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When accepting or rejecting new drugs, the FDA will be transparent

When accepting or rejecting new drugs, the FDA will be transparent

Washington Post2 days ago
Marty Makary is commissioner of the Food and Drug Administration.
The letters the Food and Drug Administration sends to pharmaceutical companies explaining its decisions on drugs are a treasure trove of valuable information. They detail how the agency thinks and reveal patterns of where companies fall short in trying to bring new drugs to the market. For too long, the contents of these letters have been seen, for the most part, only by the individual applicants. The result: Companies stumble — making common mistakes because of the lack of a road map — and cures and meaningful treatments are delayed for the American people.
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Oprah Winfrey's Weight Loss Journey: Everything She's Said About Her Health Routine
Oprah Winfrey's Weight Loss Journey: Everything She's Said About Her Health Routine

Yahoo

timean hour ago

  • Yahoo

Oprah Winfrey's Weight Loss Journey: Everything She's Said About Her Health Routine

Oprah Winfrey is reflecting on her lifelong relationship with her body and weight loss. The entertainment icon has faced public scrutiny over her body throughout her career, a topic she frequently addressed during the 25-season run of The Oprah Winfrey Show. 'It was public sport to make fun of me for 25 years,' Winfrey told PEOPLE in 2023. 'I have been blamed and shamed, and I blamed and shamed myself.' Winfrey debuted a new approach to weight loss in 2021, following a knee surgery that helped her reconnect with exercise, telling PEOPLE that she progressed from physical therapy to doing a '10-mile straight-up hike on weekends.' The former TV host voiced her support for WeightWatchers in 2015, announcing that she had acquired a 10% stake in the company and attributed 26 lbs. of her weight loss to their points-based diet program. Almost 10 years later, Winfrey stepped down from the WeightWatchers board, shortly after revealing she had begun using a doctor-prescribed GLP-1 medication to manage her weight, which she described as 'a relief.' Here's everything Oprah Winfrey has shared about her weight loss journey over the years. After an operation in 2021, Winfrey found a new approach to fitness. "After knee surgery, I started hiking and setting new distance goals each week. I could eventually hike three to five miles every day," she told PEOPLE in 2023. "I felt stronger, more fit and more alive than I'd felt in years." On a segment celebrating Al Roker's 70th birthday on Today, Winfrey shared that the knee surgery came with a wake-up call. 'There is a sense of knowing that there isn't as much time left and I am at peace with that knowing,' she explained. 'There's a sense of urgency for me about living well.' Part of Winfrey's desire to change her lifestyle came with a deeper sense of gratitude for movement, as she experienced increased pain with age. 'I had been becoming more and more debilitated to the point where it was hard to walk down even two steps just to get into the car,' she said. Ultimately, though, the knee surgery kicked off a new era of movement and wellness for Winfrey, who said that, despite feeling intimidated by the surgery at first, she considered it 'the best thing' she'd done. 'I really felt like I've had a new opportunity to live inside my body in a way that I hadn't been able to for years because being overweight, and being overweight causing the knees to be even worse," Winfrey said. Winfrey has opened up about her use of a weight-loss medication as part of her holistic wellness routine. She began to rethink her approach to weight in July 2023, after hosting a recorded panel with medical experts on obesity and weight loss as part of Oprah Daily's The Life You Want series, titled The State of Weight. "You all know I've been on this journey for most of my life," she told the audience. "My highest weight was 237 lbs. I don't know if there is another public person whose weight struggle has been exploited as much as mine over the years." She said the panel helped her let go of the shame she'd long carried about her weight, opening the door to considering doctor-prescribed medication. 'I realized I'd been blaming myself all these years for being overweight,' Winfrey told PEOPLE. 'And I have a predisposition that no amount of willpower is going to control.' The Tony winner said the medication has helped her manage weight fluctuations. 'I now use it as I feel I need it—as a tool to avoid yo-yoing,' she explained. Winfrey also shared that the medication, whose name she's chosen not to disclose, feels like a 'relief.' "The fact that there's a medically approved prescription for managing weight and staying healthier, in my lifetime, feels like relief, like redemption, like a gift, and not something to hide behind and once again be ridiculed for," she said. "I'm absolutely done with the shaming from other people and particularly myself." However, the Emmy winner also shared that the medication was not a 'magic bullet,' stressing that she had to work at her overall lifestyle to keep her results. "It's not one thing, it's everything," she told PEOPLE. "I know everybody thought I was on it, but I worked so damn hard. I know that if I'm not also working out and vigilant about all the other things, it doesn't work for me." Winfrey has shared her personal experiences with the social bias that comes with weighing more, saying she was treated poorly when she was over 200 lbs., especially when it came to shopping. "It's that thing where people are like, 'Let me show you the gloves. Would you like to look at the handbags? Because we know that there's nothing in here for you,' " she said during The State of Weight. "There is a condescension. There is stigma.' " The stigma didn't end in the store, either. Winfrey has shared that people have felt free to comment about her weight throughout her career since the very beginning, recalling her national television debut on The Tonight Show in 1985 when Joan Rivers urged her to lose weight. Winfrey shared the demoralizing experience in her 2017 cookbook, Food, Health, and Happiness. 'Joan sat behind Johnny's big wooden desk, telling me that she didn't want to hear my excuses and that I shouldn't have let this happen," she wrote. "The audience laughed nervously as she wagged her flawlessly manicured finger at me, pointed out that I was still 'a single girl,' and challenged me to come back 15 pounds lighter next time she hosted. And the whole time I just sat there smiling breezily, wanting nothing more than to crawl under my chair." The Oscar nominee told PEOPLE in 2023 that comments like these prompted internal shame, saying it took her a long time to realize she could be angry. 'I just accepted that as that's what it is, and I didn't feel angry. I felt sad. I felt hurt. I felt shame. But it didn't occur to me that I could even feel angry,' she said. 'I swallowed the shame, and I accepted that it was my fault.' Winfrey hasn't shared a number for her weight loss, saying in a 2020 WeightWatchers Q&A that she's not trying to hit a target weight. 'I don't have a goal in mind, I'll know what it is when I get there,' she said. However, Winfrey may have revealed one of her goals in a 2020 interview with PEOPLE, saying that her long-time partner, Stedman Graham, could now 'pick her up and carry her to the pool.' At the time, the media mogul had revealed she had lost 26 lbs. through her diet with WeightWatchers. 'I would like him to pick me up and carry me to the pool,' she joked. 'I've lost enough weight, he can pick me up and carry me to the pool. I can straddle him without breaking his back.' Winfrey also expressed a desire for people to be more accepting of others' bodies on her 2023 panel, The State of Weight. "Shouldn't we all just be more accepting of whatever body you choose to be in? That should be your choice,' Winfrey said. During her 2020 WeightWatchers Q&A, Oprah shared that she'd felt controlled by food, specifically potatoes, for decades. 'I have been controlled by potatoes for 40 years,' Winfrey said. 'Any kind of fried potato, baked potato, scalloped potato – oh my god.' She joked that of all of her achievements as one of the most famous women in entertainment, eating only 10 crinkle cut potato chips in a sitting was her greatest accomplishment. 'Of all the accomplishments that made in the world, all the red carpets, and the awards and those things that I've done. The fact that I could close the bag and not take another chip – it's major for me," Winfrey said. She had previously expressed her tendency to turn to food for comfort in her 2017 cookbook. 'So many of us just want to fill up on a large helping of unconditional love. When I was a girl, there wasn't always enough of that to go around. As an adult, though, I came to realize that even when people have the time and strength to care for you, the deepest care must ultimately come from your own self-acceptance, self-respect, and hard-earned truth,' Winfrey wrote. Before stepping away from WeightWatchers in 2021 after revealing she was using weight-loss medication, Winfrey served as a board member, spokesperson and investor. While she divested from the company, giving her shares to the National Museum of African American History and Culture in February 2024, she's still a supporter of the program and still uses the point system as the foundation of her diet. "I eat my last meal at 4 o'clock, drink a gallon of water a day, and use the WeightWatchers principles of counting points,' she told PEOPLE in 2023. Three years prior, at the start of her recent weight loss, Winfrey shared that she could see herself sticking to the diet for life. 'I don't feel like I'm on a diet that I'm ever going to go off of again,' she said during a call for WeightWatchers members. 'I feel like I'll be counting points for the rest of my life.' Read the original article on People

Too Much Protein: Hidden Risks for Weight Loss Patients
Too Much Protein: Hidden Risks for Weight Loss Patients

Medscape

timean hour ago

  • Medscape

Too Much Protein: Hidden Risks for Weight Loss Patients

Although many of your patients may think that increasing protein is the key to fat loss and successful weight management, there's a consensus in the medical community that patients should be aware that there can, indeed, be too much of a good thing. 'I feel like protein intake, although important, is grossly overemphasized in weight loss, and a strong focus on protein can miss other critical goals necessary for weight loss — chief among them [being] caloric restriction but also fiber intake and adequate nutrients,' said Matthew Badgett, MD, internal medicine physician at Cleveland Clinic in Ohio. 'I discuss protein but advise to not overdo it.' While protein is one of the key macronutrients our bodies need to build muscle and repair tissue, patients should know of varying sources. 'Lean proteins are a great option and can come from both animal and plant-based sources like lentils, peas, and other high-protein vegetables,' said Badgett. 'That said, a balanced diet is essential. Carbohydrates and fats also play important roles in energy production, hormone regulation, and overall body function.' Health Consequences of Protein Overconsumption Protein needs vary from person to person; however, consistently consuming excessive amounts of protein can strain the kidneys, especially in individuals with underlying kidney conditions, according to Michael Richardson, MD, family physician with Carbon Health in the Boston area. 'Over time, this strain can lead to permanent kidney damage,' he said. Additionally, if a diet is heavily meat-based, it may lead to a higher intake of saturated fat and cholesterol, increasing the risk for cardiovascular disease and insulin resistance, noted Richardson. Another risk associated with too much protein is high cholesterol; this is largely dependent on one's source of protein. 'Diets high in animal protein — especially red or processed meats — often come with increased calories and saturated fats,' said Richardson. 'This can raise your risk of heart disease, high cholesterol, and type 2 diabetes. Incorporating more plant-based protein sources can help reduce these risks and support overall metabolic health.' Protein supplementation through powders added to everyday food items such as smoothies, yogurt, and oatmeal can also greatly elevate a patient's daily protein intake. It's important to discuss how these common practices can affect overall nutritional balance. Additionally, be sure to share with your patients that packaged or fortified foods can also cause a spike in protein consumption. 'Companies often add protein powder or soy protein isolate to a variety of products, including protein chips, protein cookies, powders and drink mixes, plant-based meat substitutes, beef jerky, tortillas — especially keto versions — pancake and waffle mixes,' said Theresa Gentile, registered dietitian nutritionist and spokesperson for the Academy of Nutrition and Dietetics who is based in Brooklyn, New York. While bringing up how protein can be 'added' to fortified foods, it's also important to suggest foods that are better protein sources than others. 'The source of protein matters: Red meat, especially beef and pork, has been associated with an increase in coronary heart disease,' said Gentile. 'Processed meats, like bacon and sausage, have consistently been linked to a higher risk of coronary heart disease and diabetes.' Gentile said healthier protein choices, including poultry and fish, have been associated with a lower risk for coronary heart disease. 'Nuts, legumes, and soy are also associated with a decreased risk of coronary heart disease and diabetes,' she said. Social Media's Role in the Protein Craze Another channel fueling the quest for protein is social media. Some patients may be swayed by their favorite influencers to boost protein consumption to lose weight. 'I see a lot of people coming in with unrealistic protein goals they got off social media sites like Instagram and TikTok, and I also have some patients who want to remain on keto/carnivore diets even after I express my concern,' said Badgett. 'And for many, we discuss optimizing what we can, such as addressing blood pressure, diabetes, or cholesterol if they plan to stay on the diet.' Ultimately, Badgett said, weight loss requires a calorie deficit and although protein matters, it can be a distraction from the former, if not careful. 'To maintain lean body mass, exercise is more important that protein intake and many patients are not pushing themselves physically and would benefit more from increasing intensity rather than increasing protein intake,' Badgett said. Counseling Patients on Optimal Protein Intake Health goals should be personalized, according to Richardson. 'I always aim to align my advice with my patients' individual goals and lifestyles,' he said. 'When they understand that my recommendations are tailored to them, they're more likely to be engaged and on board with the plan.' Also, health providers should recognize there is no one-size-fits-all when it comes to protein intake. 'A patient's needs depend on [their] health goals, whether that's muscle building, weight loss, or simply maintaining a healthy lifestyle,' said Richardson. 'Moderation is key, and so is guidance.' More and more insurance providers are covering nutritional counseling for conditions like obesity. Suggesting this resource could help your patient have a more balanced diet. 'Take a deep look into the patient's diet and lifestyle — this is where the registered dietitian nutritionist's expertise truly shines,' said Gentile of the Academy of Nutrition and Dietetics. 'A thorough dietary recall, paired with a lifestyle assessment, can reveal an energy intake that exceeds expenditure or uncover stressors that drive excessive snacking or elevate cortisol levels.' Gentile also suggests physicians emphasize that eating a balanced diet is vital. 'Remember that we need a balanced diet in macro- and micronutrients for our bodies to run properly,' she said. 'Consuming all foods in moderation is key. Eliminating or promoting a specific food group is not a long-term or healthy approach.'

As nicotine pouches' popularity soars, they're also responsible for more poisonings in young kids, study finds
As nicotine pouches' popularity soars, they're also responsible for more poisonings in young kids, study finds

CNN

timean hour ago

  • CNN

As nicotine pouches' popularity soars, they're also responsible for more poisonings in young kids, study finds

Children's healthFacebookTweetLink Follow Nicotine pouches are a fast-growing source of nicotine poisoning in young children, according to a new study. Researchers at Nationwide Children's Hospital in Ohio analyzed more than a decade's worth of data, examining over 134,000 cases of children under 6 who accidentally ingested nicotine through products like vapes, gums, and lozenges. Most types of exposures fell after 2016. But one delivery method — nicotine pouches — shot up, rising more than 760% between 2020 and 2023. 'It's a high-concentration nicotine product, and it tastes good,' said Dr. Natalie Rine, director of the Central Ohio Poison Center at Nationwide Children's Hospital and co-author of the study, published Monday in the journal Pediatrics. 'There's nothing telling the kid, 'this is bad, you should spit it out' … and that's where you get into trouble.' The miniature white packets that users tuck between their lip and gum hit US shelves in 2014. They don't contain tobacco but are instead filled with nicotine, either synthetically or naturally derived, along with flavorings and sweeteners. The discreet, sweet and smokeless nature of nicotine pouches has raised concerns among public health advocates, who are closely watching their rising popularity among teens and young adults. They've become the second most-used nicotine product among young people, according to the US Centers for Disease Control and Prevention. The National Youth Tobacco Survey found that nicotine pouch use among teens doubled between 2021 and 2024. Still, the overall user base remains small. Just 0.5% of Americans use nicotine pouches, compared with 9% who smoke cigarettes and 3% who vape or use e-cigarettes, according to US Census Bureau data. Levels of nicotine in pouches can vary from 3 to 12 milligrams per pouch. At their lowest doses, they deliver more of the stimulant than a cigarette, and even small amounts of nicotine can be dangerous for small children. Ingesting just 1 to 2 milligrams — less than what's inside a single regular-strength pouch — can cause nausea, vomiting and tremors, among other serious symptoms, according to the National Library of Medicine. The study found that nicotine pouches were associated with a 150% greater risk of serious medical effects and were twice as likely to lead to hospitalization than other smokeless nicotine products swallowed by children, like gums, lozenges, e-liquids, tablets and powders. Although the vast majority of pediatric nicotine ingestions resulted in little to no harm, more than 1,600 children had serious medical outcomes, the study found. Two children died after ingesting liquid nicotine. Rine recommends that parents avoid using nicotine pouches in front of children to keep them from imitating potentially risky adult behaviors. She also suggests keeping nicotine products physically out of kids' reach and to have conversations with other caretakers, like babysitters and extended family, about doing the same. If a child may have ingested a nicotine pouch, Rine says, the best first step is to call Poison Control at 1-800-222-1222. Trained staff can guide caregivers based on a child's symptoms and help them decide if emergency care is needed.

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