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Tag: Medication

  • A skin patch to treat peanut allergies? Study in toddlers shows promise

    A skin patch to treat peanut allergies? Study in toddlers shows promise

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    WASHINGTON — An experimental skin patch is showing promise to treat toddlers who are highly allergic to peanuts — training their bodies to handle an accidental bite.

    Peanut allergy is one of the most common and dangerous food allergies. Parents of allergic tots are constantly on guard against exposures that can turn birthday parties and play dates into emergency room visits.

    There is no cure. The only treatment is for children 4 and older who can consume a special peanut powder to protect against a severe reaction.

    The patch, named Viaskin, aims to deliver that kind of treatment through the skin instead. In a major test with youngsters ages 1 to 3, it helped those who couldn’t tolerate even a small fraction of a peanut to eventually safely eat a few, researchers reported Wednesday.

    If additional testing pans out, “this would fill a huge unmet need,” said Dr. Matthew Greenhawt, an allergist at Children’s Hospital Colorado who helped lead the study.

    About 2% of U.S. children are allergic to peanuts, some so severely than even a tiny amount can cause a life-threatening reaction. Their immune system overreacts to peanut-containing foods, triggering an inflammatory cascade that causes hives, wheezing or worse. Some youngsters outgrow the allergy but most must avoid peanuts for life and carry rescue medicine to stave off a severe reaction if they accidentally ingest some.

    In 2020, the Food and Drug Administration approved the first treatment to induce tolerance to peanuts -– an “oral immunotherapy” named Palforzia that children ages 4 to 17 consume daily to keep up the protection. Aimmune Therapeutics’ Palforzia also is being tested in toddlers.

    France’s DBV Technologies is pursuing skin-based immunotherapy as an alternative way to desensitize the body to allergens.

    The Viaskin patch is coated with a small amount of peanut protein that is absorbed into the skin. A daily patch is worn between the shoulder blades, where toddlers can’t pull it off.

    In the new study, 362 toddlers with peanut allergy first were tested to see how high a dose of peanut protein they could tolerate. Then they were randomly assigned to use the Viaskin patch or a lookalike dummy patch every day.

    After a year of treatment, they were tested again and about two-thirds of the toddlers who used the real patch could safely ingest more peanuts, the equivalent of three to four, researchers concluded.

    That compares to about a third of youngsters given the dummy patches. Greenhawt said they likely include children who are outgrowing the allergy.

    As for safety, four Viaskin recipients experienced an allergic reaction called anaphylaxis that was deemed related to the patch. Three were treated with epinephrine to calm the reaction, and one dropped out of the study.

    Some youngsters also accidentally ate peanut-containing foods during the study, and researchers said allergic reactions were less frequent among the Viaskin users than those wearing the dummy patches. The most common side effect was skin irritation at the patch site.

    The findings were published in the New England Journal of Medicine.

    The results “are very good news for toddlers and their families as the next step toward a future with more treatments for food allergies,” Dr. Alkis Togias of the National Institutes of Health, which wasn’t involved with the study, wrote in an accompanying editorial.

    Togias cautioned that it’s too early to compare oral and skin treatments, but pointed to data suggesting each might have different pros and cons — raising the possibility that oral therapy might be stronger but also cause more side effects.

    DBV Technologies has struggled for several years to bring the peanut patch to market. Last month the company announced the FDA wants some additional safety data for toddlers, and a separate study already is tracking longer treatment. A study of 4- to 7-year-olds also is underway.

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

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  • FDA panel backs over-the-counter sales of birth control pill

    FDA panel backs over-the-counter sales of birth control pill

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    WASHINGTON — Federal health advisers said Wednesday that a decades-old birth control pill should be sold without a prescription, paving the way for a likely U.S. approval of the first over-the-counter contraceptive medication.

    The panel of FDA advisers voted unanimously in favor of drugmaker Perrigo’s request to sell its once-a-day medication over the counter. The recommendation came at the close of a two-day meeting focused on whether women could safely and effectively take the pill without professional supervision. A final FDA decision is expected this summer.

    If the agency follows the nonbinding recommendation, Perrigo’s drug, Opill, would become the first contraceptive pill to be moved out from behind the pharmacy counter onto store shelves. The company said sales could begin late this year if OK’d.

    The outside experts said they were mostly confident that women of all ages could use the drug appropriately without seeing a health provider first.

    “In the balance between benefit and risk, we’d have a hard time justifying not taking this action,” said Maria Coyle, an Ohio State University pharmacist, who chaired the panel. “The drug is incredibly effective, and I think it will be effective in the over-the-counter realm just as it is in the prescription realm.”

    The positive vote came despite numerous criticisms from FDA scientists about how Perrigo studied the drug, including questions about whether study participants were able to understand and follow labeling instructions.

    “We have an application with many complicated issues and uncertainties, including questionable reliability,” FDA’s Dr. Pamela Horn told panelists on Tuesday.

    But the panel largely set those concerns aside, emphasizing the benefits of providing more effective birth control, particularly to young people and lower-income groups, than what’s available over the counter now, like condoms and diaphragms.

    Most birth control pills used in the U.S. today contain a combination of progestin and estrogen. Opill is part of an older class of contraceptives that only contain progestin. They generally have fewer side effects and health risks but can be less effective if they’re not taken around the same time daily.

    FDA’s decision won’t apply to other birth control pills, only Opill, although advocates hope that an approval decision might push other drugmakers to seek over-the-counter sales. Birth control pills are available without a prescription across much of South America, Asia and Africa.

    Nonprescription medicines are usually cheaper, but generally not covered by insurance. Requiring insurers to cover over-the-counter birth control would require a regulatory change by the federal government.

    Opill was first approved in the U.S. five decades ago based on data showing it was more than 90% effective in preventing pregnancy when taken daily. But some women should not take it, particularly those with breast cancer, because of the risk that it could accelerate tumor growth. Women who have unusual vaginal bleeding are instructed to speak with a doctor before using it, because bleeding could indicate a serious health issue.

    But in reading comprehension studies conducted by Perrigo, 68% of women with unexplained bleeding incorrectly answered they could take the drug. And a few women with breast cancer also told researchers they could use Opill.

    Panel members said almost all women with a history of breast cancer would be under the care of a cancer specialist, who would advise them not to take hormonal drugs that could make their condition worse.

    “I would think any woman who had a breast cancer diagnosis in the past would be highly aware of that, so I don’t think that’s going to be a concern,” said Dr. Deborah Armstrong of Johns Hopkins University.

    Perrigo said its 880-patient study of the drug showed that women will consistently take the pill daily if it’s made available over-the-counter. But the FDA found several problems in the study, including more than 30% of participants who erroneously reported taking more pills than they were actually supplied. FDA reviewers said the problem called into question the company’s overall conclusions about the drug’s use and effectiveness.

    FDA regulators also suggested changes in U.S. demographics since the pill was first tested — including increased obesity and other chronic conditions— could reduce the drug’s effectiveness.

    Despite those concerns, Opill has the support of dozens of reproductive rights and medical groups that have long pushed for expanded access to birth control.

    “Opill over the counter would give us one more option for access and the more options that are available the better,” said Clare Coleman, president of the National Family Planning and Reproductive Health Association

    Coleman was one of more than 25 speakers who supported Perrigo’s application during a public comment session Tuesday.

    Catholic groups, including the United States Conference of Catholic Bishops, oppose the move, saying women should be evaluated by a doctor before getting it.

    Even if the pill is approved, it’s unclear how popular it might be. Opill has not been marketed in the U.S. since 2005 and was previously owned by Pfizer. Perrigo acquired the drug with its buyout of French drugmaker HRA Pharma last year.

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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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  • Abortion pill legal challenge threatens miscarriage care

    Abortion pill legal challenge threatens miscarriage care

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    Less than a year after losing her daughter Emilia at five days old, Jillian Phillips suffered a miscarriage.

    It was Halloween weekend in 2016, and her doctor said she could wait for it to end naturally, have a surgical procedure or take medication. She chose the medicine, passed the remains of her nine-week pregnancy at home and buried them in a memorial garden, near some of Emilia’s ashes.

    “Once I found out that the baby inside me was no longer viable, I didn’t want to just walk around carrying the emotional trauma of that,” said Phillips, a 41-year-old single mother of three from North Brookfield, Mass. “You just kind of want it finished. And the medication works pretty quickly.”

    But the future of this common miscarriage treatment is in peril. The pill, mifepristone, is used in abortions, making it a target.

    Last month, a federal judge in Texas ruled to block mifepristone’s approval by the Food and Drug Administration. The Supreme Court later preserved access to the drug while the lawsuit winds through the courts, a long road that continues with arguments before an appeals court on May 17.

    Doctors and patients fear mifepristone could be pulled off the market when the legal wrangling ends. Already, they say, a chilling effect keeps some doctors from prescribing it.

    A million U.S. women a year suffer miscarriages, which occur in at least 15% of known pregnancies. Mifepristone was approved in 2000 for early abortions but it is often used “off label” to treat early pregnancy loss or to speed up delivery when a fetus dies later in pregnancy. These uses are so common that U.S. senators urged manufacturer Danco to apply to the FDA to add miscarriage to the label of its drug, Mifeprex.

    Denise Harle, an attorney for the group that filed the Texas lawsuit on behalf of anti-abortion doctors and health care organizations, said they aren’t challenging uses of the drug beyond abortion. But legal experts say if it’s taken off the market for its approved use, it wouldn’t be available for pregnancy loss.

    Dr. Kristyn Brandi said that would take away “the gold standard of miscarriage management,” the two-drug combination of mifepristone and misoprostol that helps empty the uterus and reduce the chance of infection.

    “I offer it to every single patient whose miscarriage I manage,” said Brandi, an OB-GYN in Newark, New Jersey. “There will be a big impact if I am no longer able to use that medication.”

    HELP THROUGH THE PAIN

    Brandi said medication speeds up the miscarriage process at a time when women are already suffering physically and emotionally.

    Most patients naturally pass pregnancy tissue within two weeks of their diagnosis, but it can take several weeks, according to the American College of Obstetricians and Gynecologists. Tissue generally passes within 48 hours when women take the medication, which studies show is about 80%-90% effective.

    Brandi gives mifepristone to patients in her office. It blocks the hormone progesterone and primes the uterus to respond to the contraction-causing effect of misoprostol, which is taken later at home.

    Phillips, a social worker, said the medicine made a horrible situation a little more bearable.

    At her second ultrasound, doctors couldn’t detect cardiac activity in the fetus. Phillips considered getting a “dilation and curettage” procedure, but didn’t like that she would need general anesthesia and couldn’t take the remains home. Medication seemed a better option.

    She took mifepristone and wound up needing two doses of misoprostol. “But the miscarriage itself was not really any more significant than my worst periods,” she said. “And I was in the comfort of my home with my family.”

    Today, she finds solace in her memorial garden, where small angel figurines are arranged near a tree in her front yard.

    Myriad Norris, 25, of Lexington, Kentucky, said she was glad mifepristone was available when she had a miscarriage in late March — even though she ended up not needing it.

    About 12 hours after discovering she was pregnant, Norris started cramping, then bleeding. Worried she could develop an infection, she asked her doctor about mifepristone. She was just over five weeks pregnant, and the tissue passed on its own.

    Soon news broke about the Texas judge’s ruling. Norris, a stay-at-home mom who is active in the group Kentucky for Reproductive Freedom, said it brought “an additional layer of grief.”

    ‘CHILLING EFFECT’ AND BACKUP PLANS

    Mifepristone has long been subject to special restrictions, though experts say it’s as safe as the over-the-counter painkiller ibuprofen. For example, the FDA requires it to be dispensed by, or under the supervision of, a certified prescriber.

    Doctors say the current legal climate is tightening access further.

    “It’s kind of creating this chilling effect” where even though it’s still approved and available, doctors “aren’t going to give it because they’re too worried about whatever ramifications are coming afterward,” Brandi said.

    Dr. Sarah Prager, an OB-GYN at the University of Washington School of Medicine, said her health system doesn’t restrict mifepristone, but others in her state do.

    “Facilities that don’t want to have anything to do with abortion have chosen not to carry mifepristone on site,” she said. That includes Catholic facilities, which house a growing percentage of acute care hospital beds.

    As doctors wait to learn mifepristone’s fate, they’re making backup plans for miscarriage care.

    One involves using only misoprostol to manage miscarriages. While it’s safe, research shows it’s not as effective at helping expel pregnancy tissue — which can lead to a dangerous infection if it stays in the uterus. The treatment success rate for miscarriage patients who got misoprostol only was 67%, compared with 84% for those who took the two drugs, a 2018 study in the New England Journal of Medicine found.

    That means misoprostol-only patients are more likely to need a follow-up surgical procedure or additional doses. It also leads to “significantly more discomfort,” Prager said.

    “It really feels like we’re just punishing people by not being able to give them an evidence-based and least-impactful regimen of medication,” she said.

    Phillips said patients deserve all the options she had.

    During a miscarriage, “you already feel completely traumatized and devastated,” Phillips said. “It’s frightening to think that people may be in the same situation that I was and would not be able to get appropriate health care.”

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    Associated Press reporter Heather Hollingsworth contributed to this report from Mission, Kansas.

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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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  • Over-the-counter birth control pill faces FDA questions

    Over-the-counter birth control pill faces FDA questions

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    WASHINGTON — U.S. health regulators are weighing the first-ever request to make a birth control pill available without a prescription.

    But in an initial review posted Friday, the Food and Drug Administration raised numerous concerns about drugmaker Perrigo’s application to sell its decades-old pill over the counter.

    The FDA cited problems with the reliability of some of the company’s data on the drug, Opill, and questioned whether women with certain other medical conditions would correctly opt out of taking it. The agency also noted signs that study participants had trouble understanding the labeling instructions.

    Advisers to the FDA meet next week to review drugmaker Perrigo’s application. The two-day public meeting is one of the last steps before a final FDA decision.

    If the agency grants the company’s request, Opill would become the first contraceptive pill to be moved out from behind the pharmacy counter onto store shelves or online.

    Friday’s FDA review suggests regulators have serious reservations about broad access to the drug, including whether younger teenagers will be able to correctly follow the labeling directions.

    At the end of the meeting, the FDA panel will vote on whether the benefits of making the pill more widely available outweigh the potential risks. The panel vote is not binding and the FDA is expected to make its final decision this summer.

    Perrigo executives say Opill could be an important new option for the estimated 15 million U.S. women — or one-fifth of those who are child-bearing age — who currently use no birth control or less effective methods, such as condoms.

    “We have no doubt that our data clearly shows that women of all ages can safely use Opill in the over-the-counter setting,” Frederique Welgryn, the company’s global vice president for women’s health, said this week.

    The company’s application has no relation to the ongoing lawsuits over the abortion pill mifepristone, which is not a contraceptive. Research for over-the-counter sales of the pill began nearly a decade ago.

    Hormone-based pills, like Opill, have long been the most common form of birth control in the U.S., used by tens of millions of women since the 1960s.

    Opill was first approved in the U.S. 50 years ago. Perrigo acquired rights to the drug last year with its buyout of Paris-based HRA Pharma, which bought the pill from Pfizer in 2014. It’s not currently marketed in the U.S. but is sold without a prescription in the U.K.

    FDA’s decision won’t apply to other birth control pills, only Opill, although advocates hope that an approval decision might push other pill makers to seek over-the-counter sales. Birth control pills are available without a prescription across much of South America, Asia and Africa.

    Many common medications have made the over-the-counter switch, including drugs for pain relief, heartburn and allergies. Generally, drugmakers must show that consumers can accurately understand and follow the labeling instructions to safely and effectively use the drug. Non-prescription medicines are usually cheaper, but generally not covered by insurance. Forcing insurers to cover over-the-counter birth control would require a regulatory change by the Department of Health and Human Services.

    Perrigo’s main study tracked nearly 900 U.S. women taking its pill without professional supervision for up to six months. The group included women of different ages, races, educational and cultural backgrounds.

    Women were paid to track and record their use of the pill, including whether they followed instructions to take it during the same 3-hour window each day. That consistency is key to the drug’s ability to block pregnancy.

    But after Perrigo wrapped up its study, the FDA identified a problem: nearly 30% of women erroneously reported taking more pills than they were actually supplied.

    The FDA said Friday these cases of “improbable dosing” call into question the company’s results.

    Perrigo will present a reanalysis of the data that excludes the participants who overreported. The company says the results showed the study still achieved its goal of demonstrating that most women used the pill correctly.

    Women reported taking the pill on a daily basis 92% of the time during the study, the company says.

    The company says its data show there would be about two pregnancies for every 100 women who take its pill for a year. But the FDA called this figure “an imprecise estimate” because the study was significantly smaller than those typically used to evaluate contraceptive effectiveness.

    The most popular birth control pills today contain a combination of synthetic hormone progestin, which helps block pregnancy, plus estrogen. The addition of estrogen can help make periods lighter and more regular but it also carries the risk of rare blood clots.

    Opill contains only progestin, making it a safer option and, according to experts, an easier regulatory switch to over-the-counter status. But progestin-only pills have downsides, including reduced effectiveness if they’re not taken at the same time daily.

    The FDA review also flagged concerns that women with potential health problems will appropriately avoid taking the drug.

    Women with a history of breast cancer should not take the pill, though a few participants in preliminary research incorrectly said they thought they could. And women who have unusual vaginal bleeding are instructed to talk to a doctor first, because it could indicate a medical problem. But the FDA notes that half of women in Perrigo’s study who had unexplained bleeding incorrectly said Opill would be appropriate for them.

    Several major U.S. medical groups, including the American Medical Association, support making the drugs available over the counter. The 60-year history of birth control pills shows “the benefits of widespread, nonprescription availability far outweigh the limited risk,” the group stated in comments submitted to the FDA.

    Catholic groups, including the United States Conference of Catholic Bishops, are opposing Opill’s application, saying women should be evaluated by a doctor before getting it.

    ___

    Follow Matthew Perrone on Twitter: @AP_FDAwriter

    ___

    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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  • Autopsy: Stab wounds to heart, lungs killed Cash App founder

    Autopsy: Stab wounds to heart, lungs killed Cash App founder

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    SAN FRANCISCO — Cash App founder Bob Lee died during surgery from stab wounds that pierced his heart and a lung, according to an autopsy report released Tuesday that also shows he had alcohol and drugs in his system.

    Doctors at San Francisco General Hospital tried for hours to close the wounds in Lee’s heart and save his life, but they declared him dead at 6:49 a.m. April 4, according to an 18-page autopsy report by the San Francisco Medical Examiner.

    A toxicology test found Lee, 43, had alcohol, cocaine, ketamine and allergy medication in his system, Assistant Medical Examiner Dr. Ellen Moffatt wrote.

    Moffatt concluded Lee’s cause of death was multiple stab wounds, and that the manner and method of death was homicide by sharp injury.

    Tech consultant Nima Momeni, 38, was charged with murder with a sentencing enhancement of using a knife in the April 4 stabbing death of Lee. If convicted, he faces 26 years to life in prison.

    A plea hearing on Tuesday was continued until May 18 after Momeni’s defense attorney, Paula Canny, asked for more time.

    Outside the courtroom, Canny emphasized Lee’s drug use could have led him to make bad decisions.

    “There’s a lot of drugs in Bob Lee’s system. I mean, Bob Lee’s system is like the Walgreens of recreational drugs,” Canny said.

    “What happens when people take drugs? Generally, they act like drug people, and what drug people act like is not themselves, not happy-go-lucky,” she said. “Just kind of illusory and make bad decisions and do bad things.”

    She wouldn’t say whether Momeni did drugs with Lee, who police said was his acquaintance.

    San Francisco District Attorney Brooke Jenkins said defense attorneys often smear a homicide victim’s character as a defense strategy. “Whether or not someone has or has not done drugs — that does not give someone a license to kill him,” Jenkins said.

    Prosecutors say Momeni drove Lee to a secluded spot and stabbed him over a dispute related to Momeni’s sister. They said in court documents that surveillance video and testimony from a friend of Lee who was with him the afternoon and evening before he died led investigators to Momeni.

    A friend of Lee, who was not identified, told investigators the two of them met with Momeni’s sister, Khazar Elyassnia, at an apartment where she was drinking with another unidentified man, according to court documents. The friend said he and Lee left the apartment and went to Lee’s hotel room where he witnessed a conversation in which Momeni was questioning Lee over whether his younger sister “was doing drugs or anything inappropriate,” prosecutors said.

    The friend and Lee parted ways around 12:30 a.m. Minutes later, Lee can be seen on video surveillance entering the high-end Millennium Tower, where public records show Elyassnia and her husband, Dino Elyassnia, own a unit. The video also shows Lee and Momeni leaving the building shortly after 2 a.m. and driving off in Momeni’s BMW.

    Prosecutors say that Momeni drove to a dark and secluded spot, parked his car and after the two got out of the car, attacked Lee with a kitchen knife, stabbing him three times, including once in the heart. He then sped away “and left victim to slowly die,” according to a motion to detain. Police recovered a knife with a 4-inch (10-centimeter) blade at the scene.

    Lee is known for creating the widely used mobile payment service Cash App while working as chief technology officer of the payment company Square, now known as Block.

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  • Autopsy: Stab wounds to heart, lungs killed Cash App founder

    Autopsy: Stab wounds to heart, lungs killed Cash App founder

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    SAN FRANCISCO — Cash App founder Bob Lee died during surgery from stab wounds that pierced his heart and a lung, according to an autopsy report released Tuesday that also shows he had alcohol and drugs in his system.

    Doctors at San Francisco General Hospital tried for hours to close the wounds in Lee’s heart and save his life, but they declared him dead at 6:49 a.m. April 4, according to an 18-page autopsy report by the San Francisco Medical Examiner.

    A toxicology test found Lee, 43, had alcohol, cocaine, ketamine and allergy medication in his system, Assistant Medical Examiner Dr. Ellen Moffatt wrote.

    Moffatt concluded Lee’s cause of death was multiple stab wounds, and that the manner and method of death was homicide by sharp injury.

    Tech consultant Nima Momeni, 38, was charged with murder with a sentencing enhancement of using a knife in the April 4 stabbing death of Lee. If convicted, he faces 26 years to life in prison.

    A plea hearing on Tuesday was continued until May 18 after Momeni’s defense attorney, Paula Canny, asked for more time.

    Outside the courtroom, Canny emphasized Lee’s drug use could have led him to make bad decisions.

    “There’s a lot of drugs in Bob Lee’s system. I mean, Bob Lee’s system is like the Walgreens of recreational drugs,” Canny said.

    “What happens when people take drugs? Generally, they act like drug people, and what drug people act like is not themselves, not happy-go-lucky,” she said. “Just kind of illusory and make bad decisions and do bad things.”

    She wouldn’t say whether Momeni did drugs with Lee, who police said was his acquaintance.

    Prosecutors say Momeni drove Lee to a secluded spot and stabbed him over a dispute related to Momeni’s sister. They said in court documents that surveillance video and testimony from a friend of Lee who was with him the afternoon and evening before he died led investigators to Momeni.

    A friend of Lee, who was not identified, told investigators the two of them met with Momeni’s sister, Khazar Elyassnia, at an apartment where she was drinking with another unidentified man, according to court documents. The friend said he and Lee left the apartment and went to Lee’s hotel room where he witnessed a conversation in which Momeni was questioning Lee over whether his younger sister “was doing drugs or anything inappropriate,” prosecutors said.

    The friend and Lee parted ways around 12:30 a.m. Minutes later, Lee can be seen on video surveillance entering the high-end Millennium Tower, where public records show Elyassnia and her husband, Dino Elyassnia, own a unit. The video also shows Lee and Momeni leaving the building shortly after 2 a.m. and driving off in Momeni’s BMW.

    Prosecutors say that Momeni drove to a dark and secluded spot, parked his car and after the two got out of the car, attacked Lee with a kitchen knife, stabbing him three times, including once in the heart. He then sped away “and left victim to slowly die,” according to a motion to detain. Police recovered a knife with a 4-inch blade at the scene.

    San Francisco District Attorney Brooke Jenkins said defense attorneys often smear a homicide victim’s character as a defense strategy. “Whether or not someone has or has not done drugs — that does not give someone a license to kill him,” Jenkins said.

    Lee is known for creating the widely used mobile payment service Cash App while working as chief technology officer of the payment company Square, now known as Block.

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  • Pfizer tops Q1 forecasts; vaccine sales slide as expected

    Pfizer tops Q1 forecasts; vaccine sales slide as expected

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    Pfizer beat first-quarter forecasts as revenue took an expected dip, but the drugmaker predicted a sales rally later this year.

    The pharmaceutical giant said Tuesday that total revenue dropped 29% in quarter, as sales tumbled for its market-leading COVID-19 vaccine, Comirnaty. The vaccine brought in $3 billion in the first three months of this year compared to more than $13 billion in last year’s first quarter, when virus cases were soaring.

    Both analysts and Pfizer have predicted that drop as the drugmaker shifts this year from supplying governments through big contracts to selling the vaccine on the commercial market.

    The company said Tuesday that it also expects significantly lower sales from its vaccine and COVID-19 treatment, Paxlovid, in the second quarter compared to the first. But commercial sales are expected to kick in later this year, after leftover government inventory is absorbed.

    Plus Pfizer also expects a revenue boost later this year from new product launches and fall vaccinations.

    Both the vaccine and treatment have generated billions in revenue for Pfizer over the last several quarters and have easily become the drugmaker’s top sellers. But Pfizer also produces other vaccines and is expanding its cancer treatments.

    Sales grew 4% to $1.6 billion in the first quarter from Pfizer’s Prevnar vaccines for preventing pneumonia and related bacterial diseases. Sales of Eliquis, which is used to prevent blood clots and strokes, also grew 5% to $1.87 billion.

    The drugmaker’s research and development costs also climbed 9% in the quarter, as Pfizer prepared for some upcoming product debuts. The company expects to launch several products in the year’s second half, including a vaccine for the respiratory illness known as RSV.

    Overall, Pfizer’s net income sank 30% to $5.54 billion in the quarter on $18.28 billion in revenue. Adjusted earnings totaled $1.23 per share.

    Analysts expected earnings of 98 cents per share on $16.61 billion in sales, according to FactSet.

    Pfizer also reaffirmed on Tuesday its forecast for full-year earnings to range between $3.25 and $3.45 per share. That forecast initially fell short of Wall Street expectations when Pfizer released it in January.

    FactSet says analysts now expect earnings of $3.39 per share.

    Pfizer said in March that it would spend about $43 billion to buy biotech drug developer Seagen, which specializes in developing cancer treatments. Company officials said Tuesday that deal remains on track to close either by the end of this year or in early 2024.

    Shares of New York-based Pfizer Inc. fell 49 cents to $38.72 Tuesday afternoon while broader indexes also dropped.

    ___ Follow Tom Murphy on Twitter: https://twitter.com/thpmurphy

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  • Man arrested after $3M worth of drugs shipped to restaurant

    Man arrested after $3M worth of drugs shipped to restaurant

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    Employees of a Maine restaurant got a surprise when they opened a large wooden crate that they thought was a shipment of mugs they had recently ordered

    AUBURN, Maine — Employees of a Maine restaurant got a surprise when they opened a large wooden crate that they thought was a shipment of mugs they had recently ordered.

    Instead, they found a plastic tote that contained what law enforcement suspect is 14 kilograms (31 pounds) of the powerful synthetic opioid fentanyl with an estimated street value of $3 million, Auburn police Deputy Chief Timothy Cougle said in a statement Saturday.

    The tote had a shipping label with the restaurant’s address but the name of someone who did not work there. Employees who opened it saw what they thought looked like drugs, so they contacted police, Cougle said.

    The crate from Arizona that arrived in the Maine town about 30 miles (50 kilometers) north of Portland was taken to the police department, where a chemical field examination confirmed it contained fentanyl.

    About an hour later, the man whose name was on the shipment showed up looking for the crate and was arrested, police said.

    Jeremy Mercier, 41, of Auburn, was charged with drug offenses and for violating bail conditions. He is being held in a county jail without bail. It could not be determined if he had an attorney.

    Mercier previously spent time behind bars on a 2007 federal drug conviction, Cougle said.

    The investigation is ongoing, and Cougle said he anticipates state and federal law enforcement getting involved.

    Mike Peters, the co-owner of Mac’s Grill, told WMTW-TV in an email that he is glad the drugs did not make it to the streets.

    “The instances of overdose in our, and surrounding, communities is awful, and fentanyl seems to be front and center when it comes to fatalities,” he said. “It is very sad.”

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  • What’s behind shortages of Adderall, Ozempic and other meds?

    What’s behind shortages of Adderall, Ozempic and other meds?

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    Shortages of drugs like Adderall are growing in the United States, and experts see no clear path to resolving them. For patients, that can mean treatment delays, medication switches and other hassles filling a prescription.

    In recent months, unexpected demand spikes, manufacturing problems and tight ingredient supplies have contributed to shortages that stress patients, parents and doctors. For some drugs, such as stimulants that treat ADHD, several factors fueled a shortage and make it hard to predict when it will end.

    Shortages, particularly of generic drugs, have been a longstanding problem. The industry has consolidated and some manufacturers have little incentive to solve shortages because cheap generics generate thin profits.

    Here’s a deeper look at the issue.

    HOW MANY DRUG SHORTAGES ARE THERE?

    There were 301 active national drug shortages through this year’s first quarter, according to the University of Utah Drug Information Service. That’s 49% higher than the 202 recorded in the first three months of 2018.

    Patients don’t feel all drug shortages because doctors may be able to substitute different medications or because other parts of the drug supply system mask the issue, said Stephen Schondelmeyer, a University of Minnesota College of Pharmacy professor.

    “But there are more shortages now, and they’re becoming more visible,” he said.

    WHICH DRUGS ARE IN SHORTAGE?

    In the fall, the U.S. Food and Drug Administration announced a shortage of the attention deficit/hyperactivity disorder treatment Adderall due to a manufacturing problem. That has persisted and grown at times to include other stimulants that treat the condition.

    That situation seems to be improving, said University of Utah Health researcher Erin Fox. But several extended-release doses of the medication, its most popular form, remain in short supply.

    The FDA also has tracked a shortage of the diabetes treatment Ozempic, which doctors also prescribe for weight loss. Prescriptions for Ozempic — touted by celebrities and others on social media — have doubled since the summer of 2021 to more than 1.2 million, according to the health data firm IQVIA.

    A spokeswoman for Ozempic maker Novo Nordisk says all doses of the drug are now available at pharmacies nationwide.

    Last year, a spike in respiratory illnesses forced drugstore chains to temporarily limit purchases of fever-reducing medicines for children. A shortage of the antibiotic amoxicillin also cropped up around then.

    Injectable drugs used in hospitals and clinics, such as IV saline and some cancer treatments, are more than twice as likely as tablets or topical treatments to experience a shortage, according to a recent report written by Sen. Gary Peters, D-Mich., chairman of the Senate Committee on Homeland Security and Governmental Affairs.

    WHY DO DRUG SHORTAGES DEVELOP?

    Reasons can vary, and a combination of factors fuels many shortages.

    The Adderall manufacturing problem hit as more people started taking the drug.

    During the pandemic, prescriptions climbed as regulators started allowing doctors to prescribe the drug without first seeing a patient in person. Prescriptions for Adderall and its generic equivalents jumped 20% between February 2020 and the end of last year, according to IQVIA.

    Adderall supplies face an additional challenge when demand spikes. Federal regulators limit supplies for the drug each year because it is a controlled substance.

    Pricing might also be a factor with some drugs.

    Ozempic is a diabetes drug. The same medication, semaglutide, is sold under a different brand name, Wegovy, for weight loss. Schondelmeyer noted the per-milligram price for Wegovy can be more than twice as much as Ozempic.

    “They’ve been having a run on Ozempic because people don’t want to spend that much on Wegovy,” Schondelmeyer said.

    Novo Nordisk spokeswoman Allison Schneider said price was not connected to the shortage. She tied that to a combination of demand and global supply constraints.

    Another factor driving shortages: Medications like Adderall and amoxicillin generate thin profits so companies don’t have an incentive to make and store large amounts in case a shortage develops, Fox said.

    “Once a shortage starts with something you make just in time anyway, it’s really hard to resolve it unless all the suppliers are back,” she said.

    HOW ARE PATIENTS AFFECTED BY DRUG SHORTAGES?

    Shortages might lead to treatment delays, which can hurt patients dealing with time-sensitive conditions like cancer.

    Doctors are sometimes forced to prescribe alternatives that might not be as effective. That also can lead to medication errors if the doctor is less familiar with the other medication.

    Patients also may run out of their prescriptions or be forced to hunt for a pharmacy that has enough supply to refill it.

    FUTURE PROSPECTS

    It’s tough to predict when many shortages may be resolved, partly because measuring demand is hard.

    “You can estimate you’re going to increase your production by 10%,” said Mike Ganio, senior director of pharmacy practice and quality with the American Society of Health-System Pharmacists, “but is that going to be enough?”

    Meanwhile, conditions that could feed future shortages still exist. The Senate report cited an overreliance on foreign sources as a concern.

    Factories in China and India supply most of the raw materials used in American medicines. Early in the COVID-19 pandemic, India restricted exports of 13 active pharmaceutical ingredients and finished drugs made from those chemicals, to protect its domestic drug supply.

    Once shortages develop, they can last years. And it can be tough for patients to get reliable information. Fox said there is no legal requirement for drugmakers to update the public.

    The Senate report notes that “no federal agency or private industry partner has end-to-end visibility into the entire U.S. pharmaceutical supply chain.”

    Fox says the stimulant shortage has been particularly frustrating. Companies have said they aren’t getting enough raw materials to make the drugs, and the federal government says companies aren’t using what they have.

    “There’s been a lot of finger pointing back and forth,” Fox said.

    ___

    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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  • DIY trans care evades barriers in Missouri, other states

    DIY trans care evades barriers in Missouri, other states

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    JEFFERSON CITY, Mo. — With her insurance about to run out and Republicans in her home state of Missouri ramping up rhetoric against gender-affirming health care, Erin Stille nervously visited a foreign pharmaceutical site as a “last resort” to ensure she could continue getting the hormones she needs.

    Stille, 26, sent a $300 bank transfer to a Taiwan-based supplier for a 6-month supply of estrogen patches and androgen-blocking pills. For three weeks she feared she’d been scammed but breathed a sigh of relief when a large package arrived at her home in St. Peters.

    “It’s definitely a little scary,” Stille said. “Taking a chance like this, I could have my money stolen and there’s not much I can do about it. But I figured, at this point, that the benefits outweigh the risks.”

    Stille, and others nationwide, are scrambling to form contingency plans as Republican politicians rapidly erode access to the gender-affirming treatments many credit as life-saving.

    Fears became even more pronounced in Missouri this month after Republican Attorney General Andrew Bailey issued a first-of-its-kind emergency rule that places strict restrictions on that care for minors — and adults.

    While some doctors say self-medicating trans health care is dangerous, Stille is among a growing population who say they see no other option.

    If enacted, the Missouri rule will require people to have experienced an “intense pattern” of documented gender dysphoria for three years and to have received at least 15 hourly sessions with a therapist over 18 months or more before receiving puberty blockers, hormones, surgery or other treatment.

    Patients also must first be screened for autism and “social media addiction,” and any psychiatric symptoms from mental health issues will have to be treated and resolved. Some people will be able to maintain their prescriptions while undergoing the required assessments, which aren’t affordable for many.

    Some transgender Missourians and health care providers sued to overthrow the rule, and a St. Louis judge pushed back its effective date from last Thursday to Monday at 5 p.m. as she weighs whether to block its enforcement as the lawsuit proceeds in court. A ruling is expected Monday.

    Bailey has touted the rule as a way to shield residents, especially minors, from what he describes as experimental treatments, but puberty blockers and sex hormones have been prescribed for decades and are widely considered medically necessary for many trans people.

    Some gender-affirming treatment providers in Missouri are already planning to cut back on care.

    Vivent Health Interim President and CEO Brandon Hill said doctors are worried about meeting documentation requirements for new patients, so clinics in St. Louis and Kansas City will only provide gender-affirming health care to current patients. Vivent Health provides HIV-focused and LGBTQ+ friendly health care in St. Louis, Kansas City and other states.

    “Do-it-yourself hormone replacement therapy” has become an increasingly common way for trans residents of restrictive states to avoid involuntarily stopping hormone treatment. Trans people like Stille have been discreetly circulating a comprehensive a guide and a digital master list of hormone suppliers, some more reliable than others, through social media.

    This online marketplace, known as the gray market, is comprised of unregulated suppliers who sell legitimate medications, sometimes name-brand, outside the distribution channels authorized by the manufacturers. Some trans people in GOP-controlled states that have not yet enacted bans are buying from these suppliers to build an emergency stockpile.

    But self-administering hormones without adequate supervision can be “extraordinarily dangerous,” especially for those taking testosterone, said Dr. Robert Lash, chief medical officer at the Endocrine Society, which represents specialists who treat hormone conditions.

    Although taking testosterone can help trans men develop some desired physical features, it also increases their risk of a blood clot or stroke. Lash said doctors need to closely monitor a patient’s red blood cell count, lipids and liver function and adjust their dosage accordingly. Estrogen use can also increase risk of blood clots, he said.

    “These are powerful medications with a lot of effects on a lot of body systems, not all of which are good,” Lash said. “Taking these hormones on your own is just an invitation to running into problems. People need to be extraordinarily careful when using them and really shouldn’t without medical supervision.”

    He cautioned against taking hormones from any unregulated pharmacy, veterinary source or overseas provider.

    Even for those willing to assume the risks, not all trans people have the same level of access. Trans men like Levi Sobel, a 30-year-old from Springfield, are finding it much more difficult to source testosterone than other hormones.

    Testosterone is classified in the U.S. as a Schedule III controlled substance, along with ketamine and some opioids, and is subjected to more regulations that the typical prescription drug.

    Sobel said unregulated testosterone providers are “pretty much nonexistent” in the U.S., and it’s unwise to buy from international sellers because of the higher likelihood of the hormone being seized by U.S. Customs and Border Protection.

    “This makes it essentially impossible for me to stockpile in the same ways my transfeminine friends can,” Sobel said. “The best I can do to stretch it is to make sure I’m using every last drop from every vial.”

    Stacy Cay, an autistic trans woman and comedian in Kansas City, has already saved up enough injectable estrogen to last about a year. The more she can stockpile, the more time she has to prepare her plan to relocate if the emergency rule isn’t blocked in court, she said.

    “This feels like the end of Kansas City being my home,” Cay said. “It feels like it’s being taken away.”

    Others, like Ellie Bridgman, a gas station attendant in Union, are employing a unique strategy to stockpile hormones. The 23-year-old, who said the attorney general’s rule would cut off her treatment access because she’s autistic and has depression, started injecting only a half dose of estrogen before her routine blood tests so her hormone levels would read low.

    This led her doctor to increase her prescription.

    Bridgman said she may consider decreasing her dosage to conserve medication or supplement her supply with an unregulated purchase. Stockpiling is her “No. 1 priority.” Without hormone replacement therapy, she said, “the suicidal thoughts and ideation comes back stronger than ever. This is my lifeline.”

    ___

    Schoenbaum reported from Raleigh, North Carolina.

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  • Powerful new obesity drug poised to upend weight loss care

    Powerful new obesity drug poised to upend weight loss care

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    As a growing number of overweight Americans clamor for Ozempic and Wegovy — drugs touted by celebrities and on TikTok to pare pounds — an even more powerful obesity medicine is poised to upend treatment.

    Tirzepatide, an Eli Lilly and Co. drug approved to treat type 2 diabetes under the brand name Mounjaro, helped people with the disease who were overweight or had obesity lose up to 16% of their body weight, or more than 34 pounds, over nearly 17 months, the company said on Thursday.

    The late-stage study of the drug for weight loss adds to earlier evidence that similar participants without diabetes lost up to 22% of their body weight over that period with weekly injections of the drug. For a typical patient on the highest dose, that meant shedding more than 50 pounds.

    Having diabetes makes it notoriously difficult to lose weight, said Dr. Nadia Ahmad, Lilly’s medical director of obesity clinical development, which means the recent results are especially significant. “We have not seen this degree of weight reduction,” she said.

    Based on the new results, which have not yet been published in full, company officials said they will finalize an application to the U.S. Food and Drug Administration for fast-track approval to sell tirzepatide for chronic weight management. A decision could come later this year. A company spokeswoman would not confirm whether the drug would be marketed for weight loss in the U.S. under a different brand name.

    If approved for weight loss, tirzepatide could become the most effective drug to date in an arsenal of medications that are transforming the treatment of obesity, which affects more than 4 in 10 American adults and is linked to dozens of diseases that can lead to disability or death.

    “If everybody who had obesity in this country lost 20% of their body weight, we would be taking patients off all of these medications for reflux, for diabetes, for hypertension,” said Dr. Caroline Apovian, a director of the Center for Weight Management and Wellness at Brigham and Women’s Hospital. “We would not be sending patients for stent replacement.”

    Industry analysts predict that tirzepatide could become one of the top-selling drugs ever, with annual sales topping $50 billion. It is expected to outpace Novo Nordisk’s Ozempic — a diabetes drug used so commonly to shed pounds that comedian Jimmy Kimmel joked about it at the Oscars — and Wegovy, a version of the drug also known as semaglutide approved for weight loss in 2021. Together, those drugs made nearly $10 billion in 2022, with prescriptions continuing to soar, company reports show.

    In separate trials, tirzepatide has resulted in greater weight loss than semaglutide, whose users shed about 15% of their body weight over 16 months. A head-to-head trial comparing the two drugs is planned.

    Mounjaro was first approved to treat diabetes last year. Since then, thousands of patients have obtained the drug from doctors and telehealth providers who prescribed it “off-label” to help them slim down.

    In California, Matthew Barlow, a 48-year-old health technology executive, said he has lost more than 100 pounds since November by using Mounjaro and changing his diet.

    “Psychologically, you don’t want to eat,” said Barlow. “Now I can eat two bites of a dessert and be satisfied.”

    Rather than relying solely on diet, exercise and willpower to reduce weight, tirzepatide and other new drugs target the digestive and chemical pathways that underlie obesity, suppressing appetite and blunting cravings for food.

    “They have entirely changed the landscape,” said Dr. Amy Rothberg, a University of Michigan endocrinologist who directs a virtual weight loss and diabetes program.

    Research has shown that with diet and exercise alone, about a third of people will lose 5% or more of their body weight, said Dr. Louis Aronne, director of the Comprehensive Weight Control Center at Weill Cornell Medicine. In the latest tirzepatide trial, more than 86% of patients using the highest dose of the drug lost at least 5% of their body weight. More than half on that dose lost at least 15%, the company said.

    The obesity medications help overcome a biological mechanism that kicks in when people diet, triggering a coordinated effort by the body to prevent weight loss.

    “That is a real physical phenomenon,” Aronne said. “There are a number of hormones that respond to reduced calorie intake.”

    Ozempic and Wegovy are two versions of semaglutide. That drug mimics a key gut hormone, known as GLP-1, that is activated after people eat, boosting the release of insulin and slowing release of sugar from the liver. It delays digestion and reduces appetite, making people feel full longer.

    Tirzepatide is the first drug that uses the action of two hormones, GLP-1 and GIP, for greater effects. It also targets the chemical signals sent from the gut to the brain, curbing cravings and thoughts of food.

    Though the drugs appear safe, they can cause side effects, some serious. Most common reactions include diarrhea, nausea, vomiting, constipation and stomach pain. Some users have developed pancreatitis or inflammation of the pancreas, others have had gallbladder problems. Mounjaro’s product description warns that it could cause thyroid tumors, including cancer.

    There are other downsides: Versions of semaglutide have been on the market for several years, but the long-term effects of taking drugs that override human metabolism are not yet clear. Early evidence suggests that when people stop taking the medications, they gain the weight back.

    Plus, the medications are expensive — and in recent months, hard to get because of intermittent shortages. Wegovy is priced at about $1,300 a month. Mounjaro used for diabetes starts at about $1,000 per month.

    Apovian said that only about 20% to 30% of patients with private insurance in her practice find the medications are covered. Some insurers who previously paid for the drugs are enacting new rules, requiring six months of documented lifestyle changes or a certain amount of weight loss for continued coverage. Medicare is largely prohibited from paying for weight-loss drugs, though there have been efforts by drugmakers and advocates for Congress to change that.

    Still, experts say that the striking effects of tirzepatide — along with Ozempic, Wegovy and other drugs — underscore that losing weight is not merely a matter of willpower. Like high blood pressure, which affects about half of U.S. adults and is managed with medication, obesity should be viewed as a chronic disease, not a character flaw, Aronne emphasized.

    It remains to be seen what effect new drug treatments will have on pervasive bias against people with obesity, said Rebecca Puhl, a professor in the Rudd Center for Food Policy and Health, who studies weight stigma. U.S. culture has “deep-rooted beliefs about body weight and physical appearance” that are hard to change, she said.

    “Weight stigma could persist or worsen if taking medication is equated with ‘taking the easy way out’ or ‘not trying hard enough,’” she said.

    —-

    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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  • Powerful new obesity drug poised to upend weight loss care

    Powerful new obesity drug poised to upend weight loss care

    [ad_1]

    As a growing number of overweight Americans clamor for Ozempic and Wegovy — drugs touted by celebrities and on TikTok to pare pounds — an even more powerful obesity medicine is poised to upend treatment.

    Tirzepatide, an Eli Lilly and Co. drug approved to treat type 2 diabetes under the brand name Mounjaro, helped people with the disease who were overweight or had obesity lose up to 16% of their body weight, or more than 34 pounds, over nearly 17 months, the company said on Thursday.

    The late-stage study of the drug for weight loss adds to earlier evidence that similar participants without diabetes lost up to 22% of their body weight over that period with weekly injections of the drug. For a typical patient on the highest dose, that meant shedding more than 50 pounds.

    Having diabetes makes it notoriously difficult to lose weight, said Dr. Nadia Ahmad, Lilly’s medical director of obesity clinical development, which means the recent results are especially significant. “We have not seen this degree of weight reduction,” she said.

    Based on the new results, which have not yet been published in full, company officials said they will finalize an application to the U.S. Food and Drug Administration for fast-track approval to sell tirzepatide for chronic weight management. A decision could come later this year. A company spokeswoman would not confirm whether the drug would be marketed for weight loss in the U.S. under a different brand name.

    If approved for weight loss, tirzepatide could become the most effective drug to date in an arsenal of medications that are transforming the treatment of obesity, which affects more than 4 in 10 American adults and is linked to dozens of diseases that can lead to disability or death.

    “If everybody who had obesity in this country lost 20% of their body weight, we would be taking patients off all of these medications for reflux, for diabetes, for hypertension,” said Dr. Caroline Apovian, a director of the Center for Weight Management and Wellness at Brigham and Women’s Hospital. “We would not be sending patients for stent replacement.”

    Industry analysts predict that tirzepatide could become one of the top-selling drugs ever, with annual sales topping $50 billion. It is expected to outpace Novo Nordisk’s Ozempic — a diabetes drug used so commonly to shed pounds that comedian Jimmy Kimmel joked about it at the Oscars — and Wegovy, a version of the drug also known as semaglutide approved for weight loss in 2021. Together, those drugs made nearly $10 billion in 2022, with prescriptions continuing to soar, company reports show.

    In separate trials, tirzepatide has resulted in greater weight loss than semaglutide, whose users shed about 15% of their body weight over 16 months. A head-to-head trial comparing the two drugs is planned.

    Mounjaro was first approved to treat diabetes last year. Since then, thousands of patients have obtained the drug from doctors and telehealth providers who prescribed it “off-label” to help them slim down.

    In California, Matthew Barlow, a 48-year-old health technology executive, said he has lost more than 100 pounds since November by using Mounjaro and changing his diet.

    “Psychologically, you don’t want to eat,” said Barlow. “Now I can eat two bites of a dessert and be satisfied.”

    Rather than relying solely on diet, exercise and willpower to reduce weight, tirzepatide and other new drugs target the digestive and chemical pathways that underlie obesity, suppressing appetite and blunting cravings for food.

    “They have entirely changed the landscape,” said Dr. Amy Rothberg, a University of Michigan endocrinologist who directs a virtual weight loss and diabetes program.

    Research has shown that with diet and exercise alone, about a third of people will lose 5% or more of their body weight, said Dr. Louis Aronne, director of the Comprehensive Weight Control Center at Weill Cornell Medicine. In the latest tirzepatide trial, more than 86% of patients using the highest dose of the drug lost at least 5% of their body weight. More than half on that dose lost at least 15%, the company said.

    The obesity medications help overcome a biological mechanism that kicks in when people diet, triggering a coordinated effort by the body to prevent weight loss.

    “That is a real physical phenomenon,” Aronne said. “There are a number of hormones that respond to reduced calorie intake.”

    Ozempic and Wegovy are two versions of semaglutide. That drug mimics a key gut hormone, known as GLP-1, that is activated after people eat, boosting the release of insulin and slowing release of sugar from the liver. It delays digestion and reduces appetite, making people feel full longer.

    Tirzepatide is the first drug that uses the action of two hormones, GLP-1 and GIP, for greater effects. It also targets the chemical signals sent from the gut to the brain, curbing cravings and thoughts of food.

    Though the drugs appear safe, they can cause side effects, some serious. Most common reactions include diarrhea, nausea, vomiting, constipation and stomach pain. Some users have developed pancreatitis or inflammation of the pancreas, others have had gallbladder problems. Mounjaro’s product description warns that it could cause thyroid tumors, including cancer.

    There are other downsides: Versions of semaglutide have been on the market for several years, but the long-term effects of taking drugs that override human metabolism are not yet clear. Early evidence suggests that when people stop taking the medications, they gain the weight back.

    Plus, the medications are expensive — and in recent months, hard to get because of intermittent shortages. Wegovy is priced at about $1,300 a month. Mounjaro used for diabetes starts at about $1,000 per month.

    Apovian said that only about 20% to 30% of patients with private insurance in her practice find the medications are covered. Some insurers who previously paid for the drugs are enacting new rules, requiring six months of documented lifestyle changes or a certain amount of weight loss for continued coverage. Medicare is largely prohibited from paying for weight-loss drugs, though there have been efforts by drugmakers and advocates for Congress to change that.

    Still, experts say that the striking effects of tirzepatide — along with Ozempic, Wegovy and other drugs — underscore that losing weight is not merely a matter of willpower. Like high blood pressure, which affects about half of U.S. adults and is managed with medication, obesity should be viewed as a chronic disease, not a character flaw, Aronne emphasized.

    It remains to be seen what effect new drug treatments will have on pervasive bias against people with obesity, said Rebecca Puhl, a professor in the Rudd Center for Food Policy and Health, who studies weight stigma. U.S. culture has “deep-rooted beliefs about body weight and physical appearance” that are hard to change, she said.

    “Weight stigma could persist or worsen if taking medication is equated with ‘taking the easy way out’ or ‘not trying hard enough,’” she said.

    —-

    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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  • First pill for fecal transplants wins FDA approval

    First pill for fecal transplants wins FDA approval

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    WASHINGTON — U.S. health officials on Wednesday approved the first pill made from healthy bacteria found in human waste to fight dangerous gut infections — an easier way of performing so-called fecal transplants.

    The new treatment from Seres Therapeutics provides a simpler, rigorously tested version of stool-based procedures that some medical specialists have used for more than a decade to help patients.

    The Food and Drug Administration cleared the capsules for adults 18 and older who face risks from repeat infections with Clostridium difficile, a bacteria that can cause severe nausea, cramping and diarrhea.

    C. diff is particularly dangerous when it reoccurs, leading to between 15,000 and 30,000 deaths per year. It can be killed with antibiotics but they also destroy good bacteria that live in the gut, leaving it more susceptible to future infections. The new capsules are approved for patients who have already received antibiotic treatment.

    More than 10 years ago, some doctors began reporting success with fecal transplants — using stool from a healthy donor — to restore the gut’s healthy balance and prevent reinfections.

    The FDA approved the first pharmaceutical-grade version of the treatment last year from a rival drugmaker, Ferring Pharmaceuticals. But that company’s product — like most of the original procedures — must be delivered via the rectum.

    Cambridge Massachusetts-based Seres will market its drug as a less invasive option. The treatment will be sold under the brand name Vowst and comes as a regimen of four daily capsules taken for three consecutive days.

    Both of the recent FDA approvals are the product of years of pharmaceutical industry research into the microbiome, the community of bacteria, viruses and fungi that live in the gut.

    Currently most fecal transplants are provided by a network of stool banks that have popped up at medical institutions and hospitals across the country.

    While the availability of new FDA-approved options is expected to decrease demand for donations from stool banks, some plan to stay open.

    OpenBiome, the largest stool bank in the U.S., said it will keep serving patients who aren’t eligible for the FDA-approved products, such as children and adults with treatment-resistant cases. It has supplied more than 65,000 stool samples for C. diff patients since 2013.

    “OpenBiome is committed to maintaining safe access to ‘fecal transplantation’ for these patients as a vital last line of defense,” said Dr. Majdi Osman, the group’s medical chief.

    OpenBiome’s standard stool treatment costs less than $1,700 and is typically delivered as a frozen solution within days of ordering. Seres did not disclose the price it will charge for its capsules in a statement Wednesday evening.

    “We want to make the commercial experience for physicians and patients as easy as possible,” said Eric Shaff, the company’s chief executive officer, in an interview ahead of the announcement. “Ease of administration — in our view — is one of the aspects of the value we’re delivering.”

    Seres will co-market the treatment with Swiss food giant Nestle, which will also split the profits. Seres will receive a $125 million milestone payment from Nestle in connection with the FDA approval.

    Overseeing the fledgling industry of U.S. stool banks has created regulatory headaches for the FDA, which doesn’t traditionally police homemade products and procedures used in doctor’s offices. In the early days of the trend, the FDA warned consumers about the risks of potential infections from the fecal transplants, as some people sought out questionable “do it yourself” methods from videos and websites.

    Seres executives say their manufacturing process relies on the same techniques and equipment used to purify blood products and other biologic therapies.

    The company starts with stool provided by a small group of donors who are screened for various health risks and conditions. Their stool is likewise tested for dozens of potential viruses, infections and parasites.

    The company then processes the samples to remove the waste, isolate the healthy bacteria and kill any other lingering organisms. Thousands of capsules can be made from each stool sample, making it a more efficient process than current fecal transplants, according to the company.

    The FDA warned in its approval announcement that the drug “may carry a risk of transmitting infectious agents. It is also possible for Vowst to contain food allergens,” the agency noted.

    The FDA approved the treatment based on a 180-patient study in which nearly 88% of patients taking the capsules did not experience reinfection after 8 weeks, compared with 60% of those who received dummy pills.

    Common side effects included abdominal swelling, constipation and diarrhea.

    ___

    This story has been corrected to show that Eric Shaff is the chief executive officer of Seres Therapeutics, not its chief financial officer.

    ___

    Follow Matthew Perrone on Twitter: @AP_FDAwriter ___

    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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  • First pill for fecal transplants wins FDA approval

    First pill for fecal transplants wins FDA approval

    [ad_1]

    WASHINGTON — U.S. health officials on Wednesday approved the first pill made from healthy bacteria found in human waste to fight dangerous gut infections — an easier way of performing so-called fecal transplants.

    The new treatment from Seres Therapeutics provides a simpler, rigorously tested version of stool-based procedures that some medical specialists have used for more than a decade to help patients.

    The Food and Drug Administration cleared the capsules for adults 18 and older who face risks from repeat infections with Clostridium difficile, a bacteria that can cause severe nausea, cramping and diarrhea.

    C. diff is particularly dangerous when it reoccurs, leading to between 15,000 and 30,000 deaths per year. It can be killed with antibiotics but they also destroy good bacteria that live in the gut, leaving it more susceptible to future infections. The new capsules are approved for patients who have already received antibiotic treatment.

    More than 10 years ago, some doctors began reporting success with fecal transplants — using stool from a healthy donor — to restore the gut’s healthy balance and prevent reinfections.

    The FDA approved the first pharmaceutical-grade version of the treatment last year from a rival drugmaker, Ferring Pharmaceuticals. But that company’s product — like most of the original procedures — must be delivered via the rectum.

    Cambridge Massachusetts-based Seres will market its drug as a less invasive option. The treatment will be sold under the brand name Vowst and comes as a regimen of four daily capsules taken for three consecutive days.

    Both of the recent FDA approvals are the product of years of pharmaceutical industry research into the microbiome, the community of bacteria, viruses and fungi that live in the gut.

    Currently most fecal transplants are provided by a network of stool banks that have popped up at medical institutions and hospitals across the country.

    While the availability of new FDA-approved options is expected to decrease demand for donations from stool banks, some plan to stay open.

    OpenBiome, the largest stool bank in the U.S., said it will keep serving patients who aren’t eligible for the FDA-approved products, such as children and adults with treatment-resistant cases. It has supplied more than 65,000 stool samples for C. diff patients since 2013.

    “OpenBiome is committed to maintaining safe access to ‘fecal transplantation’ for these patients as a vital last line of defense,” said Dr. Majdi Osman, the group’s medical chief.

    OpenBiome’s standard stool treatment costs less than $1,700 and is typically delivered as a frozen solution within days of ordering. Seres did not disclose the price it will charge for its capsules in a statement Wednesday evening.

    “We want to make the commercial experience for physicians and patients as easy as possible,” said Eric Shaff, the company’s chief executive officer, in an interview ahead of the announcement. “Ease of administration — in our view — is one of the aspects of the value we’re delivering.”

    Seres will co-market the treatment with Swiss food giant Nestle, which will also split the profits. Seres will receive a $125 million milestone payment from Nestle in connection with the FDA approval.

    Overseeing the fledgling industry of U.S. stool banks has created regulatory headaches for the FDA, which doesn’t traditionally police homemade products and procedures used in doctor’s offices. In the early days of the trend, the FDA warned consumers about the risks of potential infections from the fecal transplants, as some people sought out questionable “do it yourself” methods from videos and websites.

    Seres executives say their manufacturing process relies on the same techniques and equipment used to purify blood products and other biologic therapies.

    The company starts with stool provided by a small group of donors who are screened for various health risks and conditions. Their stool is likewise tested for dozens of potential viruses, infections and parasites.

    The company then processes the samples to remove the waste, isolate the healthy bacteria and kill any other lingering organisms. Thousands of capsules can be made from each stool sample, making it a more efficient process than current fecal transplants, according to the company.

    The FDA warned in its approval announcement that the drug “may carry a risk of transmitting infectious agents. It is also possible for Vowst to contain food allergens,” the agency noted.

    The FDA approved the treatment based on a 180-patient study in which nearly 88% of patients taking the capsules did not experience reinfection after 8 weeks, compared with 60% of those who received dummy pills.

    Common side effects included abdominal swelling, constipation and diarrhea.

    ___

    This story has been corrected to show that Eric Shaff is the chief executive officer of Seres Therapeutics, not its chief financial officer.

    ___

    Follow Matthew Perrone on Twitter: @AP_FDAwriter ___

    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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  • Comedian Richard Lewis reveals he has Parkinson’s disease

    Comedian Richard Lewis reveals he has Parkinson’s disease

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    Comedian Richard Lewis is retiring from stand-up following four surgeries and a diagnosis of Parkinson’s disease

    NEW YORK — Comedian Richard Lewis is retiring from stand-up following four surgeries and a diagnosis of Parkinson’s disease.

    The 75-year-old “Curb Your Enthusiasm” star, who is known for wearing all-black and exploring his neuroses onstage, posted a video Monday to Twitter explaining his various health issues.

    “For the last three-and-a-half years, I’ve had sort of a rocky time,” he said, adding that he has suffered with back pain, and he had shoulder and hip replacement surgeries.

    He also got a brain scan because he was shuffling his feet when he walked. Doctors diagnosed him with Parkinson’s. “Luckily, I got it late in life, and they say you progress very slowly if at all, and I’m on the right meds, so I’m cool,” he said. ”I’m finished with stand-up. I’m just focusing on writing and acting.”

    Lewis’ big screen credits include “Robin Hood: Men in Tights,” “Leaving Las Vegas” and “Vamps” and TV appearances on everything from “7th Heaven” to “George Lopez” and “BoJack Horseman” to “Dr. Katz, Professional Therapist.”

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  • Dying patients protest looming telehealth crackdown

    Dying patients protest looming telehealth crackdown

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    At age 93, struggling with the effects of a stroke, heart failure and recurrent cancer, Teri Sheridan was ready to end her life using New Jersey’s law that allows medically assisted suicide — but she was bedbound, too sick to travel.

    So last Nov. 17, surrounded by three of her children, Sheridan drank a lethal dose of drugs prescribed by a doctor she had never met in person, only online. She died within minutes.

    Soon, others who seek Sheridan’s final option may find it out of reach, the unintended result of a federal move to roll back online prescribing of potentially addictive drugs allowed during the COVID-19 pandemic.

    “How much should one person suffer?” said Sheridan’s daughter, Georgene White, 68. “She wanted to just go to sleep and not wake up.”

    Online prescribing rules for controlled drugs were relaxed three years ago under emergency waivers to ensure critical medications remained available during the COVID-19 pandemic. Now, the U.S. Drug Enforcement Agency has proposed a rule that would reinstate most previously longstanding requirements that doctors see patients in person before prescribing narcotic drugs such as Oxycontin, amphetamines such as Adderall, and a host of other potentially dangerous drugs.

    The aim is to reduce improper prescribing of these drugs by telehealth companies that boomed during the pandemic. Given the ongoing opioid epidemic, allowing continued broad use of telemedicine prescribing “would pose too great a risk to the public health and safety,” the proposed rule said. It also cracks down on how doctors can prescribe other less-addictive drugs, like Xanax, used to treat anxiety, and buprenorphine, a narcotic used to treat opioid addiction.

    The rule would allow some of these drugs to be prescribed with telemedicine for an initial 30-day dose, though patients would need to be seen in person to get a refill. And patients who have been referred to a new doctor by one they had previously met in person could continue to receive prescriptions for the drugs via telemedicine.

    DEA Administrator Anne Milgram called the plan “telemedicine with guardrails.”

    The agency, with input from the Department of Health and Human Services, is working to finalize the rule by May 11, when the COVID public health emergency officially ends, an HHS spokeswoman said. If approved by then, the new requirements would take effect in November.

    The proposal has sparked a massive backlash, including more than 35,000 comments to a federal portal and calls from advocates, members of Congress and medical groups to reconsider certain patients or provisions.

    “They completely forgot that there was a population of people who are dying,” said Dr. Lonny Shavelson, a California physician who chairs the American Clinicians Academy on Medical Aid in Dying, a coalition of doctors who help patients access care under so-called right-to-die laws.

    Among the biggest complaints: The rule would delay or block access for patients who seek medically assisted suicide and hospice care, critics said. Many of the comments — including nearly 10,000 delivered in person to DEA offices — came from doctors and patients protesting the effect of the rule on seriously ill and dying patients.

    “Please do not make the end of life harder for me,” wrote Lynda Bluestein, 75, of Bridgeport, Connecticut. In March, Bluestein, who has terminal fallopian tube cancer, reached a settlement with the state of Vermont that will allow her to be the first non-resident to use its medically assisted suicide law. By the time she’s ready to use the drugs, she expects to be too ill to travel to see a doctor in person for the prescription, she wrote.

    The clash between desperate patients who need treatment and DEA’s efforts to bar telehealth companies from overprescribing dangerous medications was inevitable, said David Herzberg, a historian of drugs at the University of Buffalo.

    “The balancing act is so tricky,” he said.

    Laws in 10 states and Washington, D.C. allow dying people with a prognosis of six months or less to end their lives with a lethal combination of medications covered by the DEA rule. But such patients are often too sick to visit a doctor in person ¬– or they live hundreds of miles from the nearest willing and qualified provider, Shavelson said.

    There are similar issues for the 1.7 million Medicare recipients enrolled in hospice care in the U.S., said Judi Lund Person, who oversees regulatory compliance for the National Hospice and Palliative Care Organization. Rolling back online prescribing flexibilities could mean a dying patient would wait for days for drugs to ease pain and other symptoms.

    “They just don’t have time for that,” she said.

    Shavelson and his colleagues called for an exception to the rule for the hundreds of patients a year who qualify for medically assisted suicide. Both the American Medical Association and the California Medical Association sent letters asking the DEA to carve out provisions for doctors prescribing the most dangerous category of drugs to patients receiving hospice or palliative care.

    “These patients are extremely fragile and their medical conditions do not allow them to easily access a physician’s office,” wrote Dr. Donaldo D. Hernandez, president of the California group. Such people pose a “reduced risk for abuse” given their clear need for the medications.

    Congress directed DEA in 2008 to create exceptions for certain providers to permit remote prescribing, but the agency has not done so, Virginia Democrat Sen. Mark Warner said in a statement last month.

    DEA officials did not respond to questions about whether COVID-19 telehealth waivers would remain in effect if the proposed rule isn’t finalized by May 11 or whether the agency will allow exceptions for remote prescribing.

    During the pandemic, prescriptions for medically assisted suicide went up, in some cases significantly. In Oregon, for instance, they climbed nearly 49%, to 432 in 2022 from 290 in 2019. The number of deaths under the law in that state rose, too, to 246 from 170. Nationally, at least 1,300 people die each year using the process, according to available state figures.

    Telemedicine was key to access during the COVID emergency, said Dr. Robin Plumer, the New Jersey doctor who prescribed the drugs Teri Sheridan took. Plumer has overseen 80 assisted suicide deaths since 2020. Without online prescribing, 35% to 40% of her patients wouldn’t have been able to use the law.

    “I feel like we’ve taught people over the past couple of years that telemedicine does work in so many areas and it’s a great improvement for people,” especially for those who are homebound or dying, Plumer said.

    “And what?” she said. “They’re suddenly going to yank that away?”

    —-

    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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  • For transgender kids, a frantic rush for treatment amid bans

    For transgender kids, a frantic rush for treatment amid bans

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    SALT LAKE CITY — As a third grader in Utah, mandolin-playing math whiz Elle Palmer said aloud what she had only before sensed, telling a friend she planned to transfer schools the following year and hoped her new classmates would see her as a girl.

    Several states northeast, Asher Wilcox-Broekemeier listened to punk rock in his room, longing to join the shirtless boys from the neighborhood playing beneath the South Dakota sunshine. It wasn’t until menstruation started, and the disconnect with his body grew, that he knew he was one of them.

    Both kids’ realizations started their families on a yearslong path of doctors, therapists and other experts in transgender medicine.

    Now teenagers, their journeys have hit a roadblock.

    Republican lawmakers across the country are banning gender-affirming care for minors. Restrictions have gone into effect in eight states this year — including conservative Utah and South Dakota — and are slated to in at least nine more by next year.

    Those who oppose gender-affirming care raise fears about the long-term effects treatments have on teens, argue research is limited and focus particularly on irreversible procedures such as genital surgery or mastectomies.

    Yet those are rare. Doctors typically guide kids toward therapy or voice coaching long before medical intervention. At that point, puberty blockers, anti-androgens that block the effects of testosterone, and hormone treatments are far more common than surgery. They have been available in the United States for more than a decade and are standard treatments backed by major doctors’ organizations including the American Medical Association.

    The new laws have parents scrambling to secure the care their kids need. They worry what will happen if they can’t get the medications they’ve been prescribed, especially as their kids start puberty and their bodies change in ways that can’t be reversed.

    “My body’s basically this ticking time bomb, just sitting there waiting for it to go off,” said Asher Wilcox-Broekemeier, now 13. ___

    Elle remembers her first day at the school after she transferred. Before leaving, she came downstairs in rainbow sparkle-embroidered cowboy boots her mother worried would only spur bullies. Taunts from kids at Elle’s prior school drove her into depression so deep she had suicidal thoughts.

    But on that first day, a boy told Elle he loved her boots. Some kids bullied her, but classmates and teachers were far more supportive than at her prior school. Elle discovered new passions in hip hop and drama class, and she settled into a new school and a truer version of herself. She started to see a therapist as her uncertainty about how she fit in the gender spectrum grew more pressing.

    Elle came out as a transgender girl in fifth grade. Now in seventh, she planned to start hormone treatment this summer so potential side effects wouldn’t interfere with her life during the school year, especially her team’s extracurricular math competitions.

    But then Utah’s Republican Gov. Spencer Cox signed a gender-affirming care ban in January. In a compromise, the law let kids keep taking medications if they were already on them. So Elle’s mom rushed to get her treatment months earlier than planned, as did other parents.

    The waitlist at one Utah clinic swelled to six months. Doctors were confronted with difficult decisions about who to get in for appointments.

    Elle’s medication arrived in the mail just before Utah’s law went into effect. A small stick implanted in Elle’s forearm is slow-releasing hormone blockers to prevent the effects of male puberty from taking hold. Eventually she may be prescribed estrogen, and she and her parents will have to navigate the next steps, and whether they’ll find doctors to continue her care.

    At least for now, they have a reprieve.

    “It feels like we can breathe again now,” Cat Palmer said. ___

    There’s no relief for Asher Wilcox-Broekemeier’s family — not yet.

    When Asher began menstruating, he felt a terrifying disconnect between how his body was changing on the outside and how he felt inside.

    Elizabeth began researching online to understand what was going on with her son, while Asher’s father, Brian, looked to doctors for expertise. With referrals from his longtime pediatrician, Asher met with therapists and doctors who helped explore his history, personality and feelings over his whole life.

    Nearly two years ago, doctors prescribed puberty blockers and birth control to slow breast development, regulate menstruation and lower the pressure of his disconnect with his body.

    He’s 13 now, and finds solace in music to ground him in a world of occasional bullying and constant mistaken pronouns. He practices Blink-182’s “All the Small Things” on guitar, plays trumpet in the school band and is rehearsing various singing roles for the Cinderella school musical. When he’s not thinking about testosterone to lower his voice or eventually getting top surgery, he looks forward to playing in the high school marching band next year.

    Asher still struggles with moments of gender dysphoria. Friendships that were once strong fizzled after Asher came out as transgender. Parents have disinvited him from their houses out of fears he’s a “bad influence.”

    But his parents have noticed his emotions stabilize through his treatment.

    “From a parent’s view, I see him as being able to be himself authentically, which is wonderful for him,” Elizabeth said.

    Now he and his parents worry they’ll have to start over.

    In February, South Dakota Republican Gov. Kristi Noem signed a law banning the medications and procedures that doctors have increasingly prescribed for transgender teens.

    Asher’s current doctors in South Dakota won’t be able to prescribe his medications, so the family is looking for a new doctor in neighboring Minnesota, where the Democratic governor has signed an executive order explicitly protecting gender-affirming care for minors. They’re hoping to find a clinic close enough they can drive to appointments and don’t have to pay for hotel stays.

    The planning has been time-consuming. Logistical questions to their current South Dakota doctors for referrals have gone unanswered. They want to beat whatever onslaught of patients from other states enacting similar bans will bring to providers in Minnesota, but also want to maintain as much normalcy for Asher as they can.

    The sudden twists in Asher’s trajectory makes him question why his health care is of concern to politicians.

    “Even though trans people don’t make up a big percent of the population doesn’t mean that we’re not part of it still,” Asher said. ___

    The full consequences of the bans on care for minors aren’t yet clear.

    Dr. Nikki Mihalopoulos, an adolescent medicine doctor in a Salt Lake City specialty clinic with transgender teens, worries the new laws will make families too scared to seek help and doctors too scared of losing their licenses to provide care.

    In the middle are kids like Elle and Asher.

    Multiple studies have shown that transgender youth are more likely to consider or attempt suicide and less at risk for depression and suicidal behaviors when able to access gender-affirming care.

    Both sets of parents are trying to shelter their kids from the stress and anxiety caused by the recent changes in the laws.

    After years of worrying about their kids’ safety and mental health, they still fear what could happen if they can’t find the drugs their kids have been prescribed.

    “My kid being OK is my number one priority. I know what the suicide rate is. I do not want my child to be a statistic,” Cat Palmer said of Elle.

    ___

    Biraben reported from Pierre, South Dakota.

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  • Extra COVID-19 booster now open to some high-risk Americans

    Extra COVID-19 booster now open to some high-risk Americans

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    WASHINGTON — Older Americans and people with weak immune systems can get an extra COVID-19 booster dose this spring.

    The Centers for Disease Control and Prevention on Wednesday signed off on a more flexible booster schedule for people who remain at the highest risk from COVID-19 — giving them the choice of a second “bivalent” Pfizer or Moderna booster, the most up-to-date formula.

    “Many in the population are experiencing vaccine fatigue but there is a subset who are eager to receive additional doses,” CDC’s Dr. Sara Oliver told an agency advisory panel that expressed support for the change.

    The move came a day after the Food and Drug Administration took steps to make coronavirus vaccinations simpler for everyone. From now on, anyone getting a Pfizer or Moderna dose — whether it’s a booster or their first-ever vaccination — will get an updated version rather than the outdated original shots.

    Here are some things to know:

    WHO NEEDS A BOOSTER?

    Anyone who’s gotten their original vaccinations but hasn’t had an updated booster yet can still get one. Only 42% of Americans 65 and older — and just 20% of all adults — have gotten one of those updated boosters since September.

    WHO CAN GET A SECOND UPDATED BOOSTER?

    People 65 or older who already had one Pfizer or Moderna updated booster can roll up their sleeves again as long as it’s been at least four months since that last shot.

    The schedule is a little different for people with weak immune systems. Most can choose a second Pfizer or Moderna updated booster at least two months after their first. Under the latest FDA and CDC guidelines, they also could get additional doses if and when their physician decides they need one.

    WHY THE EXTRA LEEWAY?

    Older adults continue to have the highest rates of hospitalization from COVID-19, even as cases have declined. But a frail 85-year-old may want another booster right away while a robust 65-year-old may not see the need — or might instead time another shot for peak protection ahead of a summer vacation or other special event.

    CDC officials stressed there’s even more variety among immune-compromised patients, from people with only mild impairment to those trying to replenish immunity that grueling cancer treatment knocked out.

    The changes put the U.S. in line with Britain and Canada, which also are offering certain vulnerable populations a spring shot. It’s a reasonable choice, Dr. Matthew Laurens, of the University of Maryland School of Medicine, said before the announcement.

    “We do have vaccines that are available to protect against these severe consequences, so why not use them?” he said. “They don’t do any good just sitting on a shelf.”

    WILL YOUNGER, HEALTHIER PEOPLE GET A FALL DOSE?

    Stay tuned. The FDA will hold a public meeting in June to consider if the vaccine recipe needs more adjusting to better match the latest coronavirus strains — just like it adjusts flu vaccines every year. And part of that discussion will be whether younger, healthier people also need a booster.

    The updated Pfizer and Moderna shots being used now target the BA.4 and BA.5 omicron versions, which have been replaced by an ever-changing list of omicron descendants. Still, while protection against mild infections is short-lived, those updated doses continue to do a good job fighting severe disease and death even against the newest variants.

    TOTS ARE LEAST LIKELY TO BE VACCINATED YET

    CDC’s advisers were dismayed at how few of the youngest children are vaccinated. Just 6% of 2- to 4-year-olds have gotten their initial COVID-19 shots and 4.5% of those younger than 2. Far fewer got an updated booster.

    The FDA’s new rules mean tots under 5 who’ve never been vaccinated can get the most up-to-date formula – two Moderna shots or three of the Pfizer-BioNTech version. Unvaccinated 5-year-olds can get two Moderna doses or a single Pfizer shot. And tots already fully or partially vaccinated may get a bivalent shot or two depending on their vaccination history.

    WHAT ABOUT THE NOVAVAX VACCINE?

    Novavax makes a more traditional type of COVID-19 vaccine, and its original formula remains available for people who don’t want the Pfizer or Moderna option. Novavax also is getting ready in case FDA urges a fall update, by manufacturing several additional formulas. ___ 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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  • Kamala Harris rallies as high court eyes abortion pill rules

    Kamala Harris rallies as high court eyes abortion pill rules

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    LOS ANGELES — Vice President Kamala Harris on Saturday urged Americans to take action during “a critical point in our nation’s history” as thousands of protesters demonstrated across the country against new limits to abortion rights making their way through the courts.

    Saturday’s nationwide rallies were sparked by the U.S. Supreme Court’s actions the day before, when the high court intervened to delay rule changes that would have limited the way the abortion drug mifepristone could be used and dispensed. The limits were paused while the court reviews the case more thoroughly.

    Harris made a surprise stop in Los Angeles at one of the rallies, where she called the latest upheaval over abortion rights a further incursion by conservatives into myriad “fundamental rights” many Americans thought they had.

    “And so this is a moment that history will show required each of us — based on our collective love of our country — to stand up, and fight for, and protect our ideals. That’s what this moment is,” she said Saturday, speaking to several hundred demonstrators from the steps of City Hall. “When you attack the rights of women in America, you are attacking America.”

    Some of the protesters voiced their anger at the steps of the nation’s high court, which took Friday’s action at the request of the federal Justice Department. The agency asked the high court to lift restrictions on mifepristone imposed by an appellate court in Texas earlier in the week. The decision by the appellate court reduced the window of time when the drug could be used and prevented the drug from being dispensed by mail.

    Critics of the Texas and appellate court decisions, including pharmaceutical companies, viewed the courts’ actions as a dangerous intrusion into the authority of the FDA, which regulates how medications are sold and used in the United States.

    Demonstrators in New York City stood behind a sign with a four-letter expletive directed at Texas, where a federal judge set off the latest salvo in the battle over abortion. They held signs urging the government to defend medication abortions.

    But the crowd was modest, attracting a little more than 100 people outside the picturesque public library along Fifth Avenue.

    Still, the demonstrators attracted looks from passersby along the busy thoroughfare, some briefly joining the group to lend their voices.

    “It can be hard to get people out, because people are being bombarded with all kinds of assaults on their bodies and people are tired and poor,” said Viva Ruiz, who said she helped organize the rally.

    “The news cycle is so fast that when one thing happens something terrible happens the next day. So it’s hard to sustain the momentum or the energy for people to be on the streets,” Ruiz said.

    With few exceptions, many of the rallies — organized under the banner of a group calling itself “Bigger than Roe” — were held in smaller cities.

    Since last year’s reversal of Roe v. Wade, the 1973 Supreme Court decision that legalized the right to an abortion, more than a dozen states have effectively outlawed abortion, while additional states have moved to further tighten abortion laws.

    On Thursday, the GOP-dominated Florida Legislature moved to became the latest state to ban abortions after six weeks of pregnancy.

    Restrictions on the delivery and use of mifepristone, part of a two-drug regimen to end a pregnancy, would be a further blow to abortion rights advocates. The other drug, misoprostol, can be used on its own, but doing so is less effective than using both drugs in combination.

    When mifepristone was initially approved, 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.

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

    States that support abortion rights, including California and New York, have begun stockpiling misoprostol to assure their states have adequate supplies. Washington state is among those stockpiling a supply of mifepristone or its generic form. And Massachusetts Democratic Gov. Maura Healey said the administration is dedicating $1 million to help providers contracted with the Department of Public Health buy additional quantities of mifepristone.

    More than 5.6 million women in the U.S. had used mifepristone as of June 2022, according to the FDA. In that period, the agency received 4,200 reports of complications in women, or less than one-tenth of 1% of women who took the drug.

    __________

    Calvan reported from New York.

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  • US Supreme Court’s abortion pill order spares safe havens

    US Supreme Court’s abortion pill order spares safe havens

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    Before the U.S. Supreme Court stepped in Friday, access to an abortion pill was in line to become more cumbersome in California, New York and some other states that have positioned themselves as safe havens for those seeking to end their pregnancies.

    The order keeps in place federal rules for use of mifepristone, one of the two drugs usually used in combination in medication abortions. The legal saga isn’t over: The Supreme Court suggested it will decide the issue by Wednesday.

    The high court’s position at least pauses a ruling issued last Wednesday by the 5th U.S. Circuit Court of Appeals in New Orleans that would have allowed mifepristone sales to continue, but under rules adopted by the Food and Drug Administration in 2000, before a series of changes that relaxed access.

    The 5th Circuit ruling, which overturned another recent federal court order halting mifepristone sales nationwide, was set to take effect Saturday. It would have required the drug to be taken in the presence of a physician, ruling out mailing it to patients.

    “That’s not good for all of these states that are trying to help other people,” Jolynn Dellinger, a senior lecturing fellow at Duke Law School who has been following the mifepristone litigation, said before the Supreme Court ruled.

    None of the rulings affect the other abortion pill, misoprostol, which can be used alone to end pregnancies but is more effective when taken in combination with mifepristone.

    For the 13 states with bans on abortion at all stages of pregnancy and the one with a ban on abortion after cardiac activity can be detected, reverting to the old rules would have had little to no effect on abortion policy.

    At least 10 other states had restrictions that already placed limits on medication abortion, according to an analysis by the Kaiser Family Foundation. For instance, in Georgia, it’s legal only in the first six weeks of pregnancy; in Kansas, an ultrasound at an office visit is required before it’s dispensed; and in North Carolina, it can’t be prescribed via telehealth.

    On the other side, 17 states controlled by Democrats apparently would not have been affected by the change either; in a separate but closely related case last week, a judge sided with them in their request that mifepristone access not be changed there.

    That would have left just eight states where returning to the pre-2016 rules could have had a major impact: Democrat-controlled California, Massachusetts, New Jersey and New York — all states that have protected abortion access and welcomed out-of-staters seeking abortions — Republican-controlled Alaska and Montana and politically divided New Hampshire and Virginia.

    California, Massachusetts and New York have stockpiled abortion pills in case of restrictions, and Maryland’s governor announced Friday that his state was doing the same. New Jersey Gov. Phil Murphy has said he’s considering doing so.

    Maryland Gov. Wes Moore, a Democrat, said his administration has partnered with the University of Maryland Medical System to ensure access to mifepristone.

    “As a member of the Reproductive Freedom Alliance, Maryland will not stand for this assault on women’s health care,” Moore said. “This purchase is another example of our Administration’s commitment to ensure Maryland remains a safe haven for abortion access and quality reproductive health care.”

    ___

    Associated Press/Report for America Statehouse News Initiative journalist Maysoon Khan in Albany, New York, contributed to this report. Report for America is a nonprofit national service program that places journalists in local newsrooms to report on undercovered issues.

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