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India response to obesity drug Mounjaro is 'positive', will focus on meeting demand: Eli Lilly

India response to obesity drug Mounjaro is 'positive', will focus on meeting demand: Eli Lilly

Deccan Herald6 hours ago

The US-based Lilly beat rival Novo Nordisk in March this year to introduce its diabetes and weight-loss drug in India, which is grappling with an increasing disease burden among its population of 1.4 billion.

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As US FDA approves HIV prevention drug Lenacapavir, expert says ‘India needs to take lead for its equitable, timely distribution
As US FDA approves HIV prevention drug Lenacapavir, expert says ‘India needs to take lead for its equitable, timely distribution

Indian Express

time2 hours ago

  • Indian Express

As US FDA approves HIV prevention drug Lenacapavir, expert says ‘India needs to take lead for its equitable, timely distribution

The United States Food and Drug Administration (FDA) on Wednesday approved Lenacapavir (LEN), the most promising HIV prevention medicine to be made so far, and according to Dr I S Gilada, president emeritus, AIDS Society of India, the real breakthrough would be when LEN becomes accessible, affordable and available to everyone in India and across the world. Lenacapavir is an antiretroviral medicine that is used for HIV prevention as a pre-exposure prophylaxis or PrEP. PrEP is a medication that can reduce the risk of HIV infection for individuals who are HIV-negative but are at risk of contracting the virus. The results of two key studies have shown that it helps prevent 99.9 per cent of all HIV transmission. 'LEN is an injectable PrEP that is to be taken twice yearly,' said Dr Glory Alexander, president of AIDS Society of India (ASI) and founder director of ASHA Foundation, Bengaluru. PrEP was first approved by the US FDA in 2012, but the Indian government's National AIDS Control Organisation is yet to roll it out. 'If we invest in HIV prevention, we not only protect people's health but also save expenses in providing lifelong HIV care, including lifelong antiretroviral therapy (ART). HIV prevention must remain at the centre-stage of our national AIDS response,' said Dr Gilada. 'Indian regulators should work with Indian generic manufacturing companies to ensure that 'made in India' generic LEN versions when available, are first rolled out in India,' Dr Gilada told The Indian Express. 'The scientific breakthrough translates into public health impact in terms of stopping the spread of HIV infection. The major impediment is the cost: LEN as PrEP to be sold as Yeztugo by Gilead is priced at US$ 28,218 per person per year. However, Gilead's wisdom by giving voluntary licenses to four Indian generic companies, gives hope that the medicine may cost less than US$ 100 – that is 0.3 per cent of the innovator's cost,' Dr Gilada explained. 'India needs to lead from the front for LEN's equitable and timely distribution at the required scale to prevent HIV transmission and help end AIDS,' said Dr Gilada, adding that only India can deliver LEN to all those in need worldwide, in terms of quality, quantity and speed. Though India meets 92 per cent of the global requirement for ART and the global community (WHO, UNAIDS, Global Fund, World Bank, etc) widely uses Indian generic pharma for their strategies like Treatment as Prevention (TasP), Test and Treat, Post-exposure Prophylaxis (PEP), PreP, etc, it is unfortunate that they are shy to acknowledge this, he said. Gilead had faced a lot of backlash from health advocates and communities last year over the astronomical pricing for LEN, pegged at over US$ 40,000 per person per year, which has now been slashed by 30 per cent. Earlier, Gilead's Hepatitis C treatment, which cost $84,000 in the US for a three-month course, was made available in India for less than $300. So the firm knew what was to be done this time, and granted voluntary licensing to six generic manufacturers, including four Indian: Dr Reddy's Laboratories, Emcure, Hetero Healthcare, and Viatris. 'All international antiretroviral therapy and prevention guidelines are conceptualised and implemented on the strength of India. Only India can meet the global demand for LEN at such low cost, just as it did for ART, at 0.3 per cent of the innovator's cost,' Dr Gilada said. Anuradha Mascarenhas is a journalist with The Indian Express and is based in Pune. A senior editor, Anuradha writes on health, research developments in the field of science and environment and takes keen interest in covering women's issues. With a career spanning over 25 years, Anuradha has also led teams and often coordinated the edition. ... Read More

The Wegovy effect: A weight-loss drug reshapes the lives of teens battling obesity
The Wegovy effect: A weight-loss drug reshapes the lives of teens battling obesity

Economic Times

time3 hours ago

  • Economic Times

The Wegovy effect: A weight-loss drug reshapes the lives of teens battling obesity

High-school freshman Austin Smith sank into depression from the merciless teasing and bullying he endured from his classmates over his weight. By age 15, Katie Duncan felt unhealthy and self-conscious from the excessive weight she carried, but couldn't tame the incessant food cravings caused by a tumor that had damaged part of her brain. Stephanie Serrano, diagnosed with type 2 diabetes and liver disease related to her obesity, stopped attending high school in person and became a virtual shut-in after years of failed dieting. For these teens, obesity had become a painful physical and emotional burden, the persistent social stigma of their condition isolating them from their peers, and they were frustrated by their inability to lose weight. That's why, with support from their parents, they joined a small but fast-growing cohort of American teens who have chosen to take Novo Nordisk's weight-loss drug Wegovy, placing them at the forefront of a monumental shift in the treatment of childhood obesity. As childhood obesity rates soared in recent decades to epidemic levels, pediatricians could offer children and their families little beyond the conventional - and often ineffective - counsel of healthier diets and more exercise. That changed in December 2022, when U.S. regulators approved Wegovy, which has become a multibillion-dollar seller for treating obesity in adults, for children 12 and older. Since then, teenagers have been starting on Wegovy at quickly rising rates, as Reuters recently reported. Still, based on those rates, the overall numbers remain small - fewer than 100,000 - next to the roughly 8 million, or one in five, American teens living with obesity. Those who have embraced the treatment, including the American Academy of Pediatrics, say Wegovy gives adolescents a chance at a healthier future by reducing their risk of developing type 2 diabetes, liver disease and other debilitating, and costly, chronic illnesses. They say weight loss can also ease the harm of the teasing and social isolation teens with obesity often endure. Some doctors, though, are hesitant to prescribe the drug, citing the lack of long-term safety data, concerns that children won't get adequate nutrition while taking it, and the possibility that it could cause eating disorders. Their caution is echoed in statements by U.S. Health Secretary Robert F. Kennedy Jr., who has criticized the "overmedicalization of our kids" and emphasizes the role of healthier food in combating chronic disease. That split leaves families to consider for themselves the potential benefits and risks of Wegovy when deciding on a course of treatment for a child with obesity. For this article, Reuters reporters found children who had taken Wegovy or a similar weight-loss drug to speak with them about their experiences. The reporters spent more than a year closely following four teens and their families to examine in detail the impact of treatment. Here are their stories:GLADSTONE, Missouri - "Why do you want to lose weight?" When Elizabeth Smith asked her son Austin that question, he didn't hesitate. "To be healthier and so people will stop bullying me," he said. Elizabeth wrote his answer on the form she was filling out as they waited in the doctor's office. Austin was near the end of a miserable freshman year. At almost 300 pounds, he struggled each morning to squeeze down the aisle of the school bus. Other students teased him relentlessly. He looked pregnant, they said, and he was gross. At school, the insults continued. He found solace in woodworking class, where he could focus on his projects and tune out the taunts - until the day a classmate cornered him, jammed a power drill into his long, curly hair and turned it on, leaving the tool dangling from a messy tangle. Even before his parents learned about that incident, they knew something was wrong. Austin, who has a mild form of autism, had grown increasingly withdrawn and rarely left his bedroom, where his mother found him sobbing after school several times. "I can't make any friends," Austin told her. They feared he might contemplate suicide. They decided to seek medical help. A psychiatrist put Austin on an antidepressant. Elizabeth thought the obesity specialist who had been treating her could help, too. Five weeks earlier, Dr. Matt Lindquist at University Health in Kansas City, Missouri, near their home in suburban Gladstone, had started her on Wegovy, and she had already dropped 20 pounds, to around 220. That's how Austin and Elizabeth found themselves filling out forms in Lindquist's office in April 2023. Four months earlier, U.S. regulators had approved Wegovy for teens with obesity, defined as a body mass index at or above the 95th percentile for children of the same age and sex. The doctor judged Austin, then 15 years old, to be in good overall health and a good candidate for Wegovy. The drug would tame the constant hunger Austin described. Lindquist told Austin that after starting on Wegovy, he should cut his meal portions in half and eat more healthy proteins and vegetables. Even then, the doctor said, Austin might experience the common side effects of nausea and vomiting. Out of pocket, the more than $1,000-a-month cost of Wegovy would have been unaffordable. The Smiths live paycheck to paycheck on Elizabeth's pay as a hospital billing clerk at University Health and what her husband, Jeremy, earns building courtroom exhibits. But Elizabeth's employer-sponsored health insurance covered Wegovy. About a month after the visit with Lindquist, the first box of Austin's Wegovy injections arrived. Elizabeth, fearing Austin would get sick in class, asked him to wait to start the drug until after the school year ended in a week. "I can't wait," Austin said. She gave him his first injection that night. The effect was almost immediate. He used to come home from school and devour dozens of chicken nuggets while playing video games. Now, he felt full far sooner. Many nights, he stayed in his room at dinnertime. "I felt a little bad because I couldn't eat my parents' cooking," Austin said. The only side effect he experienced was a little stomach upset. Elizabeth began keeping a log of Austin's weight. At the start of his sophomore year, two months after starting Wegovy, Austin had lost 23 pounds. That's when he first noticed the difference: On the school bus that morning, he didn't bump into the seats while walking down the aisle. "I was so happy to go home and tell my parents about it," he said. In early September, Lindquist increased Austin's weekly dose of Wegovy to the maximum, 2.4 milligrams, as recommended on the label. Austin started vomiting after eating. Lindquist cut the dose back to the previous 1.7 milligrams. The vomiting subsided. Austin reveled in his altered appearance, and his mood lightened. He told Elizabeth the bullying had stopped. He liked to stand in his now billowing marching band uniform and pull the waistband outward to reveal gaping spaces. (The band director got him a smaller size.) He was back to tending his oregano, thyme and other herbs growing in pots outside the front door. He played in the backyard with his puggle, Lucy, or one of his family's other two dogs. He spent weekends hanging out with his best friend, an elderly man in the neighborhood, gardening, walking their dogs and watching movies. In October 2023, five months into treatment, Austin was down to 232 pounds. Elizabeth wrote Lindquist to ask about his target weight for Austin. The doctor responded that he didn't set weight goals, preferring to focus on a patient's overall health, and was encouraged by Austin's progress. "I would say he likely needs meds lifelong to support a healthy weight," the doctor wrote. Elizabeth's heart sank. "I wouldn't want him to be on this for a lifetime," she said. Austin didn't share those qualms. "Before, I would look in the mirror and hate myself and wish I could be an entirely different person," he said. "Now I feel like I can accept myself a bit more." He had dropped to 222 pounds by early December. One Saturday, he came into the kitchen and lifted his shirt to show his family his now-visible ribs. For Christmas, Elizabeth bought him extra-large pants and shirts to replace his 2XL clothes. "He's like a whole new person," his pediatrician told Elizabeth, echoing many family friends and relatives. Austin's father was cheered by his son's physical and emotional transformation. Jeremy had lost about 30 pounds while taking Ozempic, Novo's medication for type 2 diabetes that has the same active ingredient as Wegovy. At a January 2024 appointment, Lindquist chided Austin when he admitted to skipping meals. "You need to put gas in your tank to make it go," the doctor told him. He referred the teen to a nutritionist. Elizabeth scheduled an appointment, but had to cancel because of a work conflict and hasn't booked a new visit. The following April, Austin was at 200 pounds. He celebrated the end of his sophomore year by taking a trip in June to Belize with other students. He snorkeled and went on eight different zip-lines through the rainforest. The weight limit for riding the zip-lines was 280 pounds. Back home, Elizabeth wept when she watched the video Austin shared of him gliding through the trees. "He couldn't have done this before," she said. Soon after his return, he was hit hard by the death of his elderly friend. His psychiatrist prescribed a more powerful antidepressant. Austin then panicked when, after Lindquist stretched out Austin's dosages, he started eating more and putting on pounds. That stopped when he went back to regular weekly injections. The family got another shock in January, when Elizabeth's insurance through University Health quit covering Wegovy and other so-called GLP-1 drugs for weight loss. Wegovy had been free, after insurance and Novo-provided coupons. Now, the health system would be providing Wegovy at $250 for a three-month supply through its own pharmacy. Insurance coverage for Wegovy has steadily expanded since the drug's 2021 launch, and Novo has offered ways to bring down out-of-pocket costs. But employers and government agencies often impose restrictions to hold down costs associated with the drug's high price and the large number of patients eligible to take it. Last year, 64% of U.S. employers with 20,000 or more workers covered GLP-1 drugs for obesity, up from 56% in 2023, according to Mercer, a benefits consulting firm. Medicare and most state Medicaid programs don't cover the drugs solely for weight loss. Elizabeth has been able to scrape together enough to cover the cost. She also had to find Austin another doctor at University Health after Lindquist left to set up his own practice and the hospital stopped covering Wegovy for doctors outside of its network. Austin is just relieved that his parents can afford to keep his prescription going. His weight has leveled off at about 200 pounds - a 30% loss in two years. He doesn't want to contemplate life without Wegovy. "I feel I would be bigger," he said. "I don't want to go back."WILMINGTON, Delaware - At 15, Katie Duncan, 6-foot-1 and 270 pounds, was growing increasingly anxious and depressed about her weight. Some of her clothes no longer fit, she was easily winded while walking, and her back ached. Classmates occasionally lobbed mean comments about her size. Blood tests showed she had high triglyceride levels, which can increase the risk of stroke and heart disease. But Katie's hunger never let up. She often ate four or five meals a day. She would devour an entire pizza and hide snacks in her bedroom to satisfy cravings. She had tried an older weight-loss drug that did nothing. "We need to change something," she told her father, Randy, in the summer of 2023. "What I'm doing isn't working." Randy scheduled an appointment at the Healthy Weight and Wellness Clinic at the nearby Nemours Children's Hospital. The Duncans knew the hospital well: Katie had been treated there after she was diagnosed at age 7 with a brain tumor. Doctors had given her a 20% chance of surviving the cancer. Katie took an experimental drug and underwent months of chemotherapy and radiation. She was tiny at the time, only 42 pounds. The cancer went into remission within a year. However, the tumor had damaged her hypothalamus, the portion of the brain that controls hunger, and the nearby pituitary gland, which releases hormones that regulate growth and metabolism, among other key functions. Her doctors put her on a lifelong regimen of synthetic hormones and a low-dose steroid to replace what she lost. The brush with death forged a fierce bond between father, divorced since Katie was 3, and daughter, the youngest of five siblings and the only one still living at home. Randy, a paramedic and volunteer firefighter, took off from work to go to every doctor's appointment and physical therapy session with her. Katie treasured a locket with her father's photo inside and refused to go to school without it. He accompanied her on every school field trip. Katie tried a sleepaway camp hosted by the hospital and called her dad to pick her up after the first night. "I don't like being away from my family," she said. But by the time Katie was 9, Randy, now remarried, noticed something was wrong. Katie was constantly hungry, and the two clashed repeatedly over it. During a trip to SeaWorld in Florida, they shouted at each other when Katie complained that she was starving, even after a big breakfast at their hotel. Katie steadily put on weight during her middle-school years. She avoided running and other sports due to painful neuropathy in her feet, likely caused by her cancer and chemotherapy. She couldn't keep pace with classmates in physical education. At her appointment in 2023, Katie saw Dr. Thao-Ly Phan, medical director of the Nemours weight clinic. After examining Katie and reviewing her medical history, Phan determined that Katie probably has "hypothalamic obesity" from her brain injury, for which the replacement hormones don't fully compensate. "Her body isn't helping her out," Phan said. While brain cancer isn't common, Phan said, teens can have other, more common underlying conditions or treatments that lead to obesity and complicate their care. For example, polycystic ovary syndrome can cause hormonal imbalances and weight gain, especially around the belly, in young women. Antidepressants, mood stabilizers and other psychiatric medications can lead to weight gain, too. After prescribing Wegovy, Phan had Katie see the clinic's psychologist and nutritionist, a routine step the doctor requires of her patients. "We don't want kids to lose so much weight that they develop eating disorders," she said. "We want to make sure that they're still getting the nutrition they need to grow and to thrive." Katie got her first dose of Wegovy in November 2023. She lost about 20 pounds in the first couple months, with only mild side effects. At times, Katie had no interest in eating and skipped meals, despite Phan's warnings not to. Poor nutrition and eating habits during adolescence can have long-term consequences, from impairing cognitive development to increasing the risk of osteoporosis and bone fractures, research shows. About six months after Katie started treatment, the family's insurer cut off coverage of her Wegovy. Randy's appeal of that decision failed, and he switched Katie's prescription to her secondary insurance with the state Medicaid program, which had been in place since her cancer treatment. Delaware is one of 14 states with Medicaid coverage for the newer GLP-1 weight-loss drugs. Katie missed only one weekly dose. At an appointment with Phan in March, Katie weighed 209 pounds, down 60, or 22% of her body weight, in about 18 months. Her triglycerides were no longer elevated. The weight loss has brought welcome changes. Katie said she used to lack motivation to do much at all and would lounge for hours in bed. "I used to always feel yucky before," she said. "The weight loss has actually helped a lot with my energy." The 17-year-old now enjoys regular visits to the Planet Fitness gym with her father and stepmother, Denise, and spends more time on her painting and crafts. She has more stamina to cook two hours straight in her high-school culinary class. She also doesn't get winded chasing after her 2-year-old niece at family gatherings. While she used to hide herself in baggy clothes, she now feels comfortable wearing sundresses. Randy is pleased with Katie's progress. He worries that Delaware may stop covering GLP-1 weight-loss drugs through Medicaid due to budget shortfalls or proposed cuts in federal funding. California and North Carolina are seeking to rescind Medicaid coverage of the drugs to save millions of dollars. "I hope to God they keep Wegovy around for kids," Randy said. Katie wants to stay on the drug and trusts that her dad and her doctor wouldn't let her take anything harmful. "Wegovy doesn't scare me," she said. "I've had so many needles in my life."DODGE COUNTY, Wisconsin - Early last year, after eight months on Wegovy, Leo had a choice to make. He could stop taking the drug, end the side effects that were wreaking havoc on his life and risk regaining some of the more than 25 pounds he had lost. Or he could stay on it, keep losing weight and hope the severe stomach aches, nausea and diarrhea would abate. For this article, Leo and his mother, Jamie, asked Reuters to withhold details such as their precise location and Leo's surname, and Leo declined to be photographed. They said they feared the exposure would lead to more teasing from Leo's peers about his appearance and his decision to take a weight-loss drug. Leo had been a strong candidate for Wegovy when he first saw an obesity specialist, Dr. Leslie Golden, in mid-2023. He was a compulsive eater from an early age, due in part to his attention-deficit/hyperactivity disorder, for which he takes medication. He was diagnosed with obesity at 11 years old. Three years later, he was carrying 181 pounds on his 5-foot-4 frame. Jamie tried to stock the kitchen with healthier foods. But Leo's older sister and two older stepbrothers wanted ultra-processed snacks and sugary drinks around. Leo would gulp down five cans of Coke in a day. He sneaked snacks and sodas into his bedroom at night, leaving empty wrappers and cans for his mother to find strewn about the next morning. One of his stepbrothers was severely underweight, complicating Jamie's food choices for the family. The teasing and bullying started in middle school. When he walked the halls between classes, other students hurled jeers and jokes at him. "It was always directed at my weight," he said. "The comments just got to me." Leo knew he had a problem but felt powerless to do anything about it. "I was eating way too much," he said. "I was worried I was going to get way too overweight." Jamie, a pharmacist, thought Wegovy might help. Frustrated with her own efforts to lose weight, she had started taking the drug in January 2022. She, like Leo after her, suffered severe gastrointestinal side effects, but they faded, and after a year, she had lost 50 pounds. Leo, having learned what Wegovy did for his mother, was open to trying it. In June 2023, Leo had his first appointment with Golden, at her obesity clinic in a town near where he and his family live about an hour outside Milwaukee, Wisconsin. He already bore troubling signs of the effects of his obesity. His blood pressure was high. His elevated blood sugar level put him at increased risk for type 2 diabetes. The doctor worried that Leo could develop liver and heart disease if he didn't lose weight. She prescribed Wegovy. Golden doesn't require families to undergo counseling on lifestyle changes as a prerequisite for prescribing the drug for children. She said most families have already tried other ways to lose weight before they reach her office, and imposing a months-long delay before drug therapy "is really just another form of bias and stigma." She does ask for monthly visits so she can monitor a child's progress. Her patients pick three goals for the coming month - for nutrition, movement and behavior. For Leo, at one point, that meant eating more carrots and cauliflower, playing basketball in the driveway and downing fewer sugary drinks. Soon, Leo was eating a lot less, though what he ate didn't change so much. At restaurants, he could stomach only three bites of the double cheeseburgers he usually ordered. He was happy with the weight he was losing. The bullying was easing up, and some classmates even complimented him on looking thinner. He grew comfortable raising his hand in class. "It feels pretty good to get myself out there," he said. But as his doses steadily increased - the standard of care for GLP-1 medicines is to up the dose every four weeks - the side effects started taking a toll. He took medicines to quell the nausea and diarrhea. He dropped off anti-diarrhea pills with the school nurse. Some days, his stomach upset was so bad that Jamie had to pick him up at lunchtime. Leo was experiencing by far the most common side effects of Wegovy. In the largest clinical trial of the medicine on teens, 62% of patients experienced nausea, vomiting and diarrhea. Most reported mild to moderate side effects that lasted two to three days. Since their launch, Wegovy and other GLP-1 drugs have also been associated with much rarer incidents of gastric paralysis, pancreatitis, depression and blindness. As his absences piled up, Leo's grades suffered, and he grew moodier. At a parent-teacher conference in October 2023, teachers told Jamie that Leo had become more withdrawn in class. At a checkup with his regular pediatrician later that month, his answers on a questionnaire indicated depression. The doctor prescribed an antidepressant. That didn't lessen the side effects, though, and Leo's school absences persisted. In February 2024, the high school notified his mother that he had missed 10 days, the maximum allowed for the year. Soon after that is when Golden presented Leo with the choice about continuing with Wegovy. Jamie favored sticking with the drug. The doctor wanted the choice to be Leo's. "Jamie is a very involved parent who wants to protect and do what's best for him," Golden later told Reuters. "I had to really zone in on Leo: Do you want to keep taking this?" Despite the physical pain and discomfort, the problems at school, the depression, Leo was adamant. "I'll do whatever it takes," Leo told Golden. "No matter how sick I get, I don't want to stop." Several weeks later, the side effects began to ease. By last summer, Leo had dropped under 150 pounds. His waist had shrunk by five inches. Based on his body mass index, he no longer had obesity. "I am happy that I don't get called names anymore," Leo said. Then last autumn, he started to put on weight. Golden had reminded Leo that some additional weight was expected as he grew three inches taller over the span of a year, eventually reaching 5 foot 7. But Leo's mother found food wrappers and soda cans in his bedroom. In November, Leo wept when he stepped on the scale at home and saw that he had gained 14 pounds, up to 164. "I'm getting fat again," he told his mother. At an appointment with Golden the following month, the doctor put Leo on the highest weekly dose of Wegovy to help counter his cravings. That worked, without the side effects he had experienced earlier. At a checkup in April, Leo weighed 154 pounds, down nearly 30 pounds in the past two years. Leo took a cooking class during his sophomore year and hopes to attend culinary school one day. He also took a part-time job stocking shelves at the local hardware store. Leo's pediatrician was pleased with his improved self-esteem and energy level. She asked Jamie: "What is the end game? When is Dr. Golden going to stop it?" That's an open question. Golden has repeatedly advised Leo that he will probably have to take Wegovy for the rest of his life to maintain a healthy weight. Leo and his mother are OK with that. "There is no end game," Jamie told the Maryland - Stephanie Serrano didn't want to take a weight-loss drug. She didn't think it would work, and even if it did, she didn't like injections, especially if she had to get them for the rest of her life. But Stephanie was desperate. At 320 pounds, she had already been diagnosed with type 2 diabetes and liver disease. She was tired of being the biggest kid in class and had become a virtual shut-in after years of failed dieting. "Every doctor that I had ever seen would just tell me to eat healthier, like it was that simple," Stephanie said. In 2022, her family doctor referred the then-16-year-old to the obesity clinic at Children's National Hospital in Washington, D.C. There, initial tests revealed that she had polycystic ovary syndrome, a common cause of weight gain in young women. "That diagnosis changed everything," she said. "I wasn't lazy or not trying hard enough. My body was actually working against me." In October that year, Stephanie's doctor at Children's National, Susma Vaidya, prescribed Ozempic, Novo's drug for type 2 diabetes with the same active ingredient as Wegovy, which hadn't yet been approved for teens. Ozempic has been widely used off-label for weight loss, both prior to Wegovy's launch and after due to shortages and spotty insurance coverage of the latter. By the time she saw Vaidya, Stephanie had her heart set on weight-loss surgery, swayed by TikTok videos of young adults showing their dramatic before-and-after transformations. "Seeing how much they changed, it's incredible," she said. "So that's kind of what I wanted for my life. I wanted a permanent change." Vaidya, medical director of the obesity clinic at Children's National, persuaded Stephanie to accept a compromise: Stephanie would give Ozempic a try while undergoing a six-month evaluation, including sessions with a dietician and a psychologist, to determine whether she was a good candidate for surgery, based on factors like adequate family support and eating regular, well-balanced meals. Stephanie started taking the lowest recommended dose of Ozempic. The side effects were mild, though she occasionally experienced nausea and stomach pain after a big meal. She lost nine pounds in the first month. After four months, in February 2023, she was surprised - and pleased - that she had lost about 30 pounds. "I had never seen the number on the scale go down," she said. At that point, Vaidya told Stephanie she could continue taking the drug, or she could undergo surgery. Stephanie's father, Jose, who was taking Ozempic for his type 2 diabetes, preferred that she stick with the drug. He worried about her risk of complications from a major operation. Stephanie held firm. Despite her weight loss on Ozempic, she felt that surgery was the only way to end the isolation she had endured for years. Since the start of the COVID-19 pandemic, Stephanie had retreated from school and friends. In 2021, during her sophomore year, her high school gave students the option to return or continue with online classes. She never went back to the classroom. Through the lens of social media, she watched classmates gloat about their beauty "glow ups" and post photos of themselves with new makeup routines and outfits. Stephanie quit the school's Junior Reserve Officers' Training Corps, a leadership program sponsored by the U.S. military, to avoid being around other people. "I hid myself for those years," she said. "I no longer wanted to be a prisoner." In April 2023, Stephanie, at about 285 pounds, had gastric-sleeve surgery, which involved removing a large portion of her stomach to reduce food intake. She came through the surgery and recovery without complications. Today, the 19-year-old college freshman is down to about 175 pounds. She eats small meals and exercises regularly. Her diabetes is in remission, and her liver function is normal. She takes a full load of classes at a nearby community college and plans to transfer to a four-year university soon. She aspires to be a sports psychologist. As Stephanie lost weight, she became more outgoing at school and in church and found she could make friends. She opened up to the possibility of a relationship and flirted with a young man at church. That didn't go anywhere, but she had surprised herself with her willingness to even try. "Having a crush on anyone seemed so silly before. I could never imagine someone loving me," she said. "I was always ashamed of myself." Amid all this progress, another problem emerged: Stephanie was consumed with fear of gaining the weight back. She started skipping meals and guzzling energy drinks. After eating a small meal, she would run a mile to burn off the calories. Her legs and back began to ache, and she sometimes lost her balance - signs of possible muscle loss. Vaidya told her, "This is your body asking for protein." Vaidya diagnosed Stephanie with an eating disorder in April 2024 and referred her to a hospital psychologist. Vaidya also prescribed bupropion, an antidepressant sometimes used to manage binge eating. The possibility that weight-loss drugs may put teens at risk of disordered eating is why some doctors urge rigorous screening of patients and continuous monitoring during treatment. Research on any association between weight-loss drugs or bariatric surgery and eating disorders is limited. Some small studies found that the use of GLP-1 drugs may decrease binge eating episodes among those who already had the disorder. But the studies only tracked patients for three to six months, leaving longer-term effects unknown. Stephanie's psychologist urged her to stop counting calories and poring over the nutrition labels on packaged foods. She's making progress, but it's a "constant battle," she said. Stephanie still gives in sometimes to count calories, and when she exceeds her target, "I completely shut down." At home, Stephanie does much of the cooking for her parents and older sister, Lily. She rarely eats what she cooks. At a recent dinner, her family enjoyed the carne asada, beans and pico de gallo she had prepared while she picked at a small bowl of rice and a homemade tortilla. She didn't finish either. Later, Stephanie, her mother, Vanessa Serrano, and Lily visited a local mall - a place she used to avoid because it was hard to find clothes her size there. At the American Eagle store, she tried on a pair of black jeans. She emerged hesitantly from the dressing room to have a look in a mirror. After Lily told her she looked incredible and snapped photos, Stephanie checked herself out from several angles. She bought the jeans and wore them to church the next day.

How weight-loss drugs blew out the US trade deficit
How weight-loss drugs blew out the US trade deficit

Mint

time5 hours ago

  • Mint

How weight-loss drugs blew out the US trade deficit

Planes have been jetting from Ireland to the U.S. this year carrying something more valuable than gold: $36 billion worth of hormones for popular obesity and diabetes drugs. The frantic airlift of those ingredients—more than double what was imported from Ireland for all of last year—reflects the collision of two powerful forces: tariff-driven stockpiling and weight-loss drug demand. The peptide and protein-based hormones feed into a category of drugs that include wildly popular GLP-1 treatments and newer types of insulin known as analogues. Taken together the shipments weighed just 23,400 pounds, according to U.S. trade data, equivalent to the weight of less than four Tesla Cybertrucks. Fit into temperature-controlled air cargo containers, the pharmaceutical ingredients have had a huge impact on the U.S. trade imbalance. The shipments have vaulted Ireland, a country of only 5.4 million people, into the second-largest goods-trade imbalance with the U.S., trailing only China. They accounted for roughly half of the $71 billion in goods the U.S. imported from the country in the first four months of the year. Nearly 100% of the imports had a final destination of Indiana, according to U.S. customs records. Eli Lilly, the drug giant behind weight loss and diabetes drugs Zepbound and Mounjaro, is headquartered in Indianapolis. A Lilly spokeswoman declined to comment. President Trump's off-and-on trade war has rewritten global trading patterns this year and—temporarily, at least—widened some of the imbalances he is seeking to eliminate. Companies have scrambled to get shipments to the U.S. ahead of tariff deadlines, with a first round of front-loading ahead of the April 2 announcement, and smaller pushes after the White House paused some of its tariffs. Ireland is at the epicenter of the global rush. It is a major hub for U.S. drug giants, who have been expanding operations there in part because of Ireland's favorable tax policies. Some of the bestselling drugs in the world, such as AbbVie's anti-wrinkle treatment Botox, and U.S. drugmaker Merck's cancer treatment Keytruda, are made in the country. 'It's common sense. It's uncertain at the moment, so you're building a bit of security by stockpiling," said Matt Moran, a consultant and former director of industry group BioPharmaChem Ireland. 'There's such huge demand for those products at the moment." The trade imbalance has put Ireland into an uncomfortable position, landing it earlier this month on the U.S. Treasury Department's monitoring list for currency manipulation, which the government uses to send a warning shot to countries it thinks use unfair trade practices. Ireland's central bank said in a report Thursday that new factories making weight-loss drug ingredients helped drive the country's exports. Ireland's first-quarter economic growth expanded by nearly 10% in the first quarter thanks to the export surge. The attention is 'definitely not welcome," said Dan O'Brien, chief economist of the Institute of International and European Affairs, a Dublin think tank. 'A very big part of the U.S.-EU deficit is accounted for by Ireland alone. Trump doesn't like deficits." The White House wants American drug companies to bring production home and in April ordered a so-called Section 232 investigation that could result in tariffs on both imported drugs and ingredients like hormones. Trump said this week that such tariffs could come 'very soon." Lilly is a force in the market for weight-loss drugs, with sales of its GLP-1 medicines Mounjaro and Zepbound expected to nearly double this year to about $30 billion, according to Bank of America analysts. Maintaining supply of weight-loss drugs has been a challenge for both Lilly and rival Novo Nordisk, the Danish maker of Ozempic and Wegovy. The companies were initially unable to keep up with demand for the drugs. Lilly resolved the shortages faster, helping it to take market share from Novo. Lilly is now preparing for the potential launch of a weight-loss pill, orforglipron, which it plans to submit for U.S. approval later this year. Lilly said it began producing weight-loss and diabetes medicines at its Irish factory in Kinsale in 2023. Novo doesn't produce weight-loss drugs in Ireland, according to a spokeswoman. Peptide and protein-based hormones help to regulate processes such as appetite and metabolism. The category includes hormones that mimic a naturally occurring gut hormone called glucagon-like peptide-1, or GLP-1, but can also be used in some fertility and osteoporosis treatments. Shipping and logistics companies say they have noticed increased demand for pharma shipments, which often travel by air instead of on cheaper ocean freighters because they are so light and valuable. Pharma shipments more than doubled from Ireland to the U.S. in March and April, according to data firm WorldACD. Kuehne + Nagel, a Swiss logistics company with operations in the country, said its teams did overtime to accommodate the increase in booking requests and the customs paperwork. 'We didn't see the same increase from Ireland to the rest of the world. That was not a global trend," said Nico Sacco, the company's senior vice president of healthcare strategy. Imports of vaccines and various other drugs including cancer treatments also increased this year from Ireland, according to trade data. Merck produces cancer treatment Keytruda, the world's bestselling drug, in Ireland, among other places. Merck Chief Executive Rob Davis in April said the company has enough supply to mitigate any impact this year from tariffs and is working on navigating the long-term fallout of tariffs. Merck recently began construction on its first U.S. plant to make Keytruda. Lilly said earlier this year it plans to invest $27 billion in expanding U.S. production. The hormones are often freeze dried and shipped as powders. Obesity-related drugs can fly in the cargo sections of passenger planes, or on cargo flights reserved for pharma products, said Anand Kulkarni, head of global markets at Lufthansa Cargo. Lufthansa saw demand for U.S.-bound pharma shipments from locations such as India, Switzerland and Belgium. Volumes began to dip in April as warehouses in the U.S. reached capacity, he said. To increase shipments, drug companies likely tapped existing stocks and diverted production destined for the rest of the world to the U.S. market instead, industry executives said. 'You can't just switch on capacity. You don't go out and buy machines and start them up," said Moran, the consultant. 'They have to be built, commissioned, validated, and approved by the regulator." Write to Chelsey Dulaney at and Jared S. Hopkins at

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