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Tag: pharmaceuticals and prescription drugs

  • How a medication abortion, also known as an ‘abortion pill,’ works | CNN

    How a medication abortion, also known as an ‘abortion pill,’ works | CNN



    CNN
     — 

    While the fate of mifepristone, one of two drugs used for medication abortions, is in the hands of the US Supreme Court, the drug continues to be available in states where abortion is legal.

    “While many women obtain medication abortion from a clinic or their OB-GYN, others obtain the pills on their own to self-induce or self-manage their abortion,” said Dr. Daniel Grossman, a professor of obstetrics, gynecology and reproductive sciences at the University of California, San Francisco.

    “A growing body of research indicates that self-managed abortion is safe and effective,” he said.

    Mifepristone blocks the hormone progesterone, which is needed for a pregnancy to continue. The drug is approved to end a pregnancy through 10 weeks’ gestation, which is “70 days or less since the first day of the last menstrual period,” according to the FDA.

    In a medication abortion, a second drug, misoprostol, is taken within the next 24 to 48 hours. Misoprostol causes the uterus to contract, creating cramping and bleeding. Approved for use in other conditions, such as preventing stomach ulcers, the drug has been available at pharmacies for decades.

    Together, the two drugs are commonly known as the “abortion pill,” which is now used in more than half of the abortions in the United States, according to the Guttmacher Institute, a research group that supports abortion rights.

    “Some people do this because they cannot access a clinic — particularly in states with legal restrictions on abortion — or because they have a preference for self-care,” said Grossman, who is also the director of Advancing New Standards in Reproductive Health, a research group that evaluates the pros and cons of reproductive health policies and publishes studies on how abortion affects a woman’s health.

    READ MORE: With US Supreme Court abortion drug hearing looming, study shows how self-managed abortion became more common post-Dobbs

    What happens during a medication abortion? To find out, CNN spoke with Grossman. This conversation has been condensed and edited for clarity.

    CNN: What is the difference between a first-trimester medication abortion and a vacuum aspiration in terms of what a woman experiences?

    Dr. Daniel Grossman: A vacuum aspiration is most commonly performed under a combination of local anesthetic and oral pain medications or local anesthetic together with intravenous sedation, or what is called conscious sedation.

    An injection of local anesthetic is given to the area around the cervix, and the cervix is gently dilated or opened up. Once the cervix is opened, a small straw-like tube is inserted into the uterus, and a gentle vacuum is used to remove the pregnancy tissue. Contrary to what some say, if the procedure is done before nine weeks or so, there’s nothing in the tissue that would be recognizable as a part of an embryo.

    The aspiration procedure takes just a couple of minutes. Then the person is observed for one to two hours until any sedation has worn off. We also monitor each patient for very rare complications, such as heavy bleeding.

    A medication abortion is a more prolonged process. After taking the pills, bleeding and cramping can occur over a period of days. Bleeding is typically heaviest when the actual pregnancy is expelled, but that bleeding usually eases within a few hours. On average people continue to have some mild bleeding for about two weeks or so, which is a bit longer than after a vacuum aspiration.

    Nausea, vomiting, fever, chills, diarrhea and headache can occur after using the abortion pill, and everyone who has a successful medication abortion usually reports some pain.

    In fact, the pain of medication abortion can be quite intense. In the studies that have looked at it, the average maximum level of pain that people report is about a seven to eight out of 10, with 10 being the highest. However, people also say that the pain can be brief, peaking just as the pregnancy is being expelled.

    The level of cramping and pain can depend on the length of the pregnancy as well as whether or not someone has given birth before. For example, a medical abortion at six weeks or less gestation typically has less pain and cramping than one performed at nine weeks. People who have given birth generally have less pain.

    CNN: What can be done to help with the pain of a medication abortion?

    Grossman: There are definitely things that can be used to help with the pain. Research has shown that ibuprofen is better than acetaminophen for treating the pain of medication abortion. We typically advise people to take 600 milligrams every six hours or so as needed.

    Some people take tramadol, a narcotic analgesic, or Vicodin, which is a combination of acetaminophen and hydrocodone. Recent research I was involved in found medications like tramadol can be helpful if taken prophylactically before the pain starts.

    Another successful regimen that we studied combined ibuprofen with a nausea medicine called metoclopramide that also helped with pain. Other than ibuprofen, these medications require a prescription.

    Another study found that a TENS device, which stands for transcutaneous electrical nerve stimulator, helps with the pain of medication abortion. It works through pads put on the abdomen that stimulate the nerves through mild electrical shocks, thus interfering with the pain signals. That’s something people could get without a prescription.

    Pain can be an overlooked issue with medication abortion because, quite honestly, as clinicians, we’re not there with patients when they are in their homes going through this. But as we’ve been doing more research on people’s experiences with medication abortion, it’s become quite clear that pain control is really important. I think we need to do a better job of treating the pain and making these options available to patients.

    CNN: Are there health conditions that make the use of a medication abortion unwise?

    Grossman: Undergoing a medication abortion can be dangerous if the pregnancy is ectopic, meaning the embryo is developing outside of the uterus. It’s rare, happening in about two out of every 100 pregnancies — and it appears to be even rarer among people seeking medication abortion.

    People who have undergone previous pelvic, fallopian tube or abdominal surgery are at higher risk of an ectopic pregnancy, as are those with a history of pelvic inflammatory disease. Certain sexually transmitted infections can raise risk, as does smoking, a history of infertility and use of infertility treatments such as in vitro fertilization (IVF).

    If a person is on anticoagulant or blood thinning drugs or has a bleeding disorder, a medication abortion is not advised. The long-term use of steroids is another contraindication for using the abortion pill.

    Anyone using an intrauterine device, or IUD, must have it removed before taking mifepristone because it may be partially expelled during the process, which can be painful.

    People with chronic adrenal failure or who have inherited a rare disorder called porphyria are not good candidates.

    CNN: Are there any signs of trouble a woman should watch for after undergoing a medication abortion?

    Grossman: It can be common to have a low-grade fever in the first few hours after taking misoprostol, the second drug in a medication abortion. If someone has a low-grade fever — 100.4 degrees to 101 degrees Fahrenheit — that lasts more than four hours, or has a high fever of over 101 degrees Fahrenheit after taking the medications, they do need to be evaluated by a health care provider.

    Heavy bleeding, which would be soaking two or more thick full-size pads an hour for two consecutive hours, or a foul-smelling vaginal discharge should be evaluated as well.

    One of the warning signs of an ectopic pregnancy is severe pelvic pain, particularly on one side of the abdomen. The pain can also radiate to the back. Another sign is getting dizzy or fainting, which could indicate internal bleeding. These are all very rare complications, but it’s wise to be on the lookout.

    We usually recommend that someone having a medication abortion have someone with them during the first 24 hours after taking misoprostol or until the pregnancy has passed. Many people specifically choose to have a medication abortion because they can be surrounded by a partner, family or friends.

    Most people know that the abortion is complete because they stop feeling pregnant, and symptoms such as nausea and breast tenderness disappear, usually within a week of passing the pregnancy. A home urine pregnancy test may remain positive even four to five weeks after a successful medication abortion, just because it takes that long for the pregnancy hormone to disappear from the bloodstream.

    If someone still feels pregnant, isn’t sure if the pregnancy fully passed or has a positive pregnancy test five weeks after taking mifepristone, they need to be evaluated by a clinician.

    People should know that they can ovulate as soon as two weeks after a medication abortion. Most birth control options can be started immediately after a medication abortion.

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  • No antibiotics worked, so this woman turned to a natural enemy of bacteria to save her husband's life | CNN

    No antibiotics worked, so this woman turned to a natural enemy of bacteria to save her husband's life | CNN



    CNN
     — 

    In February 2016, infectious disease epidemiologist Steffanie Strathdee was holding her dying husband’s hand, watching him lose an exhausting fight against a deadly superbug infection.

    After months of ups and downs, doctors had just told her that her husband, Tom Patterson, was too racked with bacteria to live.

    “I told him, ‘Honey, we’re running out of time. I need to know if you want to live. I don’t even know if you can hear me, but if you can hear me and you want to live, please squeeze my hand.’

    “All of a sudden, he squeezed really hard. And I thought, ‘Oh, great!’ And then I’m thinking, ‘Oh, crap! What am I going to do?’”

    What she accomplished next could easily be called miraculous. First, Strathdee found an obscure treatment that offered a glimmer of hope — fighting superbugs with phages, viruses created by nature to eat bacteria.

    Then she convinced phage scientists around the country to hunt and peck through molecular haystacks of sewage, bogs, ponds, the bilge of boats and other prime breeding grounds for bacteria and their viral opponents. The impossible goal: quickly find the few, exquisitely unique phages capable of fighting a specific strain of antibiotic-resistant bacteria literally eating her husband alive.

    Next, the US Food and Drug Administration had to greenlight this unproven cocktail of hope, and scientists had to purify the mixture so that it wouldn’t be deadly.

    Yet just three weeks later, Strathdee watched doctors intravenously inject the mixture into her husband’s body — and save his life.

    Their story is one of unrelenting perseverance and unbelievable good fortune. It’s a glowing tribute to the immense kindness of strangers. And it’s a story that just might save countless lives from the growing threat of antibiotic-resistant superbugs — maybe even your own.

    “It’s estimated that by 2050, 10 million people per year — that’s one person every three seconds — is going to be dying from a superbug infection,” Strathdee told an audience at Life Itself, a 2022 health and wellness event presented in partnership with CNN.

    “I’m here to tell you that the enemy of my enemy can be my friend. Viruses can be medicine.”

    sanjay pkg vpx

    How this ‘perfect predator’ saved his life after nine months in the hospital

    During a Thanksgiving cruise on the Nile in 2015, Patterson was suddenly felled by severe stomach cramps. When a clinic in Egypt failed to help his worsening symptoms, Patterson was flown to Germany, where doctors discovered a grapefruit-size abdominal abscess filled with Acinetobacter baumannii, a virulent bacterium resistant to nearly all antibiotics.

    Found in the sands of the Middle East, the bacteria were blown into the wounds of American troops hit by roadside bombs during the Iraq War, earning the pathogen the nickname “Iraqibacter.”

    “Veterans would get shrapnel in their legs and bodies from IED explosions and were medevaced home to convalesce,” Strathdee told CNN, referring to improvised explosive devices. “Unfortunately, they brought their superbug with them. Sadly, many of them survived the bomb blasts but died from this deadly bacterium.”

    Today, Acinetobacter baumannii tops the World Health Organization’s list of dangerous pathogens for which new antibiotics are critically needed.

    “It’s something of a bacterial kleptomaniac. It’s really good at stealing antimicrobial resistance genes from other bacteria,” Strathdee said. “I started to realize that my husband was a lot sicker than I thought and that modern medicine had run out of antibiotics to treat him.”

    With the bacteria growing unchecked inside him, Patterson was soon medevaced to the couple’s hometown of San Diego, where he was a professor of psychiatry and Strathdee was the associate dean of global health sciences at the University of California, San Diego.

    “Tom was on a roller coaster — he’d get better for a few days, and then there would be a deterioration, and he would be very ill,” said Dr. Robert “Chip” Schooley, a leading infectious disease specialist at UC San Diego who was a longtime friend and colleague. As weeks turned into months, “Tom began developing multi-organ failure. He was sick enough that we could lose him any day.”

    Patterson's body was systemically infected with a virulent drug-resistant bacteria that also infected troops in the Iraq War, earning the pathogen the nickname

    After that reassuring hand squeeze from her husband, Strathdee sprang into action. Scouring the internet, she had already stumbled across a study by a Tbilisi, Georgia, researcher on the use of phages for treatment of drug-resistant bacteria.

    A phone call later, Strathdee discovered phage treatment was well established in former Soviet bloc countries but had been discounted long ago as “fringe science” in the West.

    “Phages are everywhere. There’s 10 million trillion trillion — that’s 10 to the power of 31 — phages that are thought to be on the planet,” Strathdee said. “They’re in soil, they’re in water, in our oceans and in our bodies, where they are the gatekeepers that keep our bacterial numbers in check. But you have to find the right phage to kill the bacterium that is causing the trouble.”

    Buoyed by her newfound knowledge, Strathdee began reaching out to scientists who worked with phages: “I wrote cold emails to total strangers, begging them for help,” she said at Life Itself.

    One stranger who quickly answered was Texas A&M University biochemist Ryland Young. He’d been working with phages for over 45 years.

    “You know the word persuasive? There’s nobody as persuasive as Steffanie,” said Young, a professor of biochemistry and biophysics who runs the lab at the university’s Center for Phage Technology. “We just dropped everything. No exaggeration, people were literally working 24/7, screening 100 different environmental samples to find just a couple of new phages.”

    While the Texas lab burned the midnight oil, Schooley tried to obtain FDA approval for the injection of the phage cocktail into Patterson. Because phage therapy has not undergone clinical trials in the United States, each case of “compassionate use” required a good deal of documentation. It’s a process that can consume precious time.

    But the woman who answered the phone at the FDA said, “‘No problem. This is what you need, and we can arrange that,’” Schooley recalled. “And then she tells me she has friends in the Navy that might be able to find some phages for us as well.”

    In fact, the US Naval Medical Research Center had banks of phages gathered from seaports around the world. Scientists there began to hunt for a match, “and it wasn’t long before they found a few phages that appeared to be active against the bacterium,” Strathdee said.

    Dr. Robert

    Back in Texas, Young and his team had also gotten lucky. They found four promising phages that ravaged Patterson’s antibiotic-resistant bacteria in a test tube. Now the hard part began — figuring out how to separate the victorious phages from the soup of bacterial toxins left behind.

    “You put one virus particle into a culture, you go home for lunch, and if you’re lucky, you come back to a big shaking, liquid mess of dead bacteria parts among billions and billions of the virus,” Young said. “You want to inject those virus particles into the human bloodstream, but you’re starting with bacterial goo that’s just horrible. You would not want that injected into your body.”

    Purifying phage to be given intravenously was a process that no one had yet perfected in the US, Schooley said, “but both the Navy and Texas A&M got busy, and using different approaches figured out how to clean the phages to the point they could be given safely.”

    More hurdles: Legal staff at Texas A&M expressed concern about future lawsuits. “I remember the lawyer saying to me, ‘Let me see if I get this straight. You want to send unapproved viruses from this lab to be injected into a person who will probably die.’ And I said, “Yeah, that’s about it,’” Young said.

    “But Stephanie literally had speed dial numbers for the chancellor and all the people involved in human experimentation at UC San Diego. After she calls them, they basically called their counterparts at A&M, and suddenly they all began to work together,” Young added.

    “It was like the parting of the Red Sea — all the paperwork and hesitation disappeared.”

    The purified cocktail from Young’s lab was the first to arrive in San Diego. Strathdee watched as doctors injected the Texas phages into the pus-filled abscesses in Patterson’s abdomen before settling down for the agonizing wait.

    “We started with the abscesses because we didn’t know what would happen, and we didn’t want to kill him,” Schooley said. “We didn’t see any negative side effects; in fact, Tom seemed to be stabilizing a bit, so we continued the therapy every two hours.”

    Two days later, the Navy cocktail arrived. Those phages were injected into Patterson’s bloodstream to tackle the bacteria that had spread to the rest of his body.

    “We believe Tom was the first person to receive intravenous phage therapy to treat a systemic superbug infection in the US,” Strathdee told CNN.

    “And three days later, Tom lifted his head off the pillow out of a deep coma and kissed his daughter’s hand. It was just miraculous.”

    Patterson awoke from a coma after receiving an intravenous dose of phages tailored to his bacteria.

    Today, nearly eight years later, Patterson is happily retired, walking 3 miles a day and gardening. But the long illness took its toll: He was diagnosed with diabetes and is now insulin dependent, with mild heart damage and gastrointestinal issues that affect his diet.

    “He isn’t back surfing again, because he can’t feel the bottoms of his feet, and he did get Covid-19 in April that landed him in the hospital because the bottoms of his lungs are essentially dead,” Strathdee said.

    “As soon as the infection hit his lungs he couldn’t breathe and I had to rush him to the hospital, so that was scary,” she said. “He remains high risk for Covid but we’re not letting that hold us hostage at home. He says, ‘I want to go back to having as normal life as fast as possible.’”

    To prove it, the couple are again traveling the world — they recently returned from a 12-day trip to Argentina.

    “We traveled with a friend who is an infectious disease doctor, which gave me peace of mind to know that if anything went sideways, we’d have an expert at hand,” Strathdee said.

    “I guess I’m a bit of a helicopter wife in that sense. Still, we’ve traveled to Costa Rica a couple of times, we’ve been to Africa, and we’re planning to go to Chile in January.”

    Patterson’s case was published in the journal Antimicrobial Agents and Chemotherapy in 2017, jump-starting new scientific interest in phage therapy.

    “There’s been an explosion of clinical trials that are going on now in phage (science) around the world and there’s phage programs in Canada, the UK, Australia, Belgium, Sweden, Switzerland, India and China has a new one, so it’s really catching on,” Strathdee told CNN.

    Some of the work is focused on the interplay between phages and antibiotics — as bacteria battle phages they often shed their outer shell to keep the enemy from docking and gaining access for the kill. When that happens, the bacteria may be suddenly vulnerable to antibiotics again.

    “We don’t think phages are ever going to entirely replace antibiotics, but they will be a good adjunct to antibiotics. And in fact, they can even make antibiotics work better,” Strathdee said.

    In San Diego, Strathdee and Schooley opened the Center for Innovative Phage Applications and Therapeutics, or IPATH, in 2018, where they treat or counsel patients suffering from multidrug-resistant infections. The center’s success rate is high, with 82% of patients undergoing phage therapy experiencing a clinically successful outcome, according to its website.

    Schooley is running a clinical trial using phages to treat patients with cystic fibrosis who constantly battle Pseudomonas aeruginosa, a drug-resistant bacteria that was also responsible for the recent illness and deaths connected to contaminated eye drops manufactured in India.

    And a memoir the couple published in 2019 — “The Perfect Predator: A Scientist’s Race to Save Her Husband From a Deadly Superbug” — is also spreading the word about these “perfect predators” to what may soon be the next generation of phage hunters.

    VS Phages Sanjay Steffanie

    How naturally occurring viruses could help treat superbug infections

    “I am getting increasingly contacted by students, some as young as 12,” Strathdee said. “There’s a girl in San Francisco who begged her mother to read this book and now she’s doing a science project on phage-antibiotic synergy, and she’s in eighth grade. That thrills me.”

    Strathdee is quick to acknowledge the many people who helped save her husband’s life. But those who were along for the ride told CNN that she and Patterson made the difference.

    “I think it was a historical accident that could have only happened to Steffanie and Tom,” Young said. “They were at UC San Diego, which is one of the premier universities in the country. They worked with a brilliant infectious disease doctor who said, ‘Yes,’ to phage therapy when most physicians would’ve said, ‘Hell, no, I won’t do that.’

    “And then there is Steffanie’s passion and energy — it’s hard to explain until she’s focused it on you. It was like a spiderweb; she was in the middle and pulled on strings,” Young added. “It was just meant to be because of her, I think.”

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  • Rite Aid files for bankruptcy | CNN Business

    Rite Aid files for bankruptcy | CNN Business


    New York
    CNN
     — 

    Rite Aid filed for Chapter 11 bankruptcy protection Sunday, a casualty of a miserable environment for drug stores, exacerbated by its runner-up status to bigger chains and expensive legal battles for allegedly filling unlawful opioid prescriptions.

    The bankruptcy was not a surprise. Its bigger rivals, CVS and Walgreens, are also facing many of the same problems. They, too, are closing stores as Amazon and big-box chains like Walmart, Target and Costco serve as more customer-friendly alternatives to nationwide pharmacy chains.

    But Rite Aid is in much worse financial shape than its competitors and unable to weather the storm that has been beating down on the industry. On Thursday, it filed a notice to the US Securities and Exchange Commission saying it would be unable to file its latest quarterly financial report because it was looking at “strategic alternatives,” which is Wall Street speak for “considering bankruptcy.”

    In that filing, the company said it expected its losses would increase significantly in the past quarter, which is saying something, considering it lost about three quarters of a billion dollars between March 2022 and March 2023 — and another $307 billion between March and May this year. Over the past six years, Rite Aid has tallied nearly $3 billion in losses.

    At the beginning of June, the last time the company filed a financial report, Rite Aid had just $135.5 million of cash on hand -— and $3.3 billion in long-term debt, which exceeded the value of the company’s assets by nearly $1 billion. With rising interest rates, that debt wasn’t cheap to finance.

    “It was always a matter of when, not if, Rite Aid would file for bankruptcy,” said Neil Saunders, managing director of GlobalData, in a note to investors. “The company has been deep in the red for the past six years.”

    The company said in a statement it had secured $3.5 billion in financing and debt reduction agreements from lenders to keep the company afloat through its bankruptcy.

    It said it would accelerate its pace of store closures and sell off some of its businesses, including prescription benefit provider Elixir Solutions. Bankruptcy could also help resolve the company’s legal disputes at a vastly reduced cost.

    As part of the bankruptcy plan, Rite Aid appointed a new CEO, Jeff Stein, who will also serve as the head of restructuring and a board member. Stein, in the statement, said the company plans to remain in business.

    “With the support of our lenders, we look forward to strengthening our financial foundation, advancing our transformation initiatives and accelerating the execution of our turnaround strategy,” he said. “In doing so, we will be even better able to deliver the healthcare products and services our customers and their families rely on -— now and into the future.”

    Rite Aid has had an interim CEO since January 2023.

    Rite Aid’s losing battle against mounting debt was exacerbated by its legal troubles stemming from accusations of filing unlawful opioid prescriptions for customers.

    The Department of Justice filed suit against the company in March, claiming that it knowingly processed “unlawful prescriptions for controlled substances.” That stands in violation of the False Claims Act and Controlled Substances Act. The government accused Rite Aid of missing “obvious red flags” when it filled the prescriptions for addictive pain killers.

    When the US Justice Department filed its lawsuit, Attorney General Merrick Garland said the department would use “every tool at our disposal” to hold Rite Aid accountable for contributing to the opioid epidemic.”

    Walgreens, CVS and others settled similar lawsuits over the past few years, but they remain in better financial shape and were largely able to weather the tens of billions of dollars owed to various government agencies in settlements.

    More than half a million people have died from drug overdoses in the United States between 1999 and 2020, according to the US Centers for Disease Control and Prevention.

    Rite Aid is a distant third-largest nationwide standalone pharmacy chain in the United States — and the seventh largest pharmacy overall, when taking into account big box chains. It has more than 2,200 stores in 17 states.

    It was offered a $17 billion lifeline in 2015 when Walgreens offered to buy the chain. But the deal was met with stiff scrutiny from US regulators who feared the combination would violate federal antitrust laws and reduce competition in the drug store market.

    Ultimately, in 2017, the companies agreed to a smaller, $4.4 billion deal, in which Walgreens bought just under 2,000 Rite Aid locations, leaving Rite Aid diminished in stature and unable to compete at the scale of its bigger rivals.

    — CNN’s Nathaniel Meyersohn and Juliana Liu contributed to this report

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  • Biden administration announces charges, sanctions to crack down on China-based fentanyl traffickers | CNN Politics

    Biden administration announces charges, sanctions to crack down on China-based fentanyl traffickers | CNN Politics



    CNN
     — 

    The Biden administration announced Tuesday multiple indictments in Florida against China-based companies and Chinese nationals for allegedly manufacturing and selling fentanyl and related chemicals.

    Sanctions against 28 individuals and entities in China and Canada allegedly involved in selling precursor chemicals as well as labs and distributors of the chemicals were also announced, according to a statement from the Justice Department.

    “We know that the global fentanyl supply chain, which ends with the deaths of Americans, often starts with chemical companies in China,” Attorney General Merrick Garland said Tuesday.

    “The United States government is focused on breaking apart every link in that chain, getting fentanyl out of our communities, and bringing those who put it there to justice.”

    The charges announced Tuesday are the latest step in the US government’s yearslong push to stem the rampant importation of fentanyl, which kills tens of thousands of Americans annually.

    The new charges also come after an intensified effort by US law enforcement in recent months to trace the cryptocurrency payments and the manufacturing equipment, such as pill presses, that are fueling the fentanyl crises.

    Garland and Homeland Security Secretary Alejandro Mayorkas announced the indictments and continued investigation along with Drug Enforcement Administrator Anne Milgram.

    The DHS’s Homeland Security Investigations as well as Customs and Border Protection also announced recent seizures of more than 1,000 kilograms of precursor chemicals, which, according to Milgram, are primarily created in China and sold to cartels in Mexico who use the chemicals to create fentanyl.

    The US Postal Inspection Service also was involved in tracing packages that contained such chemicals.

    “Through the dedication and investigative abilities of agents and officers from HSI, CBP, and our federal partners, we are bringing accountability to ruthless organizations and individuals resident in the People’s Republic of China and to the cartel members that seek to profit from the death and destruction that fentanyl causes,” Mayorkas said during Tuesday’s press conference.

    Garland and Mayorkas are set to meet their Mexican counterparts in Mexico City later this week alongside Secretary of State Antony Blinken and other senior US officials for the 2023 US-Mexico High-Level Security Dialogue.

    As part of the fentanyl crackdown, the DEA has invested in crypto-tracing software and identifying the Mexican cartels’ most sophisticated money launderers, the IRS has its most tech-savvy agents tracing payments on dark web forums, and a DHS investigations unit is leading a team of forensic specialists to pore over digital clues from stash houses near the Mexican border, CNN previously reported.

    But it remains to be seen how effectively indictments and sanctions can disrupt traffickers from participating in the multibillion-dollar fentanyl trade.

    A CNN investigation into the activities of US-sanctioned Chinese chemical companies that advertise fentanyl ingredients found that when one sanctioned company shut down, another company launched and bought the sanctioned company’s email, phone number and Facebook page to “attract internet traffic.”

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  • ‘This isn’t some random dude with a duffel bag’: To catch fentanyl traffickers, feds dig into crypto markets | CNN Politics

    ‘This isn’t some random dude with a duffel bag’: To catch fentanyl traffickers, feds dig into crypto markets | CNN Politics


    Washington
    CNN
     — 

    The Biden administration has intensified its focus on tracing cryptocurrency payments that some of the most dangerous Mexican drug cartels use to buy fentanyl ingredients from Chinese chemical companies, the latest step in a renewed attempt to crack down on the multibillion-dollar fentanyl trade that kills thousands of Americans each year.

    The use of digital currency has exploded among fentanyl traffickers, with transactions for fentanyl ingredients surging 450% in the last year through April, according to data from private crypto-tracking analysis firm Elliptic.

    Federal agents are doing everything they can to catch up. While US diplomats have made fentanyl a point of emphasis in high-level talks with Mexican and Chinese counterparts, behind the scenes, a multi-agency effort is underway to keep pace with the rapidly changing nature of how fentanyl is financed and trafficked into the US. The work goes beyond the cartels to include tracking dark-web forums where Americans buy fentanyl.

    Current and former law enforcement officials from across the federal government described to CNN the digital-first tactics the administration is developing to disrupt the fentanyl trade.

    The Drug Enforcement Agency is investing in crypto-tracing software and identifying the cartels’ most sophisticated money launderers. The IRS has its most tech-savvy agents tracing payments on dark web forums. And a Department of Homeland Security investigations unit is leading a team of forensic specialists to pore over digital clues from stash houses near the Mexican border.

    Federal agents have been tracking the cartels’ finances and supply routes for years, but DHS, in particular, has ramped up its surveillance efforts in recent weeks, multiple US officials told CNN.

    There have been some notable busts recently, including nearly five tons of fentanyl seized this spring along the border. But there is still a lot of work left to do, officials caution, and the impact of the current surge may not be felt for months down the road.

    Agents have focused on the activities of two Mexican cartels, Sinaloa and Jalisco New Generation Cartel (CJNG), which officials say account for the majority of fentanyl on US streets. Sinaloa Cartel, in particular, has developed sophisticated crypto operations to finance its fentanyl business.

    “We’re dealing with a Fortune 50 company, which is what the Sinaloa Cartel is,” a US official with knowledge of the matter told CNN. “This isn’t some random dude with a duffel bag” selling fentanyl in daylight.

    Cryptocurrency has enhanced cartels’ ability to smuggle fentanyl into the US by allowing them to move vast sums of money instantaneously across a decentralized, digital banking system – all without having to deal with actual banks.

    “The speed the criminals can muster, it’s very hard for law enforcement to keep up,” said one top DEA official, who spoke to CNN on condition of anonymity to describe the agency’s counter-narcotics work.

    Cash is still king for the cartels and often preferred for local operations. But the expanded use of digital currency at both the supply and demand ends of the drug trade has made some traditional law enforcement methods obsolete. For example, drug dealers might hold fewer in-person meetings to hand over cash, reducing the opportunities for stakeouts by federal agents, said Jarod Koopman, head of the IRS’s Cyber and Forensics Services division.

    Cryptocurrency “eliminates the potential for hand-to-hand transactions,” said Koopman, whose team focuses on illicit financial flows, including dark-web purchases that are multiple steps removed from when the cartels get the drugs over the US border. “So now it’s … in a different world where some of the contacts might be online and we’re trying to facilitate or do transactions in a different manner.”

    But digital money also leaves a trail that investigators can follow.

    Federal agents have found cryptocurrency addresses written down on scraps of paper at stash houses in Arizona, Scott Brown, special agent in charge for Homeland Security Investigations (HSI) in that state, told CNN.

    In another case, DHS agents monitored a cartel-connected crypto account for over a year until it sent $200,000 to an accountant they were using to launder money, Brown said. After the accountant used the money to buy property in the US, federal agents are working to seize the property, he said.

    A “significant portion” of fentanyl is sold over the dark web and paid for in cryptocurrency, Brown said, adding: “That is a vulnerability that we can attack much like we attack the money movements in a traditional narcotics investigation.”

    Most of the fentanyl that enters the US comes from ingredients made in China that are then pressed into pills – or packed in powder – and smuggled in from Mexico by drug cartels, according to the DEA.

    A US indictment unsealed in June illustrates the scope of the problem. Just one Chinese chemical company allegedly shipped more than 440 pounds of fentanyl to undercover DEA agents in exchange for payment in cryptocurrency. It was enough drugs to kill 25 million Americans, according to prosecutors.

    The two cartels, Sinaloa and CJNG, have used their control of the fentanyl trade to develop sophisticated money-laundering techniques that exploit cryptocurrency, according to US officials.

    “We’ve identified people in the cartels that specialize in cryptocurrency movements,” the senior DEA official told CNN, describing longstanding efforts to surveil both the cartels.

    The Sinaloa Cartel has made hundreds of millions of dollars from the fentanyl trade, according to the Justice Department. Run by the sons of imprisoned drug lord Joaquín “El Chapo” Guzmán, the cartel has allegedly used airplanes, submarines, fishing boats and tractor trailers to transport fentanyl chemicals and other drugs. Four of the “Chapitos,” as Guzmán’s sons are known, are under indictment in the US for fentanyl trafficking, money laundering and weapons charges.

    With their father in jail, the younger generation of Sinaloa leaders is making more of an effort to cover their tracks and avoid law enforcement scrutiny, including by using cryptocurrency, the senior DEA official told CNN.

    In one case, the Sinaloa Cartel laundered more than $869,000 using cryptocurrency between August 2022 and February 2023, according to a US indictment unsealed in April. But that was likely just a fraction of the Sinaloa money laundered during that time, based on the huge profits the cartel has made in recent years.

    The scheme involved two of the cartel’s top money launderers directing US-based couriers to pick up cash from fentanyl traffickers and deposit the money to cryptocurrency accounts controlled by the cartel, the indictment said.

    “Not every seizure is going to get you to Chapo Guzman,” said Brown, the DHS official in Arizona. “It’s certainly more impactful when we can go after the people that are behind the production of the drugs, behind the production of the precursors, behind the movement of the money, behind running the transportation cells.”

    That’s why Brown and his colleagues are trying to make the most of a huge series of fentanyl busts in Arizona and California this spring, when agents seized nearly five tons of the deadly drug, worth over $100 million.

    Evidence was quickly shipped to a forensics lab in Northern Virginia, where DHS analysts hunted for digital clues – things like a common cell phone number called by drug runners near border towns or, better yet, a cryptocurrency account connected to one of the Mexican cartels, according to Brown.

    Based in Phoenix, Brown’s office oversees a recently announced federal task force that aims to thwart drug sales online by infiltrating dark-web forums and tracking crypto payments. The goal is to find “another vulnerability [in] the larger cartel infrastructure” that agents can attack, he said.

    The cartels “are very willing to invest in technology,” Brown said. “That’s one of the things that we need to be equally willing to do.”

    Crypto-based transactions can be traced publicly, giving US officials a much clearer picture of the Mexican cartels’ reliance on Chinese chemical companies to produce fentanyl.

    The Chinese government banned the sale of fentanyl in 2019. But Chinese chemical companies have since shifted to making fentanyl ingredients instead of the finished product, according to US officials and outside experts.

    A recent CNN investigation dug into the activities of US-sanctioned Chinese chemical companies that advertise fentanyl ingredients. When one sanctioned company shut down, another company launched, and told CNN it purchased the sanctioned company’s email, phone number and Facebook page to “attract internet traffic.”

    While the amount of fentanyl directly mailed to the US from China fell dramatically following the 2019 Chinese ban, according to a Brookings Institution study, US officials say Chinese companies are still producing and exporting large quantities of fentanyl ingredients.

    This January 2019 photo shows a display of fentanyl and meth that was seized by federal officers at the Nogales Port of Entry.

    Chinese companies selling ingredients to make fentanyl have received cryptocurrency payments worth tens of millions of dollars over the last five years, enough to potentially produce billions of dollars’ worth of fentanyl sold in the US and other markets, according to research from crypto-tracking firms.

    One of the firms, London-based Elliptic, found 100 China-based chemical companies touting fentanyl, fentanyl ingredients or equipment to make the drugs that accepted payments in cryptocurrency.

    Elliptic didn’t identify any cartel-controlled crypto accounts that sent money to the Chinese companies. That could be due to the cartels’ use of middlemen to buy ingredients and the fact that fentanyl traffickers in Europe also buy from the Chinese companies, according to US officials and cryptocurrency experts interviewed by CNN

    But that data is still only a partial picture of the problem. The Chinese chemicals industry is worth over a trillion dollars, according to some estimates, and comprises tens of thousands of companies, most of them doing legitimate business.

    “It’s impossible to know how many of [those companies] are actually sending chemicals over” to the US that can be used to make fentanyl, a former DEA agent who worked in Mexico told CNN. The former agent spoke on the condition of anonymity because they were not authorized to speak to the media.

    Barring more cooperation from the Chinese government on the issue, which US officials say has been limited, the Biden administration has sanctioned and secured federal indictments against several Chinese companies allegedly involved in the production of fentanyl. Federal agents, meanwhile, follow the money and look for opportunities to seize it.

    “You can at least try to pinch off the financial flow to [the Chinese companies] and then … follow that money trail to whether it’s the Mexican cartels or if it’s in Guatemala or other places, for the actual supply,” Koopman told CNN.

    Cryptocurrency has also allowed cartels to diversify the way they move money around the world. The cartels have a network of money launderers in dozens of countries, from Thailand to Colombia, the senior DEA official said.

    These money launderers, known as “spinners,” might receive drug money in one type of cryptocurrency and convert it to another to try to obscure the source of the funds.

    “They might take Bitcoin and then buy Ethereum with it, and then send the Ethereum to the cartel members,” the senior DEA official said, referring to different types of cryptocurrencies. “The cartels have insulated themselves so they’re not receiving the cryptocurrency directly.”

    The cartels also use “mixing” services, or publicly available cryptocurrency tools, to try to obscure the source of their digital money, the DEA official said. That process is also favored by North Korean hackers who launder stolen cryptocurrency to support Pyongyang’s weapons program, CNN investigations have found.

    The volatility of cryptocurrency means the cartels often quickly look to convert their crypto to cash by moving it through a series of virtual currencies, the senior DEA official told CNN.

    But there are moments in the laundering process where federal agents can strike. A cryptocurrency exchange serving a customer in Mexico might be headquartered in the US, allowing federal agents to issue a subpoena and potentially seize money.

    For Brown, the DHS agent in Arizona, the issue is personal: one of his employees had a family member who died of a fentanyl overdose after buying the drug online , he said.

    “My people are burned out, and yet they come to work and work exceedingly hard every day,” Brown told CNN.

    But he’s optimistic when the subject turns to high-tech methods to hunt the cartels.

    “Are they as anonymous as they think they are? Absolutely … not.”

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  • Lisa Marie Presley died of complications from prior weight-loss surgery, autopsy report shows | CNN

    Lisa Marie Presley died of complications from prior weight-loss surgery, autopsy report shows | CNN



    CNN
     — 

    A report by the Los Angeles County Medical Examiner states Lisa Marie Presley’s death in January was caused by a “sequelae of a small bowel obstruction.”

    A small bowel obstruction is a blockage in the small intestine, often because of things like scar tissue, a hernia or cancer. Without surgery, it can cause bowel tissue to die or perforate, leading to death.

    Presley’s autopsy report, obtained by CNN on Thursday, included the official opinion of deputy medical examiner Dr. Juan M. Carrillo, who attributed her small bowel obstruction to “adhesions (or, scar tissue) that developed after bariatric surgery years ago. This is a known long term complication of this type of surgery.”

    Carrillo also stated that he reviewed the autopsy toxicology results, which showed “therapeutic” levels of oxycodone in Presley’s blood – i.e., levels that are in the range of medically helpful, and not dangerous. He added that quetapine metabolite (used to treat depression, schizophrenia or manic episodes) and buprenorphine (a painkiller that can also be used to treat opioid addiction) were present but “not contributory to death.”

    “There is no evidence of injury or foul play. The manner of death is deemed natural,” Carrillo concluded.

    Dr. Michael Camilleri, a consultant and professor in the Division of Gastroenterology and Hepatology at the Mayo Clinic, told CNN on Thursday that the medications found in Presley’s may “have slowed down the motility of the intestine and would have made it perhaps more likely” for it to get “obstructed by the adhesions.”

    “Unfortunately, adhesions can happen to anybody,” he added. “And just because there were these other medications on board doesn’t necessarily mean that the person was more prone to develop the complications.”

    Lisa Marie Presley, the only daughter of the late Elvis Presley and Priscilla Presley, died hours after being hospitalized following an apparent cardiac arrest on January 12. The medical examiner’s report also detailed that she was complaining of abdominal pain on the morning of her death.

    Dr. Folasade P. May, associate professor of medicine at the David Geffen School of Medicine at UCLA and director of the Melvin and Bren Simon Gastroenterology Quality Improvement Program, told CNN Thursday that she suspects Presley “developed a cardiac arrest because she had a severe complication from the small bowel obstruction.” Neither doctor interviewed by CNN for this report was directly involved in Presley’s case.

    She was 54.

    Video shows Lisa Marie Presley on the Golden Globes red carpet

    “Priscilla Presley and the Presley family are shocked and devastated by the tragic death of their beloved Lisa Marie,” the family said in a statement at the time. “They are profoundly grateful for the support, love and prayers of everyone, and ask for privacy during this very difficult time.”

    Lisa Marie Presley’s last public appearance just days before her death was at the Golden Globe Awards, which she attended with her mother to support the Baz Luhrmann film “Elvis,” about her late father.

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  • New York governor signs bill to legally protect doctors who prescribe abortion pills for out-of-state patients into law | CNN Politics

    New York governor signs bill to legally protect doctors who prescribe abortion pills for out-of-state patients into law | CNN Politics



    CNN
     — 

    New York Democratic Gov. Kathy Hochul signed a bill into law Friday that legally protects doctors who prescribe and send abortion pills to patients in states where abortion services are outlawed or restricted.

    “We are witnessing a shameful regression of women’s rights in this country as abortion access is restricted in states across the nation,” Hochul said in a news release, adding that the law will ensure that more women will be able to access reproductive health care.

    The measure – passed by the state legislature Tuesday – will block out-of-state litigation, prohibiting prosecution against doctors in New York who provide telehealth services, prescribe medication abortion, or deliver reproductive health care to patients living in states with restrictive abortion laws.

    Telehealth medication abortions have accounted for an increasing share of total US abortions since last year’s Supreme Court ruling that established there is no constitutional right to abortion, CNN previously reported. Prior to the June 2022 ruling, medication abortions provided by virtual-only providers made up 4% of all abortions in April 2022 and 5% in May 2022, according to data from the Society of Family Planning. However, between June and December 2022, the share of such procedure grew from 6 to 11%. And as of 2020, more than half of US abortions were conducted using medication.

    Assemblymember Karines Reyes, a registered nurse who sponsored the bill, said Tuesday she was “proud to sponsor this critical piece of legislation to fully protect abortion providers using telemedicine.”

    Hochul previously signed legislation aimed at expanding reproductive rights. Last month, the governor signed a bill to ensure that every student at a State University of New York (SUNY) or City University of New York (CUNY) college will be able to access medication abortion, along with another bill that allows pharmacists across the state to dispense contraceptives over the counter.

    The governor’s recent moves demonstrate the changing abortion landscape nationwide. As Democratic-led states aim to expand access, states with Republican majorities have enacted widespread restrictions, including near-total bans.

    Last month, North Carolina’s Republican-controlled legislature overrode a veto by its Democratic governor to ban most abortions after 12 weeks.

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  • New details emerge about the alleged search history of the Utah mom charged with her husband’s murder | CNN

    New details emerge about the alleged search history of the Utah mom charged with her husband’s murder | CNN



    CNN
     — 

    “What is a lethal dose of fentanyl” is one of many phone searches that investigators say were made by Kouri Richins, a Utah widow accused of killing her husband before she authored a children’s book about grief.

    The new details on the widow’s alleged search history emerged as part of the prosecution’s case against Richins, 33, who will be in a Park City, Utah, court Monday for a detention hearing. A judge is expected to decide if she should be released or remain in custody pending the outcome of her trial.

    Prosecutors allege she killed Eric Richins, her husband of nine years, with a lethal dose of fentanyl. She faces charges of criminal homicide, aggravated murder and three counts of possession of a controlled substance with intent to distribute. She has not yet entered a plea.

    The documents released Friday also give insight into Richins’ defense. Her attorneys argue “there is no substantial evidence to support the charges” and say she should be released as she awaits trial.

    Among the details released in the documents are internet searches investigators say were found on Richins’ phone that were described by prosecutors as “incriminating.”

    Some of the articles pulled up through her searches focused on fentanyl, life insurance payments and others relating to police investigations and how data is collected from electronic devices.

    The searches found on Richins’ iPhone include the phrases: “can cops force you to do a lie detector test?” “Luxury prisons for the rich in America,” “death certificate says pending, will life insurance still pay?” “If someone is poisoned what does it go down on the death certificate as,” and “How to permanently delete information from an iPhone remotely.”

    Eric Richins was found dead at the foot of the couple’s bed in March 2022. His wife told investigators at the time that she brought her husband a Moscow Mule cocktail in the bedroom of their Kamas, Utah, home, then left to sleep with their son in his room and returned around 3 a.m. to find her husband lying on the floor cold to the touch.

    About a year to the day after her husband died, Richins published a children’s book, “Are You With Me?” about navigating grief after the loss of a loved one.

    Prosecutors say Richins withdrew money from bank accounts without her husband’s knowledge and tried to change a life insurance policy to make herself the sole beneficiary. They also point to various incidents where she allegedly may have attempted to poison him.

    Meanwhile, her lawyers argue in filings made Friday that Richins had the right to withdraw money from their joint accounts, claim “there is no evidence identifying the computer from which the login was initiated” when the life insurance policy change was attempted, and say she did not attempt to poison him.

    Investigators also detailed a series of illicit fentanyl purchases in the months leading up to her husband’s death, according to the documents. His death was six days after the latest alleged pill delivery, investigators say.

    An autopsy and toxicology report revealed that Eric Richins, 39, had about five times the lethal dosage of fentanyl in his system, according to a medical examiner.

    The defense insists there is no proof their client gave her husband the lethal dose.

    “Law enforcement never identified or seized any fentanyl or other illicit drugs from the Family Home,” her defense lawyers wrote in a motion. Also, “the State has provided no evidence that there was fentanyl found in the home. Nor have they provided any evidence that Kouri gave Eric the fentanyl at issue.”

    Eric Richins is described as a “partier” and someone who “loved a good time,” in the defense motion. “He would consume alcohol and THC in any form,” the document said.

    The defense motion also points to discrepancies in witness testimony, adding that law enforcement told one witness that “if she gave them what they wanted, it would constitute her ‘get out of jail free card,’” the document says.

    Potentially previewing what may be presented in trial, another filing in the case includes allegations that some of Eric Richins’ financial documents may have been forged.

    The professional opinion of Matt Throckmorton – a forensic document examiner who looked at three specific documents relating to durable power of attorney and life insurance – is included in the filings.

    After comparing those documents with dozens of other documents Eric Richins authored, Throckmorton indicated that signatures on the three items in question appear to have been forged.

    “The forgeries in this case are ‘simulated forgeries.’ That is when someone tries to copy, draw or duplicate another person’s characteristics and habits and tries to create a fraudulent signature or set of initials with enough similarities they might get passed off as genuine,” Throckmorton explained.

    “Eric made and requested several unusual to highly unusual choices and provisions to his estate plan,” said attorney Kristal Bowman-Carter, who counseled Eric on estate planning, according to the documents.

    Those unusual requests included that his wife not be designated as his health care agent should one be needed and that his wife and children be provided for, but with the caveat that she should be unable to control the financials. Eric chose his father and sister to be trustees on his family’s behalf, according to the documents.

    Eric sought to “protect the three young sons he and Kouri had together in the long-term by ensuring that Kouri would never be in a position to manage his property after his death,” Bowman-Carter said.

    In a phone conversation the day after Eric’s death, Bowman-Carter explained the trust to Kouri. She said Kouri “became extremely upset. Her behavior (led) me to believe she was learning this for the first time.”

    In an email included in the filings, Richins wrote to police clarifying information about her previous testimony, including a reference to an affair her husband previously had. “Eric’s affair was the same year I ‘moved out,’ the trust was created as well as him looking into a divorce,” she wrote. “Eric and I figured things out like most couples do,” she added.

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  • As horse racing’s best trainers rake in millions, records show they’ve violated rules aimed at keeping the animals safe | CNN

    As horse racing’s best trainers rake in millions, records show they’ve violated rules aimed at keeping the animals safe | CNN



    CNN
     — 

    As horse racing’s elite saddle up for the final race of the coveted Triple Crown at New York’s Belmont Stakes, the sport’s top trainers will face off for their share of the $1.5 million purse at the lavish, star-studded event – amid growing scrutiny after a recent spate of horse deaths.

    A CNN analysis of disciplinary records found that the top earning trainers in the sport – whose thoroughbreds win them millions of dollars – have all broken rules meant to keep their horses safe. Trainers slapped with violations have continued racing, pocketing winnings while paying minimal fines.

    Records show that horse racing’s most successful trainers have violated the sport’s rules multiple times over the course of thousands of races across decades-long careers. The violations range from failed drug tests on race day to falsifying a trainer license. At least three of the trainers have horses competing at the Belmont Stakes this weekend.

    Many of the violations center on the use of drugs that could mask pain prior to a race, potentially leading racehorses – bred for speed with spindly legs – to run on preexisting injuries that increase the risk of fatal breakdowns on the tracks. Researchers have found that about 90% of fatal horse injuries involve preexisting issues, such as small fractures that weaken horses’ bones.

    While therapeutic medications are often legal for treating horses, several are banned on race day.

    “If a horse has an anti-inflammatory, it could compromise an inspection,” said Dr. Jennifer Durenberger, a veterinarian with the Horseracing Integrity and Safety Authority, the national regulatory body established in 2020. “It’s one of the reasons we do restrict medications in the pre-race period.”

    In many ways, the violations say more about the sport than the trainers themselves. Historically, drug limits and rules have varied from state to state, and punishments, which typically led to fines of a few hundred dollars, seemed more like slaps on the wrists than true deterrents. Trainers suspended from one racetrack were still able to compete on others.

    Horse racing reform advocates, and even some trainers, say that national standards for drug violations will help with compliance and improve horse safety.

    Trainers and their representatives interviewed by CNN, however, largely dismissed their disciplinary records, citing unaccredited testing labs, sensitive testing which picks up on minute traces of medication and inconsistent rules among tracks that led to mistakes often beyond their control. They also say the violations must be placed in the context of the thousands of races their horses have started.

    It was supposed to be a triumphant comeback for legendary horse trainer Bob Baffert, but his Preakness Stakes win was underscored by tragedy.

    Just hours before a horse he trained, National Treasure, won the second-leg of the Triple Crown last month, Baffert’s powerful bay-colored colt, Havnameltdown, suffered an injury to its fore fetlock, the equivalent of an ankle, during an earlier race that day. A veterinarian deemed the injury “non-operable,” leaving the three-year-old horse to be euthanized on the track. The Maryland Racing Commission is investigating the death.

    During his short life, Havnameltdown earned $708,000 in prize money for his handlers, including Baffert, who has said the horse got “hit pretty hard” by another horse coming out of the starting gate.

    The Maryland race marked Baffert’s anticipated return to a Triple Crown race – the first since his 2021 Kentucky Derby win was disqualified after his horse, Medina Spirit, failed a post-race drug test. Baffert was cited by the state horse racing commission and Churchill Downs handed him a suspension that banned him from the next two Derby races.

    The drug test revealed that Medina Spirit had betamethasone in his system. The drug is legal for horses in Kentucky, but state rules don’t allow any detectable levels on race day. Baffert disputed the test result and appealed the commission’s citation.

    During his suspension, Baffert continued to race at other tracks and claimed his cut of millions in prize money. Months after the Derby, Medina Spirit died while training at California’s Santa Anita Park; the necropsy report was inconclusive.

    Equine deaths are quite common – hundreds die on and off the track annually. The root cause of what can bring down a massive, muscular horse can range from the natural to the exploitive, including being overworked and overdrugged in the quest for winnings.

    But while some deaths are difficult to prevent, the recent spate of tragedies, especially ones like the public euthanasia of Havnameltdown, have cast a dark shadow over the multi-billion-dollar industry.

    In the span of a month, 12 horses died at Churchill Downs, Kentucky’s most prominent track, since the stable opened this season. The track has suspended racing there while the fatalities are investigated.

    Bob Baffert-trained horse Havnameltdown, behind the curtain, had to be euthanized on May 20, 2023, during the sixth race of Preakness Day in Baltimore.

    The deaths sparked public outrage and thrust the industry back into the national spotlight just a week after HISA rolled out regulations that include medication control.

    But that’s done little to assuage critics’ concerns over the treatment of horses in what was once called the sport of kings.

    “All of it sounds really impressive and it’s quite a show, but that’s all it is: A show. Meanwhile, the horses continue to die,” said Patrick Battuello, an advocate who has tracked horse deaths for the last decade. “The killing is built into the system. … In what other sport are the athletes drugged and doped without their consent?”

    Defenders of the sport argue that the number of horse racing deaths have declined in recent years, and that the industry is safer than it ever was. They point to falling annual death counts collected by The Jockey Club, an influential industry organization, which reports the number of horses who die or are euthanized after racing injuries. The group has tallied several hundred racing deaths each year, with 328 in 2022, down from 709 a decade earlier.

    But those numbers don’t include horses who die during training or between races, which critics argue leads to a severe undercounting of deaths in the sport. They also only include thoroughbred horses, not quarter horses and standardbred horses. Battuello has tallied more than 9,500 racehorses that died since 2014, largely based on death records he’s collected from state horse racing commissions – roughly 1,000 a year.

    While the exact rules vary from state to state, trainers are generally required to report horse deaths that occur at racetracks or as a result of injuries sustained during races. Most deaths are categorized as racing-related or training-related.

    In a statement, The Jockey Club argued that its numbers were “the most accurate data possible” and noted that it had different criteria for including racing-related deaths than Battuello.

    The sport’s highest-earning trainers were among those who had the most horses die at racetracks or due to racing injuries, according to a CNN analysis of state records collected by Battuello over the last decade, as well as data from the horse racing website Equibase.

    Some prominent trainers saw far more of their horses die during training than in actual races. CNN’s review found that Todd Pletcher, who’s earned more than any horse trainer in the industry over the course of his career, has trained at least 38 horses whose deaths were reported to state racing commissions since 2014.

    Trainer Todd Pletcher watches a workout at Churchill Downs Tuesday, May 2, 2023, in Louisville, Kentucky.

    More than three-fourths of those deaths were related to training, not racing, according to Battuello’s count – meaning that Pletcher largely avoided the national spotlight shone on deaths that took place during prominent races like the Preakness or Belmont.

    Similarly, four of the seven deceased horses trained by Baffert that CNN documented did not die as a direct result of injuries sustained during races, and thus likely wouldn’t be included in the official tally of deaths counted by The Jockey Club.

    CNN’s review is an undercount of deaths because it only counted deaths reportable to state commissions. The review connected horses to their most recent trainer of record as of their last race – so it’s possible that some of the horses could have moved to a different trainer before their deaths.

    Horse trainers bear the ultimate responsibility for the wellbeing of the horse and adherence to the rules on the track, an industry standard known as the “absolute insurer rule.”

    “We are completely responsible for the horses. When they arrive on the racetrack that day, we’re responsible for what’s going into that horse, whether it’s medication or feed,” said Graham Motion, a 30-year horse trainer in Maryland. “That has to be our responsibility. There’s no other way really to make it work.”

    The most successful trainers in the sport have all been cited for medical or drug violations.

    Pletcher has racked up nine drug-related violations throughout his career. On one occasion, regulators found he broke rules regarding Lasix – known as the “water drug” – which makes a horse urinate and potentially run faster. New regulations have banned the drug – though state commissions can apply for three-year exemptions – while the effect on horse safety is studied, according to HISA.

    Pletcher was suspended for 10 days last month, after a delayed drug test showed that his horse, Forte, had elevated levels of a common pain-reliever and anti-inflammatory drug during a race he won in New York back in September.

    Irad Ortiz Jr. rides Forte to victory during the Breeders' Cup Juvenile race at Keenelend Race Course, on Nov. 4, 2022, in Lexington, Kentucky.

    “Forte came into our care on March 25, 2022, and he has never been prescribed or administered meloxicam,” Pletcher, who did not respond to CNN’s multiple requests for comment, told Bloodhorse.com. “We did an internal investigation and could not find an employee who had used the drug.”

    Records show Pletcher plans to appeal the ruling.

    Baffert, too, was suspended after his horse, Medina Spirit – who placed first in a 2021 race at Churchill Downs – tested positive for an anti-inflammatory. The suspension was one of about two dozen drug-related violations during Baffert’s career; the vast majority included anti-inflammatories like betamethasone and phenylbutazone.

    One of the three highest earning trainers, Steve Asmussen, has been cited for violations of medication rules about 40 times, in many instances finding elevated levels of anti-inflammatories or thyroid medication, according to records from the Association of Racing Commissioners International, an umbrella organization of horse racing regulators. Research has shown thyroid medication in horses can cause cardiac arrythmias and new regulations ban its use in thoroughbreds, including on race day.

    Clark Brewster, an attorney for both Baffert and Asmussen, said the tally of violations from ARCI data paints an unfair picture of his clients because many of those citations involved therapeutic medications that only slightly exceeded allowable limits in the rules, which he said have repeatedly shifted. “These guys are painstakingly trying to get it right.”

    Motion, the veteran Maryland trainer, himself has been cited at least twice in his career for medication violations, once after one of his horses tested positive for methocarbamol – a muscle relaxer that is permissible to treat horses, but not allowed on race day.

    “It was a very difficult time for me. And I fought it. And I almost regret fighting it now,” said Motion, adding that he felt his team “handled the medication the proper way.”

    He said the new rules around when horses need to withdraw from such medication ahead of race day could have prevented this type of incident.

    Trainer Steve Asmussen before the 149th running of the Kentucky Oaks on May 5, 2023, at Churchill Downs in Louisville, Kentucky.

    Some therapeutic drugs, including anti-inflammatories, are a big concern for the industry on race day. Before each race, horses are examined by veterinarians to determine their fitness and identify potential ailments. But medication in the horse’s system, like anti-inflammatories, can mask some of those preexisting injuries.

    “The extent [of the preexisting injury] can change dramatically and it can go from something minor to something that is potentially serious, if not life threatening” when a horse bursts onto the track from the starting stall, said Dr. Mary Scollay, chief of science at the Horseracing Integrity and Welfare Unit which oversees the new medication control regulations under HISA.

    New HISA regulations, implemented last month, include strict rules about withdrawal times and allowable medication levels on race day.

    “We want to make sure that there is no lingering effects from that medication that could mask a potential injury that would put that horse at risk to the horse, the rider, the others that are in that race,” said Dr. Will Farmer, equine medical director at Churchill Downs Incorporated. “That’s why we have very strict regulation around use of therapeutics in regards to a race specifically.”

    For decades, a patchwork of local and state rules governed the racetracks in the United States, and trainers found in violation of the rules meant to keep their horses safe have been met with minimal repercussions.

    Pletcher – whose horses have earned more than $460 million in almost 25,000 races – paid $5,000 in fines for drug-related citations over the course of his 27-year career. Baffert and Asmussen were each fined over $30,000 during their decades-long careers, according to records from the racing commissioners association. Those fines are offset by more than $340 million and $410 million in earnings, respectively, according to Equibase.

    What’s more, suspensions only banned trainers from certain tracks, allowing them to continue racing – and pocketing earnings – in other states.

    Since the 2022 New York race where Pletcher’s horse Forte had a post-race positive drug test, the horse won four more competitions for Pletcher, earning his handlers more than $2 million.

    Forte is set to race this weekend and is one of the favorites to win the Belmont Stakes.

    Baffert, too, was able to continue racing after he was hit with the suspension following Medina Spirit’s positive drug test. During that time, Baffert entered hundreds of races on other tracks, competing for purses totaling nearly $125 million, according to Equibase data. In 2022 alone, Baffert’s horses brought in nearly $10 million in prize money.

    A general view at the start during the 145th running of the Kentucky Derby at Churchill Downs.

    The biggest change in the governance of American horse racing was tucked into a 2020 federal spending bill. That proviso ultimately created the national Horseracing Integrity and Safety Authority, or HISA – a move that, after three previous legislative attempts, found support from federal lawmakers after a particularly deadly season at a California racetrack.

    During the 2018-2019 season, a staggering 56 horses died at one of the most glamorous racetracks in the country, Santa Anita Park, once home to the famous 1940s thoroughbred Seabiscuit.

    The California Horse Racing Board could not determine a common denominator for the fatalities but found that the vast majority of horses that died had preexisting injuries. And, while no illegal substances or procedures were found, many of the horses were on anti-inflammatories and various other medications.

    “Horse racing must develop a culture of safety first,” the California board wrote in its investigative report. “A small number of participants refusing to change will harm the entire industry.”

    Initially a local scandal, the deaths in Santa Anita Park would have national implications. The fatalities led not only to a complete overhaul of racing practices in Santa Anita – improved track maintenance, restrictions on the use of medications, and softer whips on race day – but also to new national rules under the new regulator, HISA.

    As a private entity under the supervision of the Federal Trade Commission, HISA creates uniform regulations and penalties to govern racetracks throughout the country. The latest set of rules, implemented last month, include anti-doping and medication control programs. They also state that any suspension for a rule violation will carry across all tracks under HISA’s jurisdiction.

    HISA CEO Lisa Lazarus said the goal is to ensure that “there is a level playing field, that the horses are treated properly, that there is built-in safety and integrity” in the sport.

    But some pockets of the industry aren’t welcoming the changes – most notably the National Horsemen’s Benevolent and Protective Association, which has questioned the constitutionality of HISA and filed suits arguing regulatory overreach.

    In an annual NHBPA conference held in March, trainers spoke out against HISA citing an increased administrative burden and added costs of higher fees and required veterinary checks.

    “The whole thing is a façade. It’s been all smoke and mirrors,” said Bret Calhoun, a horse trainer and member of the Louisiana HBPA board, according to the Thoroughbred Daily News. “They sold this thing as the safety of the horse. It’s absolutely not about safety of horse. It’s a few people, with self-interest and they have their own personal agenda.”

    There are several lawsuits challenging HISA’s legitimacy and authority in the sport, some backed by the NHBPA, making their way through courts across the country. But while legal battles are fought in the courts, horses keep dying on the tracks.

    Last week, a horse death at Belmont Park meant that there have been fatalities around all three racetracks in the Triple Crown this season.

    “There is risk in any sport. We cannot eliminate risk. We can continue to diminish risk as best we can. We are never going to eliminate a horse getting injured,” said Motion, adding “the most important thing is the welfare of the horse. It’s not winning at all costs. It’s winning with a healthy animal.”

    To identify racehorses who died while being trained by the industry’s highest-earning trainers, CNN combined a list of dead horses compiled by activist Patrick Battuello with data from the horse racing website Equibase.

    Since 2014, Battuello has collected state horse racing commission reports on horse deaths through public records requests and published a list of racehorses who died each year on his website. Most of the horse deaths Battuello has identified are based on state records, although a handful are based on news reports or verbal confirmation he received from racetrack officials.

    CNN matched Battuello’s list of deceased horses with data downloaded from Equibase that listed each horse’s trainer as of its most recent race. For the top three trainers with the highest earnings, Pletcher, Asmussen and Baffert, CNN reviewed the original documents Battuello collected from the commissions, which he provided to reporters.

    Because the Equibase data on trainers is based on each horse’s most recent race, some horses may have moved to other trainers before they died. In a handful of cases, when state death records listed a different trainer for a horse than Equibase does, CNN used the trainer listed in the records.

    CNN’s review only included horse deaths that were required to be reported to state commissions, so it undercounts the total deaths associated with individual trainers. In addition, not all of the dead horses Battuello has documented were able to be reliably matched with Equibase’s data, so additional deaths may also be missing from the review.

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  • A mother was raising her son in a city she loved. Then San Francisco changed and stole her boy | CNN

    A mother was raising her son in a city she loved. Then San Francisco changed and stole her boy | CNN

    Watch how drugs, homelessness and crime have changed a city, and what is being done about it. CNN’s Sara Sidner asks “What Happened to San Francisco?” on “The Whole Story with Anderson Cooper,” Sunday at 8 p.m. ET.


    San Francisco
    CNN
     — 

    Tanya Tilghman moved to the Bay Area as a teenager to live with her mom. Later, she married, had two sons and made a home in San Francisco’s historically Italian North Beach district, up the hill from the tourist and financial centers.

    Even when her marriage broke down, she never thought of leaving. This was her city, her people. Liberal like her, with a mix of income levels and a general sense of community. She didn’t worry about her growing boys going out on the streets where she herself always felt safe.

    But those streets have changed, she says. She believes policies from City Hall and even groups who advocate for the homeless have exacerbated some of the problems and the community she once felt a part of has gone, she says. And her son got caught up in a scene you can almost not avoid in the city: the drug scene.

    Roman Vardanega first tried illegal drugs at the start of high school, Tilghman said, taking a prescription medication at a friend’s house.

    He quickly became hooked, his mother said, moving on to cocaine, heroin and later fentanyl, all available in the city’s seedy Tenderloin area.

    Tilghman admits she was uneducated about the prevalence of hard drugs, even naïve. But it was not something she encountered every day. Back then “I think it’s a lot worse now than when I was growing up here,” she said. “We used to come to the Tenderloin when I was a teenager because we thought it was just kind of fun, edgy and I never as a teenager felt unsafe. But I also don’t remember people coming up to me and asking me if I want to buy drugs.”

    One of her first clues that her son was getting in deep was when she was with him on a tour outside City Hall while he was in high school. It was a few blocks from the Tenderloin and some of the unhoused people on the street knew him by name, as if he spent a lot of time out there with them – which is what he was doing, scoring his drugs.

    She tried to help. Vardanega spent the 11th grade in rehab but persuaded his mom to let him return. She welcomed him home, but so did the streets.

    Roman Vardanega showed musical talent from a young age, his mother said, before his addictions consumed him.

    By then, her neighborhood had changed, with drugs seemingly freely available, even just heading home on the Bay Area Rapid Transit (BART) local transport system.

    “When I got out of the BART station, the first thing that I was asked is if I wanted to buy drugs,” Tilghman said. The ease of getting and using drugs made the city a dangerous and sometimes deadly playground for people like her son.

    Vardanega started to live on the streets full-time when the Covid pandemic hit in 2020. The city shut down, residents either left or stayed inside and at the height of the pandemic, more people died of drug overdoses than Covid-19.

    “All the tents started going up in the city,” Tilghman said. “The open-air drug market became a lot worse. And so it became easier for him to buy drugs and to use it out in the open.”

    And confusingly to Tilghman, the city just seemed to look away.

    “The city’s policies have absolutely hurt my son, has hurt us, and has caused him to, I would say go into his addiction even a lot more,” she said.

    “If you got busted with drugs, most likely you’re not going to jail, the police officers would just let you go,” she said. “That made the situation a lot worse, especially for my son because he’s really young, and still kind of in that party state of mind.”

    Tilghman’s state of mind was focused on one goal: finding her son. She knew he was an addict. She knew she loved him so much it hurt. And she knew she would not stop searching until she found him even if that meant putting herself in danger.

    She would walk the streets looking at things most people try to avoid, looking directly into the eyes of the people living on the streets. Sometimes she got back blank stares. Other times a sympathetic ear or a hopeful hint about where her son might be.

    She didn’t find him, but so many people were like him. “What makes me sad is that I see my son’s face in everybody’s faces … out on the streets,” Tilghman said.

    As Covid descended, many housed residents began disappearing and the tent cities exploded onto the sidewalks, along with the drugs, the addictions and signs of mental illness.

    Rectangles are painted on the ground to encourage homeless people to keep social distancing at a city-sanctioned homeless encampment across from City Hall in San Francisco in May 2020.

    Mayor London Breed declared a state of emergency in the city, to include a “linkage center” in the Tenderloin, promoted as a place where addicts could get services to help them.

    When it opened in January 2022, Tilghman was hopeful it could be somewhere her son would find himself, and one day she went to take a look. When she got there, she heard music blaring and tried to get a look inside.

    “I saw people doing drugs. I couldn’t believe it. I’m like, this is a place where people are supposed to get help. And they’re actually doing drugs?” Tilghman said.

    A little later, she posed as an addict and went to the center for a closer look.

    “I said to them that I wanted to get off drugs, and that I needed help,” she said. “And they laughed at me. And the guy at the door said, ‘We can help you do drugs. But if you want help getting off drugs, you’re gonna have to come back tomorrow’,” Tilghman said.

    The center had what was supposed to be an area where overdoses could be treated, but it became known as a place to take drugs, not seek other services.

    “The most upsetting thing … was that the harm reduction area was more like a party scene,” Tilghman said. “If my son were to go there wanting to access services, him being addicted to drugs, if he were to see a party scene with people dancing and singing and doing drugs, and most likely selling drugs inside, there’s just no way he would access services. Because he would get so distracted, and be so triggered that he would go and use.”

    The city’s laissez-faire philosophy had just gone too far, she felt.

    “When you could walk into a store and steal under $1,000 worth of merchandise and get away with it – that’s going way too far,” she said. “It’s going too far when you could smoke crack in front of a police officer and the police officer just looks at you and doesn’t even arrest you.”

    The struggle to try to save her son wore her down. Not once, but three times Tilghman says she got so low and so hopeless she attempted suicide.

    The situation is beginning to change, both for Tilghman personally, and perhaps her city.

    The Tenderloin Linkage Center, which was later renamed to just the Tenderloin Center, closed last December. Tilghman has found new support and a mission working with Mothers Against Drug Addiction and Deaths. A new district attorney took over after the previous one was recalled by voters who perceived him as soft on crime. Tilghman’s son Vardanega got in trouble with the law, served jail time and was sent to a court-mandated rehab program.

    Incarceration is a good thing for him in Tilghman’s mind – keeping him alive, off the streets and giving him a chance in a treatment program.

    San Francisco is still beautiful to her – with the Golden Gate Bridge, the Presidio and Fisherman’s Wharf, the Italian enclave of North Beach. But it has become scarier, and she feels some of the blame has to go to politicians whose job it is to clean up the streets.

    “I’m liberal,” Tilghman said. “My politics have stayed the same and things have gone crazy around me.”

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

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



    CNN
     — 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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  • A 13-year-old died in Ohio after participating in a Benadryl TikTok ‘challenge’ | CNN

    A 13-year-old died in Ohio after participating in a Benadryl TikTok ‘challenge’ | CNN



    CNN
     — 

    A 13-year-old in Ohio has died after “he took a bunch of Benadryl,” trying a dangerous TikTok challenge that’s circulating online, according to a CNN affiliate and a GoFundMe account from his family.

    Jacob Stevens was participating in a TikTok challenge with some friends at home when he ingested the antihistamine, the family donation account states. Jacob was on a ventilator for almost a week before he died, according to WSYX.

    CNN has not independently confirmed his cause of death.

    Overdosing on Benadryl can result in “serious heart problems, seizures, coma, or even death,” the US Food and Drug Administration said in a 2020 warning to the public about the deadly “Benadryl Challenge” on TikTok.

    Here’s what your teen could see on TikTok

    Jacob’s grandmother is doing anything she can “to make sure another child doesn’t go through” with the challenge, she told CNN affiliate WSYX.

    In a statement to CNN, TikTok said, “Our deepest sympathies go out to the family. At TikTok, we strictly prohibit and remove content that promotes dangerous behavior with the safety of our community as a priority. We have never seen this type of content trend on our platform and have blocked searches for years to help discourage copycat behavior. Our team of 40,000 safety professionals works to remove violations of our Community Guidelines and we encourage our community to report any content or accounts they’re concerned about.”

    The maker of Benadryl, Johnson & Johnson, has called the challenge “dangerous.”

    “We understand that consumers may have heard about an online ‘challenge’ involving the misuse or abuse of diphenhydramine,” the undated online statement reads.

    “The challenge, which involves ingestion of excessive quantities of diphenhydramine, is a dangerous trend and should be stopped immediately. BENADRYL® products and other diphenhydramine products should only be used as directed by the label.”

    “We are working with TikTok and other social platforms to remove content that showcases this behavior,” the statement added. “We will look to partner across industry and with key stakeholders to address this dangerous behavior.”

    CNN has reached out to the Stevens family and Columbus Public Health for comment.

    The FDA’s 2020 warning said the agency had “contacted TikTok and strongly urged them to remove the videos from their platform and to be vigilant to remove additional videos that may be posted.”

    Benadryl is an antihistamine used to treat symptoms such as a runny nose or sneezing from upper respiratory allergies, hay fever or the common cold. It’s safe and effective when used as recommended, the FDA said.

    “Diphenhydramine is marketed under the brand-name Benadryl, store brands, and generics. It is also available in combination with pain relievers, fever reducers, and decongestants,” the agency said.

    Consumers and parents should store Benadryl and other over-the-counter medications and prescription medicines out of the reach of children, the FDA said.

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  • ADHD medication abuse in schools is a ‘wake-up call’ | CNN

    ADHD medication abuse in schools is a ‘wake-up call’ | CNN



    CNN
     — 

    At some middle and high schools in the United States, 1 in 4 teens report they’ve abused prescription stimulants for attention deficit hyperactivity disorder during the year prior, a new study found.

    “This is the first national study to look at the nonmedical use of prescription stimulants by students in middle and high school, and we found a tremendous, wide range of misuse,” said lead author Sean Esteban McCabe, director of the Center for the Study of Drugs, Alcohol, Smoking and Health at the University of Michigan in Ann Arbor.

    “In some schools there was little to no misuse of stimulants, while in other schools more than 25% of students had used stimulants in nonmedical ways,” said McCabe, who is also a professor of nursing at the University of Michigan School of Nursing. “This study is a major wake-up call.”

    Nonmedical uses of stimulants can include taking more than a normal dose to get high, or taking the medication with alcohol or other drugs to boost a high, prior studies have found.

    Students also overuse medications or “use a pill that someone gave them due to a sense of stress around academics — they are trying to stay up late and study or finish papers,” said pediatrician Dr. Deepa Camenga, associate director of pediatric programs at the Yale Program in Addiction Medicine in New Haven, Connecticut.

    “We know this is happening in colleges. A major takeaway of the new study is that misuse and sharing of stimulant prescription medications is happening in middle and high schools, not just college,” said Camenga, who was not involved with the study.

    Published Tuesday in the journal JAMA Network Open, the study analyzed data collected between 2005 and 2020 by Monitoring the Future, a federal survey that has measured drug and alcohol use among secondary school students nationwide each year since 1975.

    In the data set used for this study, questionnaires were given to more than 230,000 teens in eighth, 10th and 12th grades in a nationally representative sample of 3,284 secondary schools.

    Schools with the highest rates of teens using prescribed ADHD medications were about 36% more likely to have students misusing prescription stimulants during the past year, the study found. Schools with few to no students currently using such treatments had much less of an issue, but it didn’t disappear, McCabe said.

    “We know that the two biggest sources are leftover medications, perhaps from family members such as siblings, and asking peers, who may attend other schools,” he said.

    Schools in the suburbs in all regions of the United States except the Northeast had higher rates of teen misuse of ADHD medications, as did schools where typically one or more parent had a college degree, according to the study.

    Schools with more White students and those who had medium levels of student binge drinking were also more likely to see teen abuse of stimulants.

    On an individual level, students who said they had used marijuana in the past 30 days were four times as likely to abuse ADHD medications than teens who did not use weed, according to the analysis.

    In addition, adolescents who said they used ADHD medications currently or in the past were about 2.5% more likely to have misused the stimulants when compared with peers who had never used stimulants, the study found.

    “But these findings were not being driven solely by teens with ADHD misusing their medications,” McCabe said. “We still found a significant association, even when we excluded students who were never prescribed ADHD therapy.”

    Data collection for the study was through 2020. Since then, new statistics show prescriptions for stimulants surged 10% during 2021 across most age groups. At the same time, there has been a nationwide shortage of Adderall, one of the most popular ADHD drugs, leaving many patients unable to fill or refill their prescriptions.

    The stakes are high: Taking stimulant medications improperly over time can result in stimulant use disorder, which can lead to anxiety, depression, psychosis and seizures, experts say.

    If overused or combined with alcohol or other drugs, there can be sudden health consequences. Side effects can include “paranoia, dangerously high body temperatures, and an irregular heartbeat, especially if stimulants are taken in large doses or in ways other than swallowing a pill,” according to the Substance Abuse and Mental Health Services Administration.

    Research has also shown people who misuse ADHD medications are highly likely to have multiple substance use disorders.

    Abuse of stimulant drugs has grown over the past two decades, experts say, as more adolescents are diagnosed and prescribed those medications — studies have shown 1 in every 9 high school seniors report taking stimulant therapy for ADHD, McCabe said.

    For children with ADHD who use their medications appropriately, stimulants can be effective treatment. They are “protective for the health of a child,” Camenga said. “Those adolescents diagnosed and treated correctly and monitored do very well — they have a lower risk of new mental health problems or new substance use disorders.”

    The solution to the problem of stimulant misuse among middle and high school teens isn’t to limit use of the medications for the children who really need them, McCabe stressed.

    “Instead, we need to look very long and hard at school strategies that are more or less effective in curbing stimulant medication misuse,” he said. “Parents can make sure the schools their kids attend have safe storage for medication and strict dispensing policies. And ask about prevalence of misuse — that data is available for every school.”

    Families can also help by talking to their children about how to handle peers who approach them wanting a pill or two to party or pull an all-night study session, he added.

    “You’d be surprised how many kids do not know what to say,” McCabe said. “Parents can role-play with their kids to give them options on what to say so they are ready when it happens.”

    Parents and guardians should always store controlled medications in a lockbox, and should not be afraid to count pills and stay on top of early refills, he added.

    “Finally, if parents suspect any type of misuse, they should contact their child’s prescriber right away,” McCabe said. “That child should be screened and assessed immediately.”

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  • Opinion: Mifepristone saved my life | CNN

    Opinion: Mifepristone saved my life | CNN

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



    CNN
     — 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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  • Biden administration declares fentanyl laced with xylazine ‘an emerging threat’ in the US | CNN

    Biden administration declares fentanyl laced with xylazine ‘an emerging threat’ in the US | CNN



    CNN
     — 

    The White House has declared that the powerful synthetic opioid fentanyl combined with xylazine – an animal tranquilizer that’s increasingly being used in illicit drugs – is an “emerging threat” facing the United States due to its role in the ongoing opioid crisis.

    Administration officials call the threat FAAX, for fentanyl-adulterated or -associated xylazine.

    The move, announced Wednesday, marks the first time in history that any administration has declared a substance to be an emerging threat to the country, said Dr. Rahul Gupta, director of the Office of National Drug Control Policy. The SUPPORT Act of 2018 established that the office has authority to declare such “emerging threats,” and no administration has used it until now. Last year, Congress declared methamphetamine an emerging drug threat but none have been declared by an administration previously. Under other agencies or in separate circumstances, concerns such as bioterrorism, infectious diseases or climate change may be identified as “emerging threats.”

    “This drug, which is an animal sedative, is being mixed with fentanyl and is being found in almost all 50 states now,” Gupta said Tuesday. “It’s become an important part for us to make sure that we’re declaring it an emerging threat.”

    Now that the administration has declared fentanyl combined with xylazine an emerging threat, it has 90 days to coordinate a national response. “We are working quickly to develop and implement a whole of government nationwide plan, with real deliverable action, that will save lives and will be published within 90 days of this designation,” Gupta said.

    Xylazine, also known as tranq or tranq dope, has been linked to an increasing number of overdose deaths in the United States due to its rising illicit use. Between 2020 and 2021, overdose deaths involving xylazine increased more than 1,000% in the South, 750% in the West and about 500% in the Midwest, according to an intelligence report released last year by the US Drug Enforcement Administration.

    And in some cases, people might not even know that xylazine was in the drug they used.

    Just last month, authorities at the DEA issued a public safety alert about the “widespread threat” of fentanyl mixed with xylazine, reporting that in 2022 approximately 23% of fentanyl powder and 7% of fentanyl pills seized by the DEA contained xylazine.

    Fentanyl, which has been driving the opioid crisis, is a fast-acting opioid, and people who use it illicitly say that adding xylazine can extend the duration of the high the drug provides.

    Xylazine is not an opioid. It is approved by the US Food and Drug Administration for use as a tranquilizer in veterinary medicine, typically in horses, but it is not approved for use in humans. And xylazine can do major damage to the human body, including leaving drug users with severe skin ulcers, soft-tissue wounds and necrosis – sometimes described as rotting skin – that can lead to amputation.

    “Xylazine is one of the contaminants in fentanyl, but there could be others,” Gupta said. “So, I think with the declaration of an emerging threat, we’re sending a clear message to producers and traffickers of illicit xylazine and illicit fentanyl that we’re going to respond quicker, we’re going to match the challenge of evolution of these drugs supply, and that we’re going to protect lives first and foremost.”

    Now that xylazine has been declared an emerging threat, some of President Biden’s $46 billion drug budget request to Congress can be used to respond.

    This year, the Biden administration announced that the President has called on Congress to invest $46.1 billion for agencies overseen by the Office of National Drug Control Policy to tackle the nation’s illicit drug crisis.

    If the budget request is not approved, there could be the option to reallocate money within the Office of National Drug Control Policy, but “we don’t want to be in a position where moneys that are being utilized for some other important aspect of saving lives has to be moved away for this purpose,” Gupta said Tuesday. “That is the reason we are asking Congress to act.”

    Such funds could be used to test drugs on the street for xylazine, collect data on FAAX, invest in care for people exposed to FAAX and develop potential treatments for a xylazine-related overdose.

    The medication naloxone, also known as Narcan, is an antidote for an opioid overdose, but people who have overdosed on a combination of opioids and xylazine may not immediately wake up after taking naloxone, as it may not reverse the effects of xylazine in the same way it does opioids.

    “We need to recognize, first of all, that there is a shift that is occurring from organic compounds and substances like heroin and cocaine to more synthetics,” Gupta said of the state of the nation’s illicit drug crisis.

    “Both the types of drugs have changed – from predominantly organic to predominantly synthetics – but the way drugs are bought and sold have also changed,” he said. “Now, all you need is a phone in the palm of your hand and a social media app to order and buy some of the most dangerous substances on planet Earth.”

    Xylazine is just one of the many adulterants – or substances that are typically added to others – found in the nation’s illicit drug supply.

    “All of a sudden, you can synthesize hundreds of compounds and kind of mix them together and see what does the best in the market,” Joseph Friedman, a researcher at the University of California, Los Angeles, told CNN in March. “People are synthesizing new benzodiazepines, new stimulants, new cannabinoids constantly and adding them into the drug supply. So people have no idea what they’re buying and what they’re consuming.”

    Some of these adulterants may be as simple as sugar or artificial sweeteners added for taste or additives or fillers that bulk up the drug. Sometimes, they may be contaminants left over from the manufacturing process.

    But all of these things can carry real-life health harms, says Naburan Dasgupta, an epidemiologist and senior scientist at the Gillings School of Global Public Health at the University of North Carolina, Chapel Hill.

    Like an opioid, xylazine can depress the respiratory system, so the risk of overdose multiplies when it’s combined with heroin or fentanyl.

    Also, “in the veterinary literature, we know that it causes a really bad severe form of anemia. And so when people are injecting heroin that’s contaminated with xylazine, they can end up with a near-fatal form of blood iron deficiency,” Dasgupta said in March. “We had one person here who ended up going to the hospital needing multiple blood transfusions. And it was all because of the xylazine.”

    US lawmakers are moving to classify xylazine as a controlled substance.

    In March, bipartisan legislation – the Combating Illicit Xylazine Act – was introduced in the House and Senate. It describes illicit xylazine as an “urgent threat to public health and safety” and calls for it to be a Schedule III drug under the Controlled Substances Act, a category on the five-level system for substances with moderate to low potential for physical or psychological dependence. Xylazine would be one level below opioids like fentanyl.

    “Our bipartisan bill would take important steps to combat the abuse of xylazine by giving law enforcement more authority to crack down on the illicit distribution of this drug, including by putting stiffer penalties on criminals who are spreading this drug to our communities,” Sen. Maggie Hassan, D-N.H., said in a statement in March.

    The bill would also require manufacturers to send reports on production and distribution to the DEA so the agency can ensure that the product is not being diverted to the black market.

    “This bill recognizes the dangers posed by the increasing abuse of animal tranquilizers by drug traffickers, and provides new tools to combat this deadly trend,” Sen. Chuck Grassley, R-Iowa, said in the statement.

    “It also ensures that folks like veterinarians, ranchers and cattlemen can continue to access these drugs for bona fide animal treatment.”

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

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



    CNN
     — 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    “The court’s disregard for well-established scientific facts in favor of speculative allegations and ideological assertions will cause harm to our patients and undermines the health of the nation,” the AMA president said.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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



    CNN
     — 

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

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

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

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

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

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

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

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

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

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

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

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  • The US sanctioned Chinese companies to fight illicit fentanyl. But the drug’s ingredients keep coming | CNN

    The US sanctioned Chinese companies to fight illicit fentanyl. But the drug’s ingredients keep coming | CNN



    CNN
     — 

    The seller, who went by the name Linda Wang, was curt when asked if she sold a chemical often used to create fentanyl.

    “That’s banned,” Wang replied, before quickly providing an alternative: “CAS79099 powder is best. U can have a try.” 

    After more than a week of back and forth, she seemed impatient. “Ok. 79099 powder in USA warehouse now…if you need. Pls order asap,” she wrote in a text message exchange.

    The interaction is part of a CNN investigation that explored whether US-sanctioned chemical companies in China are evading Washington DC’s crackdown on illicitly made fentanyl – finding at least one China-based company that had links to a sanctioned entity, and a seller eager to ship potential ingredients for the lethal drug.

    More than 100,000 Americans died from drug overdoses in 2021, and two-thirds of the fatalities involved synthetic opioids – much of it believed from illicitly made fentanyl, according to the Centers for Disease Control.

    The drug can be 50 times stronger than heroin and 100 times stronger than morphine – and pharmaceutical grade versions of it can be prescribed by doctors for severe pain. But illegally manufactured fentanyl has turbocharged the US’s opioid overdose crisis in the last decade, according to data from the CDC.

    Controlling the illegal trade of the drug has turned into a geopolitical headache for the Biden administration, as China’s vast chemicals market – which supplies the world with raw materials for everything from perfume to explosives– is also a major pipeline of the building blocks of fentanyl, known as fentanyl precursors, according to US officials. 

    Further complicating the fight against fentanyl is the sheer variety of precursors that can be used to make fentanyl and other illicit drugs. Most such precursors also have legitimate uses – including for medical research – and are perfectly legal to sell, making up part of the booming transnational trade.

    China has strict anti-drug policies domestically, but critics in the US say it is not doing enough to help monitor or regulate purchases from buyers aiming to use Chinese-made ingredients to manufacture illegal drugs overseas.

    In 2019, Beijing stepped up its crack down on the production and sale of finished fentanyl and its variants, but US-China anti-drug cooperation has since stalled amid disagreements on trade, human rights, the Covid-19 outbreak and Taiwan. Hopes that US Secretary of State Antony Blinken would bring up fentanyl during a planned visit to Beijing died in early February, when Blinken postponed his trip after a surveillance balloon from China floated over the continental US. 

    As the opioid crisis topped the domestic agenda in 2021, the US sanctioned four companies in China accused of exporting fentanyl or fentanyl precursor chemicals. Online commercial records suggest ties between one of those sanctioned companies, Hebei Atun Trading Co., Ltd., and another China-based company called Shanxi Naipu Import and Export Co., Ltd., that continues to sell fentanyl precursors legally.

    According to official public records in China, Hebei Atun Trading Co., Ltd., began liquidating in June 2021 and was formally dissolved in August that year. Shanxi Naipu Import and Export Co., Ltd. was registered in the same period, according to official records, and it shares a number of key things in common with Hebei Atun.

    For example, Hebei Atun’s still-active Facebook page once linked to a now-defunct website of Shanxi Naipu – which is where CNN found Wang’s phone number.

    The two companies’ websites are registered to the same email address, and at one time appeared to share an IP address. Today, Shanxi Naipu’s websites appear to be carbon copies of Hebei Atun’s since-deleted page – with the same navigation tabs, email address and stock photo of a pipette dropping amber-colored liquid into a cell tray. The Russian and Portuguese versions of the site list “Hebei Atun Trading Co. Ltd.” as their copyright holder.

    One post on a Shanxi Naipu website was titled, “Hebei ATUN Trading Co., Ltd. Wishes you a Happy New Year!” (sic). It has since been deleted. 

    When presented with CNN’s findings, Shanxi Naipu denied ties to Hebei Atun, saying, “we are not related at all.” In statements emailed to CNN, Shanxi Naipu said it had purchased the sanctioned company’s Facebook account, email and cell phone number in order to “attract internet traffic.”

    Shanxi Naipu also denied selling the fentanyl precursor that Wang offered by text, and stressed that everything they sell is legal, and said that they were taking steps to stop the repercussions from the apparent links to Hebei Atun.

    “To prevent further impact from Hebei Atun, we have immediately removed relevant promotional websites and platforms,” the company said in an emailed statement.”

    Logan Pauley, a China analyst who tracks criminal and drug networks, told CNN, “It’s easy on the Chinese side to start a new company to copy and paste the same text that you’re posting on social media or you’re posting on a trade website, and then just to recreate the same operation over and over again.”

    And Gary Hufbauer, trade expert at the Peterson Institute for International Economics and former US treasury official, likens it to a game of cat-and-mouse. While the US government can add an entity to its sanctions list “overnight,” said Hufbauer, there may not be the resources in the US Treasury’s Office of Foreign Assets Control, which enforces sanctions, to keep tabs on new companies that may leverage sanctioned companies’ branding or operations. 

    In a statement to CNN, a spokesperson for the US Treasury said it “had not hesitated” to go after “bad actors” – citing the four sanctioned Chinese companies – and would continue to sanction companies and individuals involved in the drug trade.

    “Treasury continues to monitor the effects of our designations,” they said. “If additional information becomes available that can assist sanctions compliance efforts, when appropriate, we provide that information to industry and/or the public.”

    Asked if Beijing was knowingly lax in its efforts to stem the flow of precursor chemicals from its country, the Chinese Foreign Ministry pointed out that most were not controlled substances, in a lengthy statement that also questioned US efforts to treat addiction and demand for opioids.

    “China has always strictly controlled precursor chemicals in accordance with international conventions and domestic laws. The US side’s so-called ‘fentanyl precursors,’ a small number of them are listed substances by the United Nations, and China has always been resolute in implementing the listed measures. But most of the rest are common chemicals that are not listed by the United Nations, China or even the United States itself,” it said in a written statement to CNN.

    “Government departments do not have the right or the possibility to regulate non-listed chemicals and common commodities,” it added.

    The ministry statement went on to highlight China’s harsh domestic penalties on drug trade and consumption. “The Chinese people deeply resent drugs. the Opium War was the beginning of China’s modern history of humiliation. The Chinese government has always cracked down on drug crime, and China is a no-go area for international drug dealers.”

     Such unregulated precursors, like the one offered by Wang, are not illegal to sell but can be used in the manufacture of illicit substances like fentanyl, methamphetamine, and cocaine.

    Several precursors used to create fentanyl have been put under international control since 2017, but a savvy chemical engineer can combine legal precursors further up the synthesis chain to make similar compounds.

    “What we have seen illicit chemists doing now is that certain components of the synthesis are now … harder for them to purchase, so what they’re doing now is they’re buying compounds that are structurally very, very similar,” Alexandra Evans, a forensic chemist with the D.C. Department of Forensic Sciences, told CNN from her lab in the US capital.

    Or they can create fentanyl analogues, substitutes that are chemically similar to fentanyl and which has made the crisis more deadly in recent years. One fentanyl analogue was found to be 10,000 times stronger than morphine, according to a 2021 US government report.

    Controlling the stream of chemicals has turned into a deadly game of whack-a-mole – where manufacturers are able to use a variety of precursors to synthesize fentanyl and its analogues faster than either can be identified, banned, or regulated. 

    Many of the building blocks to fentanyl have benign purposes and are legal to buy, but a menu Wang sent of Shanxi Naipu’s chemical products for sale appeared designed to support illegal drug manufacture, according to a synthetic chemist who analyzed the list for CNN. 

    It was “obviously a list curated to help people create illicit drugs,” Lyle Isaacs, a professor in the Department of Chemistry and Biochemistry at the University of Maryland, told CNN of the more than 25 chemical compounds on the menu. 

    At least three compounds on the list could be made into fentanyl, he said. One of the compounds, CAS 79099-07-3, also known as 1-Boc-4-piperidone, was what Wang offered to sell CNN; the other two compounds also have legitimate uses and can be found, for example, in academic laboratories researching future medicines, Isaacs said. 

    Still more compounds on the list appeared to be building blocks for meth, ecstasy, ketamine, and the cutting of cocaine, as well as over-the-counter drugs like paracetamol, a common pain medication that can also be used to cut heroin and other narcotics, he added. 

    Asked about the list, Shanxi Naipu reiterated in its statement to CNN that all products on it are legal in China, stating: “We are not professional chemists but just a trading company. Even though we don’t have an intimate knowledge of the composition and use of thousands of chemicals, we have always strictly ensured the legality of our products!”

    Attempts to contact Wang through the company for comment were not successful, and the company said in its statement that she no longer works for them.

    There are measures that responsible chemical sellers can take to avoid their products being used for illegal drugs.

    Identity checks are a hallmark of reputable sellers, said a former Drug Enforcement Administration (DEA) official. The source spoke to CNN on the condition of anonymity because they were not authorized to speak to the media. To sell non-listed chemicals, a good-faith seller would normally ask a buyer about the intended use of the compound, and whether the buyer had the backing of a company or institution, such as a research organization or university.  

    American buyers of regulated chemicals require licenses from the DEA, depending on how hazardous they are. Reputable sellers may also ask for tax identifications even for chemicals that are not controlled, like precursor materials, the source said.

    At no point in the conversation was Wang aware, nor did she ask for the identities of the CNN reporters speaking to her or what CNN planned on using it for. She even offered a “door to door” precursor delivery service via warehouses in the US or Mexico – locations that CNN has been unable to verify.

    In its statement to CNN, Shanxi Naipu denied that it had warehouses in either country.

    The small quantity of precursor needed to manufacture fentanyl ultimately makes shipments destined for illicit ends hard to catch at the border, points out Martin Raithelhuber, an illicit synthetic drugs expert at the United Nations Office on Drugs and Crime.

    “You have hundreds of thousands of tonnes (of chemicals in a shipment), and you are looking for a few kilograms, which are sufficient to produce a supply of millions of doses (of fentanyl),” he said. 

    Since China banned the production of fentanyl and related substances in 2019, Mexican criminal organizations have largely taken control of the drug’s production and sale, smuggling finished fentanyl to consumers in the US, according to a 2022 report from the Congressional Research Service.

    Mexico is now the source of “the vast majority” of meth, heroin and illicit fentanyl seized in the US, according to the US International Narcotics Control Strategy Report (INCSR) released in March 2023. “In 2022, the United States identified Mexico as the sole significant source of illicit fentanyl and fentanyl analogues significantly affecting the United States,” it reads.

    “Criminal elements, mostly in the People’s Republic of China, ship precursor chemicals to Mexico, where they are used to produce illicit fentanyl,” Dr. Rahul Gupta, director of the White House’s Office of National Drug Control Policy, told the Senate Foreign Relations Committee earlier this year. 

    “The only limit on how much fentanyl they can make is the amount of precursor chemicals they can get,” DEA Administrator Anne Milgram told CNN in early March.

    The Biden administration has taken aim at these groups and in February sanctioned a network of Sinaloa Cartel members and associated entities for their involvement in the fentanyl and methamphetamine trade. 

    Mexico’s law enforcement has also fought the trade, seizing and impounding hundreds of kilos of fentanyl precursors and pills – including a cache of over a million potential fentanyl pills in the Mexican border city of Tijuana on March 13.

    Ultimately, tackling fentanyl requires close coordination between the US, Mexico, and China. Even if countries like Mexico had the best national control measures, international cooperation is needed to understand “which flows are the ones we need to watch or [be] worried about,” Raithelhuber said.

    Former DEA official Matthew Donahue told CNN he would like to see Mexico do more, including cracking down on properties and other assets of those involved in the drug trade.

    But as the US pressures other governments to help slow the flow of illicit fentanyl, relations between the three countries have turned into a three-way blame game.

    Following the kidnapping of four Americans in a Mexican border town by cartel members in early March, US Republicans called for the US military to be allowed to fight cartels and destroy drug labs in Mexico – something Mexican President Andrés Manuel López Obrador called “an offense to the people of Mexico.” 

    “We are not a protectorate of the United States or a colony of the United States. Mexico is a free, independent, sovereign country. We don’t take orders from anyone,” López Obrador said at a news conference on March 9. 

    Washington has also called on Beijing to do more, with the latest US INCSR report describing China’s oversight functions as “poorly staffed and under-resourced to oversee its massive chemical industry.” Though it acknowledges Beijing’s harsh penalties for drug trafficking, the report laments ineffective controls on shipment labeling, customer vetting and pill-making equipment.

    The Ministry of Foreign Affairs’ statement to CNN emphasizes its “stringent” control of listed chemicals that could be used for drug-making and argues that Beijing has “improved” several “regulatory mechanisms such as end-user verification, leakage monitoring, and source backtracking, and has strengthened management of more than 200,000 chemical companies.”

    Both China and Mexico have called on the US to do some soul-searching about demand for illicit fentanyl.

    “US legislators and the authorities there are not doing their job because they are not addressing the causes (of addiction); there are no care programs for young people in the US,” López-Obrador said last week.

    “Using China as a scapegoat will not solve the drug crisis in the United States … ,” the Chinese Foreign Ministry’s statement to CNN read. “We advise the US side to reflect on itself, stop shifting blame, strengthen domestic prescription drug control, enhance publicity on the dangers of drugs, and take practical measures to reduce domestic drug demand.”

    Prescription opioids like oxycodone and hydrocodone – which have a similar chemical structure to heroin and fentanyl – were major contributors to the early opioid crisis in the US. Pharmaceutical giants, notably Purdue Pharma, downplayed the potentially addictive properties of the drugs and incentivized US doctors to prescribe the painkillers. But prescribing was curtailed as overdoses from prescription opioids climbed and now waves of heroin and illicit fentanyl took over, making the crisis far more deadly. 

    Amid the recriminations, fentanyl products continue to pour through US borders and Americans continue to die. 

    To raise awareness of the human toll, the US Drug Enforcement Administration last year created “The Faces of Fentanyl” exhibit at its headquarters in Arlington, Virginia where families can submit a photo of a loved one lost to the fentanyl crisis. So far more than 5,000 photos have been submitted.

    “We can’t be desensitized” to the number of lives lost to drug overdoses,” Donahue, the former DEA official, said. “The pain and suffering that these families are going through. That has got to mean something.” 

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  • 19th century chastity law endangers 21st century abortion medicine | CNN Politics

    19th century chastity law endangers 21st century abortion medicine | CNN Politics

    A version of this story appears in CNN’s What Matters newsletter. To get it in your inbox, sign up for free here.



    CNN
     — 

    The Wild West of the post-Roe v. Wade legal landscape is focused on a lone federal judge in Amarillo, Texas, who could use a 19th century law to limit access to abortion medication for every American woman.

    The judge, 45-year-old Matthew Kacsmaryk, held a hearing Wednesday about whether he should impose a preliminary injunction that would require the US Food and Drug Administration to withdraw or suspend its approval of the drug, mifepristone, while a larger case progresses.

    Mifepristone is taken along with another drug, misoprostol, as part of the two-step medication abortion process. Misoprostol can be prescribed on its own, but it is considered less effective.

    Kacsmaryk, who sounded open to the idea of restricting access to mifepristone, will have to agree with some or all of these general points raised if he decides to issue an injunction:

    • That doctors who don’t perform abortions and live in Texas, where abortions are already banned, are harmed by abortions conducted elsewhere.
    • That an FDA approval conducted over the course of four years and finalized 23 years ago was so flawed that it should be rescinded.
    • That a single federal judge in Amarillo should do what no federal judge has ever done and unilaterally rescind an FDA approval.
    • That a drug, which studies suggest is on par with ibuprofen in terms of safety, is actually so harmful it should be reconsidered by the FDA.

    CNN’s Tierney Sneed wrote a longer list of takeaways from the hearing, where anti-abortion rights doctors and activist groups teed up their lawsuit in Kacsmaryk’s courtroom to further limit access to abortion care in the US.

    It’s important to note that no matter what Kacsmaryk does, it will be appealed up through the 5th US Circuit Court of Appeals and potentially to the Supreme Court.

    But perhaps the most incredible question Kacsmaryk faces is whether an 1870s chastity law named for an anti-vice crusader, Anthony Comstock, should be resuscitated and applied to the medicine that now accounts for a majority of US abortions.

    Comstock operated the New York Society for the Suppression of Vice and was a special agent of the US Postal Service. He was known for seizing contraband like contraceptives and condoms in the name of rooting out obscenity, according to the New York Historical Society.

    Mary Ziegler, a law professor at the University of California, Davis who has written about the Comstock Act for CNN Opinion, described Comstock as being “obsessed by what he saw as the decaying morals of a country preoccupied with sex.”

    Ziegler writes:

    The law he inspired barred not just the mailing of “obscene books” but also birth control and abortion drugs and devices. In the 19th and early 20th centuries, the Comstock Act was used to prohibit the mailing of many literary classics, from Geoffrey Chaucer’s “The Canterbury Tales” to works by James Joyce and Walt Whitman.

    Comstock himself proudly carried a gun and scoured the mail for cases involving information about abortion or contraception, even if a doctor provided it. By Comstock’s standard, the law was a great success: he claimed to have destroyed 15 tons of books, arrested more than 4,000 people and driven at least 15 people to suicide.

    While Congress has acted to relax elements of the Comstock Act, including to allow the mailing of contraceptives, it is still technically on the books with regard to the mailing of anything that could be used for an abortion.

    During the Covid-19 pandemic, the FDA dropped its requirement that a person obtain mifepristone in person. A prescription is still required.

    In December, the Department of Justice notified the US Postal Service that the Comstock Act did not apply as long as “the sender lacks the intent that the recipient of the drugs will use them unlawfully.”

    The FDA permanently removed the in-person requirement in January, hoping to guarantee more access to the medication after the Supreme Court ended Roe v. Wade last June.

    The group that brought the Texas lawsuit, the Alliance for Hippocratic Medicine, wants to reapply the Comstock Act and restrict the mailing of abortion medication.

    The FDA’s already exhaustive and detailed drug approval process was especially scrutinized for mifepristone, which was more commonly known as part of the RU-486 regimen when it became available to American women at the turn of the century.

    It had been available in Europe for a dozen years before that. Here’s CNN’s report from September 2000.

    That the drug works safely as a means of abortion is not really up for dispute as a medical matter after all that time, according to CNN’s Jen Christensen, who explains more about the medication in this article about mifepristone.

    Another CNN data analysis suggests mifepristone is safer than penicillin and Viagra.

    Mifepristone has a death rate of 0.0005% – five deaths for every 1 million people in the US who used it. Penicillin’s death rate is four times greater. Viagra’s is 10 times greater, according to the analysis by CNN’s Annette Choi and Will Mullery.

    Kacsmaryk had a long history of challenging laws providing greater access to reproductive rights before he became a federal judge. While he has promised to be an impartial judge, every Democrat and one Republican, Sen. Susan Collins of Maine, opposed his nomination in 2019.

    Now Kacsmaryk is the only federal judge at the courthouse in Amarillo, which almost guarantees he hears cases filed there.

    So it may be no coincidence that the group challenging use of mifepristone set up an outpost months before filing its lawsuit. The group is based in Tennessee, but one of the doctors named as a plaintiff in the lawsuit practices near Amarillo.

    However one feels about judicial shopping and whether that happened in this case, the word appears to be out that a conservative judge is alone in Amarillo and open for business.

    According to a CNN profile, Kacsmaryk has also put on hold Biden administration policies related to immigration and overseen cases related to vaccine requirements and gender identity. Last December, he halted a federal program in Texas that allowed minors to get birth control without their parents’ consent.

    That suit regarding the birth control program established in 1970 was brought by a Texas father “raising each of his daughters in accordance with Christian teaching on matters of sexuality,” which he said forbids premarital sex.

    Kacsmaryk agreed, even citing the Catechism of the Catholic Church in his decision to say “contraception (just like abortion) violates traditional tenets of many faiths, including the Christian faith Plaintiff practices.”

    His sister described him to The Washington Post as an anti-abortion rights activist and detailed her own decision to give a child up for adoption rather than seek an abortion.

    “He’s very passionate about the fact that you can’t preach pro-life and do nothing,” Jennifer Griffith told the Post. “We both hold the stance of you have to do something. You can’t not.”

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  • Takeaways from the Texas hearing on medication abortion drugs | CNN Politics

    Takeaways from the Texas hearing on medication abortion drugs | CNN Politics


    Amarillo, Texas
    CNN
     — 

    Over the course of about four hours of arguments, a federal judge in Texas asked questions that suggested he is seriously considering undoing the US Food and Drug Administration’s approval of a medication abortion drug and the agency’s moves to relax the rules around its use.

    But the judge, US District Judge Matthew Kacsmaryk, an appointee of former President Donald Trump, also indicated he was thinking through scenarios in which he could keep the drug’s 2000 approval intact while blocking other FDA rules.

    Anti-abortion doctors and medical associations are seeking a preliminary injunction that would require the FDA to withdraw or suspend its approval of the drug, mifepristone, and that would block the agency’s more recent regulatory changes making the pills more accessible.

    Here are takeaways from the hearing:

    Kacsmaryk showed a particular interest in the arguments by the abortion opponents that the FDA approved mifepristone in an unlawful way.

    He zeroed in on a claim by the abortion foes that the studies that the FDA looked at when deciding whether to approve the drug did not match the conditions under which the agency allows it to be administered.

    Erik Baptist, attorney for the challengers, alleged that those studies all featured patients who received ultrasounds before being treated with the drug, which is not among the FDA’s requirements for prescribing abortion pills. Baptist accused the FDA of “examining oranges and declaring apples to be safe.”

    Kacsmaryk returned to that “apples to oranges” argument several times throughout the hearing.

    Justice Department attorney Daniel Schwei defended the FDA’s approach, arguing that the relevant law gives the FDA discretion to determine what studies are adequate for approving a drug’s safety. He also said the challengers’ claims were factually flawed, because the FDA also was looking at studies where the patients did not receive an ultrasound.

    Kacsmaryk was similarly focused on a claim by the plaintiffs that the FDA violated the law in the special, accelerated process that it used to approve mifepristone in 2000.

    At one point the judge revealed in the hearing that he had downloaded a list of the other drugs the FDA had approved through the process. He ticked through the list of drugs, which were made up mostly of treatments for HIV and cancer, and he asked the Justice Department for its “best argument” for why mifepristone fit into the list.

    One of the sharpest questions from the judge was whether the anti-abortion activists could point to another analogous case when a court intervened in the way he is being asked to intervene here.

    Baptist conceded there was none and blamed FDA delays in addressing citizen petitions and challenges. Later in the hearing, Baptist raised other times the FDA had suspended or withdrawn drugs based on court cases in other contexts, arguing those cases showed that Kascmaryk had the authority to grant the plaintiffs’ request.

    Attorneys for the defendants – which include both the FDA and a drug company that manufactures mifepristone and intervened in the case – pushed back on those examples. They said that the plaintiffs were relying on patent cases, where the dispute was between a brand name drug and a generic counterpart, and those examples were not analogous here.

    The medication abortion lawsuit targets actions the FDA took around medication abortion pills before last summer’s Supreme Court reversal of Roe v. Wade’s abortion rights protections.

    While that decision, known as Dobbs v. Jackson Women’s Health Organization, didn’t play a major role in Wednesday’s arguments, the judge referenced it and suggested it could have an impact on his thinking about the case.

    He brought up Dobbs early on in the hearing and raised it specifically in connection with a friend of the court brief filed by 22 GOP-led states supporting the challengers.

    The judge noted that the red states’ brief argued that the FDA’s actions were infringing on their state laws concerning abortion pills.

    He asked Erin Hawley, an attorney for the challengers, whether Dobbs was an “intervening event” that has “changed the landscape” around the relationship between state and federal government concerning abortion policy.

    Hawley agreed, calling it a “sea change.”

    If Kacsmaryk has any sore feelings over the blow up around his efforts to keep Wednesday’s hearing plans quiet, he didn’t show them at the proceedings.

    When questioning both sides of the case, Kacsmaryk had a restrained, straight-forward tone. He had occasional follow-up questions for the plaintiffs, but did not aggressively push back on their arguments. The substance of his questions for the FDA’s defenders was more skeptical, but he kept with the measured approach in his questioning, and avoided any pushiness when grilling the government and the drug company about the approval process.

    At the end of the hearing, he thanked the parties, as well as those who filed dozens of friend of the courts briefs, for their “superb” briefing. He also acknowledged the logistical hurdles the lawyers at the hearing went through to get to his courthouse in Amarillo, which is a several hours’ drive from Texas’ biggest cities.

    Left unmentioned by the judge was the fact that he tried to delay the announcement of the hearing until the evening before, which would have made it difficult for members of the public and the media to attend Wednesday’s proceedings. When there was blowback to The Washington Post reporting about his plan – laid out in a private teleconference with attorneys where he pointed to death threats and harassment that had been directed to the courthouse staff – he announced the hearing on Monday.

    The courtroom was open to the public, but only with limited seating: 19 seats for reporters and 19 for members of the public. By 6 a.m. CT Wednesday there were already lines outside the courtroom to claim those seats. Those attendees were not allowed to bring electronics in with them, and if they left the courthouse, they were not allowed back in.

    Kacsmaryk warned at the beginning of the hearing that anyone who disrupted the proceedings would be immediately removed without warning. But there were no such disruptions.

    Kacsmaryk wrapped up the hearing without any explicit timeline for when he’ll rule, telling the parties he would issue an order and opinion “as soon as possible.”

    While he was arguing, Schwei, the DOJ attorney, requested that the judge – if he were to rule against the FDA – to immediately put that ruling on pause so it could be appealed. The judge stopped short of promising an automatic stay in the event of an adverse ruling, but he acknowledged he understood what DOJ was asking for.

    An appeal would first go to a panel of three judges of the 5th US Circuit Court of Appeals, arguably the most conservative appeals court in the country. The panel’s decision could then be appealed either to the full 5th Circuit or the US Supreme Court.

    Beyond these procedural questions, Kacsmaryk seemed to be grappling with the practical impact of a ruling in favor of the plaintiffs. He asked plaintiffs’ attorneys, the DOJ lawyers and the attorneys for the drug company Danco whether it would be possible for him to block some but not all of the FDA actions the challengers were targeting. He returned to the question again when the plaintiffs were back up for the rebuttal.

    He also pressed Baptist, the attorney for the abortion opponents, on whether the plaintiffs were seeking an order that the FDA begin the withdrawal of the drug – a process that would take months – or if they thought the judge could directly take if off the market.

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