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Tag: Medication

  • Matthew Perry’s death leads to sweeping indictment of 5, including doctors and a reputed dealer

    Matthew Perry’s death leads to sweeping indictment of 5, including doctors and a reputed dealer

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    LOS ANGELES (AP) — Nearly 10 months after the death of Matthew Perry, the long-simmering investigation into the ketamine that killed him came dramatically into public view with the announcement that five people had been charged with having roles in the overdose of the beloved “Friends” star.

    Here are key things to know about the case, including the two key figures who could be headed for trial and the possibility of the steepest of prison sentences.

    A sweeping set of indictments

    One or more arrests had been expected since investigators from three different agencies revealed in May they had been conducting a joint probe into how the 54-year-old Perry got such large amounts of ketamine.

    The actor had been among the growing number of patients using legal but off-label medical means to treat depression, or in other cases chronic pain, with the powerful surgical anesthetic.

    Recent reports suggested indictments might be imminent, but few outside observers, if any, knew how wide-ranging the prosecution would be, reaching much further than previous cases stemming from celebrity overdoses.

    When Michael Jackson died in 2009 from a lethal dose of the anesthetic propofol, his doctor was charged with providing it. After rapper Mac Miller died in 2017, two men who prosecutors described as a dealer and a middleman were convicted of providing fentanyl-laced oxycodone that helped kill him.

    But Perry’s case pulled in both, with indictments against doctors and illegal distributors who prosecutors say preyed on his long and public struggles with addiction. The investigation even went after the live-in personal assistant who prosecutors say helped him get ketamine and injected it directly into him before Perry was found dead in his hot tub on Oct. 28, 2023.

    “They knew what they were doing was risking great danger to Mr. Perry. But they did it anyway,” U.S. Attorney Martin Estrada said in announcing the charges.

    The prosecution was well under way even before the announcement. Two people including the assistant, Kenneth Iwamasa, and a Perry acquaintance, Eric Fleming, have pleaded guilty to conspiracy to distribute the drug. A San Diego physician, Dr. Mark Chavez, has agreed to enter a guilty plea.

    That leaves prosecutors free to pursue their two biggest targets.

    The doctor and the ‘Ketamine Queen’

    An indictment unsealed Thursday alleges Perry turned to Los Angeles doctor Salvador Plasencia when his regular doctors refused to give him more ketamine. Prosecutors allege Plasencia cashed in on Perry’s desperation and addiction, getting him to pay $55,000 in cash for large amounts of the drug in the two months before his death.

    “I wonder how much this moron will pay,” Plasencia texted a co-defendant, according to his indictment.

    He pleaded not guilty to seven counts of distribution of ketamine in an appearance in federal court on Thursday afternoon.

    Plasencia’s attorney, Stefan Sacks, said outside court that he “was operating with what he what he thought were the best of medical intentions,” and his actions “certainly didn’t rise to the level of criminal misconduct.”

    Prosecutors allege Jasveen Sangha, whom they describe as a drug dealer known to customers as the “Ketamine Queen,” provided the doses of the drug that actually killed Perry, injected into the actor by Iwamasa with syringes supplied by Plasencia.

    Sangha also pleaded not guilty. Her attorney Alexandra Kazarian derided the “queen” moniker as made-for-media consumption during the hearing. The lawyer declined comment on the case outside court.

    Prosecutors say the other doctor in the case, Chavez, helped Plasencia obtain the ketamine he gave to Perry, while Perry’s acquaintance, Fleming, helped get ketamine from Sangha to Perry.

    Chavez could get up to 10 years in prison, Iwamasa up to 15 years and Fleming up to 25 years.

    Multiple messages seeking comment from attorneys for the three men were not returned.

    Looking ahead to trial

    Sangha could get life in prison if convicted as charged, while Plasencia could get up to 120 years. Each has a trial date in October, but it is highly unlikely any would be facing a jury by then, and the two may be tried together. They also could face testimony from the co-defendants who reached plea agreements.

    Magistrate Judge Alka Sagar ruled Sangha should be held without bond while awaiting trial, citing prosecutors’ contentions that she had destroyed evidence and funded a lavish lifestyle with drug sales even after Perry’s death.

    The judge agreed to release Plasencia after he posted a $100,000 bond.

    His attorney argued the Perry case was “isolated” and the doctor should be allowed to treat patients who depended on him at his one-man practice while awaiting trial.

    “I’m not buying that argument,” Sagar said, but agreed Plasencia could see patients so long as they signed a document in which he acknowledged the charges.

    “People have probably already heard about it from the amount of press,” Sacks told the judge, noting if they hadn’t, they would soon.

    Records show Plasencia’s medical license has been in good standing with no records of complaints, though it is set to expire in October and he could face action. He already has surrendered his federal license to prescribe more dangerous drugs.

    What is ketamine?

    Ketamine is a powerful anesthetic approved by U.S. health regulators for use during surgery. It can be given as an intramuscular injection or by IV.

    The drug is a chemical cousin of the recreational drug PCP. Ketamine itself has been used recreationally for its euphoric effects. It can cause hallucinations and can impact breathing and the heart.

    Pushing back against ketamine

    Prosecutors and police presented the Perry case as part of a major pushback against a rise in the illegal use of ketamine that has shadowed the broadening of its legal use.

    Los Angeles police said in May they were working with the U.S. Drug Enforcment Administration and the U.S. Postal Inspection Service with a probe into how Perry got the drug. His autopsy, released in December, found the amount of ketamine in his blood was in the range used for general anesthesia during surgery.

    “As Matthew Perry’s ketamine addiction grew, he wanted more and he wanted it faster and cheaper. That is how he ended up buying from street dealers and stole the ketamine that ultimately led to his death,” U.S. Drug Enforcement Administrator Anne Milgram said Thursday. “In doing so, he followed the arc that we have tragically seen with many others. The substance use disorder begins in a doctor’s office and ends in the street.”

    Perry had years of struggles with addiction dating back to his time on NBC’s megahit sitcom, “Friends,” for 10 seasons from 1994 to 2004. Playing Chandler Bing, he became one of the biggest television stars of his generation alongside Jennifer Aniston, Courteney Cox, Lisa Kudrow, Matt LeBlanc and David Schwimmer.

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  • Macy Gray Opens Up About Being On Ozempic & Its Side Effects

    Macy Gray Opens Up About Being On Ozempic & Its Side Effects

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    Singer and actress Macy Gray has opened up about her experience using Ozempic and dealing with its side effects.

    RELATED: Khloé Kardashian Speaks On Ozempic While Opening Up About Her Weight Loss Journey

    Macy Gray Opens Up About Using Ozempic

    According to PEOPLE, Gray opened up about her experience with the medication during a recently aired episode of MTV’s ‘The Surreal Life.’ The 56-year-old was reportedly speaking to her castmates about how Ozempic impacted her digestive system.

    “Oh boy, my stomach hurts. I’ve just been really constipated,” Gray reportedly told her castmates, reflecting on the experience. “I took Ozempic. I can’t go to the bathroom, and I was up all night.”

    The outlet adds that during a confessional on the show, Gray delved into her reasoning behind using the medication.

    “Quietly, I’m kind of a vain person. I’ve gained a lot of weight over the past couple years…” she reportedly explained. “So, I thought, okay, I’m not taking [the weight] off the right way, let me see if I can get one of these Ozempic.”

    Additionally, Gray explained that she was trying to lose weight ahead of her time on ‘The Surreal Life.’

    “I was actually trying to take it off [the weight] before the show because I didn’t want to be super fat on TV, but here we are,” she said.

    A New Study Has Revealed More Information About Ozempic Use

    Amid Gray’s recent comments, a new study has reportedly revealed more information about the potential benefits of using the medication. According to Newsweek, researchers from Case Western Reserve School of Medicine have been looking into the possibility that Ozempic could curb one’s desire to smoke cigarettes.

    Their study reportedly utilized the experiences of Ozempic users with type 2 diabetes, “who noted a decreased desire to smoke while taking the medication.”

    Additionally, researchers are reportedly looking into Ozempic’s effects on “treating tobacco use disorders (TUD).” However, the outlet notes that “further clinical trials” will need to be conducted.

    Khloé Kardashian Previously Spoke About The Diabetes-Turned-Weightloss Drug

    Meanwhile, Gray isn’t the only celebrity who recently opened up about their experience with the diabetes-turned-weight loss drug. As The Shade Room previously reported, Kandi Burruss spoke about her experience with the medication in June.

    At the time, Burruss revealed to Page Six that she took the drug in 2023. However, it failed to curb her appetite.

    “The sad thing about it is when you see it work for other people and it doesn’t work for you, it makes you depressed,” she explained. “…It makes you feel like, ‘What’s wrong with me? Why is it not working for me?’”

    Ultimately, Burruss explained that after she stepped away from Ozempic and took a fresh approach to her weight loss, she began to achieve her goals.

    RELATED: Kandi Burruss Opens Up About Her Experience With Ozempic

    What Do You Think Roomies?

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    Jadriena Solomon

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  • FDA approves a second Alzheimer’s drug that can modestly slow disease

    FDA approves a second Alzheimer’s drug that can modestly slow disease

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    WASHINGTON — U.S. officials have approved another Alzheimer’s drug that can modestly slow the disease, providing a new option for patients in the early stages of the incurable, memory-destroying ailment.

    The Food and Drug Administration approved Eli Lilly’s Kisunla on Tuesday for mild or early cases of dementia caused by Alzheimer’s. It’s only the second drug that’s been convincingly shown to delay cognitive decline in patients, following last year’s approval of a similar drug from Japanese drugmaker Eisai.

    The delay seen with both drugs amounts to a matter of months — about seven months, in the case of Lilly’s drug. Patients and their families will have to weigh that benefit against the downsides, including regular IV infusions and potentially dangerous side effects like brain swelling.

    Physicians who treat Alzheimer’s say the approval is an important step after decades of failed experimental treatments.

    “I’m thrilled to have different options to help my patients,” said Dr. Suzanne Schindler, a neurologist at Washington University in St. Louis. “It’s been difficult as a dementia specialist — I diagnose my patients with Alzheimer’s and then every year I see them get worse and they progress until they die.”

    Both Kisunla and the Japanese drug, Leqembi, are laboratory-made antibodies, administered by IV, that target one contributor to Alzheimer’s — sticky amyloid plaque buildup in the brain. Questions remain about which patients should get the drugs and how long they might benefit.

    The new drug’s approval was expected after an outside panel of FDA advisors unanimously voted in favor of its benefits at a public meeting last month. That endorsement came despite several questions from FDA reviewers about how Lilly studied the drug, including allowing patients to discontinue treatment after their plaque reached very low levels.

    Costs will vary by patient, based on how long they take the drug, Lilly said. The company also said a year’s worth of therapy would cost $32,000 — higher than the $26,500 price of a year’s worth of Leqembi.

    The FDA’s prescribing information tells doctors they can consider stopping the drug after confirming via brain scans that patients have minimal plaque.

    More than 6 million Americans have Alzheimer’s. Only those with early or mild disease will be eligible for the new drug, and an even smaller subset are likely to undergo the multi-step process needed to get a prescription.

    The FDA approved Kisunla, known chemically as donanemab, based on results from an 18-month study in which patients given getting the treatment declined about 22% more slowly in terms of memory and cognitive ability than those who received a dummy infusion.

    The main safety issue was brain swelling and bleeding, a problem common to all plaque-targeting drugs. The rates reported in Lilly’s study — including 20% of patients with microbleeds — were slightly higher than those reported with competitor Leqembi. However, the two drugs were tested in slightly different types of patients, which experts say makes it difficult to compare the drugs’ safety.

    Kisunla is infused once a month compared to Leqembi’s twice-a-month regimen, which could make things easier for caregivers who bring their loved ones to a hospital or clinic for treatment.

    “Certainly getting an infusion once a month is more appealing than getting it every two weeks,” Schindler said.

    Lilly’s drug has another potential advantage: Patients can stop taking it if they respond well.

    In the company’s study, patients were taken off Kisunla once their brain plaque reached nearly undetectable levels. Almost half of patients reached that point within a year. Discontinuing the drug could reduce the costs and safety risks of long-term use. It’s not yet clear how soon patients might need to resume infusions.

    Logistical hurdles, spotty insurance coverage and financial concerns have all slowed the rollout of competitor Leqembi, which Eisai co-markets with U.S. partner Biogen. Many smaller hospitals and health systems aren’t yet setup to prescribe the new plaque-targeting Alzheimer’s drugs.

    First, doctors need to confirm that patients with dementia have the brain plaque targeted by the new drugs. Then they need to find a drug infusion center where patients can receive therapy. Meanwhile, nurses and other staff must be trained to perform repeated scans to check for brain swelling or bleeding.

    “Those are all things a physician has to have set up,” said Dr. Mark Mintun, who heads Lilly’s neuroscience division. “Until they get used to them, a patient who comes into their office will not be offered this therapy.”

    ___

    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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  • France’s Macron, African leaders push for vaccines for Africa after COVID-19 exposed inequalities

    France’s Macron, African leaders push for vaccines for Africa after COVID-19 exposed inequalities

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    PARIS — French President Emmanuel Macron is joining several African leaders on Thursday to kick off a planned $1 billion project to accelerate the rollout of vaccines in Africa, after the coronavirus pandemic exposed gaping inequalities in access to them.

    The launch of the African Vaccine Manufacturing Accelerator, which will provide financial incentives to vaccine manufacturers, offered a momentary break for Macron from domestic political concerns as legislative elections loom on June 30 and July 7.

    Many African leaders and advocacy groups say Africa was unfairly locked out of access to COVID-19 treatment tools, vaccines and testing equipment — that many richer countries bought up in huge quantities — after the pandemic swept the world starting in 2020.

    WHO, advocacy groups and others want to help Africa get better prepared for the next pandemic, which many health experts say is inevitable. When the coronavirus pandemic began, South Africa was the only country in Africa with any ability to produce vaccines, officials say, and the continent produced a tiny fraction of all vaccines worldwide.

    WHO failed in its efforts to help countries agree to a “pandemic treaty” — to improve preparedness and response to pandemics — before its annual meeting last month. The project was shelved largely over disagreements about sharing of information about pathogens that cause epidemics and the high-tech tools used to fight them.

    Negotiators will resume work on the treaty in hopes of clinching a deal by the next WHO annual meeting in 2025.

    Thursday’s event in Paris also aims to give a funding shot-in-the-arm to Gavi, the Vaccine Alliance, a public-private partnership that helps get needed vaccines to developing countries around the world.

    Gavi says the project aims to make up to US$ 1 billion available over the next ten years help boost Africa’s manufacturing base, to improve global vaccines markets and improve preparedness and response to pandemics and outbreaks like HIV, malaria, TB and COVID-19.

    The Geneva-based alliance says the accelerator will inject funds into manufacturers in Africa once they hit supply and regulatory milestones, with an aim to use market forces to drive down prices and encourage investment upstream.

    Officials say the project will explore issues like technology transfer — which has been resisted by some Western countries with powerful pharmaceutical companies — as well as the possible creation of a African medicines agency and tackling regulatory hurdles faced in Africa’s patchwork of legal systems.

    ___

    AP journalist Jamey Keaten in Geneva contributed to this report.

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  • Plastic surgeon charged in death of wife who went into cardiac arrest

    Plastic surgeon charged in death of wife who went into cardiac arrest

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    PENSACOLA, Fla. — A plastic surgeon in the Florida Panhandle was charged with his wife’s death after she suffered a cardiac arrest and died days after he performed after-hours procedures on her in his clinic last year, authorities said.

    Benjamin Brown was arrested Monday on a charge of manslaughter by culpable negligence, which is a second-degree felony. He was released from the Santa Rosa County Jail after posting a $50,000 bond.

    His defense attorney said Tuesday that Benjamin Brown intended to plead not guilty. An arraignment was scheduled for next month.

    “Dr. Brown intends to plead not guilty and vigorously fight the allegations against him in court,” defense attorney Barry Beroset said in a phone call.

    Brown’s wife, Hillary Brown, went into cardiac arrest in November while her husband was performing procedures on her at his clinic in the Pensacola area, according to the Santa Rosa County Sheriff’s Office. She was taken to a hospital and died a week later, the sheriff’s office said.

    Last month, the Florida Department of Health filed an administrative complaint before the state Board of Medicine, seeking penalties against Brown up to the revocation or suspension of his license. The complaint involved his wife’s case and other cases.

    Unsupervised by her husband or any other health care practitioner, Hillary Brown prepared her own local anesthesia and filled intravenous bags for the procedures which included arm liposuction, lip injections and an ear adjustment, according to the Department of Health complaint.

    She also ingested several pills, including a sedative, pain killer and antibiotic, before falling into a sedated state, though the consumption of those pills wasn’t documented, the complaint said.

    “The minimum prevailing professional standard of care requires that physicians not permit a patient to prepare medication for use in their own surgery,” the complaint said.

    During the procedures, Hillary Brown’s feet began twitching and she told her husband that her vision was starting to blur and that she saw “orange.” Benjamin Brown injected more lidocaine, an anesthetic, into her face. The Department of Health said she became unresponsive and had a seizure.

    A medical assistant asked Benjamin Brown if they should call 911, and he said “no,” according to the complaint. Over the next 10 or 20 minutes, the medical assistant repeated her question about whether they should call for paramedics, and he said, “no” or “wait,” the complaint said.

    When Hillary Brown’s breathing became shallow and her pulse and blood oxygen levels became low, after about 10 to 20 minutes, Benjamin Brown told his assistants to call 911 and he began performing resuscitation efforts on her, the complaint said.

    However, a medical assistant told a sheriff’s office investigator that she made the decision to call 911, not Benjamin Brown. Emergency room doctors at the hospital where Hillary Brown was transported later told the investigator that they treated her for lidocaine toxicity, according to a sheriff’s office report.

    Also last month, the Department of Health issued an emergency order restricting Benjamin Brown’s license to performing procedures only at a hospital under the supervision of another physician. His wife had given injections and performed laser treatment on patients even though she wasn’t a licensed health care practitioner, the order said.

    Addressing the procedures involving his wife last November, the order noted that muscle twitches and blurred vision are early signs of lidocaine toxicity. The order described Benjamin Brown’s treatment of his wife as “careless and haphazard.”

    “The level of disregard that Dr. Brown paid to patient safety, even when the patient was his wife, indicates that Dr. Brown is unwilling or incapable of providing the appropriate level of care his future patients,” the order said.

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  • Key Information For The 60+ About Marijuana

    Key Information For The 60+ About Marijuana

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    It is a big summer for the cannabis industry – will Boomers join Gen Z in embracing marijuana?

    It is the summer of cannabis with the potential for rescheduling.  Both the Food and Drug Administration (FDA) and Health and Human Services (HHS) has recognized marijuana has medical benefits and is not a dangerous drug. The American Medical Association also recognized it can help patients and they and research show it is better for you than alcohol.  Gen Z has started moving away from alcohol (mainly beer) and embracing cannabis.  With all these changes – here is key information for the 60+ about marijuana in today’s world.

    RELATED: What Is California Sober

    There are two uses for cannabis – recreational (fun stuff) and medical. Even though a little high has never hurt anybody, you don’t have to get high to benefit from medical marijuana. Effective medicinal CBD strains contain small amounts of THC. These strains focus their efforts on the therapeutic side of the plant, producing little to no psychoactive effect.

    The other interesting update is the days of smoking cannabis tends to be waning. it is used more by the aficionado and the old school consumers.  Today, most users have used a vape or a gummy. You can manage dosing better, they are discreet and you take it to events without the smell.  Gen Z has truly embrace the on-the-go aspect of today’s marijuana.

    Photo by rawpixel.com

    With aging, bodies start to deteriorate in every way, leading to some pain and discomfort. Seniors are more prone to experience inflammation, mental and bone health issues and high blood pressure. Evidence and studies show cannabis is a good way of providing some relief, especially in the chronic pain area.

    One of the most common wellness ways cannabis is used is for sleep. Like most natural medicines, it needs to be taken occasionally, but enough to change your sleep patterns. With the correct dosage, it can increase total sleep time and decrease the frequency of arousals during the night.

    Another key issue is anxiety. Some people use marijuana to cope with anxiety, especially those with social anxiety disorder. THC appears to decrease anxiety at lower doses and increase anxiety at higher doses. Studies has shown CBD appears to decrease anxiety at all doses.

    In the fun category, marijuana is healthier than alcohol and can make experiences much more vibrant and alive. Science shows listening to music, watching a movie, or just looking at scenery is more vibrant.  Part of the reason is while on THC, is slows the “memory search part” of the brain and allows it to focus on the moment. Also, cannabis and cannabis creams can help in the intimacy department, sometimes reopening a door which might have been closed.

    RELATED: 6 Ways Cannabis Can Improve The Life Of Seniors

    There needs to be an awareness on the possible effect marijuana can have with common medications taken by older adults. A review published in the Journal of the American College of Cardiology says that marijuana can interact with common heart medications, such as statin and blood thinners. Marijuana use can alter the time in which these medications have an effect and could also result in bleeding.

    People should also avoid pairing marijuana with anti-seizure medications or any other substance that produces strong effects. If having surgery, it’s important for older adults to disclose marijuana use to doctors, even including the use of CBD. The compound has also been linked with altering the way in which the liver processes dosages in medications.

    RELATED: Survey: Seniors In Pain Want To Try Cannabis, But This Is Preventing Them

    Like alcohol, cannabis can make you a bit unstable on your feet. Using either could result in dizziness and in feeling out of control of your body. This in turn could increase the risk of falling and getting involved in all sorts of accidents. Falls pose serious risks for seniors, with 1 out of 5 resulting in a head injury or broken bones. The good news, if done right, cannabis makes you chill.

    How CBD Helps Seniors Exercise
    Photo by Caiaimage/Trevor Adeline/Getty Images

    According to a study published in the journal Gerontology and Geriatric Medicine, like with alcohol, older marijuana users are more likely to experience depression than non-users. While it’s not know exactly why this occurs, it’s likely a combination of things; these users might be taking cannabis instead of seeking medical help, or maybe cannabis is interacting with the medications they’re already taking in ways that are not beneficial.

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    Amy Hansen

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  • Israel maintains a shadowy hospital for Gaza detainees. Critics allege mistreatment

    Israel maintains a shadowy hospital for Gaza detainees. Critics allege mistreatment

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    JERUSALEM — Patients lying shackled and blindfolded on more than a dozen beds inside a white tent in the desert. Surgeries performed without adequate painkillers. Doctors who remain anonymous.

    These are some of the conditions at Israel’s only hospital dedicated to treating Palestinians detained by the military in the Gaza Strip, three people who have worked there told The Associated Press, confirming similar accounts from human rights groups.

    While Israel says it detains only suspected militants, many patients have turned out to be non-combatants taken during raids, held without trial and eventually returned to war-torn Gaza.

    Eight months into the Israel-Hamas war, accusations of inhumane treatment at the Sde Teiman military field hospital are on the rise, and the Israeli government is under growing pressure to shut it down. Rights groups and other critics say what began as a temporary place to hold and treat militants after Oct. 7 has morphed into a harsh detention center with too little accountability.

    The military denies the allegations of inhumane treatment and says all detainees needing medical attention receive it.

    The hospital is near the city of Beersheba in southern Israel. It opened beside a detention center on a military base after the Oct. 7 Hamas attack on Israel because some civilian hospitals refused to treat wounded militants. Of the three workers interviewed by AP, two spoke on condition of anonymity because they feared government retribution and public rebuke.

    “We are condemned by the left because we are not fulfilling ethical issues,” said Dr. Yoel Donchin, an anesthesiologist who has worked at Sde Teiman hospital since its earliest days and still works there. “We are condemned from the right because they think we are criminals for treating terrorists.”

    The military this week said it formed a committee to investigate detention center conditions, but it was unclear if that included the hospital. Next week Israel’s highest court is set to hear arguments from human rights groups seeking to shut it down.

    Israel has not granted journalists or the International Committee of the Red Cross access to the Sde Teiman facilities.

    Israel has detained some 4,000 Palestinians since Oct. 7, according to official figures, though roughly 1,500 were released after the military determined they were not affiliated with Hamas. Israeli human rights groups say the majority of detainees have at some point passed through Sde Teiman, the country’s largest detention center.

    Doctors there say they have treated many who appeared to be non-combatants.

    “Now we have patients that are not so young, sick patients with diabetes and high blood pressure,” said Donchin, the anesthesiologist.

    A soldier who worked at the hospital recounted an elderly man who underwent surgery on his leg without pain medication. “He was screaming and shaking,” said the soldier.

    Between medical treatments, the soldier said patients were housed in the detention center, where they were exposed to squalid conditions and their wounds often developed infections. There was a separate area where older people slept on thin mattresses under floodlights, and a putrid smell hung in the air, he said.

    The military said in a statement that all detainees are “reasonably suspected of being involved in terrorist activity.” It said they receive check-ups upon arrival and are transferred to the hospital when they require more serious treatment.

    A medical worker who saw patients at the facility in the winter recounted teaching hospital workers how to wash wounds.

    Donchin, who largely defended the facility against allegations of mistreatment but was critical of some of its practices, said most patients are diapered and not allowed to use the bathroom, shackled around their arms and legs and blindfolded.

    “Their eyes are covered all the time. I don’t know what the security reason for this is,” he said.

    The military disputed the accounts provided to AP, saying patients were handcuffed “in cases where the security risk requires it” and removed when they caused injury. Patients are rarely diapered, it said.

    Dr. Michael Barilan, a professor at the Tel Aviv University Medical School who said he has spoken with over 15 hospital staff, disputed accounts of medical negligence. He said doctors are doing their best under difficult circumstances, and that the blindfolds originated out of a “fear (patients) would retaliate against those taking care of them.”

    Days after Oct. 7, roughly 100 Israelis clashed with police outside one of the country’s main hospitals in response to false rumors it was treating a militant.

    In the aftermath, some hospitals refused to treat detainees, fearful that doing so could endanger staff and disrupt operations. They were already overwhelmed by people wounded during the Hamas attack and expecting casualties to rise from an impending ground invasion.

    As Israel pulled in scores of wounded Palestinians to Sde Teiman, it became clear the facility’s infirmary was not large enough, according to Barilan. An adjacent field hospital was built from scratch.

    Israel’s Health Ministry laid out plans for the hospital in a December memo obtained by AP.

    It said patients would be treated while handcuffed and blindfolded. Doctors, drafted into service by the military, would be kept anonymous to protect their “safety, lives and well-being.” The ministry referred all questions to the military when reached for comment.

    Still, an April report from Physicians for Human Rights-Israel, drawing on interviews with hospital workers, said doctors at the facility faced “ethical, professional and even emotional distress.” Barilan said turnover has been high.

    Patients with more complicated injuries have been transferred from the field hospital to civilian hospitals, but it has been done covertly to avoid arousing the public’s attention, Barilan said. And the process is fraught: The medical worker who spoke with AP said one detainee with a gunshot wound was discharged prematurely from a civilian hospital to Sde Teiman within hours of being treated, endangering his life.

    The field hospital is overseen by military and health officials, but Donchin said parts of its operations are managed by KLP, a private logistics and security company whose website says it specializes in “high-risk environments.” The company did not respond to a request for comment.

    Because it’s not under the same command as the military’s medical corps, the field hospital is not subject to Israel’s Patients Rights Act, according to Physicians for Human Rights-Israel.

    A group from the Israeli Medical Association visited the hospital earlier this year but kept its findings private. The association did not respond to requests for comment.

    The military told AP that 36 people from Gaza have died in Israel’s detention centers since Oct. 7, some of them because of illnesses or wounds sustained in the war. Physicians for Human Rights-Israel has alleged that some died from medical negligence.

    Khaled Hammouda, a surgeon from Gaza, spent 22 days at one of Israel’s detention centers. He does not know where he was taken because he was blindfolded while he was transported. But he said he recognized a picture of Sde Teiman and said he saw at least one detainee, a prominent Gaza doctor who is believed to have been there.

    Hammouda recalled asking a soldier if a pale 18-year-old who appeared to be suffering from internal bleeding could be taken to a doctor. The soldier took the teenager away, gave him intravenous fluids for a few hours, and then returned him.

    “I told them, ‘He could die,’” Hammouda said. “‘They told me this is the limit.’”

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    AP writer Sarah El Deeb in Beirut contributed to this report.

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  • Police pressured him to confess to a murder that never happened. Now, Fontana will pay him $900,000

    Police pressured him to confess to a murder that never happened. Now, Fontana will pay him $900,000

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    The city of Fontana has agreed to pay nearly $900,000 to settle a federal lawsuit filed by a man who said police pressured him to falsely confess to a murder that never happened.

    During a 17-hour interrogation in August 2018, Fontana Police Department officers questioned Thomas Perez Jr. about the disappearance of his father, whom Perez had reported missing. Officers alleged Perez had murdered his father and, when Perez denied the accusation, officers tried to convince him that he had forgotten the crime, according to a federal lawsuit, court records and video of the interrogation.

    Throughout their lengthy questioning of Perez, officers used a variety of tactics aimed at goading him into confessing. They brought his dog into the interrogation room, told him the dog had walked through blood and would be sent away to be euthanized. They drove Perez to a dirt lot and asked him to walk around in search of his dad’s body. They told him that his father’s body was in a morgue.

    “You murdered your dad,” one of the officers said, according to video of the interrogation. “Daddy’s dead because of you.”

    The officers told Perez that he would have “closure” if he told them what happened. Perez repeatedly told them that he didn’t know.

    “Stop lying to yourself,” officers told Perez.

    Perez, who was distressed, visibly sleep-deprived and later testified that he had been denied medication for depression and other mental disorders, sobbed during the interview. At one point he tore out his hair and ripped open his shirt. When officers stepped out of the room, he tied his shoestrings around his neck in an attempt to hang himself, records and video show.

    At the 16-hour mark, Perez told police that he had gotten into an altercation with his father and had stabbed him.

    But a major problem with that confession soon emerged: Perez’s father was alive and safe. He had left the house he shared with his son and stayed overnight at a friend’s home near Union Station, according to court records. Later, he waited to catch a flight at Los Angeles International Airport to visit his daughter in Northern California. When police learned that Perez’s father was safe, they initially withheld the information and put Perez on a psychiatric hold.

    “In my 40 years of suing the police I have never seen that level of deliberate cruelty by the police,” said Perez’s attorney, Jerry L. Steering. “After what I saw on the video of what they did to him, I now know that the police can get [anyone] to confess to killing Abe Lincoln.”

    Fontana police were initially suspicious of Perez after observing that his house was in disarray, as if a “struggle” had taken place. Perez’s father’s phone was left inside the house and police said they found “visible bloodstains.” A police dog had picked up the scent of a corpse, court records show.

    After the ordeal, Perez filed a federal lawsuit against the city of Fontana, which also named Officers David Janusz, Jeremy Hale, Ronald Koval, Robert Miller and Joanna Piña as defendants. The Fontana Police Department did not respond to The Times’ request for comment about the $898,000 settlement, or the officers’ status within the department.

    U.S. District Judge Dolly Gee found that “a reasonable juror could conclude that the detectives inflicted unconstitutional psychological torture on Perez,” according to a court order last June.

    “He testified that the officers prevented him from sleeping and deprived him of his medication,” Gee said. “There is no legitimate government interest that would justify treating Perez in this manner while he was in medical distress.”

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    Colleen Shalby

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  • A gene long thought to just raise the risk for Alzheimer’s may cause some cases

    A gene long thought to just raise the risk for Alzheimer’s may cause some cases

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    WASHINGTON — For the first time, researchers have identified a genetic form of late-in-life Alzheimer’s disease — in people who inherit two copies of a worrisome gene.

    Scientists have long known a gene called APOE4 is one of many things that can increase people’s risk for Alzheimer’s, including simply getting older. The vast majority of Alzheimer’s cases occur after age 65. But research published Monday suggests that for people who carry not one but two copies of the gene, it’s more than a risk factor, it’s an underlying cause of the mind-robbing disease.

    The findings mark a distinction with “profound implications,” said Dr. Juan Fortea, who led the study the Sant Pau Research Institute in Barcelona, Spain.

    Among them: Symptoms can begin seven to 10 years sooner than in other older adults who develop Alzheimer’s.

    An estimated 15% of Alzheimer’s patients carry two copies of APOE4, meaning those cases “can be tracked back to a cause and the cause is in the genes,” Fortea said. Until now, genetic forms of Alzheimer’s were thought to be only types that strike at much younger ages and account for less than 1% of all cases.

    Scientists say the research makes it critical to develop treatments that target the APOE4 gene. Some doctors won’t offer the only drug that has been shown to modestly slow the disease, Leqembi, to people with the gene pair because they’re especially prone to a dangerous side effect, said Dr. Reisa Sperling, a study coauthor at Harvard-affiliated Brigham and Women’s Hospital in Boston.

    Sperling hunts ways to prevent or at least delay Alzheimer’s and “this data for me says wow, what an important group to be able to go after before they become symptomatic.”

    But the news doesn’t mean people should race for a gene test. “It’s important not to scare everyone who has a family history” of Alzheimer’s because this gene duo isn’t behind most cases, she told The Associated Press.

    More than 6 million Americans, and millions more worldwide, have Alzheimer’s. A handful of genes are known to cause rare “early-onset” forms, mutations passed through families that trigger symptoms unusually young, by age 50. Some cases also are linked to Down syndrome.

    But Alzheimer’s most commonly strikes after 65, especially in the late 70s to 80s, and the APOE gene – which also affects how the body handles fats — was long known to play some role. There are three main varieties. Most people carry the APOE3 variant that appears to neither increase nor decrease Alzheimer’s risk. Some carry APOE2, which provides some protection against Alzheimer’s.

    APOE4 has long been labeled the biggest genetic risk factor for late-in-life Alzheimer’s, with two copies risker than one. About 2% of the global population is estimated to have inherited a copy from each parent.

    To better understand the gene’s role, Fortea’s team used data from 3,297 brains donated for research and from over 10,000 people in U.S. and European Alzheimer’s studies. They examined symptoms and early hallmarks of Alzheimer’s such as sticky amyloid in the brain.

    People with two APOE4 copies were accumulating more amyloid at age 55 than those with just one copy or the “neutral” APOE3 gene variety, they reported in the journal Nature Medicine. By age 65, brain scans showed significant plaque buildup in nearly three-quarters of those double carriers – who also were more likely to have initial Alzheimer’s symptoms around that age rather than in the 70s or 80s.

    Fortea said the disease’s underlying biology was remarkably similar to young inherited types.

    It appears more like “a familial form of Alzheimer’s,” said Dr. Eliezer Masliah of the National Institute on Aging. “It is not just a risk factor.”

    Importantly, not everyone with two APOE4 genes develops Alzheimer’s symptoms and researchers need to learn why, Sperling cautioned.

    “It’s not quite destiny,” she said.

    The drug Leqembi works by clearing away some sticky amyloid but Sperling said it’s not clear if carriers of two APOE4 genes benefit because they have such a high risk of a side effect from the drug – dangerous brain swelling and bleeding. One research question is whether they’d do better starting such drugs sooner than other people.

    Masliah said other research aims to develop gene therapy or drugs to specifically target APOE4. He said it’s also crucial to understand APOE4’s effects in diverse populations since it’s been studied mostly in white people of European ancestry.

    As for gene tests, for now they’re typically used only to evaluate if someone’s a candidate for Leqembi or for people enrolling in Alzheimer’s research – especially studies of possible ways to prevent the disease. Sperling said the people most likely to carry two APOE4 genes had parents who both got Alzheimer’s relatively early, in their 60s rather than 80s.

    ___

    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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  • Takeaways from AP’s investigation into fatal police encounters involving injections of sedatives

    Takeaways from AP’s investigation into fatal police encounters involving injections of sedatives

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    The practice of giving sedatives to people detained by police spread quietly across the nation over the last 15 years, built on questionable science and backed by police-aligned experts, an investigation led by The Associated Press has found.

    At least 94 people died after they were given sedatives and restrained by police from 2012 through 2021, according to findings by the AP in collaboration with FRONTLINE (PBS) and the Howard Centers for Investigative Journalism. That’s nearly 10% of the more than 1,000 deaths identified during the investigation of people subdued by police in ways that are not supposed to be fatal.

    Supporters say sedatives enable rapid treatment for drug-related behavioral emergencies and psychotic episodes, protect front-line responders from violence and are safely administered thousands of times annually to get people with life-threatening conditions to hospitals. Critics say forced sedation should be strictly limited or banned, arguing the medications, given without consent, are too risky to be administered during police encounters.

    The injections spanned the country, from a desert in Arizona to a street in St. Louis to a home in Florida. They happened in big cities such as Dallas, suburbs like Lithonia, Georgia, and rural areas such as Dale, Indiana. They occurred in homes, in parking lots, in ambulances and occasionally in hospitals where police encounters came to a head.

    It was impossible to determine the role sedatives may have played in each of the 94 deaths, which often involved the use of other potentially dangerous force on people who had taken drugs or consumed alcohol. Medical experts told the AP their impact could be negligible in people who were already dying; the final straw that triggered heart or breathing failure in the medically distressed; or the main cause of death when given in the wrong circumstances or mishandled.

    While sedatives were mentioned as a cause or contributing factor in a dozen official death rulings, authorities often didn’t even investigate whether injections were appropriate. Medical officials have traditionally viewed them as mostly benign treatments. Now some say they may be playing a bigger role than previously understood and deserve more scrutiny.

    Here are takeaways from AP’s investigation:

    The investigation found that about half those who died after injections were Black.

    Behind the racial disparity is a disputed medical condition called excited delirium, which fueled the rise of sedation outside hospitals. Critics say its purported symptoms, including “superhuman strength” and high pain tolerance, play into racist stereotypes about Black people and lead to biased decisions about who needs sedation.

    Guidelines require paramedics to make rapid, subjective assessments of the potential dangers posed by the people they treat. Only those judged to be at high risk of harming themselves or others are supposed to be candidates for shots.

    But the investigation found that some whose behavior did not meet the bar — who had already largely calmed down or in rare cases even passed out — were given injections. In some cases, paramedics cited fears that people would become violent on the way to hospitals.

    The 2019 death of Elijah McClain in Aurora, Colorado, put a spotlight on the practice. A paramedic convicted of giving McClain an overdose of ketamine was sentenced last month to five years in prison, and a second paramedic was sentenced to 14 months in jail and probation Friday.

    Time and time again, the AP found, agitated people who were held by police facedown, often handcuffed and with officers pushing on their backs, struggled to breathe and tried to get free. Citing combativeness, paramedics administered sedatives, further slowing their breathing. Cardiac and respiratory arrest often occurred within minutes.

    Paramedics drugged people who were not a threat to themselves or others, violating treatment guidelines. Medics often didn’t know whether other drugs or alcohol were in people’s systems, although some combinations cause serious side effects.

    Police officers sometimes suggested paramedics should give shots to suspects they were detaining, a potential abuse of their power.

    The majority of those who died had been restrained facedown in handcuffs, which can restrict breathing.

    Experts say giving sedatives to someone who is already struggling to breathe can create a risk for death, because the drugs slow the respiratory drive. If they are unable to get enough oxygen and blow off enough carbon dioxide, their hearts can stop or they can stop breathing.

    The use of sedatives by emergency medical responders outside hospitals spread rapidly over the last two decades based on a now-discredited theory. Law enforcement leaders in the 2000s were concerned by the number of people who were dying after they were shocked with police Tasers and forcibly restrained.

    They began promoting a new strategy calling for officers to view encounters with severely agitated people, including those experiencing psychotic episodes or high on drugs, as medical emergencies. Rather than use force to try to gain compliance, officers were encouraged to call emergency medical services to sedate people and transport them to hospitals.

    Supporters of this approach promoted a term to describe behavior they said put combative people at risk of sudden death: excited delirium.

    The strategy received a boost in 2009 when the American College of Emergency Physicians recognized excited delirium and urged the rapid use of ketamine, midazolam and other drugs to treat it.

    EMS agencies quickly adopted excited delirium protocols, though drugs like ketamine had not been thoroughly studied in the field. The paramedics who injected McClain with ketamine said they were following one such policy.

    Critics have argued that the concept of excited delirium shifts blame from police in the deaths. The National Association of Medical Examiners and the American College of Emergency Physicians distanced themselves from the concept in 2023.

    Deaths involving police often result in news headlines and criminal investigations that focus on the use of force by officers. But the AP investigation found that medical personnel who gave sedatives were often largely ignored.

    The use of sedatives in nearly half the deaths has not been previously reported by news outlets. Many reasons explain this lack of attention.

    Police narratives omit the use of sedatives due to medical privacy concerns. EMS treatment records are not subject to public records laws. Medical examiners view sedatives as treatments and rarely cite them as contributing factors in deaths. Investigators are unknowledgeable about the role sedatives play and uninterested in diving into the complicated details.

    ___

    Associated Press researcher Rhonda Shafner contributed from New York.

    ___ The Associated Press receives support from the Public Welfare Foundation for reporting focused on criminal justice. This story also was supported by Columbia University’s Ira A. Lipman Center for Journalism and Civil and Human Rights in conjunction with Arnold Ventures. Also, the AP 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.

    ___

    Contact AP’s global investigative team at Investigative@ap.org or https://www.ap.org/tips/

    ___ This story is part of an ongoing investigation led by The Associated Press in collaboration with the Howard Center for Investigative Journalism programs and FRONTLINE (PBS). The investigation includes the Lethal Restraint interactive story, database and the documentary, “Documenting Police Use Of Force,” premiering April 30 on PBS.

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  • Dozens of deaths reveal risks of injecting sedatives into people restrained by police

    Dozens of deaths reveal risks of injecting sedatives into people restrained by police

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    Demetrio Jackson was desperate for medical help when the paramedics arrived.

    The 43-year-old was surrounded by police who arrested him after responding to a trespassing call in a Wisconsin parking lot. Officers had shocked him with a Taser and pinned him as he pleaded that he couldn’t breathe. Now he sat on the ground with hands cuffed behind his back and took in oxygen through a mask.

    Then, officers moved Jackson to his side so a medic could inject him with a potent knockout drug.

    “It’s just going to calm you down,” an officer assured Jackson. Within minutes, Jackson’s heart stopped. He never regained consciousness and died two weeks later.

    Jackson’s 2021 death illustrates an often-hidden way fatal U.S. police encounters end: not with the firing of an officer’s gun but with the silent use of a medical syringe.

    The practice of giving sedatives to people detained by police has spread quietly across the nation over the last 15 years, built on questionable science and backed by police-aligned experts, an investigation led by The Associated Press has found. Based on thousands of pages of law enforcement and medical records and videos of dozens of incidents, the investigation shows how a strategy intended to reduce violence and save lives has resulted in some avoidable deaths.

    At least 94 people died after they were given sedatives and restrained by police from 2012 through 2021, according to findings by the AP in collaboration with FRONTLINE (PBS) and the Howard Centers for Investigative Journalism. That’s nearly 10% of the more than 1,000 deaths identified during the investigation of people subdued by police in ways that are not supposed to be fatal. About half of the 94 who died were Black, including Jackson.

    Behind the racial disparity is a disputed medical condition called excited delirium, which fueled the rise of sedation outside hospitals. Critics say its purported symptoms, including “superhuman strength” and high pain tolerance, play into racist stereotypes about Black people and lead to biased decisions about who needs sedation.

    The use of sedatives in half these incidents has never been reported, as scrutiny typically focuses on the actions of police, not medics. Elijah McClain’s 2019 death in Aurora, Colorado, was a rare exception: Two paramedics were convicted of giving McClain an overdose of ketamine, the same drug given to Jackson. One was sentenced last month to five years in prison and the second faces sentencing Friday.

    It was impossible to determine the role sedatives may have played in each of the 94 deaths, which often involved the use of other potentially dangerous force on people who had taken drugs or consumed alcohol. Medical experts told the AP their impact could be negligible in people who were already dying; the final straw that triggered heart or breathing failure in the medically distressed; or the main cause of death when given in the wrong circumstances or mishandled.

    While sedatives were mentioned as a cause or contributing factor in a dozen official death rulings, authorities often didn’t even investigate whether injections were appropriate. Medical officials have traditionally viewed them as mostly benign treatments. Now some say they may be playing a bigger role than previously understood and deserve more scrutiny.

    Time and time again, the AP found, agitated people who were held by police facedown, often handcuffed and with officers pushing on their backs, struggled to breathe and tried to get free. Citing combativeness, paramedics administered sedatives, further slowing their breathing. Cardiac and respiratory arrest often occurred within minutes.

    Paramedics drugged some people who were not a threat to themselves or others, violating treatment guidelines. Medics often didn’t know whether other drugs or alcohol were in people’s systems, although some combinations cause serious side effects.

    Police officers sometimes improperly encouraged paramedics to give shots to suspects they were detaining.

    Responders occasionally joked about the medications’ power to knock their subjects out. “Night, night” is heard on videos before deaths in California, Tennessee and Florida.

    Emergency medical workers, “if they aren’t careful, can simply become an extension of the police’s handcuffs, of their weapons, of their nightsticks,” said Claire Zagorski, a paramedic and an addiction researcher at the University of Texas at Austin.

    Supporters say sedatives enable rapid treatment for drug-related behavioral emergencies and psychotic episodes, protect front-line responders from violence and are safely administered thousands of times annually to get people with life-threatening conditions to hospitals. Critics say forced sedation should be strictly limited or banned, arguing the medications, given without consent, are too risky to be administered during police encounters.

    Ohio State University professor Dr. Mark DeBard was an important early proponent of sedation, believing it could be used in rare cases when officers encountered extremely agitated people who needed rapid medical treatment. Today, he said he’s frustrated officers still sometimes use excessive force instead of treating those incidents as medical emergencies. He’s also surprised paramedics have given unnecessary injections by overdiagnosing excited delirium.

    Others say the premise was flawed, with sedatives and police restraint creating a dangerous mix. The deaths have left a trail of grieving relatives from coast to coast.

    “They’re running around on the streets administering these heavy-duty medications that could be lethal,” said Honey Gutzalenko, a nurse whose husband died after he was injected with midazolam in 2021 while restrained by police near San Francisco. “It’s just not right.”

    Jackson was standing on a truck outside a radio station on the border of the small Wisconsin cities of Eau Claire and Altoona. An employee called 911 before dawn on Oct. 8, 2021, hoping officers could shoo away a stranger who “doesn’t seem to be a threat, but not normal either.”

    Police video and hundreds of pages of law enforcement and medical records show how the incident escalated.

    An Altoona police officer met Jackson in the parking lot. Jackson appeared uneasy and paranoid, looking around and talking softly. He had taken methamphetamine, which a psychiatrist said he used to self-medicate for schizophrenia. He’d been in and out of jail and living on the streets, with frequent visits to the emergency room seeking a place to rest.

    The officer, joined by a second Altoona officer and a sheriff’s deputy, told him he could leave if he gave his name. Jackson refused.

    Police identified him through his tattoos, learning he was on probation for meth possession. They noticed the truck had minor damage and decided to arrest him.

    Jackson took off running. The officers chased Jackson, who stopped seconds later and staggered toward the first officer. Body-camera video shows she fired her Taser, its darts striking Jackson in the stomach and thigh. He screamed after the electrical shock and collapsed.

    When officers couldn’t handcuff Jackson, she fired additional darts, striking Jackson in the back as he lay on the ground. Officers from the Eau Claire Police Department forced Jackson onto his stomach to be handcuffed and restrained him in what’s known as the prone position.

    “I’m begging you to stop,” Jackson said. “I can’t breathe.”

    After a couple of minutes, officers moved him to his side and then sat him up, trying to improve his breathing.

    An officer wondered aloud whether Jackson had “excited delirium” and asked a colleague if paramedics were “going to stand around and do nothing.” He voiced approval when one arrived with ketamine, adding Jackson would not like it “when he gets poked.”

    The Eau Claire Fire Department’s excited delirium protocol advises, “Rapid sedation is the key to de-escalation!!!!!” The medic measured 400 milligrams after estimating the 6-foot-tall Jackson weighed 175 pounds, enough to immobilize someone within minutes. He injected the medicine into Jackson’s buttocks.

    Five medical experts who reviewed the case for AP said Jackson’s behavior did not appear to be dangerous enough to justify the intervention.

    “I don’t believe he was a candidate for ketamine,” said Connecticut paramedic Peter Canning, who said he supports sedating truly violent patients because they stop fighting and are sleeping by the time they get to the hospital.

    Minutes later, Jackson stopped breathing on the way to Sacred Heart Hospital. He’d suffered cardiac arrest and, after he was resuscitated, had no brain function.

    Jackson’s mother, Rita Gowens, collapsed while shopping at an Indiana Walmart when she learned her oldest son was hospitalized and not expected to survive.

    Gowens rushed to the hospital 500 miles away, where she was told he’d been injected with ketamine. She searched online and was stunned to read it’s used to tranquilize horses.

    Gowens spoke to Jackson, held his hand and hoped for a miracle. She eventually agreed to remove him from a ventilator after his condition didn’t improve, singing into his ear as he took his final breaths: “You’ve never lost a battle, and I know, I know, you never will.”

    She still has nightmares about how police and medics treated her son, whom she recalls as a happy boy with chunky cheeks that inspired the nickname “Meatball.” There are few days when she doesn’t ask, “Why did they give him an animal tranquilizer?”

    The practice of using ketamine to subdue people outside hospitals began in 2004 when a disturbed man scaled a fence, cut himself with a broken bottle and paced along a narrow strip of concrete on a Minneapolis highway bridge.

    The man was in danger of falling into traffic below when officers reached through the fence and grabbed him.

    Dr. John Hick, who worked with first responders, heard the emergency radio chatter while driving and rushed to the scene with an idea. Hick gave the man two shots of ketamine, started an IV and kept him breathing with an air mask.

    The man stopped struggling, and responders lowered him to safety.

    Paramedics had occasionally used other sedatives to calm combative people since the 1980s. Hick and his Hennepin County Medical Center colleague Dr. Jeffrey Ho believed ketamine worked faster and had fewer side effects, showing promise to avert fatal police encounters.

    Ho was a leading researcher on Taser safety and an expert witness for the company in wrongful death lawsuits. In a 2007 deposition in one such case, he argued for a potentially “life-saving tactic” of having sedative injections quickly follow Taser shocks, saying the combination could shorten struggles that, if prolonged, might end in death.

    Some doctors at his public hospital in Minneapolis were using “something called ketamine, which is an analog to LSD,” he said. “It’s sort of an animal tranquilizer.”

    The drug became more common outside the hospital in 2008 when Hennepin County paramedics were given permission to use it.

    An American College of Emergency Physicians panel that included Ho said in 2009 that ketamine had shown “excellent results and safety” while acknowledging no research proved it would save lives.

    In time, its use became standard from Las Vegas to Columbus, Ohio, to Palm Beach County, Florida. The earliest death involving ketamine documented in AP’s investigation came in 2015, when 34-year-old Juan Carrizales was injected after struggling with police in the Dallas suburb of Garland, Texas.

    Shortly after ketamine became authorized for such use in Arizona in 2017, deputies who were restraining David Cutler facedown in handcuffs in the scorching desert asked a paramedic to sedate him.

    The medic testified he was surprised when Cutler stopped breathing, although the dose was larger than recommended for someone weighing 132 pounds. He said he had been trained that ketamine didn’t impact respiration. Cutler’s death was ruled an accident due to heat exposure and LSD — though that was disputed by experts hired by Cutler’s family, who said heat stroke along with ketamine caused his death.

    In Minneapolis, an oversight agency found the use of ketamine during police calls rose dramatically from 2012 through 2017 and body-camera video showed instances of officers appearing to pressure paramedics to use ketamine and joking about its power. The department told officers they could never “suggest or demand” the use of sedation.

    Facing criticism, Hennepin Healthcare halted a study examining the effectiveness of ketamine on agitated patients. The Food and Drug Administration later found the research failed to protect vulnerable, intoxicated people who had not given consent.

    By 2021, the American College of Emergency Physicians warned ketamine impacted breathing and the heart more than previously believed.

    “Ketamine is not as benign as we might have hoped it to be,” a co-author of the new position, Dr. Jeffrey Goodloe, said on the group’s podcast in 2022.

    He said the practice of giving large doses of ketamine, sometimes too much for smaller patients, had spread nationwide as agencies copied each other’s protocols with little independent review.

    But the AP’s findings show risks of sedation go beyond ketamine, which was used in at least 19 cases.

    Roughly half of the 94 deaths documented by the AP came after the use of midazolam, which has long been known to heighten the risk of respiratory depression. Many came during police encounters in California, where ketamine is not widely used. Midazolam, a common pre-surgery drug known by the brand name Versed, is also part of a three-drug cocktail used in some states to execute prisoners.

    Other cases involved a range of other drugs, including the antipsychotic medications haloperidol and ziprasidone, which can cause irregular heartbeats.

    The need for monitoring side effects is often laid out for paramedics in written guidelines, many of which are based on the disputed belief that excited delirium can cause sudden death.

    The theory of excited delirium was troubling from the start.

    In the 1980s, with cocaine use soaring, Dr. Charles Wetli, a Miami forensic pathologist, coined the term to explain a handful of deaths of violent cocaine users, many of whom had been restrained by police. Wetli, who died in 2020, also blamed excited delirium for the mysterious deaths of more than a dozen Black women. He said cocaine and sexual activity triggered the fatal condition.

    The women’s deaths eventually were attributed to a serial killer. Wetli’s theory survived. And over time, symptoms described by Wetli and others — “superhuman strength,” animal-like noises and high pain tolerance — became disproportionately assigned to Black people. The terms spread to police and emergency medical services to describe certain agitated people — and explain sudden deaths.

    By the mid-2000s, police were encountering more drug users and mentally ill people as stimulant use increased and psychiatric hospitals closed. Departments adopted Tasers as a less-lethal alternative to firearms, but there was a problem — hundreds died after being jolted.

    Supporters of Wetli’s research, including the medical examiner in Miami-Dade County, ruled again and again that excited delirium was the cause of these deaths, not the effects of the weapons and other physical force. Executives at Taser’s manufacturer agreed, promoting excited delirium to medical examiners around the country and retaining experts who explained the concept to juries in wrongful death lawsuits.

    In 2006, a grand jury that investigated Taser-related deaths in Miami-Dade recommended an untested treatment that it said could save people before they died from excited delirium: squirting midazolam up their noses to cause “almost immediate sedation.” Its report acknowledged they “may experience difficulty in breathing.” Miami-Dade paramedics adopted this treatment.

    But key medical groups didn’t recognize excited delirium, and activists were calling for limits on Taser use. What happened next would help promote sedation alongside Tasers as tools to gain control.

    In 2008, the biggest names in excited delirium research gathered at a Las Vegas hotel for a three-day meeting organized by a group with ties to Taser’s manufacturer.

    “A lot of talk took place on chemical sedation because the cops didn’t know what to do with these people,” recalled John Peters, president of the Institute for the Prevention of In-Custody Deaths, which sponsored the meeting. “Jeff Ho had done some work up in Minnesota. He said, ‘Look. I’ve been using ketamine. It knocks them out quicker.’”

    The timing was fortuitous: The American College of Emergency Physicians would soon form a task force to study excited delirium and how police and medics should respond.

    The 19-member panel included Ho, who became Taser’s medical director under an arrangement in which the company paid part of his hospital salary; Dr. Donald Dawes, a Taser research consultant; and University of Miami researcher Deborah Mash, who testified for Taser about several deaths she blamed on excited delirium. At least two other panelists were routinely retained by officers and their departments as expert witnesses.

    The panel’s 2009 paper disclosed none of these relationships. It found excited delirium was real, could result in death regardless of whether someone was shocked with a Taser and called for “aggressive chemical sedation” to treat the symptoms.

    DeBard, the now-retired Ohio doctor who chaired the panel, told AP he recruited relevant experts to join and that disclosure of conflicts wasn’t required by the ER doctors group then. He said Taser didn’t influence the outcome, which reflected the panel’s consensus. Mash said she had no conflict because Taser didn’t fund her research. Dawes declined an interview request. Ho didn’t return messages.

    Taser rebranded itself in 2017 as Axon. A spokesperson for the company declined interview requests and did not respond to written questions.

    Dr. Brooks Walsh, an emergency physician in Connecticut who was not on the panel, said the 2009 paper reinforced racial bias as it formalized “loaded terms” used to describe excited delirium, influencing how the diagnosis would be applied.

    Ho and other Taser- and police-aligned experts joined a federally sponsored panel in 2011 that built on the work, recommending four actions on a checklist for officers and paramedics: Identify excited delirium symptoms; control (with a Taser if necessary); sedate; and transport to a hospital.

    No test measures for excited delirium, so paramedics faced a judgment call: Which patients were so agitated, strong, impervious to pain and dangerous that they needed to be sedated?

    DeBard said the symptoms were based on medical observations, not race. “If you’ve got somebody that’s delirious, irrational, aggressive, hyperactive, running around naked, I mean, it’s really pretty easy” to recognize, he said.

    Yet, over time, prominent medical groups and some experts pointed to overuse of sedation during police encounters and a disproportionate impact on Black people. Even supporters of the practice have acknowledged that the wrong patients at times have been injected.

    The deaths of Black men in police custody, including the 2020 killing of George Floyd, put pressure on the medical community to re-examine excited delirium. The ER doctors group in 2023 withdrew approval of the 2009 paper and said excited delirium shouldn’t be used in court testimony. Some doctors called that decision political and note the group still recognizes a similar condition — hyperactive delirium with severe agitation — that can be treated with sedation. But today no major medical association legitimizes excited delirium.

    In more than a dozen cases reviewed by AP, police asked for or suggested the use of sedatives, calling into question whether medics were working for law enforcement or in patients’ interests. Officers often suggested their detainees had excited delirium.

    University of California, Berkeley, law and bioethics professor Osagie Obasogie, who has studied excited delirium and sedation, said officers should be banned from influencing medical care.

    “We need to be sure that folks are treated in a way that meets their medical needs and not simply given a chemical restraint because it’s convenient for law enforcement,” he said.

    Officers are told not to dictate medical treatment but “some knuckleheads” have done otherwise, said Peters, whose group hosted the 2008 Las Vegas meeting that focused on excited delirium.

    Paramedics say they make medical decisions independently from police, following guidelines that call for sedating people who may be dangerous. But in several cases AP found, people were injected though they had calmed down or even passed out after struggles with police.

    Ivan Gutzalenko, a 47-year-old father, was struggling to breathe as two officers restrained him in Richmond, California. Gutzalenko told the officers they were hurting him, and bucked to try to get one off his back.

    A paramedic viewed Gutzalenko’s action as aggression, and went to his ambulance to get a 5-milligram dose of midazolam. When he returned three minutes later, Gutzalenko lay motionless. “He’s faking like he’s unconscious,” an officer said.

    The medic plunged the needle into his bicep. Gutzalenko’s heart stopped. He was declared dead at a hospital. A pathologist testified that midazolam was given to “quiet him down” during an episode of excited delirium but did not contribute to the death, which he blamed on prone restraint and meth use.

    His wife said Gutzalenko, a former critical care nurse, would never have consented to receive midazolam that day.

    “I know from being a registered nurse since 2004, you don’t administer a sedative to someone who is clearly already in respiratory distress,” she said, adding that his death has been devastating to their two teenage children.

    Dr. Gail Van Norman, a University of Washington professor of anesthesiology and pain medicine, said it’s dangerous for officers to put pressure on the backs and necks of detainees before and after they’re injected with sedatives.

    “It’s a recipe for disaster, because you may have created a situation in which you are impeding a person’s ability to get oxygen,” she said.

    The AP investigation found half who died following sedation had been shocked with a Taser and the majority had been restrained facedown.

    Their blood acid levels may already have been spiking from drugs, adrenaline and pain while oxygen levels may have been plummeting — life-threatening conditions called acidosis and hypoxia.

    Sedatives can dull the instinct to compensate by breathing quickly and heavily to blow off carbon dioxide, essential for the heart to beat, said Dr. Christopher Stephens, a UTHealth Houston anesthesiologist and former paramedic.

    Under sedation, he said, the body doesn’t respond as efficiently to the buildup of carbon dioxide. “Your brain doesn’t care as much about it,” Stephens said. “And they can go into respiratory and cardiac arrest.”

    Paramedics usually have no idea whether their patients have alcohol, opioids or other depressants in their bodies that increase sedatives’ effects on breathing.

    More than a dozen who died had been drinking, including Jerica LaCour, 29, a Colorado Springs, Colorado, mother of five young children.

    She was stressed about family finances, husband Anthony LaCour recalled, when deputies found her trespassing at a trucking company.

    “Guess who gets ketamine?” paramedic Jason Poulson of AMR, the nation’s largest ambulance company, said as LaCour was restrained on a gurney, according to body-camera footage.

    An EMT said in a report that she told Poulson that LaCour had calmed and didn’t need ketamine, and later warned that LaCour was no longer breathing. In a disciplinary agreement with state regulators, Poulson admitted he was unsuccessful in protecting LaCour’s airway despite multiple attempts, mishandled the syringe and failed to document the ketamine use properly. His state certification was put on probation.

    AMR and Poulson denied responsibility for LaCour’s death in court filings, arguing LaCour was experiencing excited delirium and ketamine was appropriate. This week they settled a long-pending wrongful death lawsuit, LaCour family attorney Daniel Kay said Friday. He said the settlement amount was confidential and the proceeds would help her children. AMR didn’t immediately respond to a request for comment and a man who answered a cellphone number listed for Poulson hung up on a reporter.

    When people died, the use of sedation often went unacknowledged publicly and unquestioned by investigators.

    After Jackson’s death in Wisconsin, police press releases said nothing about ketamine. State police redacted mention of the drug from investigation records and blurred video of the prone restraint and injection, saying his family’s privacy outweighed the public interest in disclosure.

    The fire department, which declined comment, blacked out the information in its incident report. But when AP uploaded the document, redactions disappeared, revealing Jackson was given 400 milligrams of ketamine.

    An autopsy concluded Jackson died from complications caused by meth. The report said Jackson’s ketamine dose was 100 milligrams, a quarter of what the fire department report said.

    Two longtime forensic pathologists who reviewed the case for AP said meth use wasn’t the only factor. Dr. Joye Carter said she believed the police altercation and ketamine caused the death, saying the sedative can cause heart problems when given to a meth user.

    Dr. Victor Weedn said the level of meth in Jackson’s blood was high but generally not lethal. He said Jackson likely died from high blood acid levels, with police restraint and possibly ketamine contributing.

    The autopsy was performed in Ramsey County, Minnesota. A county spokesperson defended the findings from a now-retired medical examiner, saying the discrepancy on the ketamine dose wasn’t significant.

    Citing the autopsy’s finding that meth was the cause, Eau Claire County District Attorney Peter Rindal ruled Jackson’s case was not an “officer-involved death” under Wisconsin law and closed the investigation.

    In nearly 90% of the deaths examined by AP, coroners and medical examiners did not list sedation as a cause or contributing factor. Some autopsy reports failed to document that the deceased had been sedated.

    The most common ruling was an accidental death in which other drugs, often meth or cocaine, were causes or contributing factors. More than a quarter were at least partially attributed to excited delirium.

    Medical examiners view sedatives as safe treatments to control patients and wouldn’t question their use unless there was a grievous error, said Dr. James Gill, the chief medical examiner of Connecticut and past president of the National Association of Medical Examiners.

    “Generally we’re going to default then back to what’s the underlying disease or injury that started this chain of events,” Gill said.

    He said sedatives rarely cause deaths by themselves but additional studies could look at whether they play a role in fatal police struggles where many factors are involved.

    Even when autopsies implicated sedatives, investigations didn’t always follow.

    In LaCour’s case, the coroner found she died from “respiratory arrest associated with acute alcohol and ketamine intoxication.” The district attorney’s office said it had no record of reviewing her death.

    Nine miles from LaCour’s injection, a paramedic injected 26-year-old Hunter Barr with ketamine as officers held him facedown in the dirt outside his Colorado Springs home in September 2020.

    Retired postal worker Mark Barr had called 911 for help controlling his son, who he said wasn’t violent but was having a bad reaction to LSD. He watched as a medic gave two injections just minutes apart. He said he couldn’t figure out why the second injection was necessary, saying his son was subdued. Hunter Barr became unconscious on the way to a hospital and died within hours.

    The coroner ruled Barr died from the effects of ketamine. The Colorado Springs Police Department closed the case as “non-criminal” and the DA’s office again had no review.

    When deaths were investigated, inquiries usually focused on whether police used excessive force. In audio and video reviewed by AP, investigators seemed uninterested in how sedation may have contributed.

    “I’m not trying to get in the weeds with a whole bunch of that,” an investigator told a paramedic explaining the ketamine injection he gave 18-year-old Giovani Berne before Berne’s heart stopped in Palm Bay, Florida, in 2016.

    Berne’s sister, Christina, said the family didn’t know he had been given ketamine until contacted by AP years later, but “we knew something bad happened in the ambulance.” A medical examiner ruled that Berne died of excited delirium.

    The death of McClain, 23, in Colorado is the only one that resulted in charges against paramedics. Prosecutors argued Aurora paramedics Jeremy Cooper and Peter Cichuniec didn’t assess McClain, gave him too much ketamine for someone his size and didn’t monitor him afterward.

    Their convictions shook the EMS field, whose leaders say treatment mistakes shouldn’t be criminalized. Defense attorneys argued the paramedics followed their training on excited delirium and ketamine. A judge gave Cichuniec five years in prison while Cooper is scheduled to be sentenced Friday.

    Civil liability is also rare, in part because deaths have multiple causes and some courts have ruled that unwilling injections aren’t excessive force even when they cause harm. That hasn’t stopped families from trying: A number of wrongful death lawsuits involving sedation are pending.

    Lawmakers in Colorado banned excited delirium as a justification for using ketamine and put other restrictions on the drug, but changes in the law elsewhere have been few.

    Paramedic reformers are working to address the failures that increase the risk of sedatives contributing to deaths.

    Paramedic Eric Jaeger helped rewrite New Hampshire’s protocols and, at a fire station in Hooksett, recently used Jackson’s death as a training scenario after evaluating the case for AP. He questioned whether sedation was necessary. He said medics failed to thoroughly evaluate Jackson and should have had monitoring equipment ready before any injection.

    He said he had been aware of a handful of deaths but the number found by AP “dramatically increases” the scope.

    “If we don’t change the training, change the protocols, change the leadership to make the system safer,” Jaeger said, “then we all bear responsibility for future deaths.”

    ___

    Associated Press researcher Rhonda Shafner contributed from New York.

    ___

    The Associated Press receives support from the Public Welfare Foundation for reporting focused on criminal justice. This story also was supported by Columbia University’s Ira A. Lipman Center for Journalism and Civil and Human Rights in conjunction with Arnold Ventures. Also, the AP 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.

    ___

    Contact AP’s global investigative team at Investigative@ap.org or https://www.ap.org/tips/

    ___ This story is part of an ongoing investigation led by The Associated Press in collaboration with the Howard Center for Investigative Journalism programs and FRONTLINE (PBS). The investigation includes the Lethal Restraint interactive story, database and the documentary, “Documenting Police Use Of Force,” premiering April 30 on PBS.

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  • PillSafe Spearheads Solutions to Opioid Crisis With Revolutionary Technology

    PillSafe Spearheads Solutions to Opioid Crisis With Revolutionary Technology

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    Government and industry have tried and failed to stem the overdose epidemic for more than two decades. Open-source PillSafe Technologies offer hope.

    About 1.2 million people will die from opioid overdoses in the United States and Canada this decade, demonstrating the urgent need for a solution to the drug epidemic. The PillSafe Bottle is the culmination of five patented feature sets that together create a “smart” pill delivery system to ensure patients take medications safely and as prescribed by their physician.

    Opioids are a class of drugs used to control pain, including oxycodone (OxyContin, Percocet), hydrocodone (Vicodin, Norco), fentanyl, morphine, and others. The illegal drug heroin also is an opioid.   

    Because of aggressive marketing of these controlled substances, ineffective regulations and a trend of physicians placing more emphasis on treating pain, U.S. opioid use has soared. Americans, just 5% of the world’s population, consume 80% of the world’s opioid supply and 90% of the hydrocodone supply. Since the late 1990s, opioid overuse has become a crisis: overdose deaths doubled from 2000 to 2010 and then tripled from 2010 to 2020. More than 80,000 Americans died from opioid overdoses in 2021.  

    Dr. John Barr created PillSafe in response to two decades of efforts by pharmaceutical companies and the U.S. Food and Drug Administration to stem the opioid epidemic. That response began with pushing for labeling changes on OxyContin as early as 2001, and as late as December 15, 2023, the FDA is still implementing labeling requirements for immediate-release and extended-release opioid painkillers. Debate over safer forms of opioids has continued for decades.  

    Barr cites, in particular, the focus of pharmaceutical companies and the FDA on developing “abuse deterrent formulations” (ADFs) of opioid painkillers. The process began in 2013 and continues today, but after more than a decade, the effectiveness of those formulations in preventing abuse is still unproven, Barr said.   

    The failed market and regulatory response left Barr determined to find a better solution.   

    “PillSafe can help protect patients and offers a safer way to deliver medication in the healthcare and drug manufacturing industries,” Barr said. “The way our technology works is that every pill stays within the confines of our system, and that has the potential to save lives from drug abuse.”  

    The PillSafe medication delivery system secures medications at the source.  

    The pharmacist inserts the medication into the PillSafe container, snaps the lid in place, and programs the bottle to deliver the proper dosage on the precise schedule set by the doctor. Each PillSafe bottle has a unique, preset three-digit access code that the patient enters to dispense the medication at the time intervals set by the physician. The patient presses down on the lid and rotates it clockwise to access the medication. Then the device is locked again, and the countdown timer restarts for the next dose.  

    An electronic net inside each PillSafe container can detect any breach attempt. PillSafe can be programmed to destroy the medication or notify the physician or the pharmacy to confirm compliance. The PillSafe container is single-use and disposable.  

    “We created PillSafe to keep patients safe, by ensuring they comply with their doctor’s orders,” Barr said. “This is an innovative technology that can battle the opioid epidemic on the front lines and provide a solution that has been elusive for more than 20 years.”  

    For more information, please visit https://pillsafeprotection.com/.  

    About PillSafe  

    PillSafe is a pioneering “smart” open technology consisting of five patented feature sets that uniquely impact compliance, the standard of care and the managed delivery of additive medications. In recognizing the potential for numerous solutions to this challenge, the PillSafe Team is offering its technology to all interested parties, from manufacturing to medical, software and product producers, to insurance and the government. PillSafe technology provides an opportunity for packaging manufacturers and pharmaceutical companies to lead the industry in designing truly child-resistant senior-friendly (CRSF) packaging for medicines.   

    PillSafe technology as a delivery tool helps the doctor manage pain effectively, identify issues, confirm compliance, and prevent misuse and abuse. PillSafe technology is a protection against counterfeit drugs, utilizing a secure tamper-proof, adult-proof bottle, that cannot be duplicated by nefarious pill-mills. Cities, counties, and states can verify that medications have arrived safely to the intended recipient, aiding in the accuracy of the required governmental reporting.   

    Now more than ever, the medical community and government must think of out-of-the-box solutions to achieve better results. PillSafe Technology offers advantages that can make a significant difference at many levels. For more detailed information and a demonstration of PillSafe Technologies, contact the PillSafe team at https://pillsafeprotection.com/.   

    Source: PillSafe

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  • The Ozempic Revolution Is Stuck

    The Ozempic Revolution Is Stuck

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    Millions more Americans are now eligible for obesity drugs. But the injections remain maddeningly hard to find.

    Illustration by The Atlantic. Source: Getty.

    The irony undergirding the new wave of obesity drugs is that they initially weren’t created for obesity at all. The weight loss spurred by Ozempic, a diabetes drug in the class of so-called GLP-1 agonists, gave way to Wegovy—the same drug, repackaged for obesity. Zepbound, another medication, soon followed. Now these drugs have a new purpose: heart health.

    On Friday, the FDA approved the use of Wegovy for reducing the risk of heart attack, stroke, and death in adults who are overweight and have cardiovascular disease. The move had been anticipated since the publication of a landmark trial in the fall, which showed the drug’s profound effects on cardiovascular  health. The decision could usher in a new era where GLP-1 drugs become mainstream, opening up access to millions of Americans who previously didn’t qualify for Wegovy.

    Some of the obstacles stopping people from getting the drug may also begin to crumble. Insurance companies commonly deny coverage of Wegovy because obesity is seen as a cosmetic concern rather than a medical one, but that argument may not hold up for cardiovascular disease. “This new FDA indication is HUGE,” Katherine Saunders, an obesity-medicine physician at Weill Cornell Medicine, told me in an email. Wegovy may soon be within reach for many more Americans—that is, if they can find it.

    In practice, Wegovy is maddeningly hard to get hold of. Shortages of injectable semaglutide, the active ingredient in Wegovy and Ozempic, have been ongoing since March 2022; currently, most doses of Wegovy are in limited supply. As the popularity of semaglutide has skyrocketed, demand has completely outstripped the capacity of its manufacturer, Novo Nordisk. The drug comes in injection pens containing a glass vial; “these are not easy products to make,” Lars Fruergaard Jørgensen, the CEO of Novo Nordisk, said in August. In response to the shortages, the company withheld its supply of lower Wegovy doses last year. Because treatment on the medication must begin in low doses, this meant that new patients who wanted to start on Wegovy functionally couldn’t. In January, the company began “more than doubling the amount of the lower-dose strengths” of the drug, a Novo Nordisk spokesperson told me, and it plans to gradually increase overall supply throughout the rest of the year.

    The ongoing shortages have left providers and patients feeling stuck. “It is devastating to prescribe a lifesaving medication for a patient and then find out it’s not covered or we can’t locate supply,” Saunders said. Doctors are scrambling to make do with what’s available. Ivania Rizo, an endocrinologist at Boston Medical Center, told me she has had to turn to older GLP-1 drugs such as Saxenda to “bridge” patients to higher doses of Wegovy, although now that is in shortage too. Patients can spend each day calling pharmacy after pharmacy in search of one with Wegovy in stock, Rizo said. In desperation, some have turned to versions of the drug that are custom-made by compounding pharmacies with little oversight, despite the FDA expressing concerns about them. The shots are supposed to be taken weekly, but others have attempted to stretch their doses beyond that.

    That the new FDA approval could very mainstream obesity drugs may create long-needed pressure to help resolve these shortages. It makes clear that Wegovy is a lifesaving medication not only for people with obesity but also for those with cardiovascular disease—the leading cause of death in the U.S.—putting the impetus on Novo Nordisk to ramp up production. But in the short term, the access issues may persist. “The new approval is very likely to worsen shortages, because the demand for Wegovy will continue to climb—now at an even faster pace,” Saunders said.

    If patients think they’re stuck now, they’re about to feel entrenched. Wegovy is the only obesity drug that has been approved to reduce the risk of heart attacks, but none of its competitors is easily available either. Supplies of certain dosages of Eli Lilly’s Mounjaro, a diabetes drug whose active ingredient is sold for obesity as Zepbound, are limited, and shortages are expected later this year. “We need supply to increase dramatically,” Saunders said. Both Novo Nordisk and Eli Lilly have invested heavily in expanding production capacity, but some of the new plants won’t open until 2029.

    For all of its advantages, the FDA approval has a sobering effect on the unrelenting hype around GLP-1s. So much of the excitement around obesity drugs has focused on the future, as dozens of pharmaceutical companies develop more powerful drugs, and commentators imagine a world without obesity. In the process, the issues of the present have gone overlooked. More drugs won’t make much of a difference if the drugs themselves are out of reach.

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    Yasmin Tayag

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  • ‘Very aggressive treatment’ on the streets of Skid Row from a renegade M.D.

    ‘Very aggressive treatment’ on the streets of Skid Row from a renegade M.D.

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    The team gathered at 4th and Crocker streets and headed south, into the blue-tented netherworld of social collapse, armed with life-saving drug-overdose kits and injectable, long-acting anti-psychotic medication.

    “We’re trying very aggressive treatment on the streets,” said Dr. Susan Partovi. “Housing definitely saves your life, but there’s a small sub-group of people who won’t accept housing because of their mental illness.”

    She figures that if she administers medication that lasts a month and can help stabilize patients — with their consent — they’ve got a chance.

    “They don’t think there’s anything wrong, and they think they don’t need housing,” Partovi said. “They don’t think rationally, and so once you treat their delusions and their irrationality, they start to realize, ‘Oh, I do need resources.’ ”

    California is about to be hit by an aging population wave, and Steve Lopez is riding it. His column focuses on the blessings and burdens of advancing age — and how some folks are challenging the stigma associated with older adults.

    Partovi, who began practicing street medicine in 2007 in Santa Monica, has never been shy about her lack of patience with the official response to the entrenched humanitarian crisis. In 2017, I shadowed her as she walked through Skid Row with County Supervisor Kathryn Barger, advocating for broader authority to assist those in obvious acute mental and physical distress, even if they refused help, and despite opposition from civil rights attorneys and others.

    By administering long-acting meds, Partovi—author of the just-published “Renegade M.D.: A Doctor’s Stories From the Streets”—is once again pushing boundaries. She’s acting out of a belief that her approach is medically sound, and with frustration sharpened by her street-level view of the countless bureaucratic cracks and canyons in the system. She’s driven, too, by an uncompromising compassion for homeless people who are so sick, she can sometimes predict who will die next.

    Critics might say a person in the throes of impairment isn’t competent to give consent for a month-long dose of medication, and that such meds are neither a panacea nor a substitute for intensive ongoing case management. But to Partovi, the slow pace of intervention — along with multiple daily deaths on the streets — add up to a human rights violation and a moral failure, so she’s stepping into the breach.

    But she’s not a psychiatrist, and her street medicine team’s approach is not fully embraced by the L.A. County Department of Mental Health. DMH has psychiatric street medicine teams operating in several parts of the county. The Skid Row unit —which is led by Dr. Shayan Rab and injcludes psychiatric nurses, social workers and addiction counselors, and sometimes conducts sidewalk court hearings for those who resist treatment — was featured in a September 2022 article by my colleague Doug Smith.

    Sally Flores waits to receive medical attention from outreach workers with Substance Use Disorder Integrated Services.

    Dr. Susan Partovi, left, and Dr. Steven Hochman talk to a woman during their medical outreach.

    (Genaro Molina / Los Angeles Times)

    Dr. Curley Bonds, chief medical officer of the department, says DMH psychiatrists first establish a working relationship with the client and invest time in determining a clinical history, including prescribed medications and dosage. It can be difficult, he said, to distinguish between psychosis and the effects of street drugs like methamphetamine, but trained psychiatrists have an advantage over doctors with other specialties. Treatment would ordinarily begin with short-term oral medication, Bonds said, to establish the “efficacy and tolerability of the agent.”

    Only then would long-acting injectables be an option, he continued, but even then, the civil rights of the patient would have to be a consideration.

    “We are more cautious about making sure there is informed consent and … we really want to respect a person’s autonomy for decision-making,” Bonds said. Despite procedural differences and quibbles over the Partovi team’s approach, Bonds added, “I don’t want to put us at odds with them … because what they are doing is important work.”

    A glance at the reality on the streets of Los Angeles makes clear that far more help and substantially greater urgency are badly needed. And Partovi is not alone in practicing what she calls “low barrier bridge psychiatry.”

    Dr. Coley King, director of homeless healthcare at the Venice Family Clinic, is not a psychiatrist, either. But as a street medic in L.A., the national capital of homelessness, he works in what is essentially an outdoor mental hospital, with tents instead of beds. King treats mental illness and whatever else he sees — and what, often, no one else is treating.

    He told me he has used both short-term and long-term anti-psychotics, depending on the situation. The risks posed by medication are not as great, he said, as the risk of being homeless, sick and untreated.

    “The need is so dire, and the patients are dying at such a young age, and the lack of available psychiatry is so marked,” said King, who leads a street medicine team through Westside streets four days a week and often works with a psychiatric nurse practitioner. “We’re not doing this in any sort of cavalier fashion. We’re doing it very thoughtfully with a mind to knowing our medications and knowing our diagnosis and treatment are based on a ton of experience and a lot of exposure to working side-by-side with psychiatrists in the field.”

    In 2020, I wrote about a formerly homeless Santa Monica woman whose life had been turned around after King treated her for her addiction and physical and mental ailments. The treatment included a long-acting injection the woman agreed to, and when I met her, she was living in a hotel before moving into housing arranged by the outreach team.

    ::

    When I met with Partovi last month on Skid Row, her team consisted of Dr. Steven Hochman, an addiction specialist; David Dadiomov, director of USC’s psychiatry pharmacy program; and social worker Sylvia Meza. It was Meza who established this nonprofit outreach team — it’s called SUDIS, for Substance Use Disorder Integrated Services — and brought in Partovi as medical director last year.

    Overdose bags contain Naloxone, a medication designed to reverse an opioid overdose, were distributed.

    Overdose bags contain Naloxone — a medication designed to reverse an opioid overdose — fentanyl strips to detect the presence of fentanyl and reading materials about avoiding overdose.

    (Genaro Molina / Los Angeles Times)

    As someone who works the aging beat, I was struck by how many of the people we encountered were late middle age and beyond. Partovi estimated that about 50% of the people served by the team are 50 and older.

    “They got caught up in Skid Row when they were young and were never able to get out of it,” Meza said. “Skid Row is like bondage. People are trapped in there. They have this poverty mentality where they feel like they can’t get out, but they can. It’s just about motivating them to see the cup as half full and not half empty.”

    A gray-haired man crossed the street before us, and just up ahead, 63-year-old Israel stood near a tent, not far from a woman named Diane, who said she was 60 and was caring for her two cats, Gold and Silver, along with two dogs owned by a woman who’s in jail.

    “That’s French Fry,” Partovi said as one of the dogs, a white terrier, crossed the street.

    She knew the dog’s name because that’s how outreach works— you get to know people, their routines, their histories, even their pets. Neither Diane nor Israel was interested in medication on this day, but a connection was made, the first step in building trust.

    Hochman spoke to Israel in Spanish and English, letting him know he’d be back again, and that medication was available. He told me the outreach team tries to determine a patient’s medical history, and at times does prescribe short-term medication if there are concerns about tolerability. But people often lose their daily medication, Hochman said. Or they forget to take it. Or it gets stolen, or swept away in storms or street-cleaning sweeps. A month-long dose can up the chances of turning things around.

    On Crocker Street, where the team distributed Narcan kits to slow the epidemic of overdose deaths, Meza was joking with a 68-year-old man when we noticed that Partovi, a half block away, was waving for the team to join her.

    Dr. Steven Hochman, left, Dr. Susan Partovi and Sylvia Meza check on the well-being of a man in downtown L.A.

    Dr. Steven Hochman, left, Dr. Susan Partovi and Sylvia Meza check on the well-being of a man in downtown Los Angeles.

    (Genaro Molina / Los Angeles Times)

    The doctor had spotted a woman she thought would be a candidate for an injection. Amanda, 51, said she had been diagnosed with two psychiatric conditions. She listed her most recent medications and said she wanted something to treat her depression.

    Partovi asked several questions, including whether Amanda had a history of adverse reactions. Partovi has a network of psychiatrists she can consult, but she didn’t think she needed to in this case. She informed Amanda that with the injection, she’d be medicated for a month. Amanda gave her approval.

    “I’m gonna hold your hand,” Meza said as Partovi rolled up Amanda’s sleeve and poked a syringe into the soft tissue of her right shoulder.

    “We want to do this every month,” Partovi said as Amanda grimaced from the sting.

    “Sorry, sorry, sorry, sorry, almost done,” Partovi said before adding: “OK, now you’re good.”

    Partovi said that in the best scenarios, the “word salad” dissipates, patients express themselves more clearly, and they make better decisions about recovery. “In my experience, once they get their mental health stabilized, then they want to work on substance abuse,” she said.

    I asked how she can distinguish between mental illness and the effects of drug use.

    “We’re not treating a diagnosis,” she said. “We’re treating symptoms. If someone is having psychiatric symptoms, the literature shows that whether it’s meth-related or organic schizophrenia, the anti-psychotics are going to work. That’s been my experience as well.”

    Among the homeless people of Skid Row or anywhere else, the back stories are usually long and messy narratives involving childhood trauma, domestic abuse, sexual assault, chronic disease, poverty, incarceration, a lack of affordable housing, mental illness and self-medication with increasingly dangerous street drugs.

    Amanda said she’d been homeless since 2017 after doing some jail time and that she couldn’t recall having a place of her own. Meza promised Amanda she would investigate options for housing and other services.

    “Do not lose my number,” Meza said, handing Amanda her business card. “This is my personal cell number.”

    They posed together for a photo, and then the team kept moving, getting approval for injections from two more clients over the next 20 minutes.

    I first connected with Partovi many years ago, after I’d met a homeless Juilliard-trained street musician whose career had been derailed after a diagnosis of mental illness. In full disclosure, at her request, I interviewed Partovi about her work and “Renegade M.D.” at her book-launch party last month.

    In the book — a compelling and personal front-lines look at who becomes homeless and why, complete with triumphs and tragedies and an unflinching examination of a fragmented system that is a often a barrier to recovery — Partovi says that as a Westside teenager, she traveled to a leprosy clinic in Mexico with a Christian service group and medical team. She knew then what she wanted to do with her life.

    “I made the commitment to become a doctor and focus on patients who experience the worlds of poverty and injustice,” she writes.

    In 2007, while working as a street doctor in Santa Monica, she came upon “a woman who looked to be in her 80s but was probably younger. Living on the streets ages people quickly.”

    She thought of her own grandmother, who had passed away in her 90s.

    “If my grandmother had wanted to panhandle on the Promenade in her flannel nightgown, I would have picked her up … and thrown her into my car. … I would never allow my family member to live on the streets. … Why do we, as a society, allow it?”

    steve.lopez@latimes.com

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    Steve Lopez

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  • Ozempic Can Turn Into No-zempic

    Ozempic Can Turn Into No-zempic

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    No medication in the history of modern weight loss has inspired as much awe as the latest class of obesity drugs. Wegovy and Zepbound are so effective that they are often likened to “magic and “miracles.” Indeed, the weekly injections, which belong to a broader class known as GLP-1s, can lead to weight loss of 20 percent or more, fueling hype about a future in which many more millions of Americans take them. Major food companies including Nestlé and Conagra are considering tailoring their products to suit GLP-1 users. Underlying all this excitement is a huge assumption: They work for everyone.

    But for a lot of people, they just don’t. Anita, who lives in Arizona, told me she “took it for granted” that she would lose weight on a GLP-1 drug because “the people around me who were on it were just dropping weight like mad.” Instead, she didn’t shed any pounds. Likewise, Kathryn, from Florida, hasn’t lost any weight since starting the medication in October. “I was really hoping this was something that would be a game changer for me, but it feels like it was just a lot of wasted money,” she told me. (I’m identifying both Anita and Kathryn by their first name only to allow them to speak openly about their health issues.)

    Some people can’t tolerate the side effects of the drugs and have to stop taking them. Others simply don’t respond. For some, the strength of the dose, or length of the treatment, does not seem to make a difference. Appetites might remain robust; the “food chatter” in the brain may stay noisy. Together, both groups of less successful GLP-1 users account for a not-insignificant share of patients on these drugs—potentially up to a third. “We don’t really know why it happens, [but] we know it does happen,” Louis Aronne, an obesity-medicine specialist at Weill Cornell Medical College, told me. Despite the promise of a so-called Ozempic revolution, lots of “No-zempics” have been left behind.

    Of the two biggest reasons some people don’t lose weight on GLP-1 drugs—side effects and nonresponse—the former is much more straightforward. The GLP-1 drugs Wegovy and Zepbound (which contain the active ingredients semaglutide and tirzepatide, respectively), are known for causing potentially gnarly gastrointestinal symptoms, such as nausea and vomiting, although most people’s reactions are mild and temporary. Yet some have it far worse. Severe, albeit uncommon, side effects include pancreatitis, severe gastrointestinal distress, low blood sugar, and even hair loss, which “can push people off” the drugs, Steven Heymsfield, a professor who studies obesity at Louisiana State University, told me. In one of the biggest studies of semaglutide, encompassing more than 17,000 people over about five years, nearly 17 percent of patients discontinued the medication because of side effects.

    Far more mysterious are the people who tolerate the drugs but respond weakly to them—or sometimes not at all. Researchers have known this might happen since these drugs were in early clinical trials. About 14 percent of people who took semaglutide for obesity saw minimal impacts of less than 5 percent weight loss in one study, as did 9 to 15 percent of people who took tirzepatide in a similar one. In her own experience working with patients, “somewhere between a quarter and a third” are nonresponders, Fatima Cody Stanford, an obesity-medicine specialist at Harvard, told me, adding that it can take up to three months to determine whether the drug is working or not. That the same medication at the same dosage can lead to dramatic weight loss in one person and hardly any in another “remains confounding,” Aronne told me.

    The broad explanation is that it has something to do with genetics. The drugs work by masquerading as the appetite-suppressing hormone GLP-1 and binding to its receptor, like a key fitting into a lock. Although the lock’s overall shape is generally consistent from person to person, its nooks and crannies can vary because of genetic differences. “For some people, that key just won’t fit right,” Eduardo Grunvald, an obesity-medicine doctor at UC San Diego Health, told me. In other cases, genes may limit the effects of these drugs after they bind to GLP-1 receptors. One possibility is that people metabolize the drugs differently: Some patients may break them down too quickly for them to take effect; others may process them too slowly, potentially building up such high levels of the medications that they become toxic, Heymsfield said.

    For No-zempic patients, perhaps the most consequential impact of individual variation is on the propensity for obesity itself. “We are all very different from a genetic standpoint, in terms of our risk of weight gain,” Grunvald said. Numerous factors can drive obesity, including diet, environment, stress, and—most pertinent to GLP-1 drugs—altered brain function.

    GLP-1 drugs target a pathway that regulates appetite and insulin levels. Some cases of obesity can be caused by a disruption in that particular mechanism, in which case GLP-1s can indeed be wondrous. But “not everyone has dysfunction in this particular pathway,” Stanford said. When that is the case, the drugs won’t be very effective. A different pathway, for example, controls the absorption of fat from food; another increases energy expenditure. In these people, GLP-1s might tamp down appetite to a degree, maybe leading to some weight loss, but a different drug may be required to treat obesity at its root. “It is not all about food intake,” Stanford said.

    That’s not to say that No-zempics are out of options. They might have better success switching from one GLP-1 to the other, or even stacking them, Heymsfield said. Some patients who don’t respond to GLP-1s at all can get better results with older drugs that work on different obesity pathways, Aronne said. One, called Qysmia, a combination of the decades-old drugs phentermine and topiramate, can lead to an average weight loss of 14 percent body weight at its highest dose. If medications don’t work, bariatric surgery remains a powerful option, one that may even be growing in popularity. Last year, the number of bariatric surgeries performed in the U.S. grew despite the boom in GLP-1 usage, a trend that some expect to continue, because so many people don’t tolerate the drugs.

    The intense hype around the game-changing nature of GLP-1s makes it easy to forget that they are, in fact, just drugs. “Every drug that’s ever been made” works in some people and not in others, Heymsfield said; there’s no reason to think GLP-1s would be any different. Remembering that they are in an early stage of development has a sobering effect. Eventually, obesity drugs may leave fewer people behind. The category is expanding rapidly: By one count, more than 90 new drug candidates are in development.

    They are evolving to attack obesity from multiple fronts, which, at least in theory, widens their net of potential users. In an early study on an experimental candidate named retatrutide—called a triple agonist because it acts on GLP-1 as well as two other targets involved in obesity, GIP and glucagon receptors—100 percent of people on the highest dose lost 5 percent or more of their body weight. New candidates are also expected to have fewer side effects. They have to, Heymsfield said, because the competition is so steep that any new drug has to be “as good with less side effects, or better.”

    But no matter how good these drugs get, it’s unrealistic to think that they’ll become a one-size-fits-all treatment for everyone with obesity. The disease is simply too complex, with too many drivers, for a single type of medication to treat it. More than 200 different drugs exist for treating high blood pressure alone; in comparison, Aronne said, regulating weight is “far more complicated.” The future, rife with options, holds promise that No-zempics may find a way forward. Yet considering all the unknowns about obesity and what causes it, that may not be enough to guarantee that they will see the results they want.

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    Yasmin Tayag

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  • Drug Maker Recalls ADHD Medicine Over Label Mixup | High Times

    Drug Maker Recalls ADHD Medicine Over Label Mixup | High Times

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    The U.S. Food and Drug Administration last week announced the voluntary recall of a medicine used to treat attention deficit hyperactivity disorder (ADHD) and narcolepsy after the manufacturer of the drug revealed that the wrong pills were found in packages of the medication. The recall covers one lot of the drug Zenzedi, an ADHD and narcolepsy medication manufactured by Massachusetts-based Azurity Pharmaceuticals.

    In a notice about the recall, the FDA noted that a pharmacist had reported finding pills of an antihistamine, carbinoxamine maleate, in a package of Zenzedi. The voluntary recall was announced by Azurity on January 24 and covers packages of Zenzedi 30 milligram tablets with lot number F230169A and an expiration date of June 2025.

    The recalled medication was distributed nationwide through retail pharmacies. Pharmacies and drug wholesalers have reportedly pulled the drug from their shelves to comply with the recall. Customers who purchased packages of the recalled lot of Zenzedi are urged to return any remaining pills to the place of purchase. Patients who take the mislabeled medication and have adverse reactions are encouraged to see their doctor. 

    Drugs Have Opposite Effects

    The two drugs have opposite effects when taken, according to a report from CBS News. Carbinoxamine maleate is an antihistamine that is used to treat allergies and has a sedative effect on some patients, while Zenzedi, a brand name for the drug dextroamphetamine sulfate,  is a stimulant that generally increases a patient’s attentiveness. Zenzedi is used to treat narcolepsy, a sleep disorder that causes overwhelming daytime drowsiness, and ADHD.

    The FDA added that patients who take carbinoxamine maleate instead of Zenzedi will experience undertreatment of their symptoms. Patients can also have a potentially deadly elevated risk of accidents or injuries and may have drowsiness, increased eye pressure, urinary obstruction and thyroid disorder, among other symptoms, according to the FDA’s recall notice.                                           

    “Patients who take carbinoxamine instead of Zenzedi® will experience undertreatment of their symptoms, which may result in functional impairment and an increased risk of accidents or injury,” the FDA wrote in a notice about the recall. “Patients who unknowingly consume carbinoxamine could experience adverse events which include, but are not limited to, drowsiness, sleepiness, central nervous system (CNS) depression, increased eye pressure, enlarged prostate urinary obstruction, and thyroid disorder.”

    Azurity Pharmaceuticals sent recall notification letters to drug wholesalers on January 4 via an overnight letter and has arranged for the return of all affected product at the wholesale level. The company said that no reports of serious injury have been made as a result of the mixup.   

    Recall Comes During Shortage of ADHD Meds

    The Zenzedi recall comes in the midst of a nationwide shortage of medications used to treat ADHD. The shortage has been affecting supplies of the drug Adderall since a manufacturer experienced production delays in Fall 2022, according to a report from CNN.

    At least 11 manufacturers of Adderall or generic versions of the drug were listed on the FDA’s shortage list in September 2023. The shortage of ADHD medication has left many patients struggling to fill their prescriptions, according to healthcare professionals. 

    “A lot of the young people that I’ve been treating have had difficulties getting their medications month to month,” Dr. Warren Ng, a professor of psychiatry at Columbia University Medical Center who also serves as president for the American Academy of Child and Adolescent Psychiatry, told CNN.

    When taking their prescribed medication, many patients with ADHD are able to function better. But when they run out of their medication, it can have a tremendous impact on their self-esteem.

    “I’ve seen kids who want to drop out of school, don’t want to continue with their educational path or drop out of college suddenly making the honor roll,” Ng said. And “instead of seeing, being seen as being lazy or dumb or slow, they can envision themselves really utilizing all of their mental, psychological and intellectual abilities to really see themselves for who they are, which is so much more.”

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    A.J. Herrington

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  • Consulting firm McKinsey agrees to $78 million settlement with insurers over opioids

    Consulting firm McKinsey agrees to $78 million settlement with insurers over opioids

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    Consulting firm McKinsey and Co. has agreed to pay $78 million to settle claims from insurers and health care funds that its work with drug companies helped fuel an opioid addiction crisis.

    The agreement was revealed late Friday in documents filed in federal court in San Francisco. The settlement must still be approved by a judge.

    Under the agreement, McKinsey would establish a fund to reimburse insurers, private benefit plans and others for some or all of their prescription opioid costs.

    The insurers argued that McKinsey worked with Purdue Pharma – the maker of OxyContin – to create and employ aggressive marketing and sales tactics to overcome doctors’ reservations about the highly addictive drugs. Insurers said that forced them to pay for prescription opioids rather than safer, non-addictive and lower-cost drugs, including over-the-counter pain medication. They also had to pay for the opioid addiction treatment that followed.

    From 1999 to 2021, nearly 280,000 people in the U.S. died from overdoses of prescription opioids, according to the U.S. Centers for Disease Control. Insurers argued that McKinsey worked with Purdue Pharma even after the extent of the opioid crisis was apparent.

    The settlement is the latest in a years-long effort to hold McKinsey accountable for its role in the opioid epidemic. In February 2021, the company agreed to pay nearly $600 million to U.S. states, the District of Columbia and five U.S. territories. In September, the company announced a separate, $230 million settlement agreement with school districts and local governments.

    Asked for comment Saturday, McKinsey referred to a statement it released in September.

    “As we have stated previously, we continue to believe that our past work was lawful and deny allegations to the contrary,” the company said, adding that it reached a settlement to avoid protracted litigation.

    McKinsey said it stopped advising clients on any opioid-related business in 2019.

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  • New weight loss drugs are out of reach for millions of older Americans because Medicare won't pay

    New weight loss drugs are out of reach for millions of older Americans because Medicare won't pay

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    WASHINGTON — New obesity drugs are showing promising results in helping some people shed pounds but the injections will remain out of reach for millions of older Americans because Medicare is forbidden to cover such medications.

    Drugmakers and a wide-ranging and growing bipartisan coalition of lawmakers are gearing up to push for that to change next year.

    As obesity rates rise among older adults, some lawmakers say the United States cannot afford to keep a decades-old law that prohibits Medicare from paying for new weight loss drugs, including Wegovy and Zepbound. But research shows the initial price tag of covering those drugs is so steep it could drain Medicare’s already shaky bank account.

    A look at the debate around if — and how — Medicare should cover obesity drugs:

    The Food and Drug Administration has in recent years approved a new class of weekly injectables, Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound, to treat obesity.

    People can lose as much as 15% to 25% of their body weight on the drugs, which imitate the hormones that regulate appetites by communicating fullness between the gut and brain when people eat.

    The cost of the drugs, beloved by celebrities, has largely limited them to the wealthy, A monthly supply of Wegovy rings up at $1,300 and Zepbound will put you out $1,000. Shortages for the drugs have also limited the supplies. Private insurers often do not cover the medications or place strict restrictions on who can access them.

    Last month, a large, international study found a 20% reduced risk of serious heart problems such as heart attacks in patients who took Wegovy.

    Long before Oprah Winfrey and TikTok influencers alike gushed about the benefits of these weight loss drugs, Congress made a rule: Medicare Part D, the health insurance plan for older Americans to get prescriptions, could not cover medications used to help gain or lose weight. Medicare will cover obesity screening and behavioral treatment if a person has body mass index over 30. People with BMIs over 30 are considered obese.

    The rule was tacked onto legislation passed by Congress in 2003 that overhauled Medicare’s prescription drug benefits.

    Lawmakers balked at paying high costs for drugs to treat a condition that was historically regarded as cosmetic. Safety problems in the 1990s with the anti-obesity treatment known as fen-phen, which had to be withdrawn from the market, were also fresh in their minds.

    Medicaid, the state and federal partnership program for low-income people, does cover the drugs in some areas, but access is fragmented.

    New studies are showing the drugs do more than help patients slim down.

    Rep. Brad Wenstrup, R-Ohio, introduced legislation with Rep. Raul Ruiz, D-Calif., this year that would allow Medicare to cover the now-forbidden anti-obesity drugs, therapy, nutritionists and dieticians.

    “For years there was a stigma against these people, then there was a stigma about talking about obesity,” Wenstrup said in an interview with The Associated Press. “Now we’re in a place where we’re saying this is a health problem we need to deal with this.”

    He believes the intervention could alleviate all sorts of ailments associated with obesity that cost the system money.

    “The problem is so prevalent,” Wenstrup said. “People are starting to realize you have to take into consideration the savings that comes with better health.”

    Last year, about 40% of the nearly 66 million people enrolled in Medicare had obesity. That roughly mirrors the larger U.S. population, where 42% of adults struggle with obesity, according to the Centers for Disease Control and Prevention.

    Notably, Medicare does cover certain surgical procedures to treat medical complications of obesity in people with a body mass index of 35 and at least one related condition. Congress approved the exception in 2006, noted Mark McClellan, a former head of the Centers for Medicare and Medicaid Services and the FDA.

    The 17-year-old law may provide a blueprint for expanding coverage of the new drugs, which mirror the results of bariatric surgery in some cases, McClellan said. Evidence showed that the surgery reduced the risks of death and serious illness from conditions related to obesity.

    “And that’s been the basis for coverage all this time,” McClellan said.

    Still, the upfront price tag for lifting the rule remains a challenge.

    Some research shows offering weight loss drugs would assure Medicare’s impending bankruptcy. A Vanderbilt University analysis this year put an annual price of about $26 billion on anti-obesity drugs for Medicare if just 10% of the system’s enrollees were prescribed the medication.

    Other research, however, shows it could also save the government billions, even trillions over many years, because it would reduce some of the chronic conditions and problems that stem from obesity.

    An analysis this year from the University of Southern California’s Schaeffer Center estimated the government could save as much as $245 billion in a decade, with the majority of savings coming from reducing hospitalizations and other care.

    “What we did is we looked at the long-term health consequences of treating obesity in the Medicare population,” said the study’s co-author, Darius Lakdawalla, the director of research at the center. The Schaeffer Center receives funding from pharmaceutical companies, including Eli Lilly.

    Lakdawalla said it’s nearly impossible to put a cost on covering the drugs because no one knows how many people will end up taking them or what the drugs will be priced at.

    The Congressional Budget Office, which is tasked with pricing out legislative proposals, acknowledged this difficulty in an October blog post, with the director calling for more research on the topic.

    Overall, the agency “expects that the drug’s net cost to the Medicare program would be significant over the next 10 years.”

    The cost of the legislation is the biggest hang up in getting support, Ruiz said.

    “When we talk about the initial cost, I often have to educate the members that the CBO does not take into account cost savings in their cost benefit analysis,” Ruiz told the AP. “Taking that number in isolation, one does not get the full picture of the full economies of reducing obesity and all of its comorbidities in our patients.”

    Doctors say weight loss drugs are only a part of the most effective strategies to treat a patient with obesity.

    When Dr. Andrew Kraftson develops a plan with his patients at the University of Michigan’s Weight Navigator program, it involves a “perfect marriage” of behavioral intervention, health and diet education, and possibly anti-obesity medication.

    But with Medicare patients, he is limited in what he can prescribe.

    “A blanket prohibition for use of anti-obesity medication is an antiquated way of thinking and does not recognize obesity as a disease and is perpetuating health disparities,” Kraftson said. “I’m not so ignorant to think that Medicare should just start covering expensive treatments for everyone. But there is something between all or nothing.”

    Lawmakers have introduced some variation of legislation that would permit Medicare coverage of weight loss drugs over the last decade. But this year’s bill has garnered interest from more than 60 lawmakers, from self-proclaimed budget hawk Rep. David Schweikert, R-Ariz., to progressive Rep. Judy Chu, D-Calif.

    Passage is a top priority for two lawmakers, Wenstrup and Sen. Tom Carper, D-Del., before they retire next year.

    Pharmaceutical companies also are readying for a lobbying blitz next year with the drugs getting the OK from the FDA to be used for weight loss.

    “Americans should have access to the medicines that their doctors believe they should have,” Stephen Ubl, the president of the lobbying group, Pharmaceutical Research and Manufacturers of America, said on a call with reporters last week. “We would call on Medicare to cover these medicines.”

    Already, Novo Nordisk has employed eight separate firms and spent nearly $20 million on lobbying the federal government on issues, including the Treat & Reduce Obesity Act, since 2020, disclosures show. Eli Lilly has spent roughly $2.4 million lobbying since 2021.

    Advocates for groups such as the Obesity Society have been pushing for Medicare coverage of the medications for years. But the momentum may be shifting, thanks to the growing evidence that the obesity drugs can prevent strokes, heart attacks, even death, said Ted Kyle, a policy advisor.

    “The conversation has shifted from debating whether obesity treatment is worthwhile to figuring out how to make the economics work,” he said. “This is why I now believe the change is inevitable.”

    ___

    Associated Press writers JoNel Aleccia in Temecula, California, and Brian Slodysko contributed to this report.

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  • Ozempic overdose? Poison control experts explain why thousands OD'd this year

    Ozempic overdose? Poison control experts explain why thousands OD'd this year

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    Some of those taking Ozempic or Wegovy are learning that too much of a good thing is never good.

    Semaglutide, the medication prescribed under the brand names Ozempic, for treating Type 2 diabetes, and Wegovy, for weight management, works by mimicking the hormone GLP-1, which is released by the gut after eating. The hormone has several effects in the body, such as stimulating insulin production, slowing gastric emptying and lowering blood sugar.

    It has been hailed for its weight-loss benefits, most conspicuously among celebrities. Oprah Winfrey recently said she uses weight-loss medication and lauded “the fact that there’s a medically approved prescription for managing weight and staying healthier, in my lifetime.” She said it felt “like a gift.”

    But between Jan. 1 and Nov. 30 this year, at least 2,941 Americans reported overdose exposures to semaglutide, according to a recent report from America’s Poison Centers, a national nonprofit representing 55 poison centers in the United States.

    California accounted for about 350 of the reports, or around 12%, according to Raymond Ho, the managing director of the California Poison Control System. Ho said the number roughly corresponds to the proportion of California’s population to the rest of the country.

    The nationwide number of semaglutide overdoses this year is more than double the 1,447 reported in 2022, which was more than double the 607 semaglutide overdoses reported in 2021.

    There were only 364 reported semaglutide overdoses in 2020 and 196 in 2019, less than 10% of the number that occurred so far this year.

    America’s Poison Centers released the data with a disclaimer that the figures likely represent an undercount in the number of cases involving semaglutide, as the center only included those voluntarily reported to poison control centers.

    “It is an alarming trend from a poison center perspective,” Ho said. “We get the usual dosing error calls, and all of a sudden there’s an explosion of people calling much more regularly about this.”

    The use of semaglutide and other GLP-1 imitators has surged in popularity over the last year as a quick and effective way to manage weight loss. More than 4 million prescriptions for semaglutide were issued in the United States in 2020, according to federal data, and usage of the drug has continued to grow since then.

    Dr. Stephen Petrou, an emergency medicine physician and toxicology fellow with California Poison Control, said there were multiple factors contributing to the increase in overdoses.

    “Not only is there rising social popularity” of the drug, Petrou said, “but there’s also wider FDA indications for use.”

    Semaglutide was patented by the Danish pharmaceutical company Novo Nordisk in 2012 and has been available in the United States since the FDA approved it in 2017. The drug was originally released as Ozempic for Type 2 diabetics to manage blood sugar levels. Moderate weight loss was found to be a common side effect of the drug, and the FDA approved a different formulation of semaglutide, called Wegovy, for that purpose in 2021.

    Ho and Petrou said the different formulations of semaglutide could help explain why it has led to so many more overdoses than other drugs of its class. Both are administered via weekly injections, with Wegovy in single-use pens and Ozempic in needles that can vary in dosage. Standard dosages range from 0.25 mg to 2.4 mg for weekly injections, depending on the prescription.

    “Someone who is unable to get Wegovy can resort to using Ozempic instead, because it is the same medication, but they may start to [adjust] their dose” upward, Petrou said. “That’s when they might encounter problems.”

    Ho and Petrou said the vast majority of semaglutide overdose reports are accidental, either due to patients not waiting a week between doses or by misunderstanding dosing instructions. Unlike the GLP-1 hormone, which is rapidly metabolized by the body, semaglutide and similar medications have much longer half-lives, meaning the medication can build up inside the body if not enough time elapses between doses.

    Furthermore, semaglutide can also be taken orally as a daily pill — sold under the name Rybelsus — but overdoses are rarely reported.

    “We’re not seeing cases of mis-administration or toxicity or overdose with that medication,” Petrou said.

    Ho and Petrou explained the signs of semaglutide overdose can resemble those of hypoglycemia, also known as low blood sugar. Symptoms can begin with increased heart rate, sweating, dizziness and irritability. More serious cases can cause confusion, delirium and coma.

    “If they have hypoglycemia, the good majority of them will have to be admitted to the hospital and monitored and watched closely, because of how long these drugs last,” Ho said.

    Ho encourages everyone who is prescribed semaglutide to thoroughly read the medication’s label and follow the dosing instructions listed.

    “We always say this: The dose makes the poison,” Ho said.

    Anyone who needs emergency poison assistance or has other poisoning-related inquiries can call the national Poison Helpline at (800) 222-1222 or visit the Poison Help website.

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    Jeremy Childs

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  • Matthew Perry died from the effects of ketamine, autopsy report says

    Matthew Perry died from the effects of ketamine, autopsy report says

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    LOS ANGELES — LOS ANGELES (AP) — Matthew Perry died from the acute effects of the anesthetic ketamine, according to the results of an autopsy on the 54-year-old “Friends” actor released Friday.

    The Los Angeles County Department of Medical Examiner said in the autopsy report that Perry also drowned in “the heated end of his pool,” but that it was a secondary factor in his Oct. 28 death, deemed an accident.

    People close to Perry told investigators that he was undergoing ketamine infusion therapy, an experimental treatment used to treat depression and anxiety. But the medical examiner said the levels of ketamine in Perry’s body were in the range used for general anesthesia during surgery, and that his last treatment 1 1/2 weeks earlier wouldn’t explain those levels. The drug is typically metabolized in a matter of hours.

    The report says coronary artery disease and buprenorphine, which is used to treat opioid use disorder, also contributed.

    The amount of ketamine detected “would be enough to make him lose consciousness and lose his posture and his ability to keep himself above the water,” said Dr. Andrew Stolbach, a medical toxicologist with Johns Hopkins Medicine who reviewed the autopsy report at the request of The Associated Press.

    “Using sedative drugs in a pool or hot tub, especially when you’re alone, is extremely risky and, sadly, here it’s fatal,” said Stolbach, who noted that both ketamine and buprenorphine can be used safely.

    Perry was declared dead after being found unresponsive at his home in the Pacific Palisades area of Los Angeles. Investigators performed the autopsy the following day.

    The actor had taken drugs in the past but had been “reportedly clean for 19 months,” according to the report.

    Perry had played pickleball earlier in the day, the report says, and his assistant, who lives with him, found him face down in the pool after returning from errands.

    The assistant told investigators Perry had not been sick, had not made any health complaints, and had not shown evidence of recent alcohol or drug use.

    Postmortem blood tests showed “high levels” of ketamine in his system, which could have raised his blood pressure and heart rate and dulled his impulse to breathe.

    Buprenorphine, commonly used in opioid addiction and found found in therapeutic levels in Perry’s blood, could have contributed to the breathing problem, the autopsy said. It would have been risky to mix the central nervous system depressant with ketamine “due to the additive respiratory effects when present with high levels of ketamine,” according to the autopsy report.

    The report said his coronary artery disease would have made him more susceptible to the drugs’ effects.

    Perry was among the biggest television stars of his generation when he played Chandler Bing alongside Jennifer Aniston, Courteney Cox, Lisa Kudrow, Matt LeBlanc and David Schwimmer for 10 seasons from 1994 to 2004 on NBC’s megahit sitcom “Friends.”

    His castmates, like many of his friends, family and fans, were stunned by his death, and paid him loving tribute in the weeks that followed.

    Perry was open about discussing his struggles with addiction dating back to his time on “Friends.”

    “I loved everything about the show but I was struggling with my addictions which only added to my sense of shame,” he wrote in his 2022 memoir. “I had a secret and no one could know.”

    A woman whose name is redacted in the autopsy report told investigators that Perry had been in good spirits when she spoke to him a few days earlier, but had been taking testosterone shots which she said were making him “angry and mean.” She said he had quit smoking two weeks earlier.

    The woman said he had been receiving the ketamine infusions for his mental health, and that his doctor had been giving them to him less often because he had been feeling well.

    Ketamine is a powerful anesthetic approved by U.S. health regulators for use during surgery, but in the past decade it has emerged as an experimental treatment for a range of psychiatric and hard-to-treat conditions, including depression, anxiety and chronic pain.

    While not approved by regulators, doctors are free to prescribe drugs for these alternate uses if they think their patients could benefit, and hundreds of clinics across the U.S. offer ketamine infusions and other formulations for various health conditions.

    ___

    AP Medical Writer Carla K. Johnson in Washington state, Health Writer Matthew Perrone in Washington, D.C., and Ryan J. Foley in Iowa City, Iowa, contributed reporting.

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