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Tag: Medication

  • Promising new malaria vaccine for kids approved in Ghana

    Promising new malaria vaccine for kids approved in Ghana

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    DAKAR, Senegal — Ghana on Thursday became the first country to approve a new malaria vaccine for young children, one that officials hope will offer better protection against the disease that kills hundreds of thousands every year.

    Final results from late-stage trials have not yet been published, and the vaccine is under review at the World Health Organization. Preliminary results from early testing of the new vaccine, developed at the University of Oxford, have suggested the vaccine is far more effective than the only malaria vaccine now authorized for use by the WHO.

    Late-stage testing of the vaccine still is underway in Burkina Faso, Kenya, Mali and Tanzania, with results expected later this year.

    Results from an earlier trial released last year showed that in children vaccinated in Burkina Faso, the vaccine was up to 80% effective depending how much of an immune-boosting ingredient was included in the shots.

    The WHO has already rolled out a pilot program of the world’s first authorized malaria vaccine, piloted in three African countries, including Ghana, Kenya and Malawi. But that vaccine, sold by GlaxoSmithKline as Mosquirix, is about 30% effective.

    That vaccine “is saving lives” in the three pilot countries and has been delivered to over 1.4 million kids, according to Tarik Jasarevic, a WHO spokesman.

    Jasarevic said its advisory panel on malaria vaccines is reviewing available information on the new vaccine but is waiting for more data about its safety and efficacy from ongoing trials. “Initial results appear promising,” he wrote in an email.

    “We would welcome a second malaria vaccine that is safe and efficacious and approved by WHO to complement the roll-out of the first malaria vaccine,” he said.

    It’s not clear how soon the new vaccine will be available. Ghana’s Food and Drug Authority approved its use for children ages 5 months to 36 months, the group at highest risk of death from malaria, its developers said in a statement.

    Once the new Oxford vaccine is in use, Ghanaian health officials will weigh the “pros and cons before making a final decision” on which one is more effective, said Kwame Amponsa-Achiano the head of Ghana’s immunization program. Ghana is currently using the WHO-approved vaccine.

    The new vaccine can be manufactured at large scale and modest cost, its developers say. The Serum Institute of India says it could produce up to 100 million doses depending on demand, which will in turn depend on approval from the WHO.

    Ghana’s decision to approve the vaccine quickly was welcomed by health officials on the continent.

    ″(The) more we wait (the) more we’ll have thousands of children dying from malaria,” said Halidou Tinto, a malaria researcher who is leading the vaccine trial in Burkina Faso.

    ___

    Associated Press reporters Francis Kokutse in Accra, Ghana, Aniruddha Ghosal in New Delhi and Jamey Keaten in Geneva contributed.

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  • Court preserves access to abortion drug, tightens rules

    Court preserves access to abortion drug, tightens rules

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    AUSTIN, Texas — A federal appeals court has preserved access to an abortion drug for now but under tighter rules that would allow the drug only to be dispensed up to seven weeks, not 10, and not by mail.

    The drug, mifepristone, was approved for use by the Food and Drug Administration more than two decades ago. It’s used in combination with a second drug, misoprostol. The 5th U.S. Circuit Court of Appeals in New Orleans ruled Wednesday just before midnight and the case may now be headed to the U.S. Supreme Court.

    By a 2-1 vote a panel of three judges narrowed for now a decision by a lower court judge in Texas that had completely blocked the FDA’s approval of the drug following a lawsuit by mifepristone’s opponents.

    The lower court ruling had been on pause for a week to allow an appeal.

    Under the appeals court order, the FDA’s initial approval of mifepristone in 2000 is allowed to remain in effect.

    But changes made by the FDA since 2016 relaxing the rules for prescribing and dispensing mifepristone would be placed on hold. Those include extending the period of pregnancy when the drug can be used and also allowing it to be dispensed by mail, without any need to visit a doctor’s office.

    The two judges who voted to tighten restrictions, Kurt Engelhardt and Andrew Oldham, are both appointees of former President Donald Trump. The third judge, Catharina Haynes, is an appointee of former President George W. Bush. She said she would have put the lower court ruling on hold entirely temporarily to allow oral arguments in the case.

    Either side, or both, could take the appeals court’s action to the Supreme Court. Opponents of the drug could seek to keep the full lower court ruling in effect. The Biden administration, meanwhile, could ask the high court to allow all the FDA changes to remain in place while the case continues to play out.

    The appeals court judges in the majority noted that the Biden administration and mifepristone’s manufacturer “warn us of significant public consequences” that would result if mifepristone were withdrawn entirely from the market under the lower court ruling. But the judges suggested changes the FDA made making mifepristone easier to obtain since 2016 were less consequential than its initial approval of the drug in 2000. It would be “difficult” to argue the changes were “so critical to the public given that the Nation operated — and mifepristone was administered to millions of women — without them for sixteen years” the judges wrote.

    When the drug was initially approved in 2000 the FDA limited its use to up to seven weeks of pregnancy. It also required three in-person office visits: the first to administer mifepristone, the next to administer the second drug misoprostol and the third to address any complications. It also required a doctor’s supervision and a reporting system for any serious consequences associated with the drug.

    If the appeals court’s action stands, those would again be the terms under which mifepristone could be dispensed for now.

    Democratic leaders in states where abortion remains legal since the Supreme Court overturned Roe v. Wade last year say they are preparing in case mifepristone becomes restricted.

    New York Gov. Kathy Hochul said Tuesday that her state would stockpile 150,000 doses of misoprostol, another drug used in medication abortions.

    Pharmaceutical executives this week also signed a letter that condemned the Texas ruling and warned that FDA approval of other drugs could be at risk if U.S. District Judge Matthew Kacsmaryk’s decision stands. There is virtually no precedent for a lone judge overturning the medical recommendations of the FDA.

    The lawsuit challenging mifepristone’s approval was brought by the Alliance Defending Freedom, which was also involved in the Mississippi case that led to Roe v. Wade being overturned. At the core of the lawsuit is the allegation that the FDA’s initial approval of mifepristone was flawed because the agency did not adequately review safety risks.

    Mifepristone has been used by millions of women over the past 23 years, and complications from mifepristone occur at a lower rate than problems in wisdom teeth removal, colonoscopies and other routine procedures, medical groups have recently noted.

    ___

    Gresko reported from Washington. Associated Press writer Mark Sherman also contributed from Washington.

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  • Some US states stock abortion medications after court ruling

    Some US states stock abortion medications after court ruling

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    BOSTON — A growing number of states led by Democratic governors are stockpiling doses of drugs used in medication abortions, amid fears that a court ruling could restrict access to the most commonly used method of abortion in the U.S.

    Massachusetts has purchased enough doses of the drug mifepristone — one of two drugs used in combination to end pregnancies — to last for more than a year, Democratic Gov. Maura Healey said Monday. California has secured an emergency stockpile of up to 2 million pills of misoprostol, the other drug used in abortion medication, Gov. Newsom, also a Democrat, announced.

    And in Washington state, Democratic Gov. Jay Inslee announced last week that the state purchased 30,000 doses of the generic version of mifepristone — which he said is enough to last the state’s residents three years. The shipment arrived in late March.

    “Abortion is still legal and accessible here in California and we won’t stand by as fundamental freedoms are stripped away,” Newsom said Friday.

    The actions come as U.S. District Judge Matthew Kacsmaryk, a Trump appointee in Amarillo, Texas, overruled decades of scientific approval Friday and put on hold federal approval of mifepristone.

    The judge stayed his ruling for a week so federal authorities could file a challenge.

    The Biden administration slammed the ruling and on Monday appealed the decision, saying it would thwart the U.S. Food and Drug administration’s scientific judgment and “severely harm women, particularly those for whom mifepristone is a medical or practical necessity.”

    Adding to the confusion was a second opinion also released on Friday by District Judge Thomas O. Rice, an Obama appointee, directing U.S. authorities not to make any changes that would restrict access to the drug in at least 17 states where Democrats sued in an effort to protect availability.

    Healey said the Kacsmaryk ruling threatens access to the medication even in states supportive of abortion rights like Massachusetts.

    “It harms patients, undermines medical expertise, and takes away freedom. It’s an attempt to punish, to shame, to marginalize women. It’s unnecessary,” Healey said, surrounded by fellow Democratic lawmakers including U.S. Sen. Elizabeth Warren on the steps of the Massachusetts Statehouse.

    “It is terrible. It is terrible,” she added.

    Newsom said the ruling by Kacsmaryk “ignores facts, science, and the law,” and puts the health of millions of women and girls at risk.

    Inslee said it’s important for states to take steps to ensure access to the drug.

    “After we announced our actions last week to protect access to mifepristone, it’s heartening to see other states doing the same,” Inslee wrote on Twitter on Monday. “To be clear: no matter the outcome of the TX case, WA’s laws ensure we will be able to sell and distribute this medication.”

    The 15,000 doses in Massachusetts were purchased by the University of Massachusetts-Amherst at Healey’s request.

    Massachusetts health care providers have also agreed to buy additional quantities of mifepristone, according to Healey, who said the administration is dedicating $1 million to help providers contracted with the Department of Public Health to pay for the doses.

    While there are no plans yet in Connecticut to stockpile mifepristone, Attorney General William Tong said Monday that he has been contacting major pharmacy chains to remind them the drug is legal and they should not be influenced by pressure from GOP attorneys general in other states.

    ”(I’m) obviously deeply disappointed that my colleagues have taken that action,” he said. “We’re pushing back on that. We’re in communication with all the big pharmacy chains, advising them of their rights and obligations here in Connecticut.”

    Also on Friday, Healey signed an executive order expanding a 2022 law meant to build a legal firewall around abortion services — protecting health care providers, patients and pharmacists from out-of-state investigations into medication abortions. The law was signed after the U.S. Supreme Court ruling overturning Roe v. Wade.

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  • Competing abortion pill rulings sow broad alarm, confusion

    Competing abortion pill rulings sow broad alarm, confusion

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    Emma Hernandez is defiant even if she fears what may come in the latest stage of the nation’s fight over abortion: a widening prohibition to safe and legal ways to end unwanted pregnancies, including access to abortion pills.

    Competing rulings by two federal judges over the availability of the abortion drug mifepristone are sowing alarm and confusion for Hernandez and countless other Americans who insist that availability must be guaranteed. Others celebrated one judge’s ruling that would restrict that access but acknowledge the battle is far from over.

    Hernandez’s concerns were heightened Friday when U.S. District Judge Matthew Kacsmaryk, a Trump appointee in Amarillo, Texas, overruled decades of scientific approval and put on hold federal approval of mifepristone, one of two drugs used in combination to end pregnancies. The judge immediately stayed his ruling for a week so federal authorities could file a challenge.

    At about the same time in Spokane, Washington, U.S. District Judge Thomas O. Rice, an Obama appointee, directed federal officials not to hinder access to the drug in at least 17 states where Democrats sued to keep the drug’s availability intact. The issue will likely be settled by the U.S. Supreme Court, which last year repealed Roe v. Wade, the 1973 landmark Supreme Court decision that had established a constitutional right to abortions.

    “As a person who’s had multiple medication abortions, we know that the medication itself is safe and effective,” said Hernandez, a 30-year-old Texas resident who works for We Testify, an organization that provides an outlet for people to share their stories about abortions.

    “These restrictions are intentionally creating confusion and limiting our options to a point where we’re being asked to accept whatever abortion option remains available,” she said Saturday.

    Abortion opponents like Rose Mimms, the executive director of Arkansas Right to Life, welcomed the Texas decision.

    “That’s really going to put a big dent in the abortion industry across the country, (but) I do expect it will be appealed,” Mimms said.

    While some states like hers have sharply curtailed access to abortions, she wants stricter controls over abortion-inducing medications that can be delivered through the mail, even in states where abortion is illegal or severely restricted.

    In his ruling, Kacsmaryk noted how some groups are undermining a state’s ability to regulate abortion. He specifically mentioned New York-based Mayday Health, a nonprofit that provides information on how to obtain the medication.

    Mayday Health’s executive director, Dr. Jennifer Lincoln, urged women to begin stockpiling mifepristone in case it is banned. She said pills can be obtained from international suppliers through the mail.

    “You can order them now and keep mifepristone like you would keep Tylenol. It has a shelf life of about two years,” said Lincoln, a Portland, Oregon, obstetrician and gynecologist.

    About a million people every month visit the organization’s website. Following the Texas ruling, Lincoln said, the number of visits has become even more brisk.

    “We know those numbers will climb when people see that safe healthcare is threatened,” she said.

    Renee Bracey Sherman, founder and executive director of We Testify, said she is “frustrated that access to abortion care is hanging on by a thread.”

    While mifepristone and misoprostol, another abortion-inducing drug, remain available in the U.S., Sherman calls the court battle and debate over the drugs “a very slippery slope” toward an outright ban on abortion in any form.

    New York Gov. Kathy Hochul said during an interview Saturday on CNN that she would push legislation that would require insurance companies to cover misoprostol, which can be used alone but is more effective when taken with mifepristone.

    “We’re also concerned about the next phase,” Hochul said. “We’re trying to figure out all the different ways we can get ahead of this.”

    In recent years, abortion foes have won major victories, and they have become more emboldened in their efforts to further erode access to abortions, said Hernandez.

    “It’s something that we saw around the bend,” she said. “I do know that we’ve been preparing for these moments and understanding how we can get people to still have access in whatever way is available in their region.”

    The growing restrictions could particularly hurt people who don’t have the resources to travel to such places as California and New York to get in-clinic abortions.

    Hernandez recalls her first abortion when she was 21. She didn’t want to reveal her pregnancy to anyone; to retain her privacy, she relied on medication to abort her pregnancy. Without access to a car, she would not have had a convenient way to get to a clinic.

    “For me it was the best option because it did not require any sort of sedation,” Hernandez said. “And I did not have a support system that could assist me in traveling to and from a clinic for an abortion procedure.”

    __________

    Calvan reported from New York and Miller from Oklahoma City.

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  • Report: Florida officials cut key data from vaccine study

    Report: Florida officials cut key data from vaccine study

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    An analysis that was the basis of a highly criticized recommendation from Florida’s surgeon general cautioning young men against getting the COVID-19 vaccine omitted information that showed catching the virus could increase the risk of a cardiac-relate…

    TAMPA, Fla. — An analysis that was the basis of a highly criticized recommendation from Florida’s surgeon general cautioning young men against getting the COVID-19 vaccine omitted information that showed catching the virus could increase the risk of a cardiac-related death much more than getting the mRNA shot, according to drafts of the analysis obtained by the Tampa Bay Times.

    The nonbinding recommendation made by Florida Surgeon General Joseph Ladapo last fall ran counter to the advice provided by the federal Centers for Disease Control and Prevention. Ladapo, a Harvard-trained medical doctor who was appointed by Florida Gov. Ron DeSantis in 2021 to head the Florida Department of Health, has drawn intense scrutiny over his shared resistance with the Republican governor to COVID-19 mandates for vaccines and masks and other health policies endorsed by the federal government.

    The early drafts of the analysis obtained by the Times through a records request showed that catching COVID-19 could increase the chances of a cardiac-related death much more than getting the vaccine, but that information was missing from the final version put out by the Florida Department of Health last October.

    Ladapo said that the risk of men ages 18 to 39 having cardiac complications outweighed the benefits of getting the mRNA vaccine.

    Matt Hitchings, an infectious disease epidemiologist and professor of biostatistics at the University of Florida, told the Times that it seems that sections of the analysis were omitted because they did not fit the narrative the surgeon general wanted to push.

    “This is a grave violation of research integrity,” Hitchings said. “(The vaccine) has done a lot to advance the health of people of Florida and he’s encouraging people to mistrust it.”

    In a statement on Twitter posted Saturday in response to the Times’ story, Ladapo said, “It’s not only unfortunate that COVID has corrupted scientists’ ability to think clearly about epidemiology but also sad that people rush to defend a vaccine that has shown increased cardiovascular risk in multiple studies.”

    Last year, Ladapo released guidance recommending against vaccinations for healthy children, contradicting federal public health leaders whose advice says all kids should get the shots. In response, the American Academy of Pediatrics and its Florida chapter issued written statements reiterating support for vaccinating eligible children age 5 and older against COVID-19.

    DeSantis, who is contemplating a run for the GOP presidential nomination, also has requested that a grand jury be convened to investigate any wrongdoing with respect to the COVID-19 vaccines. DeSantis’ request argues that pharmaceutical companies had a financial interest in creating a climate in which people believed that getting a coronavirus vaccine would ensure they couldn’t spread the virus to others.

    The Florida Supreme Court agreed to the request last December.

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  • Judge halts FDA approval of abortion pill mifepristone

    Judge halts FDA approval of abortion pill mifepristone

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    A federal judge in Texas has thrown into jeopardy the most common method of abortion in the U.S., ordering regulators to temporarily halt their approval of the drug mifepristone for abortion

    ByPAUL J. WEBER and MATTHEW PERRONE Associated Press

    AUSTIN, Texas — A federal judge in Texas on Friday ordered a hold on U.S. approval of the abortion medication mifepristone, throwing into question access to the nation’s most common method of abortion in a ruling that waved aside decades of scientific approval.

    The immediate impact of the ruling by U.S. District Judge Matthew J. Kacsmaryk, which does not go into immediate effect, was unclear.

    The abortion drug has been widely used in the U.S. since 2000 and there is essentially no precedent for a lone judge overruling the medical decisions of the Food and Drug Administration. Mifepristone is one of two drugs used for medication abortion in the United States, along with misoprostol, which is also used to treat other medical conditions.

    Kacsmaryk, a Trump administration appointee in Amarillo, Texas, signed an injunction directing the FDA to stay mifepristone’s approval while a lawsuit challenging the safety and approval of the drug continues. His 67-page order gave the government seven days to appeal.

    “Simply put, FDA stonewalled judicial review — until now,” Kacsmaryk wrote.

    He didn’t go as far as the plaintiffs wanted by withdrawing or suspending the approval of the chemical abortion drug and removing it from the list of approved drugs. But he put a “stay” or hold on approval of the drug.

    Federal lawyers representing the FDA are expected to swiftly appeal.

    Clinics and doctors that prescribe the two-drug combination have said that if mifepristone were pulled from the market, they would switch to using only the second drug, misoprostol. That single-drug approach has a slightly lower rate of effectiveness in ending pregnancies, but it is widely used in countries where mifepristone is illegal or unavailable.

    Mifepristone is part of a two-drug regimen that has long been the standard for medication abortion in the U.S. Clinics and doctors that prescribe the combination say they plan to switch to using only misoprostol. The single-drug approach is slightly less effective at ending pregnancies.

    The lawsuit was filed by the Alliance Defending Freedom, which was also involved in the Mississippi case that led to Roe v. Wade being overturned. At the core of the lawsuit is the allegation that the FDA’s initial approval of mifepristone was flawed because it did not adequately review its safety risks.

    Courts have long deferred to the FDA on issues of drug safety and effectiveness. But the agency’s authority faces new challenges in a post-Roe legal environment in which abortions are banned or unavailable in 14 states, while 16 states have laws specifically targeting abortion medications.

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  • Washington stocks up on abortion pills ahead of court ruling

    Washington stocks up on abortion pills ahead of court ruling

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    BELLINGHAM, Wash. — Washington state has purchased a three-year supply of a leading abortion medication in anticipation of a court ruling that could limit its availability, Gov. Jay Inslee said Tuesday.

    The Democratic governor said he ordered the Department of Corrections, which has a pharmacy license, to buy 30,000 doses of the generic version of mifepristone at a cost of about $1.28 million, or $42.50 per pill. The shipment arrived in late March.

    A two-pill combination of mifepristone and misoprostol is the most common form of abortion in the U.S. Research shows that medication-induced abortions are safe and effective. They were approved by the Food and Drug Administration over 20 years ago.

    The awaited ruling in a Texas lawsuit brought by a Christian group — in the wake of the U.S. Supreme Court decision last year to strip away the constitutional right to end a pregnancy — would affect states where abortion is legal as well as those that outlaw it.

    “This Texas lawsuit is a clear and present danger to patients and providers all across the country,” Inslee said in a statement. “Washington will not sit by idly and risk the devastating consequences of inaction.”

    Former President Donald Trump-appointed Judge Matthew Kacsmaryk heard debate in March over the Alliance Defending Freedom’s request to revoke or suspend the FDA’s approval of mifepristone. The conservative group claims it was improperly approved.

    Kacsmaryk said he would rule “as soon as possible” without giving any clear indication of how he might decide.

    The bulk pill purchase also comes as Washington state Attorney General Bob Ferguson pursues the issue from another angle: He’s helping to lead a multistate lawsuit in federal court meant to further ease restrictions to the medication.

    The lawsuit filed with Oregon Attorney General Ellen Rosenblum in February against the FDA accuses it of singling out mifepristone for excessively burdensome regulation despite evidence that the drug is safer than Tylenol, Ferguson said in a statement at the time.

    The lawsuit asks the court to find certain FDA restrictions unlawful and to stop the federal agency from enforcing or applying them to mifepristone.

    State lawmakers are also bringing legislation that will authorize the state Department of Corrections to sell or distribute the drug stockpile to licensed providers in Washington.

    The bill’s co-sponsor, Sen. Karen Keiser, of Des Moines, said the last year has made it clear that they can’t be complacent when it comes to reproductive health.

    “The Legislature is taking a number of crucial steps this session to protect abortion rights,” Keiser said, “but those rights are meaningless without access to care.”

    Several moves have been made in Washington to strengthen abortion access, including a directive from Inslee instructing the Washington State Patrol not to cooperate with out-of-state abortion investigations. Other abortion and gender-affirming care bills are expected to pass the Washington Legislature this session.

    Abortion has been legal in Washington since a 1970 statewide ballot referendum.

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  • Activists’ network in Mexico helps U.S. women get abortions

    Activists’ network in Mexico helps U.S. women get abortions

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    CHIHUAHUA, Mexico — Marcela Castro’s office in Chihuahua is more than 100 miles from the U.S.-Mexico border, yet the distance doesn’t prevent her from assisting women in the United States in circumventing recently imposed bans on abortion.

    From the headquarters of Marea Verde Chihuahua, an organization that has supported reproductive rights in northern Mexico since 2018, Castro and her colleagues provide virtual guidance, as well as shipments of abortion pills for women who want to terminate a pregnancy on their own.

    This abortion model, in which no travel, clinics or prescriptions are needed, sparked interest in the U.S. — and a surge of requests for help — as the Supreme Court moved to eliminate the constitutional right to abortion last year. But the model was developed by Mexican activists through decades of facing abortion bans and restrictions in most of Mexico’s 32 states.

    “We don’t offer medical attention because we are not doctors,” Castro said. “Part of our work, though, is to remove the stigma toward abortion. Although it is a medical procedure, it does not require hospital measures.”

    To safely advise women on self-managed medical abortions, Castro and her colleagues were trained to become “acompañantes” — capable of serving as a guide and partner, whether in person or from long distance. They have carefully studied national abortion guidelines and they know by heart some protocols established by the World Health Organization.

    Since they do not charge for the help they provide, most “acompañantes” need jobs outside the organizations where they volunteer. Among them are lawyers, psychologists and other professionals. Over the years, they have created a nationwide network that has secured abortion access for Mexican and foreign women, whether or not abortion is legal where they live.

    “We are ordinary women working for reproductive justice,” Castro said. “We seek what the State has denied us out of prohibition.”

    Mexican women face a scenario that resembles the U.S., where more than a dozen states – including Texas — have imposed sweeping abortion bans. Unless it’s justified under certain exceptions, abortion is considered a crime in two-thirds of Mexico’s states.

    Chihuahua, where Castro lives, is ruled by a conservative governor and its penal code criminalizes most abortions.

    Among all other Mexican border states where “acompañantes” support Mexican or American women, abortion is only legal in Baja California. Additionally, a 2021 ruling by Mexico’s Supreme Court held that those who get the procedure shouldn’t be punished in Coahuila, a state south of Texas.

    More than 30 women collaborate with Castro in Marea Verde Chihuahua. They are part of what she calls a binational network, bringing together several Mexican collectives willing to facilitate self-managed abortions in the U.S.

    Most women from the U.S. contact Marea Verde Chihuahua through social media or by someone’s referral. Most communicate in Spanish, though the acompañantes are able to assist English speakers as well.

    After an initial contact, members of the team check their availability and an “acompañante” is assigned to each case. Further communications usually proceed via WhatsApp.

    The accompaniment starts with some basic questions to determine the gestational age, how the pregnancy was confirmed, and the woman’s overall health. Once the information is evaluated, the “acompañante” proposes how to proceed.

    In most cases, medication is advised and the “acompañante” is able to provide a combination of two abortion pills, misoprostol and mifepristone, both considered safe by the World Health Organization and the U.S. Food and Drug Administration.

    Although both medications require a prescription in the U.S., misoprostol can be acquired without a prescription in Mexican pharmacies — though some vendors refuse to sell pills to women. Mifepristone can be obtained through some abortion rights organizations.

    The work of the “acompañantes” troubles anti-abortion activists in Mexico. One of them, Jahel Torres of a national group called Pasos por la Vida, suggested there were health risks because abortion pills were being distributed by non-medical personnel.

    However, the WHO has depicted self-managed abortion as a safe option.

    Castro and her colleagues usually send pills by mail and provide virtual follow-up until the abortion is completed. But depending on its personnel and resources, each Mexican abortion collective has its own logistics.

    Aborto Seguro Chihuahua, which is part of the binational network, provides long-distance guidance to women in the U.S. but medication is not mailed from Mexico. Instead, the “acompañantes” collaborate with volunteers who transport the pills from Ciudad Juárez, in Chihuahua, to El Paso, Texas, where the packages are delivered either in person or through mailing services.

    Laura Dorado works alongside 20 people in Aborto Seguro Chihuahua and says her team handles around 120 abortions per month. Some requests come from Mexico; others from Texas, Arizona and Colorado.

    When she receives a message from a woman who is able to travel from the U.S. to Mexico, Dorado can offer some advice. “We have identified some pharmacies in which buying the pills is not a struggle or we suggest staying at a hotel and request the medication by delivery, to keep a low profile.”

    Dorado said Aborto Seguro Chihuahua mostly receives mifepristone pills from Las Libres, an organization founded 20 years ago in the conservative state of Guanajuato, in central Mexico, where abortion is still banned.

    Led by activist Veronica Cruz, Las Libres pioneered in training “acompañantes” to provide virtual guidance for self-managed medical abortions in Mexico and, since 2019, in the U.S. as well.

    “In January 2022, we had an average of 10 cases every day. When Roe was overturned, in June, we had up to a hundred,” Cruz said.

    She said the numbers kept rising until they reached 300 requests per day, all from the U.S. The workload was immense for her team of 10 people, so she created new networks to help.

    “In one year we have created more than 20 networks. We are about 200 people helping only the United States,” Cruz said.

    As with Marea Verde and Aborto Seguro in Chihuahua, Las Libres usually receives requests from Texas, Arizona and Colorado. Occasionally, women also reach out from Florida, Mississippi, Oklahoma, Georgia, California, New Jersey and New York.

    Though abortion is legal in some of those states, “acompañantes” believe many of these women are of Hispanic origin and either want to avoid going to an abortion clinic or can’t afford to pay up to $600 to get an abortion where they live.

    According to Cruz, many of these women are wary of self-managed abortions, and fighting that stigma has become part of their work.

    “Most people think pills aren’t safe, so changing all of that so quickly has been a challenge,” Cruz said.

    John Seago, president of Texas Right to Life, said there has yet to be any intensive effort to prosecute people involved in supplying abortion pills to Texas residents.

    “Texas simply does not have enough policy tools to efficiently stop these practices,” Seago said. His organization is pushing for new legislation, he added “so that those breaking Texas law by aiding and abetting abortion digitally or physically will be held accountable.”

    Nathan Cortez, a professor at Southern Methodist University in Dallas specializing in health law, said he considered it inevitable that women in states with abortion bans would consider options outside the U.S.

    “This demonstrates the limits of a state’s jurisdiction — the more onerous and unreasonable your state laws are, the more likely you are to push prohibited activities elsewhere.” Cortez said.

    ——

    Associated Press religion coverage receives support through the AP’s collaboration with The Conversation US, with funding from Lilly Endowment Inc. The AP is solely responsible for this content.

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  • Talking With Your Child About CPP

    Talking With Your Child About CPP

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    Some kids seem to grow up faster than others. That’s even truer if your child has central precocious puberty (CPP). That’s sexual maturity that starts before age 8 in girls or age 9 in boys.

    Puberty can affect how your child looks, feels, and acts. And when it happens too early, kids may get confused or embarrassed. You and your doctor can help talk them through the process.

    Here are some topics to bring up. 

    Body Changes

    Often, it’s not a medical problem that causes CPP. It’s just an early start to a natural part of life. Jami Josefson, MD, an endocrinologist at Ann & Robert H. Lurie Children’s Hospital in Chicago, says that’s something you should tell your child.

    “They may be the first one to have some body changes, and that’s OK,” Josefson says. “Let kids know there’s nothing wrong with them, this is just the way it goes. Soon, everybody else will have these changes, too.”

    Josefson suggests parents read about puberty with their child. There are lots of books to choose from, but she likes the Care & Keeping of You series by the American Girl doll company.

    Alla Vash-Margita, MD, chief of pediatric and adolescent gynecology at Yale Medicine, agrees that your child should know what’s happening to their body. You can tailor your talks based on your child’s level of maturity and age.

    In her practice, kids who are 7 or older usually understand the word puberty, but a 4-year-old may not. So for younger children, she’ll say they’re going through a “transition” from their childhood to teenage years.

    Vash-Margita, who treats girls and some transgender boys, says she also explains everything from breast development and growth spurts to pubic hair and periods. Sometimes she’ll use teaching aids.

    “I have lots of pictures in my office, so I show them what a body of a child looks like and the body of a girl who has had puberty.” 

    Medication

    It’s pretty common for kids with CPP to take drugs known as puberty blockers, Vash-Margita says. One of the main reasons is because early puberty shortens the window kids have to grow taller. Treatment can stop the brain from telling the pituitary gland to make the sex hormones testosterone and estrogen. If taken before puberty ends – something doctors figure out based on bone growth – medication can pause or reverse the maturing process until your child is older.

    Medical tests and treatments can be a little scary for kids. So Vash-Margita tells them why their puberty is early and why they’ll stop it. She uses illustrations to show how the brain, ovaries, and uterus all work together.

    Then she points out, “In your case, the brain started sending signals to your ovaries, and your ovaries started producing another hormone, and this hormone is making all these changes in your body, and we can give you medication to block that process.”

    It can be hard for really young children to grasp all that. So Vash-Margita sometimes just tells kids that medicine will slow some body changes down and “allow you to look just like your classmates and friends.”

    Emotional Challenges

    Girls who develop earlier than their friends may become self-conscious. “Developing breast buds when you’re 4 or 5 is stressful,” says Vash-Margita.

    On top of body changes, kids with CPP might have mood swings.

    Talk to your doctor if your child isn’t ready for puberty.

    “One of the goals of therapy is to keep girls from having a monthly menstrual cycle,” Josefson says. “Which, when girls are really young, can be a challenge to understand emotionally and also from a hygiene perspective.”

    Josefson says puberty blockers can “put everything on pause to prevent kids from developing and appearing older than their age.” 

    And let your child know they can come to you if they’re feeling low. Make sure to ask them how their schoolwork and friendships are going, too. Reach out to a mental health professional any time you or your child needs some extra help. Josefson says a social worker or therapist can help your family talk through some of the fears and anxieties around CPP.

    Keep in mind that CPP might be a little tougher on transgender children – those who don’t identify with the sex they were assigned at birth. Josefson says most kids with CPP are comfortable with their gender identity. But early puberty can be extra confusing or unwanted for those who aren’t.

    Talking to Others About CPP

    It’s important to have honest talks with your child and their doctor. But this kind of information is private, Josefson says, and you don’t have to share details with anyone else.

    If your extended family or child’s teachers bring the subject up, “you just say the child is tall for their age or this is how development runs in our family,” she says. “It’s kind of none of their business.”

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  • South Africa’s Ramaphosa welcomes Belgium’s King Philippe

    South Africa’s Ramaphosa welcomes Belgium’s King Philippe

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    South African President Cyril Ramaphosa has welcomed Belgium’s King Philippe and Queen Mathilda to the capital Pretoria, lauded the European country for its assistance to Africa during the COVID-19 pandemic

    ByMOGOMOTSI MAGOME Associated Press

    JOHANNESBURG — South African President Cyril Ramaphosa has welcomed Belgium’s King Philippe and Queen Mathilda to the capital Pretoria, lauded the European country for its assistance to Africa during the COVID-19 pandemic.

    Ramaphosa emphasized the role played by Belgium in backing the World Health Organization’s mRNA technology transfer hub initiative established in South Africa to improve Africa’s access to vaccines and therapeutics.

    “I wish to express our appreciation to the kingdom of Belgium for its role in the global fight against COVID-19. Belgium is an important donor to the vaccine alliance GAVI, for the operation of COVAX, the COVID-19 Vaccines Global Access initiative,” said Ramaphosa at a press briefing with the Belgian king on Thursday.

    He added that Belgium had donated about 10 million doses of vaccines during the pandemic, with a significant proportion going to African countries in need of vaccines.

    Ramaphosa praised the collaboration between South Africa’s Afrigen Biologics firm and Belgium’s Univercells Group to develop a novel mRNA COVID-19 vaccine and to improve preparedness for future health emergencies.

    The effects of Russia’s invasion of Ukraine were also to be discussed between the two leaders, with Ramaphosa emphasizing that South Africa supports a peaceful solution to the war. South Africa has not publicly criticized Russia for its invasion of Ukraine.

    “We look forward to sharing our perspectives on the conflict during our meeting, and to learn more about Belgium’s stance. It is also important to consider the impact of the conflict on the international economy, especially with regards to global food and energy security,” Ramaphosa said ahead of meeting privately with the king.

    Belgian Foreign Minister Hadja Lahbib said Belgium understands South Africa’s stance on the war in Ukraine and urged South Africa to use its “channels of communications to advance on a path toward peace.”

    “I think this is the major foreign policy issue for Europe and it will likely remain so, I’m afraid, for the next months. We are fully committed to help Ukraine defend itself. We see this as essential to defend European security but also the U.N. Charter’s principle,” said Lahbib.

    “We have always looked up to South Africa as a key partner for peace and the defence of human rights and basic international principles,” said Lahbib.

    The Belgian monarchs are expected to engage with South Africa’s business, academic and civil society in Johannesburg and Cape Town over the next few days and visit historical and cultural sites.

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  • Anthony Fauci documentary on PBS covers a career of crises

    Anthony Fauci documentary on PBS covers a career of crises

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    NEW YORK — There’s a moment in the new PBS documentary about Dr. Anthony Fauci when a protester holds up a handmade sign reading, “Dr. Fauci, You Are Killing Us.”

    It says something about Fauci that it’s not initially clear when that sign was waved in anger — in the 1980s as AIDS made its deadly rise or in the 2020s with COVID-19 vaccine opponents.

    “American Masters: Dr. Tony Fauci,” offers a portrait of an unlikely lightning rod: A government infectious disease scientist who advised seven presidents. Fauci hopes it can inspire more public servants like him.

    “I just felt that there needed to be a story of people understanding what public health officials go through, but also I hope as a source of inspiration for young people who are either in science or interested in going into science,” he told The Associated Press. The documentary airs Tuesday and later streams.

    Fauci allowed a film crew to follow him for 23 months starting in January 2021. The documentary covers his career and its crises, especially the way COVID-19 was handled by the Trump administration.

    “When you talk about all of the different things coming together for a disaster, that’s what happened: A divided country, a president who amplified the division and then a public health crisis — you couldn’t ask for a worse combination of things,” he said.

    Director Mark Mannucci offers an intimate look at his subject, with images of Fauci running from meeting to meeting and wolfing down Wheat Thins between Zooms. His wife attests to the stress by pointing out their security detail due to threats.

    “The story illuminates — and he’d be the first to say it — some very dark stuff about this country and how a person who has devoted his life to helping individuals got so twisted in this current climate,” said Mannucci.

    Michael Kantor, executive producer for the American Masters series, says Fauci is a figure who has been central to American life for decades and deserves an examination, even if some virulently oppose him.

    “Dr. Fauci is a very controversial figure, and there are going to be people who are going to voice — just as in the film — great displeasure about what he’s done and about his approach to things. But isn’t that the whole point of public media? It is intended to make that conversation happen in the best possible way.”

    COVID-19 may have introduced Fauci to millions of Americans, but his long career at the National Institute of Allergy and Infectious Diseases was marked by numerous previous health scares, among them HIV, SARS, MERS, Ebola and even the nation’s 2001 anthrax attacks.

    The film shows that Fauci learned a lesson in humility with AIDS, as the disease stubbornly persisted and activists argued not enough was being done from the government. “I went from a world of success and gratification to a world of frustration and failure,” he says in the film.

    Mannucci’s camera flashes-forward to today, with Fauci cordially meeting up with the former AIDS activists who once decried him. They have long since reconciled; they were all on the same side, after all — science.

    “I put aside the confrontational behavior and the attacks on me and listen to what they were saying,” Fauci explained in the interview. “And what they were saying was making perfect sense. It made me feel if I were in their shoes, I’d be doing exactly what they were doing.”

    That’s not the case when protesters in recent years began attacking Fauci for mask mandates, school closures, quarantines and bizarre claims about the COVID-19 vaccines.

    “There’s one sign that says, ‘Fauci, You’re Killing Us’ and the other sign that says ‘Fauci, You’re Killing Us’ but the rationale for those from the 1980s to 2023 is enormously different,” Fauci said. “They couldn’t be more different.”

    In one remarkable sequence in the documentary, Mannucci presses Fauci on whether he might have handled things differently looking back — like asking Americans to adopt masks sooner or ordering quarantines faster. “Maybe I should have done that,” he says. “Yeah, I was wrong.”

    Mannucci relied on 10 long sit-downs with Fauci to develop trust with his subject and didn’t clutter the documentary with testimonials from talking heads, wanting to focus on Fauci’s experiences.

    “I hope it’s not viewed as a partisan message, but as a portrait of who he is and what he went through,” said the director. “I hope that people on the other side, even if they never end up agreeing with him, will at least see somebody who is a real person, who’s a thinking person, who’s somebody maybe they can even relate to.”

    The film ends with Fauci’s retirement from the NIAID late last year. Kantor suspects only time will tell where history will judge a man who dedicated his life to public service.

    “I think 10 years from now, hopefully the furor over him as a controversial figure will die down. But the legacy of the approach to pandemics and so on will still be super valuable,” he said.

    ___

    Mark Kennedy is at http://twitter.com/KennedyTwits

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  • California, drugmaker partner to produce affordable insulin

    California, drugmaker partner to produce affordable insulin

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    DOWNEY, Calif. — The state of California and a generic drug manufacturer announced a 10-year partnership Saturday to produce affordable, state-branded insulin that they hope will rival longtime producers and push down prices for a medication used by millions of Americans.

    The product is not expected on store shelves until at least next year, and it was difficult to predict what effect it would have on a market already shaken by change. Earlier this week another major insulin maker promised steep price cuts as pressure builds on drugmakers and insurers to slash the cost of the drug.

    Democratic Gov. Gavin Newsom said he hoped California’s emergence as an insulin-maker would prompt prices to collapse. Research has shown that prices for the drug have more than tripled in the past couple of decades.

    “We are intent to make this about market disruption,” Newsom said at a ceremony announcing the pact at a pharmaceutical warehouse near Los Angeles. He called it “a game changer” for 8 million Americans who use insulin to treat diabetes.

    Many questions remain. The state and its partner, the nonprofit Civica, have yet to locate a California-based manufacturing facility. Regulatory approvals will be needed. Newsom said a 10- milliliter vial of the state-branded insulin would sell for $30, but it’s possible competitors could slash their prices and undercut the state product.

    “Is this perfect? We don’t know yet,” Newsom acknowledged at one point.

    Just days ago, President Joe Biden said his administration is focused “intensely” on lowering health care costs, including pressuring pharmaceutical companies to lower the costs of insulin. Legislation enacted last year capped copayments for insulin at $35 per month for Medicare beneficiaries. Biden has proposed extending that cap to all Americans.

    Novo Nordisk said Tuesday that it will slash some of its U.S. insulin prices up to 75% starting next year. The announcement comes less than two weeks after rival Eli Lilly said it will drop some of its prices by 70% or more later this year.

    Anthony Wright, executive director of Health Access California, a statewide consumer health care advocacy group, welcomed Newsom’s announcement, saying efforts by California and others to develop a competing generic are likely a factor in getting insulin manufacturers to cut their prices.

    Still, there are obstacles.

    “The work to develop a generic, get FDA approval and set up manufacturing will take real time,” Wright said in an email. “There may even be more time in the effort to get doctors to prescribe the drug, insurers and (pharmacy benefit managers) to include it on their formularies and patients and the public to accept and ask for it.”

    There could be other risks. State analysts have warned that California’s entry into the market could prompt other manufacturers to reduce the availability of their drugs, a potential unintended consequence.

    State lawmakers approved $100 million for the project last year, with $50 million dedicated to developing three types of insulin and the rest set aside to invest in a manufacturing facility.

    Even with the challenges of entering a competitive, established market, Newsom said taxpayers would have “very ample protections.”

    If for whatever reason the deal didn’t work out to the state’s benefit, “there’s all kinds of provisions that would allow us to … pull out,” he said.

    According to state documents, the proposed program could save many patients between $2,000 and $4,000 a year. In addition, lower costs could result in substantial savings because the state buys the product every year for the millions of people on its publicly funded health plans.

    The state also is exploring the possibility of bringing other drugs to market, including the overdose medication Naloxone. The drug, available as a nasal spray and in an injectable form, is considered a key tool in the battle against a nationwide overdose crisis.

    “We are not stopping here,” Newsom said.

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  • California, drugmaker partner to produce affordable insulin

    California, drugmaker partner to produce affordable insulin

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    DOWNEY, Calif. — The state of California and a generic drug manufacturer announced a 10-year partnership Saturday to produce affordable, state-branded insulin that they hope will rival longtime producers and push down prices for a medication used by millions of Americans.

    The product is not expected on store shelves until at least next year, and it was difficult to predict what effect it would have on a market already shaken by change. Earlier this week another major insulin maker promised steep price cuts as pressure builds on drugmakers and insurers to slash the cost of the drug.

    Democratic Gov. Gavin Newsom said he hoped California’s emergence as an insulin-maker would prompt prices to collapse. Research has shown that prices for the drug have more than tripled in the past couple of decades.

    “We are intent to make this about market disruption,” Newsom said at a ceremony announcing the pact at a pharmaceutical warehouse near Los Angeles. He called it “a game changer” for 8 million Americans who use insulin to treat diabetes.

    Many questions remain. The state and its partner, the nonprofit Civica, have yet to locate a California-based manufacturing facility. Regulatory approvals will be needed. Newsom said a 10- milliliter vial of the state-branded insulin would sell for $30, but it’s possible competitors could slash their prices and undercut the state product.

    “Is this perfect? We don’t know yet,” Newsom acknowledged at one point.

    Just days ago, President Joe Biden said his administration is focused “intensely” on lowering health care costs, including pressuring pharmaceutical companies to lower the costs of insulin. Legislation enacted last year capped copayments for insulin at $35 per month for Medicare beneficiaries. Biden has proposed extending that cap to all Americans.

    Novo Nordisk said Tuesday that it will slash some of its U.S. insulin prices up to 75% starting next year. The announcement comes less than two weeks after rival Eli Lilly said it will drop some of its prices by 70% or more later this year.

    Anthony Wright, executive director of Health Access California, a statewide consumer health care advocacy group, welcomed Newsom’s announcement, saying efforts by California and others to develop a competing generic are likely a factor in getting insulin manufacturers to cut their prices.

    Still, there are obstacles.

    “The work to develop a generic, get FDA approval and set up manufacturing will take real time,” Wright said in an email. “There may even be more time in the effort to get doctors to prescribe the drug, insurers and (pharmacy benefit managers) to include it on their formularies and patients and the public to accept and ask for it.”

    There could be other risks. State analysts have warned that California’s entry into the market could prompt other manufacturers to reduce the availability of their drugs, a potential unintended consequence.

    State lawmakers approved $100 million for the project last year, with $50 million dedicated to developing three types of insulin and the rest set aside to invest in a manufacturing facility.

    Even with the challenges of entering a competitive, established market, Newsom said taxpayers would have “very ample protections.”

    If for whatever reason the deal didn’t work out to the state’s benefit, “there’s all kinds of provisions that would allow us to … pull out,” he said.

    According to state documents, the proposed program could save many patients between $2,000 and $4,000 a year. In addition, lower costs could result in substantial savings because the state buys the product every year for the millions of people on its publicly funded health plans.

    The state also is exploring the possibility of bringing other drugs to market, including the overdose medication Naloxone. The drug, available as a nasal spray and in an injectable form, is considered a key tool in the battle against a nationwide overdose crisis.

    “We are not stopping here,” Newsom said.

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  • Judge won’t toss lawsuit over ivermectin in Arkansas jail

    Judge won’t toss lawsuit over ivermectin in Arkansas jail

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    FAYETTEVILLE, Ark. — A federal judge has refused to dismiss a lawsuit that says detainees at an Arkansas jail were given the drug ivermectin to fight COVID-19 without their knowledge.

    The lawsuit contends detainees at the Washington County Jail in Fayetteville were given ivermectin as early as November 2020 but were unaware until July 2021. Ivermectin is approved by the Food and Drug Administration to address parasitic infestations such as intestinal worms and head lice and some skin conditions, such as rosacea. It is not, and was not at the time, approved to treat COVID-19.

    U.S. District Judge Timothy L. Brooks ruled Thursday that the lawsuit could move forward, saying Dr. Robert Karas used detainees for an experiment, The Northwest Arkansas Democrat-Gazette reported.

    Plaintiffs in the case include Edrick Floreal-Wooten, Jeremiah Little, Julio Gonzales, Thomas Fritch and Dayman Blackburn. The case was filed by the American Civil Liberties Union last year against Karas, Karas Correctional Health, former Washington County Sheriff Tim Helder and the Washington County Detention Center.

    In a written opinion, Brooks said that Karas began conducting his own research and hypothesized the drug could be an effective treatment for COVID-19.

    Karas prescribed ivermectin to two groups of test subjects. The first was composed of people who sought out Karas’ services at his private medical clinic and agreed to take ivermectin as part of an experimental treatment for COVID-19, Brooks noted. The second set was composed of detainees who were incarcerated at the jail.

    “The inmates received Dr. Karas’ treatment protocol for COVID-19, but did not know it included Ivermectin,” Brooks wrote. “Dr. Karas and his staff falsely told the inmates the treatment consisted of mere ‘vitamins,’ ‘antibiotics,’ and/or ‘steroids.’ Critically, the inmates had no idea they were part of Dr. Karas’ experiment.”

    Since the detainees were never told that their “treatments” contained ivermectin, they were never warned about the drug’s side effects, Brooks said. According to the FDA, side effects for the drug include skin rash, nausea and vomiting.

    In addition, Karas hypothesized that large doses of ivermectin would be most effective in combating COVID-19. The problem, however, was that the FDA had only approved a dosage of 0.2 mg/kg to treat worms, according to Brooks. Karas ultimately prescribed lower doses of ivermectin to his clinic patients and higher doses to his imprisoned patients.

    “At first reading, it would seem highly unlikely — even implausible — that a doctor would have dosed his incarcerated patients with an experimental drug more aggressively than his private patients, but plaintiffs point to proof in their jail medical records,” Brooks wrote.

    Brooks also said it was possible that Helder knew or should have known that Karas was performing ivermectin experiments on detainees without their knowledge because of Karas’ social media postings and that he approved, condoned or turned a blind eye to this violation of their rights.

    “The incarcerated individuals had no idea they were part of a medical experiment,” Gary Sullivan, legal director of the ACLU of Arkansas, said in a news release Friday. “Sheriff Helder and Dr. Karas routinely mischaracterized the fundamental nature of plaintiffs’ claims in their request for dismissal by refusing to mention the most significant allegations in the complaint.”

    Brooks found Karas is not entitled to the immunity that protects states and local governments against damages from damages unless they violate the constitution. Brooks said Karas and his clinic had sought and won a county contract to provide health care to hundreds of detainees at the jail over many years at a cost of more than $1.3 million a year.

    Brooks also said the detainees have stated a plausible claim for battery in that Karas intentionally concealed the details of a treatment in order to induce a captive audience to take a particular drug for his own professional and private aims.

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  • California bill to protect doctors who mail abortion pills

    California bill to protect doctors who mail abortion pills

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    SACRAMENTO, Calif. — Doctors in California who mail abortion pills to people in other states would be protected from prosecution under a new bill to be unveiled Friday in the state Legislature.

    The bill would not let California extradite doctors who are facing charges in another state for providing abortion medication. It would also shield doctors from having to pay fines. And it would let California doctors sue anyone who tries to stop them from providing abortions.

    The bill would only protect doctors who are in California. If a doctor left California to provide an abortion to someone in another state, that doctor would not be protected. It also would not protect patients in other states who receive the medication.

    State Sen. Nancy Skinner, a Democrat from Berkeley and the author of the bill, said her intent is to make sure California residents who are traveling in other states or living there temporarily — like college students — can still have access to medication that’s legal in their home state. But she acknowledged the bill would also apply to California doctors who treat patients who live in other states.

    “This is essential health care,” Skinner said. “Our health care practitioners should be protected for treating their patients regardless of where their patients are geographically.”

    Massachusetts, New York, Connecticut, Maryland and Vermont have proposed or passed similar laws, according to Skinner’s office. Connecticut’s law, among other things, blocks criminal summonses from other states related to reproductive health care services that are legal in Connecticut while also blocking extradition — unless the person fled from a state requesting them.

    “Obviously, if a provider is engaging in telehealth services with someone, even if they do inquire about where they are, they kind of have to take it on faith,” said Connecticut state Rep. Matt Blumenthal, a Democrat and co-chair of the General Assembly’s Reproductive Rights Caucus. “We don’t want to make providers their police for their patients. And we don’t want to make them have to do an investigation every time they perform telehealth.”

    Other states have tried to block the distribution of the abortion pill, known as mifepristone. Attorneys general in 20 states, mostly with Republican governors, have warned some of the nation’s largest pharmacy companies they could face legal consequences if they distribute the pill within their states.

    Most abortions are outlawed in Idaho, including medication abortions. Blaine Conzatti, president of the Idaho Family Policy Center — a group that opposes abortion rights — said California has a responsibility to extradite physicians who break Idaho laws.

    “The arrogance of such a proposal is astounding,” Conzatti said of Skinner’s bill. “It flaunts the traditional relationship between states and would upend our federal system altogether.”

    Skinner’s bill goes beyond abortions. It would also protect doctors for mailing contraceptives and transgender-related medications.

    California already has laws that prevents courts from enforcing out-of-state judgments on abortion providers and volunteers. That law was aimed at protecting doctors who provide abortions to people who travel to California from other states. Abortion opponents say laws like that are illegal because they violate a clause in the U.S. Constitution that says states must give “full faith and credit” to the laws of other states.

    Federal courts have recognized an exception to that clause, including laws in one state that violate the “public policy” of another state. Skinner’s law declares it is the public policy of California that doctors should not be charged for providing abortion medication.

    “We’re very careful,” Skinner said.

    Abortion pills have been legal in the U.S. for more than two decades and can be used up to the 10th week of pregnancy. It’s now the most common abortion method in the U.S. A federal judge in Texas is weighing whether to revoke or suspend the U.S. Food and Drug Administration’s approval of the drug, a decision that would apply to all states and not just the ones who have outlawed abortions.

    Skinner’s bill is one of 17 pieces of legislation Democrats have introduced in California this year to protect abortion rights, including proposals to improve access to contraceptives and protect patients’ privacy.

    _____

    Associated Press reporter Susan Haigh in Hartford, Connecticut, contributed to this report.

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  • WV legislators OK transgender care ban with health exemption

    WV legislators OK transgender care ban with health exemption

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    CHARLESTON, W.Va. — West Virginia’s Republican supermajority House of Delegates swiftly OK’d a proposal to add mental health exemptions to a bill that would ban certain health care for transgender youth during the last day of its 60-day legislative session Saturday.

    The chamber approved changes made by the state Senate late Friday that would allow some transgender youth to continue receiving medical interventions, including hormone therapy, if they are at risk of self-harm or suicide.

    The bill now heads back to the Senate for final approval, which it is likely to receive Saturday before heading to the desk of Gov. Jim Justice. The Republican governor has not taken a public stance on the measure.

    Lawmakers in West Virginia and other states advancing bans on transgender health care for youth and young adults often characterize gender-affirming treatments as medically unproven, potentially dangerous in the long term and a symptom of “woke” culture.

    But every major medical organization, including the American Medical Association, the American Academy of Pediatrics and the American Psychiatric Association, supports gender-affirming care for youths.

    House members — who passed a much more restrictive version of the proposal last month that included no mental health exemptions — voted to approve the amendment in a unanimous voice vote with little discussion. The amended bill then passed 88-10, with all ‘no’ votes coming from the body’s shrinking delegation of Democrats.

    The only lawmaker who spoke on the floor prior to the vote was Democratic Del. Ric Griffith, who cited data from peer-reviewed medical journals showing that hormone therapy and other interventions can drastically reduce psychological distress and suicidal ideation for transgender adolescents.

    “We talk a lot about, ‘Parents know what’s best for their children,’” he said. “This is a fairly narrow allowance when a child could potentially be suicidal.”

    The rate of suicide ideation, or having suicidal thoughts or ideas, for transgender youth in Virginia is three times higher than the rate for all youth in the state, according to research complied by WVU Medicine physicians using West Virginia Youth Risk Behavior Survey data.

    West Virginia’s bill would outlaw those under 18 from being prescribed hormone therapy and fully reversible medication for suspending the physical changes of puberty.

    But the change approved by House lawmakers Saturday — proposed by Senate Majority Leader Tom Takubo, a trained physician — would allow young people to access puberty blockers and hormone therapy if they are experiencing severe gender dysphoria, under certain circumstances.

    Gender dysphoria is defined by medical professionals as severe psychological distress experienced by those whose gender identity differs from their sex assigned at birth.

    Takubo referenced 17 peer-reviewed studies showing a significant decrease in the rates of suicide ideation and suicide attempts among youth with severe gender dysphoria who have access to medication therapy.

    “These kids struggle, they have incredible difficulties,” he said.

    He found a supporter in another trained physician, Sen. Mike Maroney, chair of the Senate Health and Human Resources Committee. Maroney said lawmakers would set “a dangerous precedent” by disregarding medical research in favor of political gain.

    “Who are we, to win an election, to tell people how to practice medicine? To change treatments? It’s unbelievable,” the Republican said, adding that lawmakers wouldn’t apply the same standard for drugs for cancer or mental illness.

    The legislation includes a ban on gender-affirming surgery for minors, something medical professionals emphasize does not happen in West Virginia.

    With Takubo’s change, a person under 18 would have to be diagnosed with severe gender dysphoria by at least two medical or mental health providers to gain access to medication therapy. One would have to be a mental health provider or adolescent medicine specialist.

    The dosage must be the lowest possible necessary to “treat the psychiatric condition and not for purposes of gender alteration,” according to the bill.

    Providers must be specifically trained to diagnose and treat severe gender dysphoria in adolescents and would have to provide written testimony that medical interventions are necessary to prevent or limit self-harm or the possibility of self-harm. The minor’s parents or guardians would be required to give written consent to the treatments.

    Hormonal therapy could not be provided to minors before the age of puberty, something West Virginia physicians say doesn’t happen anyway.

    The bill includes exceptions originating in the House version for individuals born with a “medically verifiable disorder,” including people with ambiguous “external biological sex characteristics” and for people taking treatments for infection, injury, disease, or disorder that has been “caused by or exacerbated by the performance of gender transition procedures.”

    People also can access treatment if they are in “imminent danger of death, or impairment of a major bodily function unless surgery is performed.”

    The House vote came two days after a crowd of protesters descended on the state Capitol, where cries of “trans kids matter” could be heard from the Senate chamber as lawmakers debated bills. Democratic Del. Danielle Walker, the Legislature’s only openly LGBTQ member, led chants of the state motto: “Mountaineers are always free.”

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  • US agencies debunk Florida surgeon general’s vaccine claims

    US agencies debunk Florida surgeon general’s vaccine claims

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    U.S. health agencies have sent a letter to Florida’s surgeon general, warning him that his claims about COVID-19 vaccine risks are harmful to the public

    ORLANDO, Fla. — U.S. health agencies have sent a letter to Florida’s surgeon general, warning him that his claims about COVID-19 vaccine risks are harmful to the public.

    The letter from the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention was sent Friday to Florida Surgeon General Joseph Ladapo. It was a response to a letter Ladapo had written the agencies last month, expressing concerns about what he described as adverse effects from mRNA COVID-19 vaccines.

    Ladapo was appointed by Republican Gov. Ron DeSantis in 2021 and has attracted national scrutiny over his close alignment with the governor in opposing COVID-19 vaccine mandates and other health policies embraced by the federal government.

    Ladapo last year released guidance recommending against COVID-19 vaccinations for healthy children, contradicting federal public health leaders whose advice says all kids should get the shots.

    He also has recommended against men ages 18 to 39 getting the mRNA COVID-19 vaccines, claiming that an analysis by the Florida Department of Health showed an 84% increase in cardiac-related deaths.

    In their letter, the federal agencies debunked the analysis’ conclusion, saying that cardiovascular experts who studied the concern had concluded that the risk of strokes and heart attacks was lower in people who had been vaccinated, not higher.

    More than 13 billion doses of COVID-19 vaccines have been given around the world with little evidence of adverse effects, the federal health agencies said.

    “It is the job of public health officials around the country to protect the lives of the populations they serve, particularly the vulnerable. Fueling vaccine hesitancy undermines this effort,” said the letter signed by FDA Commissioner Robert Califf and CDC Director Rochelle Walensky.

    The Florida Department of Health on Saturday didn’t respond to an email inquiry about the letter.

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  • West Virginia Senate passes modified transgender care ban

    West Virginia Senate passes modified transgender care ban

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    CHARLESTON, W.Va. — West Virginia’s Republican supermajority Senate passed a bill Friday that would ban certain health care for transgender youth after approving a significant change to add exceptions for young people at risk for self harm or suicide.

    “These kids struggle, they have incredible difficulties,” said Majority Leader Tom Takubo, a pulmonologist, who urged support for mental health protections.

    The bill would outlaw those under 18 from being prescribed hormone therapy and fully reversible medication suspending the physical changes of puberty, buying patients and parents time to make future decisions about hormones.

    The rate of suicide ideation for transgender youth in Virginia is three times higher than the rate for all youth in the state, according to research and data complied by WVU Medicine physicians using the West Virginia Youth Risk Behavior Survey.

    During a speech on the Senate floor, Takubo referenced 17 peer-reviewed studies showing a significant decrease in the rates of suicide ideation and suicide attempts among youth with severe gender dysphoria who have access to medication therapy.

    He found a supporter in Senate Health and Human Resources Committee Chair Sen. Mike Maroney, another trained physician, who said lawmakers would set “a dangerous precedent” by disregarding medical research in favor of political gain.

    “Who are we, to win an election, to tell people how to practice medicine? To change treatments? It’s unbelievable,” the Republican said, adding that lawmakers wouldn’t apply the same standard for drugs for cancer or mental illness.

    The legislation also includes a ban on gender-affirming surgery for minors, something medical professionals emphasize does not happen in West Virginia.

    But Takubo’s approved change would allow young people to access puberty blockers and hormone therapy if they are experiencing severe gender dysphoria, under certain circumstances.

    Gender dysphoria is defined by medical professionals as severe psychological distress experienced by those whose gender identity differs from their sex assigned at birth.

    Lawmakers in West Virginia and other states advancing bans on transgender health care for youth and young adults often characterize gender-affirming treatments as medically unproven, potentially dangerous in the long term and a symptom of “woke” culture.

    During Friday’s debate, Republican Sen. Eric Tarr repeated those concerns, saying the medical interventions doctors are practicing are too extreme and driven by “woke” culture.

    “They’re trying to take pronouns out of our textbooks for kids,” Tarr said.

    Every major medical organization, including the American Medical Association, the American Academy of Pediatrics and the American Psychiatric Association, supports gender-affirming care for youths.

    With Takubo’s change, a person under 18 would have to be diagnosed with severe gender dysphoria by at least two medical or mental health providers to access medication therapy. One would have to be a mental health provider or adolescent medicine specialist.

    The dosage must be the lowest possible necessary to “treat the psychiatric condition and not for purposes of gender alteration,” according to the bill.

    The providers must be specifically trained to diagnose and treat severe gender dysphoria in adolescents and would have to provide written testimony that medical interventions are necessary to prevent or limit self-harm or the possibility of self-harm.

    The minor’s parents and guardians also would be required to give written consent to the treatments.

    Hormonal therapy could not be provided to minors before the age of puberty, something West Virginia physicians say doesn’t happen anyway.

    The bill now goes back to the state House of Delegates for approval. It’s unclear what House lawmakers will make of the bill’s changes in the Senate. The proposal that passed the House by a wide margin last month included a ban on puberty-blocking medication and hormone therapy, with no exemptions for mental health.

    The bill passed the House 84-10, with all ‘no’ votes coming from the body’s shrinking delegation of Democrats. They accused GOP lawmakers of putting children’s lives at risk to score political points with the national conservative movement.

    That version provides exceptions for individuals born with a “medically verifiable disorder” including people with “external biological sex characteristics that are irresolvably ambiguous” and for people taking treatments for infection, injury, disease, or disorder that has been “caused by or exacerbated by the performance of gender transition procedures.”

    People also can access the treatment if they are in “imminent danger of death, or impairment of a major bodily function unless surgery is performed.”

    Speaking against Takubo’s amendment Friday, Republican Sen. Mark Maynard said he didn’t see why any changes were necessary. He worried additions could make the state vulnerable to a lawsuit.

    “This amendment would disintegrate the clarity of the bill in its very simple terms,” Maynard said. “These guardrails are already in this bill as it came to us from the House.”

    The vote came a day after a crowd of protesters descended on the state Capitol, where cries of “trans kids matter” could be heard from the Senate chamber as lawmakers debated bills.

    Democratic Del. Danielle Walker, the only openly LGBTQ member, led chants of the state motto: “Mountaineers are always free.”

    “They are trying to come for trans kids in West Virginia, and they’re going to come for every single one of us next,” said Sam Green of Huntington, wearing a transgender pride flag draped around their shoulders while addressing the crowd.

    Cecelia Moran, an 18-year-old high school student from Marion County, said she feared banning any kind of medically proven health care could result in more young people leaving West Virginia, one of only three states to lose population in the 2020 U.S. Census.

    “I think a lot of young people already struggle to stay here and feel welcome here and are already planning on getting out of the state as soon as possible,” she said.

    Her mother, Rebecca Moran, said the bill is “just completely unnecessary” and decisions about healthcare should be made by families and health care providers.

    “This is not what’s harming our kids,” said Rebecca Moran, a city councilor in Fairmont. “There’s so many other things: homelessness, poverty.”

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  • What to know about prescription drugs promising weight loss

    What to know about prescription drugs promising weight loss

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    WeightWatchers, the 60-year-old diet firm, announced this week it would acquire a telehealth company whose providers prescribe anti-obesity drugs for growing numbers of eager online subscribers.

    The $132 million deal with Sequence is the just the latest commercial push into the red-hot market for prescription drugs that promise significant weight loss. For months, the diabetes drug Ozempic has been touted on social media by celebrities even though it’s not approved for weight loss. The demand for it sparked shortages.

    WeightWatchers will be introducing its roughly 3.5 million subscribers to a new generation of medications that go beyond behavioral changes like gym workouts and diet tracking. Obesity experts say the drugs may revolutionize treatment of the disease that affects 42% of American adults.

    Here’s a look at the promise of these new medications and cautions about their use.

    WHAT ARE THESE NEW DIET DRUGS?

    The drugs that have generated most buzz are from a class of medications called GLP-1 agonists. Two of the most popular, Ozempic and Wegovy, are different doses of the same drug, semaglutide.

    Ozempic has been used for six years to treat type 2 diabetes and is not approved for weight loss. Wegovy was approved in 2021 to treat obesity in adults and late last year to treat kids and teens 12 and older.

    Doctors prescribe the medications to people with diabetes alone, or to people who are obese or who are overweight with additional health problems. Most of these types of drugs are delivered through weekly injections.

    Supply problems and soaring demand last year led to a shortage of the drugs, but Novo Nordisk, the manufacturer, said those have been replenished.

    HOW DO THE DRUGS WORK?

    They mimic the action of a gut hormone that kicks in after people eat, boosting the release of insulin, blocking sugar production in the liver and suppressing appetite.

    A newer drug, called tirzepatide, mimics the action of two hormones for even greater effect. The Eli Lilly and Co. drug, sold under the brand name Mounjaro, is now approved to treat diabetes, but the FDA granted fast-track status to review it to treat obesity. A decision is expected this spring.

    With lower appetite and a greater feeling of fullness, people using these drugs eat less and lose weight.

    HOW EFFECTIVE ARE THE DRUGS?

    In a clinical trial, adults who took Wegovy saw a mean weight loss of nearly 35 pounds, or about 15% of their initial body weight. Adolescents lost about 16% of their body weight.

    A clinical trial of Mounjaro, which is still being studied, saw mean weight loss of 15% to 21% of body weight depending on the dose, compared with a weight loss of about 3% for people taking placebo, or dummy drug.

    WHY NOT JUST DIET AND EXERCISE?

    In a typical weight-loss program where participants rely only on diet and exercise, about a third of people enrolled will lose 5% or more of their body weight, noted Dr. Louis Aronne, director of the Comprehensive Weight Control Center at Weill Cornell Medicine.

    Most people find it difficult to lose weight because of the body’s biological reactions to eating less, he said. There are several hormones that respond to reduced calorie intake to increase hunger and maintain body mass.

    “There is a real physical phenomenon,” he said. “There is a resistance mechanism that is a coordinated effort by the body to prevent you from losing weight.”

    WHAT ARE THE SIDE EFFECTS OF THE DRUGS?

    The most common side effects are short-lived gastrointestinal issues such as nausea, vomiting, diarrhea, stomach pain and constipation.

    Other possible side effects include thyroid tumors, cancer, inflammation of the pancreas, kidney and gallbladder and eye problems. People with a family history of certain thyroid cancers or a rare, genetic endocrine disorder should avoid the drugs.

    WHAT SHOULD CONSUMERS WATCH OUT FOR?

    These new medications could be an effective part of a multifaceted approach to weight loss, said Dr. Amy Rothberg, an University of Michigan endocrinologist who directs a virtual weight management and diabetes program called Rewind.

    But she worries that programs like WeightWatchers are primarily interested in boosting enrollment — and profits.

    “My hope is that they do their due diligence and have real monitoring of the patients taking the drugs,” she said.

    It’s important to make sure that patients are taking the drugs for the intended purpose, to make sure there’s no reason they shouldn’t take the drugs and that they’re monitored for side effects, she said.

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    The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

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  • The implications of Walgreens’ decision on abortion pills

    The implications of Walgreens’ decision on abortion pills

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    Walgreens says it will not start selling an abortion pill in 20 states that had warned of legal consequences if it did so.

    The drugstore chain’s announcement Thursday signals that access to mifepristone may not expand as broadly as federal regulators intended in January, when they finalized a rule change allowing more pharmacies to provide the pill.

    Here’s a closer look at the issue.

    ABOUT THE ABORTION PILL

    The U.S. Food and Drug Administration approved mifepristone in 2000 to end pregnancy, when used in combination with a second drug, misoprostol. The combination is approved for use up to the 10th week of pregnancy.

    Mifepristone is taken first to dilate the cervix and block a hormone needed to sustain a pregnancy. Misoprostol is taken a day or two later, causing contractions to empty the uterus.

    More than half of U.S. abortions are now done with pills rather than with a procedure, according to the Guttmacher Institute, a research group that supports abortion rights. In rare cases, the drug combination can cause excess bleeding, requiring emergency care.

    WIDENING ACCESS

    For more than 20 years, the FDA limited dispensing of mifepristone to a subset of specialty offices and clinics due to safety concerns.

    The agency has repeatedly eased restrictions and expanded access, increasing demand even as state laws make the pills harder to get for many women.

    In late 2021, the agency eliminated an in-person requirement for getting the pill, saying a new scientific review showed no increase in safety complications if the drug is taken at home. That change also permitted the pill to be prescribed via telehealth and shipped by mail-order pharmacies.

    Earlier this year, the FDA further loosened restrictions by allowing pharmacies like Walgreens to start dispensing the drug after they undergo certification. That includes meeting standards for shipping, tracking and confidentially storing prescribing information.

    STATES STEP IN

    Typically, the FDA’s authority to regulate prescription drug access has gone unchallenged. But more than a dozen states now have laws restricting abortion broadly — and the pills specifically — following last year’s Supreme Court decision overturning the federal right to abortion.

    Last month, attorneys general in 20 conservative-led states warned CVS and Walgreens in a letter that they could face legal consequences if they sell abortion pills by mail in their states.

    In addition to state laws, attorneys general from conservative states have argued that shipments of mifepristone run afoul of a 19th century law that prohibited sending items used in abortion through the mail.

    WALGREENS’ REACTION

    A spokesman says the company told the attorneys general that it will not dispense mifepristone in their states and it doesn’t plan to ship the drug to them as well.

    But Walgreens is working to become eligible through the FDA’s certification process. It plans to dispense the pills where it can legally do so.

    The company is not currently dispensing the pills anywhere.

    OTHER DRUGSTORES

    Rite Aid Corp. said it was “monitoring the latest federal, state, legal and regulatory developments” and would keep evaluating its policies. The Associated Press also sought comment from CVS Health Corp., retail giant Walmart and the grocery chain Kroger.

    Some independent pharmacists would like to become certified to dispense the pills, said Andrea Pivarunas, a spokeswoman for the National Community Pharmacists Association. She added that this would be a “personal business decision,” based partly on state laws. The association has no specifics on how many will do it.

    OTHER LEGAL ISSUES

    In November, an anti-abortion group filed a federal lawsuit in Texas seeking to revoke mifepristone’s approval, claiming the FDA approved the drug 23 years ago without adequate evidence of safety.

    A federal judge could rule soon. If he sides with abortion opponents, mifepristone could potentially be removed from the U.S. market.

    In January, abortion rights supporters filed separate lawsuits challenging abortion pill restrictions imposed in North Carolina and West Virginia.

    Legal experts foresee years of court battles over access to the pills.

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    AP Health Writer Matthew Perrone contributed to this story.

    ___

    The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

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