told WABC. “They’re all welcome – just not to our school, next to our children.”

    Mayor Eric Adams has said the migrants would not interact with students, but that did little to assuage concerns from parents.

    Outside PS 17 in Brooklyn, a group of parents and students protested Wednesday morning over migrants being housed in the school’s gym.

    About 100 people marched around the block chanting, “We want our gym back!” and “Let us play!”

    Parents and children alike carried signs reading, “We need recess,” “No asylum on school grounds,” and “Safety first.”

    One protest organizer stressed the need to support migrants – though she didn’t think housing them on school grounds was appropriate.

    “What we’re gonna do is we’re going to support them. All of you kids are going to help us write notes, and we’ll make care packages, for all the people coming through here,” the organizer announced to the crowd.

    “We wish them well. We care. But they shouldn’t be on school grounds, and not in a place that only has three bathrooms for 100 people, right?”

    Elsewhere in the state, a New York state supreme court judge has granted a temporary restraining order blocking New York City’s mayor from sending asylum seekers to nearby Orange County to try to ease the influx of migrants arriving in the nation’s most populous city.

    The order, requested last week by Orange County Executive Steven Neuhaus, allows for the 186 asylum seekers already staying at the Crossroads Hotel and Ramada by Wyndham in the town of Newburgh to stay in the county, according to the filing.

    But new migrants won’t be allowed to stay at the hotels if any of the current occupants leave, the order states.

    The pushback comes as New York City scrambles to house a crush of migrants – some of them bused to New York by Republican governors and local officials from Southern states.

    Since last spring, New York City has processed more than 65,000 migrants and around 35,000 remain in the city’s care, city officials have said. The city has opened more than 140 emergency shelters and eight large-scale humanitarian relief centers to manage the crisis, the mayor said.

    And a wave of new asylum seekers arrived last week with the expiration of Title 42 – the Trump-era policy enacted early in the Covid-19 pandemic that allowed authorities to quickly expel migrants at US land borders.

    New York Gov. Kathy Hochul last week asked for federal government assistance with constructing and operating temporary shelters “in anticipation of several thousand asylum seekers arriving in New York City every week.”

    Adams’ office said it’s disappointed in the judge’s ruling.

    “New York City has cared for more than 65,000 migrants – sheltering, feeding, and caring for them, and we have done so largely without incident,” Adams’ press secretary Fabien Levy told CNN on Tuesday night.

    “We need the federal government to step up, but until they do, we need other elected officials around the state and country to do their part. New York City is out of space and we’re only asking Orange County to manage approximately ¼ of 1% of the asylum seekers who have come to New York City, with New York paying for shelter, food, and services.”

    But the executive of Orange County said, “New York City should not be establishing a homeless shelter outside of its borders in Orange County.”

    “The city is a self-proclaimed sanctuary city; Orange County is not,” Neuhaus said in a statement. “We should not have to bear the burden of the immigration crisis that the Federal government and Mayor Adams created, and I will continue to fight for Orange County’s residents in regard to this important manner.”

    The New York Immigration Coalition, an immigrant’s rights advocacy group, criticized both Adams and Neuhaus, saying the two need to start working together in coordinating and addressing the needs of asylum seekers in the region.

    “But County Executive Neuhaus shouldn’t be gloating about the judge’s temporary restraining order. His actions in response to asylum seekers to his region have been shameful – he has done nothing more than stoke fear and resentment in his community,” NYIC Executive Director Murad Awawdeh said in a statement.

    “At a moment when he should be choosing to welcome, he has instead chosen cruelty.”

    Hundreds of migrants have been staying in Chicago city buildings after they were “inhumanely” bused to Chicago, former Mayor Lori Lightfoot said earlier this month, according to CNN affiliate WBBM.

    During her final days in office, Lightfoot issued an emergency declaration in hopes of getting federal and state money to help the city respond to the crisis.

    More than 70 migrant families were staying in the Chicago Police Department’s 12th district station.

    “I’ve been here for two weeks,” Johon Torres, a migrant from Venezuela, told WBBM. Torres was joined by his three daughters and niece.

    The families in limbo have received donated supplies from refugee organizations, good Samaritans and even some police officers.

    But the situation is not tenable, said Sgt. James Calvino of the Chicago Police Sergeants’ Association.

    “It’s ballooned exponentially – way out of control,” Calvino told WBBM.

    Florida Gov. Ron DeSantis’ administration has chosen three companies to execute the next phase of its migrant relocation program, according to documents obtained by CNN.

    The Florida Division of Emergency Management selected Vertol Systems Company Inc., ARS Global Emergency Management and GardaWorld Federal Services to “manage and implement a program to relocate individuals” who have been processed and released by the US government, according to a FDEM document.

    The contract sets up the framework to once again send migrants to Democratic-led cities, as seen in 2022 when Vertol Systems Company Inc., provided two planes to relocate migrants from San Antonio, Texas, to Martha’s Vineyard, Massachusetts, under DeSantis’ direction.

    The state requires vendors to be “solely responsible” from beginning to end of the transporting of participants, including social services that should be provided to them at the destination cities.

    The newly selected vendors are tasked with providing ground and air transportation services to assist with what the DeSantis administration is calling the “voluntary relocation of Inspected Unauthorized Aliens,” who have agreed to be relocated from “Florida, or another state, to a location within the United States.”

    The FDEM did not indicate the number of migrants expected to be transferred and says it will be determined “based on circumstances on the ground.” One vendor noted its capability of moving 40-50 passengers per week, or about 2,200 a year.

    A document showing questions and answers between unnamed vendors and the FDEM, posted on the state’s contract procurement website, sheds light on how the state wants the companies to carry out the program.

    One vendor mentioned California, New York, and Georgia as potential destinations for flights originating from Florida.

    The state wants vendors to start transportation of migrants “within 72 hours of notification by the Division,” and must fulfill their contract until June 30, 2025, unless terminated earlier.

    In response to a question about handling the transportation of minors, FDEM said it does not “anticipate relocating juveniles without a parent or guardian.”

    FDEM said it anticipates this contract to be “turnkey,” saying “vendors will locate and identify, vet and verify individuals for program eligibility and transport.”

    The document states $10 million has been allocated to FDEM for the 2022-23 fiscal year for this program, which expires June 30.

    CNN has reached out to Vertol Systems Company, ARS Global Emergency Management and GardaWorld Federal Services for comment.

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  • FDA advisers vote unanimously in support of over-the-counter birth-control pill | CNN

    FDA advisers vote unanimously in support of over-the-counter birth-control pill | CNN

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    CNN
     — 

    Advisers for the US Food and Drug Administration voted unanimously on Wednesday in support of making the birth-control pill Opill available over-the-counter, saying the benefits outweigh the risks.

    Two FDA advisory panels agreed that people would use Opill safely and effectively and said groups such as adolescents and those with limited literacy would be able to take the pill at the same time every day without help from a health care worker.

    The advisers were asked to vote on whether people were likely to use the tablet properly so that the benefits would exceed the risks. Seventeen voted yes. Zero voted no or abstained.

    Opill manufacturer Perrigo hailed the vote as a “groundbreaking” move for women’s health.

    “Perrigo is proud to lead the way in making contraception more accessible to women in the U.S.,” Murray Kessler, Perrigo’s president and CEO, said in a statement. “We are motivated by the millions of people who need easy access to safe and effective contraception.”

    The FDA doesn’t have to follow its advisers’ advice, but it often does. It is expected to decide whether to approve the over-the-counter pill this summer.

    If it’s approved, this will be the first birth-control pill available over the counter in the United States. Opill is a “mini-pill” that uses only the hormone progestin.

    At Wednesday’s meeting, Dr. Margery Gass of the University of Cincinnati College of Medicine thanked the FDA for its consideration of switching Opill to an over-the-counter product.

    “I think this represents a landmark in our history of women’s health. Unwanted pregnancies can really derail a woman’s life, and especially an adolescent’s life,” she said.

    The FDA has faced pressure to allow Opill to go over-the-counter from lawmakers as well as health care providers.

    Unwanted pregnancies are a public health issue in the US, where almost half of all pregnancies are unintended, and rates are especially high among lower-income women, Black women and those who haven’t completed high school.

    In March 2022, 59 members of Congress wrote a letter to FDA Commissioner Dr. Robert Califf about OTC contraception.

    “This is a critical issue for reproductive health, rights, and justice. Despite decades of proven safety and effectiveness, people still face immense barriers to getting birth control due to systemic inequities in our healthcare system,” the lawmakers wrote.

    A recent study showed that it’s become harder for women to access reproductive health care services more broadly – such as routine screenings and birth control – in recent years.

    About 45% of women experienced at least one barrier to reproductive health care services in 2021, up 10% from 2017. Nearly 19% reported at least three barriers in 2021, up from 16% in 2017.

    Increasing reproductive access for women and adolescents was a resounding theme among the FDA advisers.

    “We can take this opportunity to increase access, reduce disparities and, most importantly, increase the reproductive autonomy of the women of our nation,” said Dr. Jolie Haun of the James A. Haley Veterans’ Hospital and the University of Utah.

    Dr. Karen Murray, deputy director of the FDA’s Office of Nonprescription Drugs, said the agency understands the importance of “increased access to effective contraception” but hinted that the FDA would need more data from the manufacturer.

    Some of the advisers and FDA scientists expressed concern that some of Perrigo’s data was unreliable due to overreporting of “improbable dosing.”

    Murray said the lack of sufficient information from the study poses challenges for approval.

    “It would have been a much easier time for the agency if the applicant had submitted a development program and an actual use study that was very easy to interpret and did not have so many challenges. But that was not what happened for us. And so the FDA has been put in a very difficult position of trying to determine whether it is likely that women will use this product safely and effectively in the nonprescription setting,” she said. “But I wanted to again emphasize that FDA does realize how very important women’s health is and how important it is to try to increase access to effective contraception for US women.”

    Ultimately, the advisers said, they don’t want further studies of Opill to delay the availability of the product in an over-the-counter setting.

    “I just wanted to say that the improbable dosing issue is important, and I don’t think it’s been adequately addressed and certainly leads to some uncertainty in the findings. But despite this, I would not recommend another actual use study this time, and I think we can make a decision on the totality of the evidence,” said Kate Curtis of the US Centers for Disease Control and Prevention.

    Curtis said she voted yes because “Opill has the potential to have a huge positive public health impact.”

    Earlier in the discussion, Dr. Leslie Walker-Harding of the University of Washington and Seattle Children’s Hospital said the pill is just as safe as many other medications available on store shelves.

    “The safety profile is so good that we would need to take every other medicine off the market like Benadryl, ibuprofen, Tylenol, which causes deaths and people can get any amount of that without any oversight. And this is extremely safe, much safer than all three of those medications, and incorrect use still doesn’t appear to have problematic issues,” she said.

    Dr. Katalin Roth of the George Washington University School of Medicine and Health Sciences also emphasized the safety of the pill over the 50 years it has been approved as a prescription drug in the US.

    “The risks to women of an unintended pregnancy are much greater than any of the things we were discussing as risks of putting this pill out out over-the-counter,” she said. “The history of women’s contraception is a struggle for women’s control over their reproduction, and we need to trust women.”

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  • Mental illness may put people under 40 at a greater chance of heart attack and stroke | CNN

    Mental illness may put people under 40 at a greater chance of heart attack and stroke | CNN

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    CNN
     — 

    Adults in their 20s and 30s with mental disorders have a higher chance of having a heart attack or stroke, according to a new study.

    The study published Monday in the European Journal of Preventive Cardiology looked at the health data of more than 6.5 million people through the Korean National Health Insurance Service database.

    The people included in the new study ranged in age from 20 to 39 and underwent health examinations between 2009 and 2012. Their health was monitored until December 2018 for new onset heart attacks and stroke.

    About 13% of participants had some type of mental disorder — which included insomnia, anxiety, depression, somatoform disorder, post-traumatic stress disorder, substance use disorder, eating disorders, bipolar disorder, schizophrenia or a personality disorder, according to the study.

    Those people younger than 40 with a mental disorder were 58% more likely to have a heart attack and 42% more likely to have a stroke than those with no disorder, the study found.

    “We have known for some time that mental health and physical health are linked, but what I find surprising about these findings is that these links were observable at such a young age,” said Dr. Katherine Ehrlich, an associate professor of behavioral and brain sciences at the University of Georgia. Ehrlich was not involved in the research.

    Coronary arterial disease and heart attacks are rare before the age of 40, so a study as large as this one was needed to see the relationship between mental health and such an unusual occurrence in young people, she said.

    Ehrlich said she would like to know more about the physical activity and diets of the people involved to understand better if those factors have an influence on the relationship between mental health conditions and heart attack and stroke.

    “For example, if you are chronically depressed, you may struggle to maintain a healthy diet and get adequate physical activity, which might in turn increase your risk for cardiac events over time,” she said.

    But the increased risk could not be attributed to lifestyle differences alone, as the authors controlled for factors including age, sex, high blood pressure, diabetes, high cholesterol, metabolic syndrome, chronic kidney disease, smoking, alcohol, physical activity and income, the study said.

    That doesn’t mean lifestyle should be ignored, however, said study author Dr. Eue-Keun Choi, a professor of internal medicine at Seoul National University College of Medicine in South Korea.

    “While lifestyle behaviours did not explain the excess cardiovascular risk, this does not mean that healthier habits would not improve prognosis,” Choi said in a statement. “Lifestyle modification should therefore be recommended to young adults with mental disorders to boost heart health.”

    One in eight people between ages 20 and 39 studied had some sort of mental illness, meaning a substantial number of people could be predisposed to heart attack and stroke, study author Dr. Chan Soon Park, a researcher at Seoul National University Hospital in South Korea said in a statement.

    That could point to a greater need for managing psychological conditions and monitoring heart health in those at risk, Park added.

    “If we can reduce the number of people living with chronic mental illness, we may find secondary benefits in future years regarding the number of people managing cardiac-related conditions,” Ehrlich said.

    It is important to note that the findings do not show that mental illness causes heart attacks or stroke, she added. But the research does indicate a risk factor to watch out for.

    There may be benefit in preventive measures to minimize risks, Ehrlich said, which can include maintaining a healthy diet and incorporating physical activity.

    Choi recommends that people with mental health conditions receive regular checkups as well.

    These findings may also emphasize the importance of addressing loneliness, she added.

    “Many individuals with mental illness suffer from social isolation and loneliness, and for years researchers have been sounding the alarm that loneliness is detrimental for physical health,” Ehrlich said.

    “Efforts to improve social connectedness among young people may be critical to addressing the rising rates of cardiometabolic conditions in adulthood,” she added.

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  • Two hospitals under federal investigation over care of pregnant woman who was refused abortion | CNN

    Two hospitals under federal investigation over care of pregnant woman who was refused abortion | CNN

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    CNN
     — 

    The Centers for Medicare and Medicaid Services is investigating two hospitals that “did not offer necessary stabilizing care to an individual experiencing an emergency medical condition, in violation of the Emergency Medical Treatment and Labor Act (EMTALA),” according to a letter from US Health and Human Services Secretary Xavier Becerra.

    Under EMTALA, health care professionals are required to “offer treatment, including abortion care, that the provider reasonably determines is necessary to stabilize the patient’s emergency medical condition,” Becerra said Monday in his letter to national hospital and provider associations.

    The National Women’s Law Center, which said in a statement that it filed the initial EMTALA complaint on behalf of Mylissa Farmer, identified the hospitals as Freeman Hospital West of Joplin, Missouri, and the University of Kansas Health System in Kansas City, Kansas.

    The patient was nearly 18 weeks pregnant when she had a preterm premature rupture of membranes, Becerra wrote, but she was told that her pregnancy wasn’t viable.

    “Although her doctors advised her that her condition could rapidly deteriorate, they also advised that they could not provide her with the care that would prevent infection, hemorrhage, and potentially death because, they said, the hospital policies prohibited treatment that could be considered an abortion,” Becerra wrote.

    Becerra added in a statement Monday, “fortunately, this patient survived. But she never should have gone through the terrifying ordeal she experienced in the first place. We want her, and every patient out there like her, to know that we will do everything we can to protect their lives and health, and to investigate and enforce the law to the fullest extent of our legal authority.”

    Abortion is banned in Missouri, with limited exceptions, such as to save the mother’s life. State law requires counseling and a 72-hour waiting period. In Kansas, abortion is generally banned at or after 22 weeks of pregnancy, with a 24-hour waiting period and counseling required.

    Passed in 1986, EMTALA requires that hospitals provide stabilizing treatment to patients who have emergency medical conditions, or transfer them to facilities where such care will be provided, regardless of any conflicting state laws or mandates.

    Changes to state laws in the wake of the US Supreme Court decision that overturned the right to an abortion have left many hospitals and providers uncertain or confused about the steps they can legally take in such cases. HHS issued guidance last year reaffirming that EMTALA requires providers to offer stabilizing care in emergency cases, which might include abortion.

    Hospitals found to be in violation of EMTALA could lose their Medicare and Medicaid provider agreements and could face civil penalties. An individual physician could also face civil penalties if they are found to be in violation.

    HHS may impose a $119,942 fine per violation for hospitals with more than 100 beds and $59,973 for hospitals with fewer than 100 beds. A physician could face a $119,942 fine per violation.

    The National Women’s Law Center says the new actions are the first time since Roe v. Wade was overturned that EMTALA has been enforced against a hospital that denied emergency abortion care.

    “The care provided to the patient was reviewed by the hospital and found to be in accordance with hospital policy,” the University of Kansas Health System said in a statement to CNN. “It met the standard of care based upon the facts known at the time, and complied with all applicable law. There is a process with CMS for this complaint and we respect that process. The University of Kansas Health System follows federal and Kansas law in providing appropriate, stabilizing, and quality care to all of its patients, including obstetric patients.”

    Freeman Hospital did not immediately respond to CNN’s request for comment.

    An HHS spokesperson told CNN that both hospitals are working toward coming into compliance with the law.

    In the law center’s statement, Farmer said she was pleased with the investigations, “but pregnant people across the country continue to be denied care and face increased risk of complications or death, and it must stop. I was already dealing with unimaginable loss and the hospitals made things so much harder. I’m still struggling emotionally with what happened to me, but I am determined to keep fighting because no one should have to go through this.”

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  • A Texas family fought for weeks to regain custody of their newborn. Experts say the case shows how Black parents are criminalized. | CNN

    A Texas family fought for weeks to regain custody of their newborn. Experts say the case shows how Black parents are criminalized. | CNN

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    CNN
     — 

    A Black Texas couple has been reunited with their newborn daughter after authorities removed the baby and placed her in foster care last month citing a doctor’s concerns about how they were treating a jaundice diagnosis.

    Rodney and Temecia Jackson of DeSoto, Texas, regained custody of their daughter, Mila, on April 20 following a nearly month-long battle with the state’s Child Protective Services, according to The Afiya Center, a reproductive justice advocacy group.

    A spokesperson for the Texas Department of Family Protective Services, which includes CPS, confirmed to CNN that the office had recommended a dismissal of the case to an assistant district attorney. Mila’s release was granted on Thursday, according to a court filing.

    The Jacksons had been pleading for Mila’s return in videos posted to social media, and news conferences as reproductive justice activists protested and rallied behind the family.

    The removal, the Jacksons say, was sparked by their decision to let their midwife treat Mila’s jaundice instead of taking her to the hospital for care as their doctor had recommended. Temecia Jackson said during a news conference earlier this month that she gave birth to Mila at home on March 21 with the help of a midwife and wanted that same trusted midwife to provide medical care for her baby. But Mila’s pediatrician disagreed with this decision and ultimately contacted CPS, Temecia Jackson said.

    “We’ve been treated like criminals,” Rodney Jackson said during the news conference. “This is a nightmare that I wouldn’t wish on anyone.”

    Reproductive justice advocates say Mila’s removal is just the latest example of the criminalization of Black parents, who lose their children to the child welfare system at disproportionate rates. In the US in 2018, Black children made up 23% of youth in foster care, but only 14% of the nation’s child population, according to the Annie E. Casey Foundation. Additionally, one study found that between 2003-2014, 53% of Black children were the subjects of child welfare investigations by the time they reached age 18.

    Marsha Jones, executive director of The Afiya Center – a Dallas, Texas, based non-profit that advocates for Black women and girls – said there is a systemic problem with the child welfare system that unfairly targets Black parents. In many cases, Black families have their first experiences with the criminal justice system in family court, Jones said.

    “It’s almost unspoken and unseen because there is just this thought that Black women are not good parents and that we are criminalized because of poverty,” Jones told CNN. “This is not new.”

    Jones said the center stepped in last month to support the Jackson family and put pressure on public officials to return Mila home. She believes this played a role in reuniting the family last week.

    “There’s no reason this baby should have been removed from her home,” Jones told CNN. “This family was not being heard. The Black midwife wasn’t being heard.”

    Rodney and Temecia Jackson could not be reached for comment.

    In a letter to CPS obtained by CNN affiliate WFAA, the family’s pediatrician, Dr. Anand Bhatt, who is with the Baylor Scott & White healthcare system, wrote that while the Jacksons “are very loving and they care dearly” about Mila, “their distrust for medical care and guidance has led them to make a decision for the baby to refuse a simple treatment that can prevent brain damage.”

    “I authorized the support of CPS to help get this baby the care that was medically necessary and needed,” the letter continued.

    CBS News, which obtained a copy of the affidavit filed by the Texas Department of Family and Protective Services, reported that Bhatt reached out to a DFPS investigator on March 25 and indicated that Mila’s bililrubin test showed levels of 21.7 milligrams.

    A bilirubin test can screen for jaundice and other conditions. That level was “cause for a lot of concern,” Bhatt told the investigator, according to CBS News, and could lead to brain damage, he said, “because the bilirubin can cross the blood brain barrier.”

    Bhatt said he reserved a bed for Mila at Children’s Medical Center of Dallas and asked the Jacksons to take her there or he would call police for a welfare check, according to court documents obtained by CBS News. WFAA reported that Bhatt wanted Mila to receive phototherapy – a common treatment for jaundice.

    But court documents, according to CBS News, say Rodney Jackson told Bhatt he and Temecia Jackson planned to treat their baby “naturally” and didn’t believe in “modern medicine.”

    The midwife, Cheryl Edinbyrd, told CBS News the family had ordered a blanket and goggles to provide light therapy to treat Mila’s jaundice.

    When the Jacksons didn’t show up at the hospital, a CPS investigator and police went to the Jackson’s home at 4 a.m. on March 25 but Rodney Jackson declined to speak with them, according to court documents obtained by CBS News. An hour later, authorities returned with an ambulance and fire truck and Rodney Jackson still denied them entry.

    Authorities returned to the home on March 30 with a warrant and arrested Rodney Jackson on charges of preventing the execution of a civil process, according to CBS News. Police entered the home and took Mila from Temecia Jackson. According to CBS News, the Jacksons’ other two children were not removed.

    Temecia Jackson said in a press conference that when she asked to see the affidavit, she noticed it had the name of a different mother on it.

    “Instantly I felt like they had stolen my baby as I had had a home birth and they were trying to say that my baby belonged to this other woman,” Temecia Jackson.

    Marissa Gonzales, a spokesperson from the Texas Department of Family and Protective Services, said in an email to CNN that her department was given an incorrect name for the initial affidavit. The mistake, she said, was corrected in the case filings.

    Gonzales declined an interview with CNN to discuss the case further, citing “state confidentiality restrictions.”

    “It is always the goal of DFPS to safely reunite children with their parents,” Gonzales also said. “The decision about when that happens rests with the judge who ordered the removal.”

    CNN’s request to interview Bhatt was also denied by Baylor Scott & White.

    “In respect of patient privacy, it is inappropriate to provide comment on this matter,” the health system said in an emailed statement. “We do abide by reporting requirements set forth in the Texas Family Code and any other applicable laws.”

    Advocates say the racial bias of professionals such as teachers, doctors and social workers has created inequity in the child welfare system.

    Dorothy Roberts, a law professor and sociologist at the University of Pennsylvania, said decisions to report neglect and abuse are largely shaped by racist stereotypes of Black families.

    The child welfare system, she said, needs to consider the trauma inflicted on children when they are separated from their families.

    “We have to ask whether there is a better way of addressing children’s medical needs instead of the system we have now where doctors are reporting suspicions, which we know is highly biased, and investigating families, which we know is very traumatic,” said Roberts, author of “Torn Apart: How the Child Welfare System Destroys Black Families – and How Abolition Can Build a Safer World.” “Hospitals should not be places of fear for parents.”

    Roberts said there is also a longstanding cultural conflict between the healthcare system and midwives who are often devalued. Black midwives provided care for mothers for hundreds of years, delivering the babies of enslaved women and even slave owners’ wives. But as medicine became more professionalized in the late 1800s, male doctors wanted to take control of childbirth, with some suggesting midwives were unfit, according to a report by Vox.

    Monica Simpson, executive director of Sistersong, a reproductive justice organization advocating for women of color, said many Black women are choosing midwives because they have lost trust in doctors and hospitals.

    Much of that is driven by the harrowing statistics: Black women are 2.6 times likelier to die of pregnancy-related complications than White women, according to the most recent data from the National Center for Health Statistics.

    Black infants also die at more than twice the rate of White infants, according to the Centers for Disease Control and Prevention.

    Simpson said the child welfare system is broken. She said racism has played a part in the continued criminalization and separation of Black families.

    “There’s been this narrative that Black women can’t parent their children properly,” Simpson said. “We have been battling these narratives for decades. The way that Black women are criminalized around their motherhood, it’s horrible.”

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  • FDA clears the way for additional bivalent boosters for certain vulnerable individuals | CNN

    FDA clears the way for additional bivalent boosters for certain vulnerable individuals | CNN

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    CNN
     — 

    The U.S. Food and Drug Administration amended the terms of its emergency use authorizations for the Pfizer and Moderna bivalent vaccines on Tuesday, allowing people ages 65 and older and certain people with weakened immunity to get additional doses before this fall’s vaccination campaigns.

    The bivalent vaccines made by Pfizer and Moderna carry instructions for fighting both the original strain of the Covid-19 virus as well as Omicron and its spinoffs.

    They have been available in the United States since September under emergency use authorizations, or EUAs, which tightly restrict how the vaccines may be given.

    On Tuesday, the FDA changed the terms of the authorizations for those vaccines so that certain individuals could get an additional dose ahead of most others.

    Namely, adults ages 65 and older who have received a single dose of a bivalent vaccine may receive an additional dose at least four months following their first dose.

    Most individuals with certain degrees of immunocompromise who have received a first dose of a bivalent vaccine can get a second at least 2 months later. Additional doses may be administered at the discretion of their healthcare provider.

    Dr. Peter Hotez, who co-directs the Center for Vaccine Development at Texas Children’s Hospital, has been calling on the FDA to increase access to the bivalent boosters for those who want them. He says for the most part, today’s guidance from the agency makes sense.

    “My only question is why the 65 year age cutoff? What was that based on? Ordinarily I would have preferred that it be brought down to 60 or even 50,” Hotez said in an email to CNN.

    “For those Americans who understand its importance, we should make second bivalent boosters available. Finally, we’ll soon need guidance about another annual fall booster. Presumably that information comes sometime this summer,” he added.

    For immunocompromised children ages 6 months through 4 years, eligibility for additional bivalent doses will depend on the vaccine previously received, the FDA said in a news release.

    Another big change is that most unvaccinated individuals may now receive a single dose of a bivalent vaccine, rather than mutiple doses of the original single-strain vaccines, the agency said. The FDA simplified its recommendation for unvaccinated individuals after recognizing that most Americans now have some immunity against Covid-19, even if its just through past infections.

    “Evidence is now available that most of the U.S. population 5 years of age and older has antibodies to SARS-CoV-2, the virus that causes COVID-19, either from vaccination or infection that can serve as a foundation for the protection provided by the bivalent vaccines. COVID-19 continues to be a very real risk for many people, and we encourage individuals to consider staying current with vaccination, including with a bivalent COVID-19 vaccine. The available data continue to demonstrate that vaccines prevent the most serious outcomes of COVID-19, which are severe illness, hospitalization, and death,” said Dr. Peter Marks, head of FDA’s Center for Biologics Evaluation and Research, in a news release.

    Children ages 6 months through 5 years who have not yet been vaccinated may now receive a two-dose series of the Moderna bivalent vaccine as their primary series, or a three-dose series of the Pfizer-BioNTech bivalent vaccine if they are 6 months through 4 years of age. Children who are age 5 may receive two doses of the Moderna bivalent or a single dose of the Pfizer-BioNTech bivalent vaccine.

    Children ages 6 months through 5 years who got started on their monovalent vaccines, can now get a dose of a bivalent vaccine, but the number of doses they qualify for will depend on the number of doses they’ve already had and what kind of vaccine they got.

    The agency stressed that most people who have gotten one dose of a bivalent vaccine are not currently eligible for a second dose.

    And they encouraged everyone who hasn’t yet gotten their first dose of a bivalent vaccine to do so, and many Americans are still in that bucket.

    Only about 17% of those eligible, less than 1 in 5 Americans, has gotten a recommended dose.

    As time has passed, adults with reduced immune function because of their age or an underlying health problem have been asking doctors whether they need another dose of the bivalent vaccines.

    The United States Center for Disease Control and Prevention has reported early data showing that the effectiveness of the bivalent vaccines, even against emergency room visits and hospitalizations, has already started to wane.

    But the agency has not been free to make what’s known as a “permissive use” recommendation about the boosters, which would allow doctors to offer additional doses to vulnerable patients because of the terms of the EUA.

    The updated terms give the CDC and its Advisory Committee on Immunization Practices (ACIP) greater freedom to recommend additional doses of the bivalent vaccines. The ACIP is holding a meeting on the Covid-19 vaccines Wednesday and is expected to endorse the FDA’s changes.

    For everyone not covered by today’s changes, the FDA says it intends to make decisions about future vaccinations after receiving recommendations on the fall strain composition from its advisory committee in June.

    Both Canada and the United Kingdom have offered another round of bivalent boosters to those at highest risk from Covid-19 this spring.

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  • Opinion: Mifepristone saved my life | CNN

    Opinion: Mifepristone saved my life | CNN

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    Editor’s Note: Roxanne Jones, a founding editor of ESPN The Magazine and former vice president at ESPN, has been a producer, reporter and editor at the New York Daily News and The Philadelphia Inquirer. Jones is co-author of “Say it Loud: An Illustrated History of the Black Athlete.” She talks politics, sports and culture weekly on Philadelphia’s 900AM WURD. The views expressed here are solely hers. Read more opinion on CNN.



    CNN
     — 

    The ruling earlier this month by a Texas federal judge to suspend the US Food and Drug Administration’s approval of a drug that is used frequently for medication abortions, is very personal for me.

    That’s because I took mifepristone years ago during a miscarriage, and it saved my life.

    When I was prescribed mifepristone, it had not yet taken center stage in America’s abortion wars. I did not have to make a rushed road trip across state lines to get my medicine, unlike many women who need the drug but live in one of the many states that have restricted access to medication abortion or passed near-total bans on abortion.

    I was not forced to set up a secret meet-up with a stranger in order to buy my medicine on the black market, as several women I spoke to recently said they planned to do. Nor did I have to order mifepristone online and find myself navigating the many scammers taking advantage of the current patchwork of state abortion laws in the US.

    Mifepristone is one of two drugs used in a medication abortion and the other, misoprostol, was not subject to the ruling by the Texas judge. The two drugs can be administered to someone having a miscarriage, allowing them to terminate the pregnancy when the fetus is not viable.

    It happened some years ago: After experiencing more than a day of hemorrhaging during the first trimester of my pregnancy, I visited my ob-gyn, who explained after examining me that my blood pressure was dropping rapidly and the heavy bleeding I was experiencing was an unmistakable sign of a miscarriage.

    For many women, being prescribed mifepristone is part of their routine medical care. Not so in my case: As my doctor explained, I was facing a dire medical emergency. I was grateful for the medication that saved my life.

    My miscarriage took me by surprise. I had loved being pregnant the first time around, about a decade earlier. And as a healthy woman, I had no reason for fear when I became pregnant again. By the time I was administered mifepristone, I was losing a life that I had already begun to love. And like many other women, despite my level of education or economic status, I could not outrun the statistics that put Black women at higher risk.

    Up to one in four known pregnancies will end in a miscarriage. And for Black women, the numbers are alarmingly higher. According to an analysis of 4.6 million pregnancies in seven countries, the risk of a miscarriage for Black women is 43% higher than for White women.

    In the Black community, women have traditionally been taught to bear their burdens silently — keep your business to yourself — even after something as devastating as pregnancy loss. We are conditioned to do as I did back then, and keep it moving as we try to outrun the long list of statistics that tell us our lives are in danger from every direction, whether it be from health care risks to societal injustices or other stressors.

    During my miscarriage, I was a woman who was afraid, hemorrhaging and in excruciating pain, in desperate need of safe, emergency medical care. Thanks to the administration of mifepristone, I was allowed dignity during my miscarriage. It’s what every woman deserves — whether it be facing a potentially life-threatening miscarriage or seeking an abortion.

    I learned from my experience that every miscarriage matters. Women must have access to whatever medicines and counseling we need to help us heal and that includes mifepristone. What we don’t need is to be criminalized by politicians and punitive reproductive laws that have long been out of step with public opinion. Despite the continuing political attacks on women’s reproductive rights, more than 61% of US adults say abortion should be legal in all or most cases, according to Pew Research Center.

    After the US Justice Department asked the Supreme Court to intervene, Justice Samuel Alito issued a temporary order to preserve the status quo, ensuring access to the drug while giving the justices more time to study the issue.

    I am hoping the justices can put politics aside and focus on the science surrounding the safety of mifepristone, a drug that, thankfully, I had access to when my life was in danger. Mifepristone, a synthetic steroid, is even safer than common prescription drugs including penicillin and Viagra.

    Following the science demands that, regardless of where you stand on the issue of abortion, consideration must be made for cases like mine and the millions of other women who for years have safely used this medication for complications surrounding miscarriages.

    We do not know how the legal fight over medication abortion will unfold. But women across the nation – in blue and red states alike – are watching. Punitive laws like the one signed last week by Florida Gov. Ron DeSantis seek to criminalize reproductive care providers. And worse, they are stripping us of rights that men take for granted – it’s unlikely they will be prohibited by the law from making health care decisions about their own bodies.

    It must end. And I’m betting that whether it be with our voice or our votes, women will have the last word.

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  • Double delight for Kenya as Evans Chebet and Hellen Obiri win men’s and women’s Boston Marathon races | CNN

    Double delight for Kenya as Evans Chebet and Hellen Obiri win men’s and women’s Boston Marathon races | CNN

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    CNN
     — 

    There was double delight for Kenya at the 2023 Boston Marathon as Evans Chebet and Hellen Obiri won the men’s and women’s races respectively.

    Chebet claimed his second consecutive Boston Marathon – the first man to defend his title since Robert Cheruiyot did so in 2008 – in an unofficial time of two hours, five minutes and 54 seconds, while Obiri took the honors in only her second official marathon.

    Tanzanian Gabriel Geay came in second, finishing in 2:06:04, while Kenyan Benson Kipruto placed third in 2:06:06.

    More than 30,000 athletes from all 50 states and more than 100 countries participated in the famed 26.2-mile course, starting in rural Hopkinton and finishing on Boylston Street.

    This year’s race marked the 10-year anniversary of the double bombings that took place near the finish line, killing three people and injuring at least 264.

    Obiri won the women’s elite race to claim her first Boston Marathon title in an unofficial time of two hours, 21 minutes and 38 seconds.

    An exuberant Obiri, who finished sixth in the New York Marathon in November, was greeted at the finish line by her proud daughter.

    Obiri is a two-time Olympic silver medalist, coming second in the 5000 meters at Rio 2016 and Tokyo 2020.

    Ethiopian Amane Beriso came in second, finishing in 2:21:50, while Lonah Salpeter of Israel placed third in 2:21:57.

    American Emma Bates finished fifth in 2:22:10.

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  • Refined carbs and red meat driving global rise in type 2 diabetes, study says | CNN

    Refined carbs and red meat driving global rise in type 2 diabetes, study says | CNN

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    Editor’s Note: Sign up for CNN’s Eat, But Better: Mediterranean Style. Our eight-part guide shows you a delicious expert-backed eating lifestyle that will boost your health for life.



    CNN
     — 

    Gobbling up too many refined wheat and rice products, along with eating too few whole grains, is fueling the growth of new cases of type 2 diabetes worldwide, according to a new study that models data through 2018.

    “Our study suggests poor carbohydrate quality is a leading driver of diet-attributable type 2 diabetes globally,” says senior author Dr. Dariush Mozaffarian, a professor of nutrition at Tufts University and professor of medicine at Tufts School of Medicine in Boston, in a statement.

    Another key factor: People are eating far too much red and processed meats, such as bacon, sausage, salami and the like, the study said. Those three factors — eating too few whole grains and too many processed grains and meats — were the primary drivers of over 14 million new cases of type 2 diabetes in 2018, according to the study, which was published Monday in the journal Nature Medicine.

    In fact, the study estimated 7 out of 10 cases of type 2 diabetes worldwide in 2018 were linked to poor food choices.

    “These new findings reveal critical areas for national and global focus to improve nutrition and reduce devastating burdens of diabetes,” said Mozaffarian, who is also the editor in chief of the Tufts Health & Nutrition Letter.

    Mozaffarian and his team developed a research model of dietary intake between 1990 and 2018 and applied it to 184 countries. Compared with 1990, there were 8.6 million more cases of type 2 diabetes due to poor diet in 2018, the study found.

    Researchers found eating too many unhealthy foods was more of a driver of type 2 diabetes on a global level than a lack of eating wholesome foods, especially for men compared with women, younger compared to older adults, and in urban versus rural residents.

    Over 60% of the total global diet-attributable cases of the disease were due to excess intake of just six harmful dietary habits: eating too much refined rice, wheat and potatoes; too many processed and unprocessed red meats; and drinking too many sugar-sweetened beverages and fruit juice.

    Inadequate intake of five protective dietary factors — fruits, nonstarchy vegetables, nuts, seeds, whole grains and yogurt — was responsible for just over 39% of the new cases.

    People in Poland and Russia, where diets tend to focus on potatoes and red and processed meat, and other countries in Eastern and Central Europe as well as Central Asia, had the highest percentage of new type 2 diabetes cases linked to diet.

    Colombia, Mexico and other countries in Latin America and the Caribbean also had high numbers of new cases, which researchers said could be due to a reliance on sugary drinks and processed meat, as well as a low intake of whole grains.

    “Our modeling approach does not prove causation, and our findings should be considered as estimates of risk,” the authors wrote.

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  • McConnell back after fall as Senate resumes | CNN Politics

    McConnell back after fall as Senate resumes | CNN Politics

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    CNN
     — 

    Senate Minority Leader Mitch McConnell has returned to the Senate following a period of recovery in the wake of a fall.

    McConnell arrived on Capitol Hill Monday morning and did not answer questions from CNN about how he is feeling after spending the last several weeks recovering after a fall where he suffered a concussion and fractured rib. CNN spotted McConnell in the Capitol exclusively.

    McConnell was at the Capitol on Friday, but Monday marks the GOP Senate leader’s first day back in session. The House and Senate are both returning to session today following a two-week recess period.

    McConnell also did not answer a question about how he will handle the issue of how Democrats want to temporarily replace Sen. Dianne Feinstein on the Judiciary committee. Feinstein’s absence as she recovers from shingles is making it more difficult for Democrats to process judicial nominees on the panel, setting up a potential clash with Republicans as they seek to replace her.

    McConnell was hospitalized last month after he tripped and fell at a dinner event in Washington, DC. He was treated for a concussion and a rib fracture before being released to an inpatient rehabilitation facility for physical therapy.

    At the time, a McConnell aide told CNN, “it is very common to undergo physical therapy to regain strength after a hospital stay.”

    McConnell, who is 81 years old, left the physical therapy facility on March 25. In a statement, the Senate GOP leader said that, following advice from his physical therapists, he would, “spend the next few days working for Kentuckians and the Republican Conference from home.”

    McConnell added that he remained “in frequent touch with my Senate colleagues and my staff. I look forward to returning in person to the Senate soon.”

    Earlier this year, McConnell became the longest-serving party leader in Senate history.

    During his absence, Senate Republicans who spoke with the McConnell said he was itching to get back to the chamber. The No. 2 Senate Republican, Minority Whip John Thune, noted that he was “anxious” to return, and Texas Senator John Cornyn told reporters that McConnell was “chomping at the bit” to come back to the Capitol.

    This was not McConnell’s first fall. Several years ago, he fractured his shoulder in a fall at his home in Kentucky.

    The top Republican is not the only senator returning from an extended absence.

    Across the aisle, Democrat Senator John Fetterman will return to the Senate after receiving inpatient treatment for clinical depression at Walter Reed National Military Medical Center. Fetterman was discharged from the hospital at the end of last month.

    Feinstein has been absent from the Senate after being treated in the hospital, and then at home, for shingles. It is not yet clear exactly when she may return.

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  • Rival rulings on medication abortion hypercharge the post-Roe legal war | CNN Politics

    Rival rulings on medication abortion hypercharge the post-Roe legal war | CNN Politics

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    CNN
     — 

    A pair of conflicting federal court rulings on Friday created arguably the most contentious and chaotic legal flashpoint over abortion access since the Supreme Court’s ruling last summer that overturned Roe v. Wade and ended the right to an abortion nationwide.

    Within less than an hour, two major rulings came down in separate, closely watched cases concerning medication abortion – in lawsuits that are completely at odds with each other.

    In one case, filed by anti-abortion activists in Texas, a judge said the FDA’s 2000 approval of mifepristone – one of the drugs used to terminate a pregnancy – should be halted. But the court paused its ruling for a week so that it can be appealed, and that appeal is already under way.

    In the second case, where Democratic-led states had sued in Washington to expand access to abortion pills, a judge ordered the federal government to keep the drug available in the 17 states, plus the District of Columbia, that brought the lawsuit.

    On their face, both cases deal with the administrative law that controls how the US Food and Drug Administration goes about regulating mifepristone. The disputes did not rely directly on the question of whether there is a right to an abortion – the question that was at the center of the Supreme Court’s ruling last June. But tucked in the Texas ruling, by US District Judge Matthew Kacsmaryk, was the idea that embryos could have individual rights that courts can consider in their rulings.

    Both cases emerge from a political environment that was unleashed by the Supreme Court’s Roe v. Wade reversal and a willingness to push the legal envelope that the Supreme Court ruling created. The abortion issue is now on a path back to the Supreme Court, as higher courts are asked to sort out the contradictory commands of Friday night’s decisions.

    Because the Texas judge has paused his ruling, it has no immediate impact on the availability of medication abortion drugs. But the next several days stand to be a dramatic and combustible legal fight over the order – a fight ratcheted up by the rival ruling in Washington.

    Besides pausing his ruling for one week, Kacsmaryk – an appointee of former President Donald Trump who sits in Amarillo, Texas – seemed to hold nothing back as he ripped apart the FDA’s approval of mifepristone and embraced wholeheartedly the challengers’ arguments the drug’s risks weren’t adequately considered.

    Kacsmaryk, whose anti-abortion advocacy before joining the federal bench was documented by a recent Washington Post profile, showed a striking hostility to medication abortion, which is the method used in a majority of the abortions in the United States.

    Leading medical organizations have already condemned his opinion and pushed back at the judge’s analysis of the safety of medication abortion.

    The judge said that the FDA failed to consider “the intense psychological trauma and post-traumatic stress women often experience from chemical abortion,” in what was a repeated invocation of “chemical abortion,” the term preferred by abortion opponents. Kacsmaryk suggested that the FDA’s data was downplaying the frequency with which the drug being mistakenly administered to someone who had an ectopic pregnancy, i.e. a pregnancy outside the cavity of the uterus. He repeated the challengers’ accusations that the FDA’s approval process had been the subject of improper political pressure.

    He said the FDA’s refusal to impose certain restrictions on the drug’s use “resulted in many deaths and many more severe or life-threatening adverse reactions.”

    “Whatever the numbers are, they likely would be considerably lower had FDA not acquiesced to the pressure to increase access to chemical abortion at the expense of women’s safety,” he said.

    Jack Resneck Jr., the president of the American Medical Association, said in a statement that Kacsmaryk’s ruling “flies in the face of science and evidence and threatens to upend access to a safe and effective drug.”

    “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,” the AMA president said.

    Kacsmaryk’s opinion paid no heed to the argument made by the FDA’s defenders that cutting off access to medication abortion would put the health of pregnant people at risk and that it would force abortion seekers to terminate their pregnancies through a surgical procedure instead.

    Instead, the judge wrote that a ruling in the challengers’ favor would ensure “that women and girls are protected from unnecessary harm and that Defendants do not disregard federal law.”

    As he explained why the preliminary injunction – which was being handed down before the case could proceed to a trial – was justified, he said that embryos had their own rights that could be part of the analysis. That assertion goes farther than what the Supreme Court said in its June ruling, known as Dobbs v. Jackson Women’s Health.

    “Parenthetically, said ‘individual justice’ and ‘irreparable injury’ analysis also arguably applies to the unborn humans extinguished by mifepristone — especially in the post-Dobbs era,” Kacsmaryk said Friday.

    Whereas Kacsmaryk had been asked by the challengers in Texas to block medication abortion, US District Judge Thomas Owen Rice, who sits in Spokane, Washington, was considering whether abortion pills should be easier to obtain.

    Rice, an Obama appointee, granted the Democratic attorneys general who brought the lawsuit a partial win.

    They had asked Rice to remove certain restrictions – known as REMS or Risk Evaluation and Mitigation Strategy – the FDA has imposed on mifepristone, with the blue states arguing the drug was safe and effective enough to make those restrictions unnecessary.

    While Rice is rejecting that bid for now, he granted a request the states also made that the FDA be ordered to keep the drugs on the market. But Rice’s ruling only applies in the 17 plaintiff states and the District of Columbia.

    His decision maintains the status quo for the availability of abortion pills in those places and he specifically is blocking the agency from “altering the status quo and rights as it relates to the availability of Mifepristone under the current operative January 2023 Risk Evaluation and Mitigation Strategy.”

    Rice’s opinion was a striking split screen to Kacmsaryk’s. While the Texas judge said the FDA did not adequately take into account the drug risks, Rice showed sympathy to the arguments that the rules for mifepristone’s use were too strict and that the agency should be taking a more lenient approach to how the abortion pill is regulated.

    Ultimately, he said he would not grant the Democratic states’ request that he remove some of the drug restrictions at this preliminary stage in the proceedings, because that would go well beyond maintaining the status quo while the case advances. He noted that if he had granted that request, it would also undo a new FDA rule that allows pharmacies to dispense abortion pills. That would reduce its availability and would run “directly counter to Plaintiffs’ request.”

    If Kacsmaryk’s ruling halting mifepristone’s approval is allowed to go into effect, it will run headlong into Rice’s order that mifepristone remain available in several states. Kacsmaryk’s ruling is a nationwide injunction.

    The Justice Department and Danco, a mifepristone manufacturer that intervened in the case to defend the approval, both filed notices of appeal. Both Attorney General Merrick Garland and Danco said in statements that in addition to the appeals, they will seek “stays” of the ruling, meaning emergency requests that the decision is frozen while the appeal moves forward.

    They’re appealing to the US 5th Circuit Court of Appeals, which is sometimes said to be the country’s most conservative appeals court. Yet some legal scholars were skeptical that the 5th Circuit, as conservative as it is, would let Kacmsaryk’s order take effect.

    Washington, where the blue states’ lawsuit was filed, is covered under the 9th Circuit, a liberal appellate court. But it’s unclear if the ruling from Rice will be appealed. Garland said the Justice Department was still reviewing the decision out of Washington. A so-called circuit split would increase the odds that the Supreme Court would intervene. But given how the practical impact of the two district court rulings contradict each other, the Supreme Court may have no choice but to get involved.

    The lawyer for the challengers in the Texas case, anti-abortion medication associations and doctors, said Friday evening that he had not reviewed the Washington decision, so he could not weigh in on how it impacted Kacsmaryk’s order that the drug’s approval be halted.

    “I’m not sure whether there’s a direct conflict yet and with the Washington state decision just because I haven’t read it yet, but there may not be a direct conflict,” Erik Baptist, who is an attorney with Alliance Defending Freedom, said. “But if there is a direct conflict then there may be – it may be inevitably going to the Supreme Court, but I’m not convinced that it’s necessary at this point to make that conclusion.”

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  • Florida Senate passes 6-week abortion ban | CNN Politics

    Florida Senate passes 6-week abortion ban | CNN Politics

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    Washington
    CNN
     — 

    Florida’s state Senate on Monday passed a bill that would ban most abortions in the state after the gestational age of six weeks, or about four weeks of pregnancy.

    The bill’s advance, which still needs to pass the state’s GOP-led House, comes one year after Gov. Ron DeSantis signed a 15-week ban into law. The new legislation likely further burnishes the conservative credentials of DeSantis, a potential 2024 presidential candidate, and it was met with outrage by state Democrats, two of whom were arrested during a protest near the state Capitol Monday night.

    The current bill would impose restrictions on telehealth abortions and medication. It would include exemptions for women facing life-threatening harm while pregnant and victims of rape, incest and human trafficking.

    The bill targets both physicians who perform abortions and those who “actively participate in” them, and should the bill become law, any person who violates it could be charged with a third-degree felony.

    The “Heartbeat Protection Act” passed the Florida Senate in a 26-13 vote.

    A protest over the bill near the state Capitol resulted in the arrests of 11 people who were charged with trespassing after a warning, Tallahassee police said. Florida Democrats said state party Chairwoman Nikki Fried and Florida Senate Minority Leader Lauren Book were among them.

    “As the Democratic leader in the Florida Senate, it’s my job to a lead this incredible group of 11 Democrats, other than myself, to fight against these extreme policies,” Book told CNN on Wednesday. ‘Women will die as a consequence of this piece of policy.”

    Other abortion rights advocates say the Florida bill unfairly seeks to ban abortions before many even know they are pregnant.

    “This bill will unfairly and disproportionately impact people who live in rural communities, people with low incomes, people with disabilities, and people of color,” Kara Gross, the legislative director and senior policy counsel at the American Civil Liberties Union of Florida, said in a statement.

    “Hundreds of thousands of pregnant people will be forced to travel out of state to seek the care they need. Many people will not even know they are pregnant by six weeks, and for those who do, it is unlikely they will be able to schedule the legally required two in-person doctor’s appointments before six weeks of pregnancy,” Gross said.

    The White House has also criticized the pending bill.

    “The President and Vice President believe women should be able to make health care decisions with their doctors and families – free from political interference. They are committed to protecting access to reproductive care, and continue to call on Congress to restore the protections of Roe v. Wade in federal law,” White House press secretary Karine Jean-Pierre said in a statement when the bill was first introduced.

    State Sen. Clay Yarborough, one of the bill’s Republican sponsors, said “unborn children deserve the strongest protections possible under our laws.”

    The legislation underscores the ongoing efforts across the country to restrict access to abortion in a post-Roe world. Other Republican-led states have also pursued six-week abortion bans that have been met with legal challenges.

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  • US health officials aim to ‘transform’ Alzheimer’s disease research with $300 million data platform | CNN

    US health officials aim to ‘transform’ Alzheimer’s disease research with $300 million data platform | CNN

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    CNN
     — 

    The US National Institute on Aging is moving forward with efforts to build a real-world Alzheimer’s disease database as part of its aim to improve, support and conduct more dementia research.

    Last month, the agency, part of the National Institutes of Health, posted a notice of the grant for the six-year database project, setting its earliest start date as April 2024.

    The NIH confirmed Tuesday that plans are underway to fund the Alzheimer’s disease and Alzheimer’s disease-related dementias’ real-world data platform.

    The National Institute on Aging intends to commit $50 million per year, starting in fiscal year 2024, to fund one award.

    The nonprofit Alzheimer’s Association is among those planning to apply for the grant.

    “The newly-announced NIA funding for a large-scale Alzheimer’s disease research database is truly exciting and a very important step forward for our field, and the Alzheimer’s Association will apply for that grant,” Maria C. Carrillo, Alzheimer’s Association chief science officer, said in an email Tuesday.

    “The Association is already leading ALZ-NET, which is a national network of physicians that is collecting data – including measures of cognition, function and safety – for patients treated with new FDA-approved Alzheimer’s treatments,” Carrillo said. “The NIA funding could expand ALZ-NET’s scope to the benefit of all stakeholders.”

    She added that the Alzheimer’s Association believes everyone should have access to treatments, regardless of their registration status.

    The real-world database “aims to transform” the Alzheimer’s disease research enterprise “by serving as a central hub of research access,” the National Institute on Aging said last week in its announcement of a webinar about the project that’s scheduled for April 19.

    According to the announcement, the aim of the data registry is to provide a comprehensive and diverse database that can “improve applicability and generalizability of findings,” be used as a tool for researchers and allow scientific questions to be answered more quickly.

    Last year, the National Institute on Aging convened an exploratory workshop to discuss gaps in real-world data and opportunities to expand real-world data sources for dementia research.

    Alzheimer’s disease, a brain disorder that affect memory and thinking skills, is the most common type of dementia, the NIH says.

    More than 6 million Americans are living with dementia caused by Alzheimer’s disease, according to the Alzheimer’s Association, and the number of people affected is projected to double in the next two decades, rising to 13 million in 2050.

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  • Morning after pill brand speeds up retail access, doubles supply per pack | CNN Business

    Morning after pill brand speeds up retail access, doubles supply per pack | CNN Business

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    New York
    CNN
     — 

    One maker said it is responding to high demand for the morning-after pill, after the US Supreme Court last year ended a constitutional right to abortion, by speeding up availability of the emergency contraceptive in retail stores and introducing a new two-count pack.

    Julie launched as a one-step tablet of emergency contraceptive containing Levonorgestrel, the key ingredient in the popular Plan B emergency contraceptive that was approved by FDA in late 1990s without a prescription, at 4,500 Walmart stores nationwide last September.

    The startup experienced a surge in demand for its $42 tablet at launch amid an overall spike in purchases of emergency contraceptive following the US Supreme Court’s ruling overturning Roe v. Wade in on June 24, 2022.

    The FDA-approved morning-after pill can reduce the chance of pregnancy after unprotected sex or failure of another contraceptive method like a condom, and is ideally taken within 72 hours. The pill, which is legal in all 50 US states, works by delaying ovulation or preventing implantation and cannot terminate a pregnancy.

    While the plan from the beginning was always to make the product widely accessible as quickly possible, the Supreme Court’s ruling only compelled the startup to accelerate the timetable for Julie’s nationwide rollout.

    “The Dobbs decision and overturning Roe v. Wade last year rocked everyone’s world, our customers and our retail partners,” said Amanda E/J Morrison, cofounder of Julie. “It lit a fire under us to provide our product to more women and, more importantly, to educate women about emergency contraceptives.”

    In April, just seven months after hitting the market, Julie is now expanding into 5,600 CVS stores and 1,500 Target stores. The brand is also introducing a new 2-count pack of its emergency contraception (which has a three-year expiration period). The two-count pack rolled out at CVS locations over the weekend.

    “With the two-pack, we want to make it easier for women to keep extra emergency contraceptive at home, just like they would with other birth control options like condoms,” said Morrison.

    The price for two-count pack is $70. Morrison said the pill works most effectively the closer it is taken after unprotected sex, ideally within 72 hours.

    Dr. Colleen Denny, a clinical associate professor in the department of obstetrics and gynecology at NYU Grossman School of Medicine, said she saw the upside to a two-count pack of emergency contraception, which she hasn’t seen before from other emergency contraception brands.

    “It generally makes sense for barriers to emergency contraception, prescription and over the counter, to be as low as possible,” said Denny,

    “Emergency contraception is incredibly safe and effective at preventing pregnancy when used in the right time frame,” she said. “Relationships are complicated. There can be situations where there isn’t access to emergency contraception or women might not ask the partner to use it. So being able to have access to one pill and a backup is a great idea.”

    Kelly Cleland, executive director of the American Society for Emergency Contraception, said emergency contraception brands, like Julie, still have to work harder at making the product not only more accessible, but also more affordable.

    “I am in favor of expanding access, but this is a missed opportunity when a generic brand comes into the market with a high price barrier,” Cleland said about Julie’s $70 price for the two-count pack.

    Cleland said a study done last year by the American Society for Emergency Contraception on access to emergency contraception in stores compared price at retail for branded and generic emergency contraception options. The report said some generic options were priced at $6 or less.

    Julie said it set the price for its single pill and two-count pack so it can fund its one-for-one donation program (in which the company donates one box for every box purchased) and to cover business costs tied to packaging and marketing.

    By overturning Roe v. Wade, the Supreme Court revoked the notion that the constitutional right to privacy included an abortion. In Dobbs v. Jackson Women’s Health Organization, the Supreme Court expanded states’ authority to regulate or restrict abortion.

    A total of 26 US states have since implemented new abortion restrictions or all-out bans.

    In the rulings’ immediate aftermath, doctors and prescribers saw a sharp jump in demand for different forms of contraception, including emergency contraception, and longer-lasting forms of birth control. The rush on emergency contraceptives forced some pharmacy chains to impose temporary purchase limits.

    “Every time there is a new development on restrictions to reproduction health care, there’s a run on emergency contraceptive. Our retail partners confirmed this,” said Morrison, adding that news events continue to influence buying patterns for emergency contraceptive.

    “The current political climate has emboldened Julie,” Morrison said. This, according to the company, includes expanding Julie’s available within communities through unexpected places like bars, restaurants and coffee shops.

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  • Abortion foes take aim at ballot initiatives in next phase of post-Dobbs political fights | CNN Politics

    Abortion foes take aim at ballot initiatives in next phase of post-Dobbs political fights | CNN Politics

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    CNN
     — 

    After a string of recent ballot-box victories for abortion rights groups, opponents of the procedure are redoubling their efforts – including, in some places, pushing to make it harder to use citizen-approved ballot measures to guarantee abortion access.

    An anti-abortion coalition in Ohio, for instance, recently unleashed a $5 million ad buy targeting an effort to enshrine abortion rights in the state’s constitution through a ballot initiative – just as the initiative’s organizers won approval to collect signatures to put the question to voters in November. Meanwhile, legislators in Ohio and other states are weighing bills that would make it more difficult to pass citizen-initiated changes to state constitutions.

    The US Supreme Court’s decision to overturn Roe v. Wade last year left abortion laws up to the states, and abortion rights groups quickly scored wins on ballot measures in six of them – including in the battleground state of Michigan, where voters protected abortion access, and in the Republican strongholds of Kansas, Kentucky and Montana, where voters defeated efforts to restrict abortions.

    “What we saw in the midterms last year was a wake-up call,” said Kelsey Pritchard, director of state public affairs for Susan B. Anthony Pro-Life America. She said helping local groups defeat abortion-related ballot measures is one of the top three priorities for the group’s state affairs team.

    Groups on both sides of the abortion divide have poured big sums into an upcoming state Supreme Court race in Wisconsin that has seen record spending and offers a key test of the potency of the abortion issue among voters in a battleground state. Whether a conservative or liberal candidate wins a swing seat Tuesday on the seven-member high court there could determine the fate of abortion rights in the state. A Wisconsin law, enacted in 1849, that bans nearly all abortions is being challenged in court and is likely to land before the state Supreme Court.

    More fights over ballot initiatives on abortion are stirring to life around the country. In addition to Ohio – where a state law banning abortion as early as six weeks into a pregnancy has been put on hold by a judge – abortion rights proponents have begun to push ballot proposals in South Dakota and Missouri. Most abortions are now illegal in those two states.

    And groups in at least more six states are considering citizen initiatives as a way to guarantee or expand access to abortions, said Marsha Donat, capacity building director at The Ballot Initiative Strategy Center, which helps progressive groups advance ballot measures.

    Ohio, however, looms as the next big abortion battleground on the 2023 calendar – with skirmishes already underway in the courts, the state legislature and on the airwaves.

    A state “fetal heartbeat” law that prohibits many abortions as early as six weeks into pregnancy took effect when the US Supreme Court struck down Roe with its decision last June in Dobbs v. Jackson Women’s Health Organization. But the law has been put on hold by a judge in Cincinnati in a case that’s expected to end up before the state’s high court.

    Abortion rights supporters recently won approval to begin collecting signatures to put a measure on the November ballot that would guarantee Ohioans’ access to abortion. If approved by voters, state officials could not prohibit abortion until after fetal viability, the point at which doctors say the fetus can survive outside the womb.

    The initiative says that “every individual has a right to make and carry out one’s own reproductive decisions, including but not limited to decisions” on contraception, fertility treatment, continuing one’s own pregnancy, miscarriage care and abortion.

    It also would bar the state from interfering with an individual’s “voluntary exercise of this right” or that of a “person or entity that assists an individual exercising this right.”

    A conservative group called Protect Women Ohio immediately launched an ad campaign – putting $4 million on the air and $1 million into digital advertising – to cast the amendment as one that would strip parents of their authority to prevent a child from having an abortion or undergoing gender reassignment surgery, although the proposed constitutional amendment makes no mention of transgender care.

    Officials with Protect Women Ohio argue that the initiative’s language is broad enough to be interpreted as extending to gender reassignment surgery, an assertion initiative proponents say is false.

    In the campaign aimed at defeating the amendment, “we’ll make sure they have to own every last word of this radical initiative,” said Aaron Baer, the president of Center for Christian Virtue and a Protect Women Ohio board member, told CNN. “They chose this language for a reason, and we’re not going to let them off the hook.”

    Lauren Blauvelt – who chairs Ohioans for Reproductive Freedom, the group promoting the initiative – said the ad “is completely wrong” and called it an “unfortunate talking point from the other side.”

    “Our amendment … creates the fundamental right that an individual can make their own reproductive health care decisions” and does not touch on other topics, she said.

    But the ad campaign highlights the effort to link abortion to the transgender and parental rights issues currently animating conservative activists.

    Susan B. Anthony’s Pritchard said she believes that her side can win on the issue of limiting abortions but “we believe also that we broaden our coalition and broaden awareness of what these things actually do when we highlight the parental rights issue that is very real.”

    The initiative’s supporters need to collect more than 413,000 signatures from Ohioans by July 5 to qualify for the November ballot. Under current Ohio law, changes to the state’s constitution can be approved via ballot initiative by a simple majority of voters.

    A bill introduced by Republican state Rep. Brian Stewart would increase that threshold to 60% and would mandate that the signatures needed to put an amendment on the ballot come from all 88 counties in the state, instead of 44, as currently required.

    Ohio state Senate President Matt Huffman backs raising the threshold and also supports holding an August special election to change the ballot initiative rules. If successful, the higher threshold would be in effect before November’s election when voters could consider adding abortion rights to the state constitution.

    Neither Huffman nor Stewart responded to interview requests from CNN.

    Ohio lawmakers recently voted to end August special elections, citing their expense and low participation. But Huffman recently told reporters in Ohio that a special election – with a potential price tag of $20 million – would be worth the expense if it helped torpedo the abortion initiative.

    “If we save 30,000 lives as a result of spending $20 million, I think that’s a great thing,” he said, according to Cleveland.com.

    The Ballot Initiative Strategy Center is tracking 109 measures across 35 states that could affect initiatives put to voters in 2024. Some would increase the threshold for an initiative to pass. Others would increase the minimum number of signatures – or require that they come from a broader geographic area – before an initiative could qualify for the ballot in the first place, Donat said.

    Many of the bills that seek to make it more difficult to pass ballot initiatives do not specifically target abortion issues. But they come as progressive groups increasingly turn to the initiative process as a way to bypass Republican-controlled legislatures and put a raft of issues – from legalizing marijuana to expanding Medicaid eligibility and boosting the minimum wage – directly to voters.

    “Attacks, through state legislatures, on the ballot measure process have been pretty consistent and pretty aggressive for the last several (election) cycles,” said Kelly Hall, executive director of the Fairness Project, which has helped pass progressive measures in red states.

    Hall said the abortion issue, while not the sole focus of current efforts to curb ballot initiatives, has put “additional fuel on an already burning fire.”

    In Missouri, a state law banning most abortions – including in cases of rape and incest – took effect last year after Roe was overturned. A group called Missourians for Constitutional Freedom has filed petition language that proposes adding abortion protections to the state constitution via ballot initiative. In recent cycles, voters in Missouri have expanded Medicaid eligibility and legalized recreational marijuana use through such initiatives.

    This year, the state’s Republican-controlled legislature is weighing making it harder for those initiatives to succeed. In February, the state House voted to raise the bar for amending the state constitution from a simple majority to 60%. Voters would have to approve the higher threshold.

    “I believe the Missouri Constitution is a living document but not an ever-expanding document,” Republican state Rep. Mike Henderson, the measure’s sponsor, said during House floor debate. “And right now, it has become an ever-expanding document.”

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  • WHO advisers to consider whether obesity medication should be added to Essential Medicines List | CNN

    WHO advisers to consider whether obesity medication should be added to Essential Medicines List | CNN

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    CNN
     — 

    Advisers to the World Health Organization will consider next month whether to add liraglutide, the active ingredient in certain diabetes and obesity medications, to its list of essential medicines.

    The list, which is updated every two years, includes medicines “that satisfy the priority health needs of the population,” WHO says. “They are intended to be available within the context of function health systems at all times, in adequate amounts in the appropriate dosage forms, of assured quality and at prices that individuals and the community can afford.”

    The list is “a guide for the development and updating of national and institutional essential medicine lists to support the procurement and supply of medicines in the public sector, medicines reimbursement schemes, medicine donations, and local medicine production.”

    The WHO Expert Committee on the Selection and Use of Essential Medicines is scheduled to meet April 24-28 to discuss revisions and updates involving dozens of medications. The request to add GLP-1 receptor agonists such as liraglutide came from four researchers at US institutions including Yale University and Brigham and Women’s Hospital.

    These drugs mimic the effects of an appetite-regulating hormone, GLP-1, and stimulate the release of insulin. This helps lower blood sugar and slows the passage of food through the gut. Liraglutide was developed to treat diabetes but approved in the US as a weight-loss treatment in 2014; its more potent cousin, semaglutide, has been approved for diabetes since 2017 and as an obesity treatment in 2021.

    The latter use has become well-known thanks to promotions from celebrities and on social media. It’s sold under the name Ozempic for diabetes and Wegovy for weight loss. Studies suggest that semaglutide may help people lose an average of 10% to 15% of their starting weight – significantly more than with other medications. But because of this high demand, some versions of the medication have been in shortage in the US since the middle of last year.

    The US patent on liraglutide is set to expire this year, and drugmaker Novo Nordisk says generic versions could be available in June 2024.

    The company has not been involved in the application to WHO, it said in a statement, but “we welcome the WHO review and look forward to the readout and decision.”

    “At present, there are no medications included in the [Essential Medicines List] that specifically target weight loss for the global burden of obesity,” the researchers wrote in their request to WHO. “At this time, the EML includes mineral supplements for nutritional deficiencies yet it is also described that most of the population live in ‘countries where overweight and obesity kills more people than underweight.’ “

    WHO’s advisers will make recommendations on which drugs should be included in this year’s list, expected to come in September.

    “This particular drug has a certain history, but the use of it probably has not been long enough to be able to see it on the Essential Medicines List,” Dr. Francesco Blanca, WHO director for nutrition and food safety, said at a briefing Wednesday. “There’s also issues related to the cost of the treatment. At the same time, WHO is looking at the use of drugs to reduce weight excess in the context of a systematic review for guidelines for children and adolescents. So we believe that it is a work in progress, but we’ll see what the Essential Medicines List committee is going to conclude.”

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  • Crucial Antarctic ocean circulation heading for collapse if planet-warming pollution remains high, scientists warn | CNN

    Crucial Antarctic ocean circulation heading for collapse if planet-warming pollution remains high, scientists warn | CNN

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    Brisbane, Australia
    CNN
     — 

    Melting ice in the Antarctic is not just raising sea levels but slowing down the circulation of deep ocean water with vast implications for the global climate and for marine life, a new study warns.

    Led by scientists from the University of New South Wales and published Wednesday in the journal Nature, the peer-reviewed study modeled the impact of melting Antarctic ice on deep ocean currents that work to flush nutrients from the sea floor to fish near the surface.

    Three years of computer modeling found the Antarctic overturning circulation – also known as abyssal ocean overturning – is on track to slow 42% by 2050 if the world continues to burn fossil fuels and produce high levels of planet-heating pollution.

    A slow down is expected to speed up ice melt and potentially end an ocean system that has helped sustain life for thousands of years.

    “The projections we have make it look like the Antarctic overturning would collapse this century,” said Matthew England, deputy director of the Australian Research Council’s Centre for Excellence in Antarctic Science, who coordinated the study.

    “In the past, these overturning circulations changed over the course of 1,000 years or so, and we’re talking about changes within a few decades. So it is pretty dramatic,” he said.

    Most previous studies have focused on the Atlantic Meridional Overturning Circulation (AMOC), the system of currents that carry warm water from the tropics into the North Atlantic. The cold, saltier water then sinks and flows south.

    Its Southern Ocean equivalent is less studied but does an important job moving nutrient-dense water north from Antarctica, past New Zealand and into the North Pacific Ocean, the North Atlantic and Indian Ocean, the report’s authors said in a briefing.

    The circulation of deep ocean water is considered vital for the health of the sea – and plays an important role in sequestering carbon absorbed from the atmosphere.

    According to the report, while a slowdown of the AMOC would mean the deep Atlantic Ocean would get colder, the slower circulation of dense water in the Antarctic means the deepest waters of the Southern Ocean will warm up.

    “One of the concerning things of this slowdown is that there can be feedback to further ocean warming at the base of the ice shelves around Antarctica. And that would lead to more ice melt, reinforcing or amplifying the original change,” England said.

    As global temperatures rise, Antarctic ice is expected to melt faster, but that doesn’t mean the circulation of deep water will increase – in fact the opposite, scientists said.

    In a healthy system, the cold and salty – or dense – consistency of melted Antarctic ice allows it to sink to the deepest layer of the ocean. From there it sweeps north, carrying carbon and higher levels of oxygen than might otherwise be present in water around 4,000 meters deep.

    As the current moves northward, it agitates deep layers of debris on the ocean floor – remains of decomposing sea life thick with nutrients – that feed the bottom of the food chain, scientists said.

    In certain areas, mostly south of Australia in the Southern Ocean and in the tropics, this nutrient-rich cold water moves toward the surface in a process called upwelling, distributing the nutrients to higher layers of the ocean, England said.

    However, Wednesday’s study found that as global temperatures warm, melting sea ice “freshens” the water around Antarctica, diluting its saltiness and raising its temperature, meaning it’s less dense and doesn’t sink to the bottom as efficiently as it once did.

    The report’s co-author, Steve Rintoul from Australia’s Commonwealth Scientific and Industrial Research Organisation and the Australian Antarctic Program Partnership, said sea life in waters worldwide rely on nutrients brought back up to the surface, and that the Antarctic overturning is a key component of that upwelling of nutrients.

    “We know that nutrients exported from the Southern Ocean in other current systems support about three quarters of global phytoplankton production – the base of the food chain,” he said.

    “We’ve shown that the sinking of dense water near Antarctica will decline by 40% by 2050. And it’ll be sometime between 2050 and 2100 that we start to see the impacts of that on surface productivity.”

    England added: “People born today are going to be around then. So, it’s certainly stuff that will challenge societies in the future.”

    Fishing boats at a floating fish farm off Rongcheng, China.

    The report’s authors say the slowing of the Antarctic ocean overturning has other knock-on effects for the planet – for example, it could shift rain bands in the tropics by as much as 1,000 kilometers (621 miles).

    “Shut it down completely and you get this reduction of rainfall in one band south of the equator and an increase in the band to the north. So we could see impacts on rainfall in the tropics,” said England.

    Earlier this month, the Intergovernmental Panel on Climate Change (IPCC) warned in its latest report that the impacts of rising global temperatures were more severe than expected. Without immediate and deep changes, the world is hurtling toward increasingly dangerous and irreversible consequences of climate change, it added.

    The IPCC report found that the goal of limiting global warming to 1.5 degrees Celsius (2.7 degrees Fahrenheit) above preindustrial levels was still possible, but it’s becoming harder to achieve the longer the world fails to cut carbon pollution.

    England points out that the IPCC predictions don’t include ice melt from Antarctic ice sheets and shelves.

    “That’s a very significant component of change that’s already underway around Antarctica with more to come in the next few decades,” England said.

    Rintoul said the study was another urgent warning on top of all the ones that have come before it.

    “Even though the direct effect on fisheries through reduced nutrient supply might take decades to play out, we will commit ourselves to that future with the choices we make over the next decade.”

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  • FDA sketches out plan to bolster fragile US infant formula supply management | CNN

    FDA sketches out plan to bolster fragile US infant formula supply management | CNN

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    CNN
     — 

    The US Food and Drug Administration announced Tuesday its initial strategy to boost and strengthen the management of the country’s supply of infant formula.

    The announcement came just ahead of a hearing of the House Oversight and Accountability Committee about what went wrong during last year’s infant formula shortage.

    Committee members and experts who testified were critical of formula makers and the FDA’s food safety program, which the agency has pledged to revamp in order to protect the nation’s food supply and promote better nutrition. Many experts are concerned that the formula shortage of 2022 could easily happen again, even with those changes.

    “While we stand here today, more than a year since the recall, it is my view that the state of the infant formula industry today is not much different than it was then,” testified Frank Yiannas, who stepped down from his role as the agency’s deputy commissioner of food policy and response in late February.

    “The nation remains one outbreak, one tornado, flood or cyberattack away from finding itself in a similar place to that of February 17, 2022.”

    A formula shortage that started in 2021 was exacerbated when the United States’ largest infant formula maker, Abbott Nutrition, recalled multiple products in mid-February and had to pause production after FDA inspectors found potentially dangerous bacteria at its Sturgis, Michigan, plant.

    A former Abbott employee filed a whistleblower complaint about the plant with the US Department of Labor’s Occupational Safety and Health Administration in February 2021. The complaint suggested that the plant lacked proper cleaning practices and that workers falsified records and hid information from inspectors.

    The complaint was filed February 16, 2021, and was passed on to Abbott and the FDA three days later.

    Yiannas testified that because of the siloed nature of the agency, he wasn’t made aware of the complaint until February 2022. It was only then that he learned that children had gotten sick with Cronobacter after consuming powdered formula made at the plant.

    The US Centers for Disease Control and Prevention investigated at least four illnesses and two deaths in three states in connection. The agency sequenced bacteria from two of the children to compare against the samples the FDA took at the facility, but it did not find that the samples were closely related.

    Cronobacter infections are rare but can be serious and even fatal, especially in newborns. The bacteria lives in the environment, but when these infections are diagnosed in infants, they are often linked to powdered formula.

    “Clearly, I really wish, and I should have been notified sooner, so I could have initiated containment steps earlier. Had that happened, I believe we might not be here today,” Yiannas said Tuesday. “Had the agency responded quicker to some of the earlier signals, I believe this crisis could have been averted or at least the magnitude lessened.”

    With more demand for other brands after the Abbott recalls, families across the country had to hunt through multiple stores for formula last year. Stock rates of baby formula stayed lower than they were the year before for much of 2022. Even in October, when rates had improved, nearly a third of households with a baby younger than 1 said they had trouble finding formula over the course of one week, according to a survey by the US Census Bureau.

    The FDA said Tuesday that its new national strategy helps ensure that the country’s supply of formula will remain constant and safe.

    The agency said it will work with the industry on redundancy risk management plans that will help companies identify possible supply chain problems. It will also continue to enhance inspections of infant formula plants by expanding and improving training for agency investigators.

    According to the strategy, the FDA will expedite review of premarket submissions for new products to prevent shortages. It will continue to closely monitor the formula supply and has developed a model to forecast any potential disruptions.

    It also plans to work closely with the US Department of Agriculture to build in more resiliency with its Special Supplemental Nutrition Program for Women, Infants, and Children program, or WIC, the nation’s largest purchaser of infant formula.

    The new strategy is just a first step; the long-term strategy is expected to be released in early 2024.

    Dr. Susan Mayne, director of the FDA’s Center for Food Safety and Applied Nutrition, said in a statement that the new strategy aims to incentivize “additional infant formula manufacturers to enter the market.”

    Many parts of the strategy are underway, the FDA said.

    “Safety and supply go hand-in-hand. We witnessed last year how a safety concern at one facility could be the catalyst for a nationwide shortage. That’s why we are looking to both strengthen and diversify the market, while also ensuring that manufacturers are producing infant formula under the safest conditions possible,” FDA Commissioner Dr. Robert Califf said in a news release. “Now, with this strategy, we are looking at how to advance long-term stability in this market and mitigate future shortages, while ensuring formula is safe.”

    Formula stock rates are still not where they once were before last year’s crisis, Yiannas said, but the problem can’t be solved overnight. He said it was a good step for Congress to ask for a resiliency report from the industry.

    One positive development that came out of the crisis is that manufacturers are reporting formula volume to the FDA on a weekly basis even though there is no legal requirement to do so, he said.

    Historically, the FDA has focused on food safety and nutrition, not supply chain availability, but the Covid-19 pandemic opened eyes and served as the “biggest test on the US food system in 100 years,” Yiannas said. Food supply shortages made experts realize that the agency needed more intelligence on how companies’ supply chains worked.

    “Progress is being made, but it’s not being made fast enough,” Yiannas said.

    The FDA is now tracking sales and stock rates of baby formula. He said he’s talked to formula companies that say they have ramped up production, even though they might have cut back on the number of varieties of product they offer.

    The FDA said Tuesday that it has also done a study to better understand what led to the recall of infant formula at the Abbott plant. The agency had conducted a routine surveillance inspection at the plant in September 2021 and even then found problems like standing water and inadequate handwashing among employees.

    Abbott is facing additional investigations from the US Securities and Exchange Commission, the US Federal Trade Commission and the US Department of Justice as well as lawsuits from customers.

    Yiannas told the House committee Tuesday that one strategy to head off similar shutdowns would be to require manufacturers to report Cronobacter bacteria found in its products. Currently, only the Abbott plant in Michigan is required to report the bacteria as part of the consent decree that allowed it to reopen.

    The FDA said in November that it would like Cronobacter infections added to the CDC’s list of national notifiable diseases, which would require doctors to report cases to public health officials so the CDC and the FDA could keep better track of infections. Only two states have such a reporting requirement now.

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  • Sen. Mitch McConnell released from physical therapy rehab after fall | CNN Politics

    Sen. Mitch McConnell released from physical therapy rehab after fall | CNN Politics

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    Washington
    CNN
     — 

    Senate Minority Leader Mitch McConnell said Saturday that he has been released from an inpatient physical therapy facility after he fell earlier this month and was treated for a concussion and rib fracture.

    “I want to sincerely thank everyone for all the kind wishes. I’m happy to say I finished inpatient physical therapy earlier today and I’m glad to be home,” McConnell said in a statement.

    “I’m going to follow the advice of my physical therapists and spend the next few days working for Kentuckians and the Republican Conference from home. I’m in frequent touch with my Senate colleagues and my staff. I look forward to returning in person to the Senate soon.”

    McConnell will work from his Washington, DC, home this week and is not expected to return to the Senate before the chamber breaks for their two-week recess, a McConnell aide told CNN.

    The Senate minority leader was admitted to a hospital after he tripped and fell at a dinner event earlier this month. He remained in the hospital for several days. After that, he began physical therapy at an inpatient rehabilitation facility.

    Previously, a McConnell aide had said that the length of the 81-year-old Senate Republican leader’s stay at the facility would be decided “by the Leader’s physicians and the therapists.” The aide said, “It is very common to undergo physical therapy to regain strength after a hospital stay and this ranges anywhere from a week to two weeks.”

    Republican senators who have spoken with McConnell have told CNN that he wants to get back to work. Texas Sen. John Cornyn said recently that McConnell is “chomping at the bit” to return to the Capitol, and Senate Minority Whip John Thune, a South Dakota Republican, noted that he was “anxious” to come back.

    This was not McConnell’s first fall. In 2019, he fractured his shoulder in a fall at his home in Kentucky.

    The top Republican is not the only absent senator. Across the aisle, 89-year-old Sen. Dianne Feinstein of California has been receiving treatment for shingles at home following a brief stay in the hospital. And Pennsylvania Democratic Sen. John Fetterman is undergoing inpatient treatment for clinical depression at Walter Reed National Military Medical Center.

    This story has been updated with additional information.

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  • Pandemic lowered US step count and Americans haven’t bounced back, study says | CNN

    Pandemic lowered US step count and Americans haven’t bounced back, study says | CNN

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    Editor’s Note: Sign up for CNN’s Fitness, But Better newsletter series. Our seven-part guide will help you ease into a healthy routine, backed by experts.



    CNN
     — 

    Americans took fewer steps during the height of the Covid-19 pandemic, and they still haven’t gotten their mojo back, a new study found.

    “On average, people are taking about 600 fewer steps per day than before the pandemic began,” said study author Dr. Evan Brittain, associate professor of cardiovascular medicine at Vanderbilt University Medical Center in Nashville.

    “To me, the main message is really a public health message — raising awareness that Covid-19 appears to have had a lasting impact on people’s behavioral choices when it comes to activity,” he said.

    The study used data from the National Institutes of Health’s All of Us Research Program, which is focused on identifying ways to develop individualized health care. Many of the 6,000 participants in the program wore activity trackers for at least 10 hours a day over multiple years and allowed researchers access to their electronic health records.

    Brittain and his colleagues have used the ensuing data before, publishing a study in October 2022 that found overweight people could lower their risk of obesity by 64% by increasing their steps taken from about 6,000 to 11,000 per day.

    In the new study, published Monday in JAMA Network Open, researchers compared steps taken by nearly 5,500 people who wore the program’s activity trackers. Most were White women, with an average age of 53.

    Step counts collected between January 1, 2018, and January 31, 2020, were considered pre-Covid. Steps tracked after that date until the end of 2021, which is when the study ended, were considered post-Covid.

    Results showed no difference in identified step activity based on sex, obesity, diabetes and other illnesses or conditions such as coronary artery disease, hypertension or cancer.

    People who took the fewest steps were socioeconomically disadvantaged, under psychological stress and not vaccinated, the study said.

    Age made a difference as well, but in an unexpected manner: People over 60 were not impacted by the pandemic, the study found — they continued to keep their steps up.

    Oddly, it was younger people between 18 and 30 whose step counts were most impacted, Brittain said. “In fact, we found every 10-year decrease in age was associated with a 243 step reduction per day.”

    “If this persists over time, it could certainly raise the risk of cardiovascular disease, obesity, hypertension, diabetes and other conditions strongly linked to being sedentary,” Brittian said. “However, it’s too soon to know whether this trend will last.”

    Why would a younger generations lose steps while older people did not?

    “I think it’s difficult to interpret because it’s only 600 steps, which you could argue is what some people would get simply walking into work and through their day,” said Dr. Andrew Freeman, director of cardiovascular prevention and wellness at National Jewish Health, a hospital in Denver, who was not involved in the research. “I think the question is who is more likely to work from home?”

    Younger generations make up the majority of workers in technology, software and other professions that are able to work from anywhere, “whereas older people may have less of those jobs,” Freeman said.

    Whatever the reason, the study data shows that people were not moving as much during the pandemic as they used to. That is worrisome, Freeman added.

    “If this trend remains, we should really be cognizant that if you’re going to work from home, use either a standing, treadmill or bike desk,” he said, adding that managers of remote employees should “insist people take periodic breaks for people to do exercise, which also is proven to improve mental clarity and acuity,” he said.

    Health professionals should always be talking to their patients about activity levels, but “the impact of Covid-19 might make those kinds of messages all the more important to discuss with patients,” Brittain said.

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