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Tag: Medication

  • Tornado damage to Pfizer plant unlikely to cause major drug supply shortages, FDA says

    Tornado damage to Pfizer plant unlikely to cause major drug supply shortages, FDA says

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    A tornado that tore through eastern North Carolina and struck a large Pfizer pharmaceutical plant has damaged its drug storage facility but not its medicine production areas

    ByHANNAH SCHOENBAUM Associated Press/Report for America

    RALEIGH, N.C. — Most of the destruction from a tornado that tore through eastern North Carolina Wednesday and struck a large Pfizer pharmaceutical plant affected its storage facility, rather than its medicine production areas, the company said Friday.

    The drugmaker’s ability to salvage production equipment and other essential materials could mitigate what experts feared would be a major blow to an already strained system as the United States grapples with existing drug shortages.

    “We do not expect there to be any immediate significant impacts on supply given the products are currently at hospitals and in the distribution system,” U.S. Food and Drug Administration Commissioner Robert Califf said Friday.

    An EF3 tornado touched down Wednesday near Rocky Mount, ripping the roof off a Pfizer factory responsible for producing nearly 25% of the American pharmaceutical giant’s sterile injectable medicines used in U.S. hospitals, according to the drugmaker.

    Pfizer said Friday that a warehouse for raw materials, packaging supplies and finished medicines awaiting release had endured most of the damage to its 1.4 million square foot plant. An initial inspection by the company found no major damage to its medicine manufacturing areas, and all 3,200 local employees are safe and accounted for.

    Pfizer Chairman and CEO Dr. Albert Bourla said staff are rushing products to nearby sites for storage and identifying sources to rapidly replace raw materials lost in the storm. The drug company says it is also exploring alternative manufacturing locations across its U.S. network to fill gaps in production while the North Carolina site remains closed for repairs.

    The FDA’s initial analysis identified fewer than 10 drugs for which Pfizer’s North Carolina plant is the sole source for the U.S. market, Califf said.

    The Rocky Mount plant produces anesthesia and many other drugs needed for surgeries but does not make or store Pfizer’s COVID-19 vaccine or the Comirnaty and Paxlovid treatments. Medications produced at that facility alone account for nearly 8% of all sterile injectables used in U.S. hospitals, Pfizer said on its website.

    The FDA said it will complete in the coming days a more extensive evaluation of the products that might be affected and the current domestic supply of those medications. “Many weeks’ worth” of the destroyed drugs should be available in Pfizer’s other warehouses, Califf said.

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    Hannah Schoenbaum is a corps member for the Associated Press/Report for America Statehouse News Initiative. Report for America is a nonprofit national service program that places journalists in local newsrooms to report on undercovered issues.

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  • Tornado damage to Pfizer plant unlikely to cause major drug supply shortages, FDA says

    Tornado damage to Pfizer plant unlikely to cause major drug supply shortages, FDA says

    [ad_1]

    A tornado that tore through eastern North Carolina and struck a large Pfizer pharmaceutical plant has damaged its drug storage facility but not its medicine production areas

    ByHANNAH SCHOENBAUM Associated Press/Report for America

    RALEIGH, N.C. — Most of the destruction from a tornado that tore through eastern North Carolina Wednesday and struck a large Pfizer pharmaceutical plant affected its storage facility, rather than its medicine production areas, the company said Friday.

    The drugmaker’s ability to salvage production equipment and other essential materials could mitigate what experts feared would be a major blow to an already strained system as the United States grapples with existing drug shortages.

    “We do not expect there to be any immediate significant impacts on supply given the products are currently at hospitals and in the distribution system,” U.S. Food and Drug Administration Commissioner Robert Califf said Friday.

    An EF3 tornado touched down Wednesday near Rocky Mount, ripping the roof off a Pfizer factory responsible for producing nearly 25% of the American pharmaceutical giant’s sterile injectable medicines used in U.S. hospitals, according to the drugmaker.

    Pfizer said Friday that a warehouse for raw materials, packaging supplies and finished medicines awaiting release had endured most of the damage to its 1.4 million square foot plant. An initial inspection by the company found no major damage to its medicine manufacturing areas, and all 3,200 local employees are safe and accounted for.

    Pfizer Chairman and CEO Dr. Albert Bourla said staff are rushing products to nearby sites for storage and identifying sources to rapidly replace raw materials lost in the storm. The drug company says it is also exploring alternative manufacturing locations across its U.S. network to fill gaps in production while the North Carolina site remains closed for repairs.

    The FDA’s initial analysis identified fewer than 10 drugs for which Pfizer’s North Carolina plant is the sole source for the U.S. market, Califf said.

    The Rocky Mount plant produces anesthesia and many other drugs needed for surgeries but does not make or store Pfizer’s COVID-19 vaccine or the Comirnaty and Paxlovid treatments. Medications produced at that facility alone account for nearly 8% of all sterile injectables used in U.S. hospitals, Pfizer said on its website.

    The FDA said it will complete in the coming days a more extensive evaluation of the products that might be affected and the current domestic supply of those medications. “Many weeks’ worth” of the destroyed drugs should be available in Pfizer’s other warehouses, Califf said.

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    Hannah Schoenbaum is a corps member for the Associated Press/Report for America Statehouse News Initiative. Report for America is a nonprofit national service program that places journalists in local newsrooms to report on undercovered issues.

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  • Florida family accused of selling fake COVID-19 cure through online church goes on trial in Miami

    Florida family accused of selling fake COVID-19 cure through online church goes on trial in Miami

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    A Florida family accused of selling a toxic industrial bleach as a fake COVID-19 cure through their online church is on trial this week in Miami

    MIAMI — A Florida family accused of selling a toxic industrial bleach as a fake COVID-19 cure through their online church is on trial this week in Miami.

    Mark Grenon, 65, and his sons, 37-year-old Jonathan, 35-year-old Joseph and 29-year-old Jordan, are all charged with conspiring to defraud the United States and deliver misbranded drugs, according to court records.

    The Grenons are representing themselves but declined to make opening statements as the trial began Monday, the Miami Herald reported. They have pleaded not guilty.

    Prosecutors called the Grenons “con men” and “snake-oil salesmen” and said the Bradenton family’s Genesis II Church of Health and Healing sold $1 million worth of their so-called Miracle Mineral Solution. In videos, it was pitched as a purported cure for 95% of known diseases, including COVID-19, Alzheimer’s, autism, brain cancer, HIV/AIDS and multiple sclerosis, prosecutors said.

    What the Grenons were selling was actually chlorine dioxide, officials said. When ingested, the solution becomes a bleach that is typically used for such things as treating textiles, industrial water, pulp and paper, according to the Food and Drug Administration. Authorities said it is the same as drinking bleach and can be fatal.

    A Miami federal judge ordered the church to stop selling the substance in 2020, but that was ignored.

    Jonathan and Jordan Grenon were arrested in Bradenton, just south of the Tampa Bay area. Mark and Joseph Grenon fled to Colombia, where they were arrested and extradited back to the U.S.

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  • New drug to protect babies and toddlers from RSV gets FDA approval ahead of cold season

    New drug to protect babies and toddlers from RSV gets FDA approval ahead of cold season

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    WASHINGTON — U.S. officials on Monday approved the first long-acting drug to protect babies and toddlers against a respiratory virus that sends tens of thousands of American children to the hospital each year.

    RSV is a cold-like nuisance for most healthy people, but it can be life-threatening in the very young and the elderly.

    The Food and Drug Administration approved the injection for infants and children up to 2 years old who face increased risk of severe RSV.

    “Today’s approval addresses the great need for products to help reduce the impact of RSV disease on children, families and the health care system” said FDA’s Dr. John Farley in a statement.

    Last year, a surge in RSV cases flooded U.S. hospitals with wheezing children. There are no vaccines for babies yet, though Pfizer and other companies are working on them.

    AstraZeneca’s drug, to be sold under the brand name Beyfortus, is a laboratory-made version of an antibody that helps the immune system fight off RSV. Under the FDA approval, babies — including preterm infants — can receive a single injection to protect against their first season of RSV, which typically lasts about five months. Children up to age 2 can receive another dose to protect them during their second season facing the virus.

    Beyfortus, which will be marketed in the U.S. by Sanofi, is already approved in Canada, Europe and the U.K. Sanofi did not immediately announce the U.S. price of the treatment.

    FDA officials approved the drug based on three studies showing Beyfortus reduced the risk of RSV infection between 70% and 75% among infants and children 2 and younger.

    Advisers to the Centers for Disease Control and Prevention will meet early next month to recommend exactly who should get the drug.

    A similar antibody drug won FDA approval more than 20 years ago, but it’s only recommended for high-risk babies and requires monthly injections. Pediatricians say the drug is underutilized and they expect the longer-lasting effect of AstraZeneca’s shot to improve uptake.

    In the U.S., about 58,000 children younger than 5 are hospitalized for RSV each year and several hundred die.

    After decades of setbacks for RSV research, drugmakers have made big strides this year, launching the first vaccines against the virus. In May, the FDA approved two RSV vaccines for older adults from GlaxoSmithKline and Pfizer. In August, the FDA is expected to make a decision on approving Pfizer’s vaccine for pregnant women, with the aim of passing along protection to their newborns.

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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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  • Woman arrested on drug charges in death of Robert De Niro’s grandson, official says

    Woman arrested on drug charges in death of Robert De Niro’s grandson, official says

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    NEW YORK — A 20-year-old woman has been arrested on federal narcotics charges and is accused of selling the drugs that led to the death of actor Robert De Niro’s 19-year-old grandson, a law enforcement official said Friday.

    The woman, Sofia Haley Marks, appeared in Manhattan federal court on Friday and agreed to remain behind bars until she requests bail at a later date. Prosecutors said they would oppose a request for her release.

    Marks was arrested Thursday evening on three counts of narcotics distribution stemming from the sale of drugs to Leandro De Niro Rodriguez, the law enforcement official said. The official was not authorized to discuss details of the investigation publicly and spoke to The Associated Press on condition of anonymity.

    Rodriguez was found dead in his Manhattan apartment on July 2. His mother, Drena De Niro, announced the death on Instagram. Amy Gallicchio, an assistant federal defender who represented Marks on Friday, said Marks planned to hire a lawyer. Gallicchio declined comment outside court.

    U.S. Attorney Damian Williams said in a statement that at least one of the fake oxycodone pills sold by Marks was “taken by a teenager who subsequently died of a suspected overdose.” Rodriguez was not identified by name in court documents.

    Williams said the arrest “was critical because, as we allege, Marks knew the pills could kill, and she continued selling them anyway.”

    The prosecutor said fentanyl was now the primary killer of Americans from ages 18 to 49. An estimated 109,680 people died from drug overdoses in 2022, including about 75,000 from fentanyl and other synthetic opioids.

    “More than cancer, car accidents, or gun violence. It is a law enforcement crisis and a public health crisis. And we are doing everything we can to stop it,” he said.

    Rodriguez’s cause of death remains under investigation, a spokesperson for the city medical examiner’s office said.

    When Drena De Niro announced her son’s death, she responded to a question to her post by writing that her son died after “someone sold him fentanyl laced pills.”

    Rodriguez was the oldest child of Drena De Niro and artist Carlos Mare.

    Like his famous grandfather, Rodriguez was an actor who had appeared with his mother in projects including Bradley Cooper’s 2018 remake of “A Star is Born.”

    Robert De Niro said after Rodriguez’s death that he was “deeply distressed by the passing of my beloved grandson Leo.” A representative for him didn’t immediately respond to a message seeking comment about the arrest.

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    Associated Press writer Larry Neumeister contributed to his report.

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  • First over-the-counter birth control pill gets FDA approval

    First over-the-counter birth control pill gets FDA approval

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    WASHINGTON — U.S. officials have approved the first over-the-counter birth control pill, which will let American women and girls buy contraceptive medication from the same aisle as aspirin and eyedrops.

    The Food and Drug Administration said Thursday it cleared Perrigo’s once-a-day Opill to be sold without a prescription, making it the first such medication to be moved out from behind the pharmacy counter. The company won’t start shipping the pill until early next year, and there will be no age restrictions on sales.

    Hormone-based pills have long been the most common form of birth control in the U.S., used by tens of millions of women since the 1960s. Until now, all of them required a prescription.

    Medical societies and women’s health groups have pushed for wider access, noting that an estimated 45% of the 6 million annual pregnancies in the U.S. are unintended. Teens and girls, women of color and those with low incomes report greater hurdles in getting prescriptions and picking them up.

    Some of the challenges can include paying for a doctor’s visit, getting time off from work and finding child care.

    “This is really a transformation in access to contraceptive care,” said Kelly Blanchard, president of Ibis Reproductive Health, a non-profit group that supported the approval. “Hopefully this will help people overcome those barriers that exist now.”

    Ireland-based Perrigo did not announce a price. Over-the-counter medicines are generally much cheaper than prescriptions, but they typically aren’t covered by insurance.

    Forcing insurers to cover over-the-counter birth control would require a regulatory change by the federal government, which women’s advocates are urging the Biden administration to implement.

    Many common medications have made the switch to non-prescription status in recent decades, including drugs for pain, heartburn and allergies. Birth control pills are available without a prescription across much of South America, Asia and Africa.

    Perrigo submitted years of research to FDA to show that women could understand and follow instructions for using the pill. Thursday’s approval came despite some concerns by FDA scientists about the company’s results, including whether women with certain underlying medical conditions would understand they shouldn’t take the drug.

    FDA’s action only applies to Opill. It’s in an older class of contraceptives, sometimes called minipills, that contain a single synthetic hormone and generally carry fewer side effects than more popular combination hormone pills.

    But women’s health advocates hope the decision will pave the way for more over-the-counter birth control options and, eventually, for abortion pills to do the same.

    That said, FDA’s decision has no relation to the ongoing court battles over the abortion pill mifepristone. The studies in Perrigo’s FDA application began years before the Supreme Court’s reversal of Roe v. Wade, which has upended abortion access across the U.S.

    With some states curtailing women’s reproductive rights, the FDA has faced pressure from Democratic politicians, health advocates and medical professionals to ease access to birth control. The American Medical Association and the leading professional society for obstetricians and gynecologists backed Opill’s application for over-the-counter status.

    An outside panel of FDA advisers unanimously voted in favor of the switch at a hearing in May where dozens of public speakers called for Opill’s approval.

    Dyvia Huitron was among those who presented, explaining how she has been unable to get prescription birth control more than three years after becoming sexually active. The 19-year-old University of Alabama student said she still isn’t comfortable getting a prescription because the school’s health system reports medical exams and medications to parents.

    “My parents did not let me go on the pill,” Huitron said in a recent interview. “There was just a lot of cultural stigma around being sexually active before you’re married.”

    While she uses other forms of contraception, “I would have much preferred to have birth control and use these additional methods to ensure that I was being as safe as possible.”

    Huitron spoke on behalf of Advocates for Youth, one of the dozens of groups that have pushed to make prescription contraceptives more accessible.

    The groups helped fund some of the studies submitted for Opill and they encouraged HRA Pharma, later acquired by Perrigo, to file its application with the FDA.

    Advocates were particularly interested in Opill because it raised fewer safety concerns. The pill was first approved in the U.S. five decades ago but hasn’t been marketed here since 2005.

    “It’s been around a long time and we have a large amount of data supporting that this pill is safe and effective for over-the-counter use,” said Blanchard, of Ibsis Reproductive Health.

    Newer birth control pills typically combine two hormones, estrogen and progestin, which can help make periods lighter and more regular. But their use carries a heightened risk of blood clots and they shouldn’t be used by women at risk for heart problems, such as those who smoke and are over 35.

    Opill has only progestin, which prevents pregnancy by blocking sperm from reaching the cervix. It must be taken around the same time daily to be most effective.

    In its internal review published in May, the FDA noted that some women in Perrigo’s study had trouble understanding the drug’s labeling information. In particular, the instructions warn that women with a history of breast cancer should not take the pill because it could spur tumor growth. And women who have unusual vaginal bleeding are instructed to talk to a doctor first, because it could indicate a medical problem.

    Common side effects of the pill include bleeding, headaches, dizziness, nausea and cramps, according to the FDA. The label also cautions that certain drugs can interfere with Opill’s effectiveness, including medications for seizures, HIV and hypertension.

    Perrigo executives said the company will spend the rest of the year manufacturing the pill and its packaging so it can be available in stores early next year.

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    Follow Matthew Perrone on Twitter: @AP_FDAwriter

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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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  • Alzheimer’s drug Leqembi has full FDA approval now and that means Medicare will pay for it

    Alzheimer’s drug Leqembi has full FDA approval now and that means Medicare will pay for it

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    WASHINGTON — U.S. officials granted full approval to a closely watched Alzheimer’s drug on Thursday, clearing the way for Medicare and other insurance plans to begin covering the treatment for people with the brain-robbing disease.

    The Food and Drug Administration endorsed the IV drug, Leqembi, for patients with mild dementia and other symptoms caused by early Alzheimer’s disease. It’s the first medicine that’s been convincingly shown to modestly slow the cognitive decline caused by Alzheimer’s.

    Japanese drugmaker Eisai received conditional approval from the FDA in January based on early results suggesting Leqembi worked by clearing a sticky brain plaque linked to the disease.

    The FDA confirmed those results by reviewing data from a larger, 1,800-patient study in which the drug slowed memory and thinking decline by about five months in those who got the treatment, compared to those who got a dummy drug.

    “This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease,” said FDA’s neurology drug director, Dr. Teresa Buracchio, in a statement.

    The drug’s prescribing information will carry the most serious type of warning, indicating that Leqembi can cause brain swelling and bleeding, side effects that can be dangerous in rare cases. The label notes that those problems are seen with other plaque-targeting Alzheimer’s drugs.

    The process of converting a drug to full FDA approval usually attracts little attention. But Alzheimer’s patients and advocates have been lobbying the federal government for months after Medicare officials announced last year they wouldn’t pay for routine use of drugs like Leqembi until they receive FDA’s full approval.

    There were concerns that the cost of new plaque-targeting Alzheimer’s drugs could overwhelm the program’s finances, which provide care for 60 million seniors. Leqembi is priced at about $26,500 for a year’s supply of IVs every two weeks.

    The vast majority of Americans with Alzheimer’s get their health coverage through Medicare. And private insurers have followed its lead by withholding coverage for Leqembi and a similar drug, Aduhelm, until they receive FDA’s full endorsement. An FDA decision on full approval for Aduhelm is still years away.

    Medicare administrator, Chiquita Brooks-LaSure, said in a statement Thursday the program will begin paying for the drug now that it has full FDA approval. But the government is also setting extra requirements, including enrollment in a federal registry to track the drug’s real-world safety and effectiveness.

    Medicare “will cover this medication broadly while continuing to gather data that will help us understand how the drug works,” Brooks-LaSure said.

    Some Medicare patients could be responsible for paying the standard 20% of the cost of Leqembi, though the amount will vary depending on their plans and other coverage details.

    Hospitals and medical clinics have cautioned that it may take time to get people started on the drug.

    Doctors need to confirm that patients have the brain plaque targeted by Leqembi before prescribing it. Nurses need to be trained to administer the drug and patients must be monitored with repeated brain scans to check for swelling or bleeding. The imaging and administration services carry extra costs for hospitals beyond the drug itself.

    Eisai has told investors that about 100,000 Americans could be diagnosed and eligible to receive Leqembi by 2026. The drug is co-marketed with Cambridge, Massachusetts-based Biogen.

    “We want to ensure that appropriate patients only are the ones that get this product,” said Alexander Scott, a vice president with Eisai.

    Eisai studied the drug in people with early or mild disease who were evaluated using a scale measuring memory, thinking and other basic skills. After 18 months, those who got Leqembi declined more slowly — a difference of less than half a point on the scale — than participants who received a dummy infusion. Some Alzheimer’s experts say that delay is likely too subtle for patients or their families to notice.

    But federal health advisers said the difference could still be meaningful and recommended that FDA fully approve the drug at a public meeting in June.

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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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  • Arizona governor makes contraceptive medications available over the counter at pharmacies

    Arizona governor makes contraceptive medications available over the counter at pharmacies

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    Adults in Arizona can now obtain contraceptive medications over the counter at a pharmacy without a doctor’s prescription under a governor’s order announced Thursday

    FILE – Democratic Arizona Gov. Katie Hobbs delivers her State of the State address at the Arizona Capitol in Phoenix, Jan. 9, 2023. Adults in Arizona can now obtain contraceptive medications over the counter at a pharmacy without a doctor’s prescription under a governor’s order announced Thursday, July 6, 2023. (AP Photo/Ross D. Franklin, File)

    The Associated Press

    PHOENIX — Adults in Arizona can now obtain contraceptive medications over the counter at a pharmacy without a doctor’s prescription under a governor’s order announced Thursday.

    Gov. Katie Hobbs said the rule will go into effect immediately. It applies to self-administered birth control such as hormonal and oral contraceptives, and patients 18 or older need only complete a screening and a blood pressure test.

    “We are building an Arizona for everyone, which means ensuring people across the state have what they need to live a free and healthy life,” the Democratic governor said in a statement.

    Over 20 states have statutes that let pharmacists dispense FDA-approved hormonal contraceptives without a prescription, according to a statement from the Arizona Department of Health Services.

    Hobbs has used her executive powers in recent weeks to promote reproductive freedom. In June she issued a sweeping executive order effectively stripping prosecutors of their ability to pursue charges against anyone involved with a legally obtained abortion.

    She also plans to support legislation next year that would codify access to birth control.

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  • ThunderShirts, dance parties and anxiety meds can help ease dogs’ July Fourth dread

    ThunderShirts, dance parties and anxiety meds can help ease dogs’ July Fourth dread

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    PHOENIX — On the Friday before the Fourth of July, more than a dozen dog owners waited in triple-digit temperatures in south Phoenix to get into a microchipping event inside a shelter.

    It didn’t hurt that Maricopa County was offering a discount. But, several were there because they knew having a microchip with their contact information implanted in their pups would increase the likelihood of their pet being returned if the worst happens on Independence Day.

    “Ava’s a scaredy-cat of any loud noises,” said Rori Chang, who was there with her golden retriever. “Her immediate reaction is to hide in corners and after that, she will literally paw at you wanting you to pet her the whole time.”

    Most of the U.S. may be looking forward to Tuesday for dazzling displays of fireworks or setting off firecrackers and poppers with their neighbors. Those with furry, four-legged family members — maybe not so much. They’re searching for solutions to the Fourth of July anxiety that fireworks bring.

    Their behavior can range from cowering in corners to running away from home. Trying to figure out what will soothe a dog can practically feel like an annual tradition in itself.

    Without fail, Dr. Kelley DeGroff, a veterinarian in Phoenix, gets requests for anxiety medication from some pet owners starting two weeks before July 4. This past week, there have been two to three requests daily.

    “I think it has to do with certain breeds. Obviously, hunting dogs are bred for that purpose and they don’t typically have any issues with it. But a lot of other dogs, it seems to trigger a fight-or-flight response in them,” DeGroff said.

    DeGroff prescribes either a gum gel that helps with noise phobia or anxiety pills. She is expecting numerous requests for meds as late as Monday. But dog owners shouldn’t be asking so close to the holiday. A week before is best.

    “That way, when they give you medication you can do a trial dose beforehand so that you know what to expect and you know it’s going to do what you want it to do,” DeGroff said.

    If you don’t have time to obtain veterinarian assistance, she suggests calming supplements or a ThunderShirt, a wrap that is supposed to feel like a gentle hug for the dog.

    Doggy day cares are also trying to offer more resources. The franchise owners of several Phoenix-area locations of Dogtopia, a nationwide company, have brought in two to three additional staff over the past couple years, according to marketing manager David Duran.

    On Tuesday, they will be extending pickup hours until 11 p.m. if pet parents want to enjoy festivities a little longer. Even though the playrooms are mostly soundproof, employees will be having “dance parties” and blasting music to help block out the sound of fireworks.

    One fireworks seller in Butte, Montana, has found a way to be part of the solution.

    Bille Jo Gonzales is now in her fourth year of selling CBD dog treats at Gonzo’s Fire of Mines fireworks in Butte, Montana. She saw the treats made by local baker Heidi Johnson on Facebook and reached out.

    “It helps my business because my business is actually creating the problem,” Gonzales said.

    It’s a win-win situation that she thinks more fireworks vendors should consider.

    “I’d say it’s increased our business and it’s great for advertising,” Gonzales said.

    Unfortunately, dogs inevitably go missing nationwide every July Fourth. That’s where shelters come in, picking up more strays than usual in the days following.

    Maricopa County’s two shelters are already currently over capacity with more than 800 dogs, so they will be hard-pressed to receive any more during the holiday. Not as many dogs were brought there on July Fourth during the coronavirus pandemic because fireworks shows were fewer, said Kim Powell, spokesperson for Maricopa County Animal Care and Control. But with most local fireworks productions back on, county shelters are expecting the number of dogs arriving to jump by 30%-60%.

    “This is something that the shelter world dreads all year long,” Powell said. “We started talking about planning ahead of this back in March.”

    Those conversations are what led to the county’s microchipping event. If you don’t have time to get your pet microchipped, then at least write your contact information on their collar, Powell advises. Also, even if your property is enclosed, keep your dog on a leash.

    “When they get spooked, they’re not thinking rationally so it’s best to just be with them, keep an eye on them,” Powell said.

    Seattle resident James Pelletier is taking his own initiative to ensure nothing happens to his 6-year-old Papillon Chihuahua mix, Lilly. Pelletier is taking an inside-the-box approach and turning his home’s basement apartment into a “soundproof bunker.”

    “I’m just going to hang some blankets over the door and then foam-insulate the small window and then put a little stereo in there and just play music that I probably can’t stand for however many hours and/or days,” Pelletier said, chuckling.

    For him, sanctioned fireworks shows aren’t as big of a problem as residents who incessantly set off illegal fireworks or firecrackers.

    “Hopefully, people will use common sense with this stuff,” Pelletier said.

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  • Australia is the first country to let patients with depression or PTSD be prescribed psychedelics

    Australia is the first country to let patients with depression or PTSD be prescribed psychedelics

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    SYDNEY — Australia is now the first country to allow psychiatrists to prescribe certain psychedelic substances to patients with depression or post-traumatic stress disorder.

    Beginning Saturday, Australian physicians can prescribe doses of MDMA, also known as ecstasy, for PTSD. Psilocybin, the psychoactive ingredient in psychedelic mushrooms, can be given to people who have hard-to-treat depression. The country put the two drugs on the list of approved medicines by the Therapeutic Goods Administration.

    Scientists in Australia were surprised by the move, which was announced in February but took effect July 1. One scientist said it puts Australia “at the forefront of research in this field.”

    Chris Langmead, deputy director of the Neuromedicines Discovery Centre at the Monash Institute of Pharmaceutical Sciences, said there have been very few advancements on treatment of persistent mental health issues in the last 50 years.

    The growing cultural acceptance has led two U.S. states to approve measures for their use: Oregon was the first to legalize the adult use of psilocybin, and Colorado’s voters decriminalized psilocybin in 2022. Days ago, President Joe Biden’s youngest brother said in a radio interview that the president has been “very open-minded” in conversations the two have had about the benefits of psychedelics as a form of medical treatment.

    The U.S. Food and Drug Administration designated psilocybin as a “breakthrough therapy” in 2018, a label that’s designed to speed the development and review of drugs to treat a serious condition. Psychedelics researchers have benefited from federal grants, including Johns Hopkins, and the FDA released draft guidance late last month for researchers designing clinical trials testing psychedelic drugs as potential treatments for a variety of medical conditions.

    Still, the American Psychiatric Association has not endorsed the use of psychedelics in treatment, noting the FDA has yet to offer a final determination.

    And medical experts in the U.S. and elsewhere, Australia included, have cautioned that more research is needed on the drugs’ efficacy and the extent of the risks of psychedelics, which can cause hallucinations.

    “There are concerns that evidence remains inadequate and moving to clinical service is premature; that incompetent or poorly equipped clinicians could flood the space; that treatment will be unaffordable for most; that formal oversight of training, treatment, and patient outcomes will be minimal or ill-informed,” said Dr. Paul Liknaitzky, head of Monash University’s Clinical Psychedelic Lab.

    Plus, the drugs will be expensive in Australia — about $10,000 (roughly $6,600 U.S. dollars) per patient for treatment.

    Litnaitzky said the opportunity for Australians to access the drugs for specific conditions is unique.

    “There’s excitement about drug policy progress,” he said, “… about the prospect of being able to offer patients more suitable and tailored treatment without the constraints imposed by clinical trials and rigid protocols.”

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  • The next big advance in cancer treatment could be a vaccine

    The next big advance in cancer treatment could be a vaccine

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    SEATTLE — The next big advance in cancer treatment could be a vaccine.

    After decades of limited success, scientists say research has reached a turning point, with many predicting more vaccines will be out in five years.

    These aren’t traditional vaccines that prevent disease, but shots to shrink tumors and stop cancer from coming back. Targets for these experimental treatments include breast and lung cancer, with gains reported this year for deadly skin cancer melanoma and pancreatic cancer.

    “We’re getting something to work. Now we need to get it to work better,” said Dr. James Gulley, who helps lead a center at the National Cancer Institute that develops immune therapies, including cancer treatment vaccines.

    More than ever, scientists understand how cancer hides from the body’s immune system. Cancer vaccines, like other immunotherapies, boost the immune system to find and kill cancer cells. And some new ones use mRNA, which was developed for cancer but first used for COVID-19 vaccines.

    For a vaccine to work, it needs to teach the immune system’s T cells to recognize cancer as dangerous, said Dr. Nora Disis of UW Medicine’s Cancer Vaccine Institute in Seattle. Once trained, T cells can travel anywhere in the body to hunt down danger.

    “If you saw an activated T cell, it almost has feet,” she said. “You can see it crawling through the blood vessel to get out into the tissues.”

    Patient volunteers are crucial to the research.

    Kathleen Jade, 50, learned she had breast cancer in late February, just weeks before she and her husband were to depart Seattle for an around-the-world adventure. Instead of sailing their 46-foot boat, Shadowfax, through the Great Lakes toward the St. Lawrence Seaway, she was sitting on a hospital bed awaiting her third dose of an experimental vaccine. She’s getting the vaccine to see if it will shrink her tumor before surgery.

    “Even if that chance is a little bit, I felt like it’s worth it,” said Jade, who is also getting standard treatment.

    Progress on treatment vaccines has been challenging. The first, Provenge, was approved in the U.S. in 2010 to treat prostate cancer that had spread. It requires processing a patient’s own immune cells in a lab and giving them back through IV. There are also treatment vaccines for early bladder cancer and advanced melanoma.

    Early cancer vaccine research faltered as cancer outwitted and outlasted patients’ weak immune systems, said Olja Finn, a vaccine researcher at the University of Pittsburgh School of Medicine.

    “All of these trials that failed allowed us to learn so much,” Finn said.

    As a result, she’s now focused on patients with earlier disease since the experimental vaccines didn’t help with more advanced patients. Her group is planning a vaccine study in women with a low-risk, noninvasive breast cancer called ductal carcinoma in situ.

    More vaccines that prevent cancer may be ahead too. Decades-old hepatitis B vaccines prevent liver cancer and HPV vaccines, introduced in 2006, prevent cervical cancer.

    In Philadelphia, Dr. Susan Domchek, director of the Basser Center at Penn Medicine, is recruiting 28 healthy people with BRCA mutations for a vaccine test. Those mutations increase the risk of breast and ovarian cancer. The idea is to kill very early abnormal cells, before they cause problems. She likens it to periodically weeding a garden or erasing a whiteboard.

    Others are developing vaccines to prevent cancer in people with precancerous lung nodules and other inherited conditions that raise cancer risk.

    “Vaccines are probably the next big thing” in the quest to reduce cancer deaths, said Dr. Steve Lipkin, a medical geneticist at New York’s Weill Cornell Medicine, who is leading one effort funded by the National Cancer Institute. “We’re dedicating our lives to that.”

    People with the inherited condition Lynch syndrome have a 60% to 80% lifetime risk of developing cancer. Recruiting them for cancer vaccine trials has been remarkably easy, said Dr. Eduardo Vilar-Sanchez of MD Anderson Cancer Center in Houston, who is leading two government-funded studies on vaccines for Lynch-related cancers.

    “Patients are jumping on this in a surprising and positive way,” he said.

    Drugmakers Moderna and Merck are jointly developing a personalized mRNA vaccine for patients with melanoma, with a large study to begin this year. The vaccines are customized to each patient, based on the numerous mutations in their cancer tissue. A vaccine personalized in this way can train the immune system to hunt for the cancer’s mutation fingerprint and kill those cells.

    But such vaccines will be expensive.

    “You basically have to make every vaccine from scratch. If this wasn’t personalized, the vaccine could probably be made for pennies, just like the COVID vaccine,” said Dr. Patrick Ott of Dana-Farber Cancer Institute in Boston.

    The vaccines under development at UW Medicine are designed to work for many patients, not just a single patient. Tests are underway in early and advanced breast cancer, lung cancer and ovarian cancer. Some results may come as soon as next year.

    Todd Pieper, 56, from suburban Seattle, is participating in testing for a vaccine intended to shrink lung cancer tumors. His cancer spread to his brain, but he’s hoping to live long enough to see his daughter graduate from nursing school next year.

    “I have nothing to lose and everything to gain, either for me or for other people down the road,” Pieper said of his decision to volunteer.

    One of the first to receive the ovarian cancer vaccine in a safety study 11 years ago was Jamie Crase of nearby Mercer Island. Diagnosed with advanced ovarian cancer when she was 34, Crase thought she would die young and had made a will that bequeathed a favorite necklace to her best friend. Now 50, she has no sign of cancer and she still wears the necklace.

    She doesn’t know for sure if the vaccine helped, “But I’m still here.”

    ___

    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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  • No more needles? A daily pill may work as well as Wegovy shots to treat obesity

    No more needles? A daily pill may work as well as Wegovy shots to treat obesity

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    What if treating obesity could be as easy as popping an effective pill?

    That’s a notion that has long fueled hope for many of the more than 40% of Americans who are considered obese — and fueled criticism by those who advocate for wider weight acceptance. Soon, it may be a reality.

    High-dose oral versions of the medication in the weight-loss drug Wegovy may work as well as the popular injections when it comes to paring pounds and improving health, according to final results of two studies released Sunday night. The potent tablets also appear to work for people with diabetes, who notoriously struggle to lose weight.

    Drugmaker Novo Nordisk plans to ask the U.S. Food and Drug Administration to approve the pills later this year.

    “If you ask people a random question, ‘Would you rather take a pill or an injection?’ People overwhelmingly prefer a pill,” said Dr. Daniel Bessesen, chief of endocrinology at Denver Health, who treats patients with obesity but was not involved in the new research.

    That’s assuming, Bessesen said, that both ways to take the medications are equally effective, available and affordable. “Those are the most important factors for people,” he said.

    There have been other weight-loss pills on the market, but none that achieve the substantial reductions seen with injected drugs like Wegovy. People with obesity will be “thrilled” to have an oral option that’s as effective, said Dr. Katherine Saunders, clinical professor of medicine at Weill Cornell Health and co-founder of Intellihealth, a weight-loss center.

    Novo Nordisk already sells Rybelsus, which is approved to treat diabetes and is an oral version of semaglutide, the same medication used in the diabetes drug Ozempic and Wegovy. It comes in doses up to 14 milligrams.

    But results of two gold-standard trials released at the American Diabetes Association’s annual meeting looked at how doses of oral semaglutide as high as 25 milligrams and 50 milligrams worked to reduce weight and improve blood sugar and other health markers.

    A 16-month study of about 1,600 people who were overweight or obese and already being treated for Type 2 diabetes found the high-dose daily pills lowered blood sugar significantly better than the standard dose of Rybelsus. From a baseline weight of 212 pounds, the higher doses also resulted in weight loss of between 15 and 20 pounds, compared to about 10 pounds on the lower dose.

    Another 16-month study of more than 660 adults who had obesity or were overweight with at least one related disease — but not diabetes — found the 50-milligram daily pill helped people lose an average of about 15% of their body weight, or about 35 pounds, versus about 6 pounds with a dummy pill, or placebo.

    That’s “notably consistent” with the weight loss spurred by weekly shots of the highest dose of Wegovy, the study authors said.

    But there were side effects. About 80% of participants receiving any size dose of oral semaglutide experienced things like mild to moderate intestinal problems, such as nausea, constipation and diarrhea.

    In the 50-milligram obesity trial, there was evidence of higher rates of benign tumors in people who took the drug versus a placebo. In addition, about 13% of those who took the drug had “altered skin sensation” such as tingling or extra sensitivity.

    Medical experts predict the pills will be popular, especially among people who want to lose weight but are fearful of needles. Plus, tablets would be more portable than injection pens and they don’t have to be stored in the refrigerator.

    But the pills aren’t necessarily a better option for the hundreds of thousands of people already taking injectable versions such as Ozempic or Wegovy, said Dr. Fatima Cody Stanford, an obesity medicine expert at Massachusetts General Hospital.

    “I don’t find significant hesitancy surrounding receiving an injection,” she said. “A lot of people like the ease of taking a medication once a week.”

    In addition, she said, some patients may actually prefer shots to the new pills, which have to be taken 30 minutes before eating or drinking in the morning.

    Paul Morer, 56, who works for a New Jersey hospital system, lost 85 pounds using Wegovy and hopes to lose 30 more. He said he would probably stick with the weekly injections, even if pills were available.

    “I do it on Saturday morning. It’s part of my routine,” he said. “I don’t even feel the needle. It’s a non-issue.”

    Some critics also worry that a pill will also put pressure on people who are obese to use it, fueling social stigma against people who can’t — or don’t want to — lose weight, said Tigress Osborn, chair of the National Association to Advance Fat Acceptance.

    “There is no escape from the narrative that your body is wrong and it should change,” Osborn said.

    Still, Novo Nordisk is banking on the popularity of a higher-dose pill to treat both diabetes and obesity. Sales of Rybelsus reached about $1.63 billion last year, more than double the 2021 figure.

    Other companies are working on oral versions of drugs that work as well as Eli Lilly and Co.’s Mounjaro — an injectable diabetes drug expected to be approved for weight-loss soon. Lilly researchers reported promising mid-stage trial results for an oral pill called orforglipron to treat patients who are obese or overweight with and without diabetes.

    Pfizer, too, has released mid-stage results for dangulgipron, an oral drug for diabetes taken twice daily with food.

    Novo Nordisk officials said it’s too early to say what the cost of the firm’s high-dose oral pills would be or how the company plans to guarantee adequate manufacturing capacity to meet to demand. Despite surging popularity, injectable doses of Wegovy will be in short supply until at least September, company officials 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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  • Abstinence not required: How a Baltimore drug treatment program prioritizes saving lives

    Abstinence not required: How a Baltimore drug treatment program prioritizes saving lives

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    BALTIMORE — Anthony Kelly trudged through southwest Baltimore, each labored footstep a reminder of the roofing accident that left him with chronic pain and a raging opioid addiction several years after he returned home from serving in the Marines.

    Doctors used metal plates to reconstruct his lower legs and Kelly spent months learning to walk again. So began his plodding journey into the depths of substance use disorder, a downward spiral that would gradually weaken his body and consume his mind, pulling him farther and farther away from the person he once was: a supportive husband and father, a hard-working professional, a proud veteran.

    After his prescribed painkillers ran out, Kelly repeatedly traveled to Florida to take advantage of the state’s loosely regulated pain management clinics. Finally, he turned to a combination of heroin and cocaine that sometimes cost $500 per day.

    More than a decade later, his substance use is more manageable and less expensive, though it remains a controlling force in his life. He takes buprenorphine, a prescription medication that’s considered the gold standard for treating opioid addiction by reducing cravings and easing withdrawal symptoms.

    He gets the medication through a mobile health clinic housed in a retrofitted van, which parks in some of Baltimore’s most drug-ravaged communities, including Kelly’s neighborhood. Doctors and nurses meet with patients, write prescriptions and provide basic wound care, hepatitis C treatment, packages of the overdose reversal agent naloxone and more, all free of charge.

    The clinic exemplifies an ongoing shift in the nation’s approach to stemming overdose deaths, which surged during the pandemic to unprecedented heights as the potent synthetic opioid fentanyl replaced heroin in drug markets across the country.

    The so-called harm reduction model, which has received endorsement and funding from the Biden administration, offers potentially life-saving services to opioid users, without requiring abstinence in return.

    Advocates say it acknowledges the importance of keeping people alive, first and foremost, while they confront the sometimes insurmountable challenges associated with recovery. Critics argue it enables illegal activity.

    In Baltimore’s “Healthcare on the Spot” program, most patients continue using street drugs, but the vast majority report using less, according to clinic staff.

    “Being an addict, it’s more complicated than people think,” said Kelly, 49. “We built this web we’re entangled in. We didn’t get here overnight and we’re not gonna get better overnight. You can’t just snap out of it.”

    Baltimore’s overdose death rate is significantly higher than the statewide and nationwide averages, with more than 1,000 lives lost in 2020, the most recent data available. The city makes up about 10% of Maryland’s population but logs more than 35% of its overdose deaths.

    Though efforts to address the problem have fallen short of achieving large-scale change, Baltimore has long been ahead of the curve. The city launched a needle exchange program in 1994, and in recent years, officials have focused on expanding access to naloxone while reducing low-level narcotics and drug paraphernalia arrests. A local organization runs another mobile treatment program that parks outside the city’s jail and offers buprenorphine prescriptions to people getting released.

    “We should be thinking about harm reduction on a spectrum. Some people want to stop using, others want to use safer. This is about truly meeting people where they are,” said Dr. Letitia Dzirasa, who served as the city’s health commissioner until recently being appointed deputy mayor. “It’s also about reducing the stigma. Because this is a disease, not a moral failing.”

    The Spot van has a waiting area, two small exam rooms and an even smaller bathroom. During private consultations, medical providers often address their patients like old friends. They might discuss family dynamics, housing issues, mental health concerns, long-term goals, recent substance use and more.

    The clinic coordinates with several pharmacies across the city so patients can get their prescriptions filled almost immediately after leaving the van. They don’t need an ID or health insurance to enroll. And there’s just one requirement for them to keep getting buprenorphine through the clinic: They have to demonstrate they’re taking the medication somewhat regularly.

    Buprenorphine, which received federal approval for treatment of opioid use disorder in 2002, binds to opioid receptors in the brain without producing a euphoric high. Often prescribed under the brand name Suboxone, it typically comes in orange strips that dissolve under the tongue.

    Research shows the drug significantly reduces a person’s risk of overdose and death. Despite its effectiveness, a relatively small percentage of people experiencing opioid addiction are prescribed the medication. In contrast to methadone treatment, which is highly regulated and often requires patients to visit a clinic every day, buprenorphine prescriptions can last weeks or months.

    In December 2022, federal lawmakers passed legislation making it easier for doctors to prescribe buprenorphine, recognizing its life-saving potential. Drug overdoses nationwide have claimed more than 100,000 lives annually since 2020, with about two-thirds of them related to fentanyl.

    Asked why they sought treatment, many Spot patients said they’re just tired — tired of chasing fentanyl’s dangerous high and living in perpetual fear of withdrawal sickness, wondering whether the next dose would kill them, sometimes even hoping it would.

    “You’re using just to feel normal, spending all your money on dope,” said Saprena Culver, 40, who enrolled in the program earlier this year. “It controls your whole entire life, your whole entire being.”

    Culver’s four children are living with relatives in West Virginia, but she thinks about them constantly and hopes to be reunited soon. She said this isn’t her first time seeking treatment: She previously spent 12 years participating in a methadone program, which had stricter rules. Even though she ultimately was kicked out after relapsing, she found the added accountability measures helpful.

    It’s currently not uncommon for people to buy Suboxone off the street, often to stave off debilitating withdrawal symptoms, which means some Spot patients could be profiting off their prescriptions.

    Despite their firm belief in expanding access to the medication, clinic staff are continuously grappling with how best to serve people who aren’t ready to stop using.

    Kelly grew up in Baltimore, where his paternal grandparents settled after migrating from Ireland.

    Always an adrenaline junkie, he competed on his high school’s wrestling team and joined the Marines in 1992. He served eight years on active duty, including stints in Egypt, Thailand and elsewhere around the world. Kelly said he couldn’t believe his luck, finding a job that let him fulfill a lifelong dream, experience other cultures and get paid to work out.

    It was through the military that he met his future wife, a fellow Marine. Their son was born in 2000 and spent much of his childhood in Baltimore.

    Sometime after the marriage dissolved, mother and son moved to Florida while Kelly stayed put. He was living in his grandmother’s southwest Baltimore rowhouse, which he later inherited.

    During a recent visit, an unopened package of naloxone lay on the kitchen table alongside dishes, pans and groceries. A framed photo showed a teenage Kelly competing in a wrestling match, muscles bulging as he overpowered his opponent. A sign above the front door bestowed “Irish Blessings” upon the building’s occupants.

    Kelly’s beloved dog, an elderly, Pomeranian-long haired Chihuahua mix named Annie Oakley, bounded down the carpeted staircase and wriggled across the linoleum kitchen floor, wagging her tail for attention.

    “She runs this house,” Kelly said, laughing and hugging her to his chest. He recalled a time when he overdosed and Annie alerted a neighbor, who found him unconscious and called an ambulance.

    The three-story brick rowhouse is sturdy and well-maintained. For Kelly, it’s filled with family memories spanning generations. But the interior has seen better days, with sparse furniture and cluttered surfaces. Kelly rents out rooms, sometimes to people experiencing addiction and desperate for somewhere to stay, which he said can create a volatile environment.

    The previous few weeks were especially tough. He developed a leg infection after a bicycle accident and was dealing with a dispute involving a former tenant who owed someone money. Pain and stress, he said — two common triggers of addiction.

    “I’m trying to do right every day,” he said, stroking the top of Annie’s head. “But sometimes, it’s like you’re damned if you do, damned if you don’t.”

    His face softened talking about his son, who is in college studying to become an environmental engineer. Scrolling through his phone, Kelly proudly displayed a recent photo of him. Something worth fighting for, he thought. He becomes nostalgic thinking about the years before his addiction, when he was a hard-working dad.

    Kelly said he wants more people to understand the realities of substance use disorder, how it gradually consumes your life until you almost don’t recognize yourself anymore. He compared the process to a “road full of IEDs” — you’re so focused on sidestepping immediate danger that you don’t realize you’re headed deeper into hostile territory.

    Kelly was visiting his family in Florida when he first tried taking Suboxone several years ago, hoping to avoid using heroin around his son. While the medication reduces his opioid cravings, he said it makes him feel dull and doesn’t do much for the persistent pain he still experiences from the roofing accident. That demands something stronger.

    Meanwhile, heroin and fentanyl are readily available for purchase in his neighborhood, which has suffered from rising poverty and population loss in recent decades.

    “You can’t blame it on your surroundings, but they don’t make it any easier,” he said.

    Every Monday morning, the Spot van parks in west Baltimore’s Upton community, a historic Black cultural hub once known for its renowned jazz clubs, upscale shops and vibrant nightlife.

    Now a shadow of its former self, the neighborhood is filled with visible impacts of the local drug trade: dealers doing business outside vacant buildings, their customers nodding drowsily on public benches, stumbling through alleys and trying to scrounge up enough money to make it through another day.

    Baltimore police cruisers routinely patrol the area, part of the city’s crime-fighting strategy to increase law enforcement presence in communities plagued by gun violence.

    Less than a block from the van’s parking spot, a tangle of deflated balloons commemorates a January shootout that wounded three people and killed two, including a young mother who was waiting to pick up a takeout order when she and her children were caught in the gunfire.

    Lenwood Johnson, 62, often visits the location.

    After about three months on buprenorphine, Johnson said he has significantly reduced his opioid use, keeping more money in his pockets and allowing him to stay sober for family visits and other important occasions. He also is taking fewer risks with fentanyl because he’s not desperate to maintain a consistent supply.

    An ex-correctional officer at Baltimore’s jail, Johnson said he started using opioids decades earlier when an arrest for marijuana possession derailed his budding law enforcement career.

    The Spot program, which launched in 2018, operates under a partnership between the Baltimore City Health Department and the Johns Hopkins University School of Medicine. It typically serves about 900 patients annually. An estimated 40% have a recent history of intravenous drug use, almost 75% are Black and more than half are experiencing homelessness or housing instability.

    “The population we’re serving, many of these people are profoundly underserved and mistrustful of the health system,” said Dr. Kathleen Page, a Johns Hopkins medical school professor who helped launch the program. “Building trust is a big part of it.”

    Darryl Jackson Sr., who enrolled last year along with his adult son, said the clinic sometimes feels like the only source of stability in his life. He recently had to leave the apartment where stayed and has been researching rental assistance programs, which are often mired in bureaucracy and hobbled by impossibly long waitlists.

    Jackson, 58, said he can’t tolerate shelter environments because he’s a stickler for cleanliness. He takes pride in maintaining a neat appearance. After a career in construction, he still dresses almost exclusively in canvas work pants and sneakers. But on the inside, he struggles to keep his addiction in check and stave off a growing feeling of hopelessness. He recently returned to the Spot van after some missed appointments.

    “They care,” he said. “So I keep coming back.”

    Program staff are acutely aware of the daily hurdles facing Jackson and other participants. Sometimes it seems like a miracle when they show up at all.

    “I cannot imagine living a day in the shoes of my patients,” Dr. Amanda Rosecrans, clinical chief, said in a March interview. She had received news earlier that morning about a patient’s recent death, which is a tragically common occurrence as overdoses and gun violence plague Baltimore’s poorest communities.

    For this vulnerable population, stable housing is the single most important piece of the recovery equation, said Bobby Harris, the program’s medical director.

    “If folks need housing, how are you supposed to focus on anything else when you don’t feel safe?” he said.

    When the big picture seems overwhelming, he focuses on treating the patients in front of him.

    Islah Hadith, 45, said her life changed drastically after she discovered the clinic in 2019.

    That was several years after she broke her ankle playing basketball and was prescribed Percocet. When her refills ran out, she went into withdrawal and started buying pills off the street. Despite working and raising children, she said she was living in a haze, not fully present.

    Hadith said she arrived at the Spot van nervous and ashamed, but left feeling hopeful.

    She started taking buprenorphine and stopped using other opioids. After about four years on the medication, she recently began reducing her doses to wean herself off. She also sought therapy and severed ties with people and places that could jeopardize her progress.

    “It doesn’t get easier, but it does get better,” she said.

    When Kelly showed up to the clinic last month, his infected leg had taken a serious turn for the worse. He could barely walk, hobbling down the sidewalk and up the van’s steps, leaning heavily on a metal cane. His shoulders hunched, as if his body would soon collapse under the crushing weight of addiction.

    “It hurts like hell,” he said, smiling through the pain.

    Despite this latest setback, he was clear-eyed and upbeat, having recently returned from visiting family in Florida. The trip gave him a break from Baltimore and left him feeling somewhat more positive. He envisioned moving out of the city, maybe to South Carolina, where he could focus on work and start a new chapter.

    Kelly said he’s grateful for the support system he has, though he worries about becoming a burden. His addiction still threatens some of his most precious relationships.

    He thought about what it would look like to truly prioritize his health: What if he started taking the Suboxone more consistently and stopped muddying the waters with illicit drugs? What if he could finally give his family the support and stability they deserve?

    He planned to check into the hospital later that afternoon and get his leg checked. But first, he was headed to the pharmacy to fill his prescription. One step at a time.

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  • England’s health service says it won’t give puberty blockers to children at gender clinics

    England’s health service says it won’t give puberty blockers to children at gender clinics

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    LONDON — The publicly funded health service in England has decided it will not routinely offer puberty-blocking drugs to children at gender identity clinics, saying more evidence is needed about the potential benefits and harms.

    The National Health Service said Friday that “outside of a research setting, puberty suppressing hormones should not be routinely commissioned for children and adolescents.”

    Children can still be given puberty blockers in exceptional circumstances, the NHS said, and a clinical study on their impact on kids is due to start by next year.

    The four new regional clinics are due to open later this year. They replace London’s Gender Identity Development Service, previously the only facility of its kind in England. It is scheduled to shut down after a review said it was overburdened by increasing demand and there was not enough evidence about the outcomes of its treatment.

    Hormone blockers are drugs that can pause the development of puberty, and are sometimes prescribed to help children with gender dysphoria by giving them more time to consider their options.

    The NHS said the new rules were “an interim policy” that would undergo further review, including the outcome of a research study on the impact puberty suppressing hormones have on gender dysphoria in children and young people.

    Findings published last year from a review of children’s gender services led by a pediatrician, Dr. Hilary Cass, said there were “gaps in the evidence base” about the blockers.

    The NHS said doctors at the new clinics still would be allowed to prescribe the drugs outside of a research setting “on an exceptional, case by case basis” and subject to approval from a national team of medical experts.

    The health service’s decision does not prevent children and their families from obtaining puberty blockers elsewhere, but that will be “strongly discouraged,” the NHS said.

    The issue of gender-affirming care for children is not as heated in Britain as in the U.S., where several Republican-led states have banned puberty blockers and other treatment for transgender minors, but it has ended up in the courts.

    In 2020, England’s High Court ruled that children under 16 were unlikely to be able to give informed consent to medical treatment involving drugs that delay puberty. The court said that because of the experimental nature of the drugs, clinics should seek court authorization before starting such treatment.

    The ruling came in a lawsuit brought by two claimants. One, Keira Bell, who was prescribed hormone blockers at 16, argued that the clinic should have challenged her more over her decision to transition to male.

    The decision was overturned in 2021 by the Court of Appeal, which said doctors can prescribe puberty-blocking drugs to children under 16 without a parent’s consent.

    The NHS said it recognized that once the policy was adopted, it would need to end a related requirement for young people to take puberty blockers for a certain amount of time before they receive the cross-sex hormones many transgender people take to transition.

    ___

    Follow AP’s coverage of LGBTQ+ people at https://apnews.com/hub/lgbtq-people

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  • New Mexico reaches $500M settlement with Walgreens in opioid case

    New Mexico reaches $500M settlement with Walgreens in opioid case

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    New Mexico has settled with Walgreens for $500 million over the pharmacy chain’s role in distributing highly addictive prescription painkillers

    SANTA FE, N.M. — New Mexico has settled with Walgreens for $500 million over the pharmacy chain’s role in distributing highly addictive prescription painkillers.

    The agreement was signed in March, and state officials confirmed that a confidentiality provision on the agreement was lifted Friday.

    The settlement is in addition to $274 million in settlements obtained in the case last fall from Albertsons, CVS, Kroger and Walmart. Attorneys representing the state say that, in all, New Mexico’s opioid litigation has brought in more than $1 billion.

    They argued at trial last year that Walgreens failed to recognize suspicious prescriptions and refuse to fill them.

    “I’m optimistic this will help in the fight against the opioid crisis and provide the treatment New Mexicans so desperately need,” Luis Robles, one of the attorneys who worked on the case, told the Santa Fe New Mexican.

    Over the past few years, drug manufacturers, distribution companies, pharmacies and other companies with roles in the opioid business have reached settlements totaling more than $50 billion with local, state and tribal governments.

    In May, West Virginia announced its settlement with Kroger, bringing that state’s total opioid litigation dollars to more than $1 billion. West Virginia state has lost more lives to opioid overdoses per capita than any other.

    Most of the settlement money from the opioid litigation is required to be used to fight the crisis, which has been linked to more than 560,000 deaths in the U.S. over the past two decades, including more than 70,000 a year recently.

    In recent years, most of the deaths have been connected to fentanyl and other illicit synthetic opioids, not prescription painkillers, according to data from the Centers for Disease Control and Prevention.

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  • FDA warns consumers not to use off-brand versions of Ozempic, Wegovy

    FDA warns consumers not to use off-brand versions of Ozempic, Wegovy

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    The U.S. Food and Drug Administration is warning consumers not to use off-brand versions of the popular weight-loss drugs Ozempic and Wegovy because they might not contain the same ingredients as the prescription products and may not be safe or effective.

    Agency officials said this week that they have received reports of problems after patients used versions of semaglutide, the active ingredient in the brand-name medications, which have been compounded, or mixed in pharmacies. Officials didn’t say what the problems were.

    The trouble is that those versions, often sold online, contain a version of semaglutide that is used in lab research and has not been approved for use in people.

    “Compounded drugs are not FDA-approved, and the agency does not verify the safety or effectiveness of compounded drugs,” the notice said.

    Sales of semaglutide products have soared in the past few years after the drug was shown to spur fast and significant weight loss. The drugs manufactured by Novo Nordisk include brands Ozempic and Rybelsus, used to treat diabetes, and Wegovy, approved to treat obesity.

    Demand for the medications has outstripped supply. As of May, Ozempic and Wegovy remain on the FDA’s list of drug shortages. When drugs are in short supply, compounding pharmacies are permitted to produce versions of those medications.

    Consumers should only use drugs containing semaglutide with a prescription from a licensed health care provider and obtained from a state-licensed pharmacy or other facilities registered with the FDA, the agency 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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  • Maker of anti-addiction drug Suboxone reaches $102.5 million settlement over antitrust claims

    Maker of anti-addiction drug Suboxone reaches $102.5 million settlement over antitrust claims

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    PHILADELPHIA — The company that makes the opioid addiction treatment drug Suboxone has agreed to pay $102.5 million to 41 states and the District of Columbia to settle claims that the company engaged in anticompetitive practices, it announced Friday.

    The agreement with Indivior, based in North Chesterfield, Virginia, averts a trial that was scheduled to start later this year.

    States, led by Wisconsin, claimed that the company, previously a subsidiary of Reckitt Benckiser Pharmaceuticals, made modest changes to Suboxone to extend patent protection and keep generic versions of the drug off the market.

    Suboxone is a branded version of buprenorphine and naloxone. The case is distinct from claims brought by governments against other opioid makers, claiming they helped cause or deepen a nationwide overdose crisis. Those have resulted in settlements totaling more than $50 billion so far.

    Under the terms of the deal, Indivior is to notify the states when it makes product modification or changes in corporate control.

    The company said in a statement that settling the lawsuit will allow it to focus on its mission.

    Reckitt Benckiser agreed in 2019 to pay the federal government $1.4 billion to resolve potential criminal and civil liability involving its Suboxone business.

    Besides Wisconsin, attorneys general involved in the settlement represent: Alabama, Alaska, Arkansas, California, Colorado, District of Columbia, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Hampshire, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Utah, Vermont, Virginia, Washington and West Virginia

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  • FDA warns consumers not to use off-brand versions of Ozempic, Wegovy

    FDA warns consumers not to use off-brand versions of Ozempic, Wegovy

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    The U.S. Food and Drug Administration is warning consumers not to use versions of the popular weight-loss drug used in Ozempic and Wegovy and sold online because they might not contain the same ingredients as prescription products and may not be safe o…

    ByJONEL ALECCIA AP Health Writer

    FILE – This Tuesday, April 3, 2018 file photo shows a closeup of a beam scale in New York. The Food and Drug Administration is warning consumers, Thursday, June 1, 2023, not to use off-brand versions of the popular weight-loss drugs Ozempic and Wegovy sold online because they might not contain the same ingredients as the prescription products and may not be safe or effective. (AP Photo/Patrick Sison, File)

    The Associated Press

    The U.S. Food and Drug Administration is warning consumers not to use off-brand versions of the popular weight-loss drugs Ozempic and Wegovy because they might not contain the same ingredients as the prescription products and may not be safe or effective.

    Agency officials said this week that they have received reports of problems after patients used versions of semaglutide, the active ingredient in the brand-name medications, which have been compounded, or mixed in pharmacies. Officials didn’t say what the problems were.

    The trouble is that those versions, often sold online, contain a version of semaglutide that is used in lab research and has not been approved for use in people.

    “Compounded drugs are not FDA-approved, and the agency does not verify the safety or effectiveness of compounded drugs,” the notice said.

    Sales of semaglutide products have soared in the past few years after the drug was shown to spur fast and significant weight loss. The drugs manufactured by Novo Nordisk include brands Ozempic and Rybelsus, used to treat diabetes, and Wegovy, approved to treat obesity.

    Demand for the medications has outstripped supply. As of May, Ozempic and Wegovy remain on the FDA’s list of drug shortages. When drugs are in short supply, compounding pharmacies are permitted to produce versions of those medications.

    Consumers should only use drugs containing semaglutide with a prescription from a licensed health care provider and obtained from a state-licensed pharmacy or other facilities registered with the FDA, the agency said.

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

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  • More companies help with fertility care, but it is still out of reach for many

    More companies help with fertility care, but it is still out of reach for many

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    Jessica Tincopa may leave the photography business she spent 14 years building for one reason: to find coverage for fertility treatment.

    After six miscarriages, Tincopa and her husband started saving for in vitro fertilization, which can cost well over $20,000. But the pandemic wiped out their savings, and they can’t find coverage for IVF on their state’s health insurance marketplace. So, the California couple is saving again, and asking politicians to help expand access.

    “No one should ever have to go through this,” Tincopa said.

    Infertility, or the inability to get pregnant after a year or more of trying, is a common problem. The federal Centers for Disease Control and Prevention estimates that it affects nearly one in five married girls or women between the ages of 15 and 49.

    Yet coverage of fertility treatments can be hard to find in many corners of health insurance even as it grows briskly with big employers who see it as a must-have benefit to keep workers.

    It’s a divide researchers say is leading to haves and have nots for treatments, which can involve a range of prescription drugs and procedures like artificial insemination or IVF, where an embryo is created by mixing eggs and sperm in a lab dish.

    “It is still primarily for people who can afford to pay quite a bit out of pocket,” said Usha Ranji, associate director of women’s health policy at KFF, a nonprofit that studies health care issues.

    Clouding this picture are insurer concerns about cost as well as questions about how much fertility coverage should be emphasized or mandated versus helping people find other ways to build families, such as adoption.

    “If you’re going to offer one, there should be a corollary and maybe even more significant benefits for adoption,” medical ethicist Dr. Philip Rosoff said.

    A total of 54% of the biggest U.S. employers — those with 20,000 workers or more — covered IVF in 2022, according to the benefits consultant Mercer. That’s up from 36% in 2015. Walmart started offering coverage last fall and banking giant JPMorgan began this year.

    Many businesses that offer the coverage extend it beyond those with an infertility diagnosis, making it accessible to LGBTQ+ couples and single women, according to Mercer.

    The benefits consultant also said there’s big growth among employers with 500 or more workers, as 43% offered IVF coverage last year. But coverage gets spotty with smaller employers.

    Lauderhill (Florida) Fire Rescue Lt. Ame Mason estimates she and her husband have spent close to $100,000 of their own money on fertility treatments over the past few years, including several unsuccessful IVF attempts. Mason and her husband both work for the same department.

    Her brother-in-law also has a fertility issue. He works for a bigger fire department in nearby Palm Beach County and got coverage. Mason said that couple has a son.

    “It’s pretty wild. You could work a county away and have coverage,” Mason said. “There’s nothing regulating it … both government jobs.”

    Twenty-one states have laws mandating coverage of fertility treatments or fertility preservation, which some patients need before cancer treatments, according to the nonprofit patient advocacy organization Resolve. Of those states, 14 require IVF coverage.

    But most of these requirements don’t apply to individual insurance plans or coverage sold through small employers.

    “People tell us that their biggest barrier to family building is lack of insurance coverage,” Resolve CEO Barbara Collura said, adding that some insurers don’t view the care as medically necessary.

    The state and federally funded Medicaid program for people with low incomes limits coverage of fertility issues largely to diagnosis in several states, according to KFF, which says Black and Hispanic women are disproportionately affected. States also can exclude fertility drugs from prescription coverage.

    “By not covering this for poor folks, we’re saying we don’t want you to reproduce,” said medical ethicist Lisa Campo-Engelstein of the University of Texas Medical Branch in Galveston, Texas. She noted Medicaid programs do cover birth control and sterilization procedures like vasectomies.

    In California, Tincopa says she has talked to both state and federal legislators about creating some sort of option for people to purchase individual insurance with the coverage.

    The state Senate is weighing a bill that would require coverage of fertility treatments, including IVF, for large employers. But the California Association of Health Plans opposes it, just as it opposed similar bills in recent years, because of how much it might cost.

    Spokeswoman Mary Ellen Grant noted independent analysis has shown that bills like this could increase premiums by as much as $1 billion in the state. She also said it would create a coverage gap because it wouldn’t apply to the state’s Medicaid enrollees.

    “This is not about the treatment itself,” she said. “It’s strictly based on the increased costs for our members. It would impact everybody regardless of whether they received the benefit.”

    But large fertility cost estimates often overstate how many people will use the benefit, said Sean Tipton, of the American Society for Reproductive Medicine. He also said most people with fertility problems don’t need IVF.

    Tipton, who has advocated for benefit mandates in several states, said he expects to see fertility treatment coverage grow, especially with small employers who may need to offer it to attract and keep workers.

    Any states that decide to require fertility treatment coverage should also require support for adoption, said Rosoff, a retired Duke University medical school professor. He said “fairness and justice” dictate doing so, adding that adoption promotes the social good of finding homes for children.

    Many companies that have expanded fertility benefits also support adoption.

    Ame Mason’s employer helps with neither.

    Mason said she has thought about adoption, but will stick with IVF for now — scrimping wherever they can and working overtime as much as possible to pay for it. They’ve found a doctor in Florida after traveling to Barbados for care that was slightly less expensive.

    Plus, she and her husband are seeing improvements in their most recent IVF attempts. This makes her reluctant to stop trying.

    “We keep getting that glimmer of hope,” she said.

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

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  • New menopause drug for hot flashes gets FDA approval

    New menopause drug for hot flashes gets FDA approval

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    The Food and Drug Administration has approved a new type of drug to treat hot flashes caused by menopause

    ByMATTHEW PERRONE AP Health Writer

    WASHINGTON — U.S. health regulators on Friday approved a new type of drug for women dealing with uncomfortable hot flashes caused by menopause.

    The Food and Drug Administration approved the once-a-day pill from Astellas Pharma to treat moderate-to-severe symptoms, which can include sweating, flushing and chills.

    Astellas’ drug, Veozah, uses a new approach, targeting brain connections that help control body temperature. The FDA said the medication will provide “an additional safe and effective treatment option for women,” in a statement.

    More than 80% of women experience hot flashes during menopause, the FDA noted, as the body gradually produces lower levels of reproductive hormones between the ages of 45 and 55.

    The most common treatment consists of hormonal pills aimed at boosting levels of estrogen and progestin. But the treatment isn’t appropriate for some women, including those with a history of stroke, blood clots, heart attack and other health conditions. Large studies have found that the hormones can increase the chances of those problems reoccurring, although the risks vary based on a number of individual factors.

    The new pill is not a hormone. It carries an FDA warning about potential liver damage. Women will need to be screened for liver damage or infection before getting a prescription, then get a blood test every three months for nine months to monitor for safety problems, according to the FDA label.

    Astellas said the drug will cost $550 for a one-month supply. That’s the price before insurance coverage and other discounts typically negotiated by insurers and pharmacy benefit managers.

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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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