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<ul class="summary-list"><li>Novo Nordisk's Saxenda helped children reduce their BMI by 5.8% in a 56-week trial.</li><li>There are no approved obesity medications for children but Saxenda is approved for teens and adults.</li></ul><a target="_blank" class="" href="https://www.businessinsider.com/novo-nordisk-cut-prices-usa-obesity-drug-wegovy-double-demand-2024-5">Danish drugmaker Novo Nordisk's</a> weight loss drug Saxenda has helped children aged six to 11 <a target="_blank" class="" href="https://www.businessinsider.com/weight-loss-glp-1-drugs-ozempic-wegovy-mounjaro-effects-future-2023-12">reduce their body mass index</a>, according to trial results released on Tuesday.The results showed that the children receiving daily injections of Saxenda were able to cut their BMI by 5.8% on average in the 56-week trial — and by 7.4% on average compared with the placebo group. BMI is a measure of fitness based on height and weight, though it's <a target="_blank" class="" href="https://www.businessinsider.com/bmi-is-bogus-best-way-to-tell-if-youre-a-healthy-weight-2016-9">widely seen as</a> an inaccurate predictor of health.There are<a target="_blank" class="" href="https://www.businessinsider.com/weight-loss-drugs-for-kids-6-years-old-mounjaro-trial-2023-10"> no FDA-approved</a> medications for children with obesity. The agency approved Saxenda, which has the chemical name liraglutide, for teenagers in 2020 and for adults in 2014. Novo will seek FDA approval for the drug for younger children, the company's head of development told the <a target="_blank" class="" href="https://www.ft.com/content/83bfafb7-72a4-455f-8def-0caa959def3d">Financial Times</a>."To date, children have had virtually no options for treating obesity. They have been told to 'try harder' with diet and exercise," said lead researcher Claudia Fox at a meeting in Madrid, where the results of the study of 82 children were presented.The medication can allow children with obesity to live healthier and more productive lives, she said.Novo Nordisk's American rival, Eli Lilly, <a target="_blank" class="" href="https://www.businessinsider.com/weight-loss-drugs-for-kids-6-years-old-mounjaro-trial-2023-10">has also been testing </a><a target="_blank" class="" href="https://www.businessinsider.com/parents-are-putting-their-kids-on-weight-loss-drugs-2023-10">obesity-beating drugs for children </a>as young as six. Novo Nordisk is the drugmaker behind the blockbuster medications Ozempic and Wegovy, while Eli Lilly produces Mounjaro and Zepbound.Wegovy and similar <a target="_blank" rel="" href="https://www.businessinsider.com/tiktok-cracks-down-on-ozempic-content-2024-4">drugs for weight loss</a> have become a huge business. The <a target="_blank" rel="" href="https://stacks.cdc.gov/view/cdc/106273">US adult obesity rate</a> was about 40% from 2017 to 2020, and <a target="_blank" href="https://www.goldmansachs.com/intelligence/pages/anti-obesity-drug-market.html">Goldman Sachs</a> researchers estimated last year that the drugs could be prescribed to 15 million Americans by 2030. The bank's researchers said the anti-obesity drug market could grow to <a target="_blank" rel=" nofollow" href="https://www.goldmansachs.com/intelligence/pages/anti-obesity-drug-market.html">$100 billion</a> by that time.The drugs' success has made Novo Nordisk the most valuable company in Europe. Its stock is up over 25% year-to-date.<h2 id="b3771b30-588f-4b4d-9231-81903e6cdd49">Childhood obesity</h2>An FDA approval on weight loss drugs for children could open up a new market for Novo Nordisk.According to the Centers for Disease Control, <a target="_blank" href="https://www.cdc.gov/obesity/php/data-research/childhood-obesity-facts.html#:~:text=Expand%20All-,Age,%25%20among%20adolescents%2012%E2%80%9319.">one in five children</a> and adolescents in the US have obesity, and the <a target="_blank" href="https://datacenter.aecf.org/data/tables/101-child-population-by-age-group#detailed/1/any/false/2545,1095,2048,574,1729,37,871,870,573,869/62,63,64,6,4693/419,420">number of children</a> ages six to 11 with obesity is about 6 million.Novo's pricing for Ozempic and Wegovy has come under recent political scrutiny. In June, US Sen. Bernie Sanders announced that Novo Nordisk CEO Lars Jørgensen would testify before the committee on September 24 at a hearing focusing on the prices that Novo Nordisk charges Americans for their drugs, Ozempic and Wegovy.Sanders has <a target="_blank" class="" href="https://www.sanders.senate.gov/wp-content/uploads/Letter-from-Sen.-Bernard-Sanders-to-Novo-Nordisk.pdf">investigated</a> the prices, saying that they are higher in the US than in other countries.The highly-coveted drugs are being <a target="_blank" rel="" href="https://www.businessinsider.com/ozempic-celebrities-denied-semaglutide-wegovy-weight-loss-drugs-khloe-kardashian-2023-3">used by celebrities,</a> including Oprah Winfrey, <a target="_blank" rel="" href="https://www.businessinsider.com/elon-musk-weight-loss-drug-wegovy-semaglutide-fit-ripped-healthy-2022-10">Elon Musk</a>, and Charles Barkley, and by <a target="_blank" class="" href="https://www.businessinsider.com/ozempic-is-killing-keto-diet-report-suggests-2024-7">non-celebrities </a>alike.

The next big market for weight-loss drugs: children 

<ul class="summary-list"><li>A woman who had life-changing results on a popular weight loss drug struggled to afford it for years.</li><li>She found stability with a cheaper version of the medication through the booming telehealth market.</li></ul><a target="_blank" class="" href="https://www.tiktok.com/@tacklingtara">Tara Rothenhoefer</a>, a 49-year-old Florida resident, says her life changed when she joined a clinical trial for a promising new weight-loss medication.Over the course of the 18-month trial, from 2020 to 2021, she <a target="_blank" class="" href="https://www.businessinsider.com/mounjaro-weight-loss-drug-not-easy-way-out-2023-10">lost more than 200 pounds</a> — more than a third of her body weight. Suddenly, she didn't have pervasive "<a target="_blank" class="" href="https://www.businessinsider.com/weight-loss-drug-semaglutide-helping-dispel-harmful-stereotypes-patients-say-2022-12">food noise</a>" or preoccupation with eating that had bothered her for years, allowing her to freely pursue healthy habits.Rothenhoefer had been testing a drug, sold by pharmaceutical company Eli Lilly, which later won FDA approval for weight loss in 2023 under the brand name <a target="_blank" class="" href="https://businessinsider.com/eli-lilly-mounjaro-zepbound-approved-weight-loss-stronger-than-wegovy-2023-11">Zepbound</a>. A similar version of this drug, called Mounjaro, has been available to people with type 2 diabetes since 2022.But when the trial ended, she was faced with the prospect of paying over $1,000 per month to continue this drug, or try to keep the weight off unmedicated — an incredibly tricky feat since the drug's effects are not long-lasting, as far as we know.Now, after three years of navigating a nightmarish maze of shortages and lack of insurance coverage, she finally has steady, affordable access to her medication.She's not only one.The high price of weight-loss medication has left out millions of Americans who could benefit, as highlighted in recent <a target="_blank" class="" href="https://markets.businessinsider.com/news/stocks/novo-nordisk-ceo-faces-senate-questions-over-high-prices-of-ozempic-and-wegovy-in-us-1033798280">Senate Committee Hearings</a>, where Novo Nordisk's CEO faced tough questions about its versions of similar drugs, Ozempic and Wegovy.Here's how she, like many others, has found a way around the snarls of the healthcare system to stay on the drug.<h2 id="b6ae44a3-53cb-4a2c-8ff1-f68263c11f64">At first, she tried the pharma solution: coupons</h2>After the trial ended, Rothenhoefer's doctor issued her a prescription for Mounjaro but she knew she couldn't afford it with her office job.Not a problem, manufacturer Eli Lilly told her — she could get a coupon, allowing her to access the drug at a steep discount.Providing coupons is a common practice for drug makers to incentivize patients to try their product, instead of a competitor's, especially when it's a new offering in an already-hot and high-priced market.However, the coupon expired in June 2023. And all she could do was ration out her remaining doses and hope for the best."My insurance doesn't cover it. Most people can't afford it. I had no choice," she said.<h2 id="9f175e6c-deef-4bd9-8285-ccf7d1bc03be">Spreading out doses to try to make the drug last longer</h2>Rothenhoefer did what she could to make her supply of medication last, and tried to dose every 10 to 14 days instead of weekly, but the scale began creeping back up regardless of what she did."I was having a lot of fluctuations in weight even though my habits were the same," she said.Research suggests that people who lose weight on GLP-1 medications need to continue taking them or they'll <a target="_blank" class="" href="https://www.businessinsider.com/zepbound-weight-gain-stop-taking-tirzepatide-2023-12">regain the weight</a> so Rothenhoefer needed a long-term plan just to keep her weight stable."I'm in maintenance, which I'll be in for the rest of my life," she said.But she's since been able to find a steady, affordable supply, and now takes a dose of 7.5 - 10 mg of compounded tirzepatide weekly, delivered to her door, and plans to stay this course for at least the next year, if not longer.<h2 id="86a425c0-21ca-447d-a94f-5bc79360d4e5">The promise of cheaper 'compounded drugs'</h2>Rothenhoefer said she had heard about a cheaper version of the GLP-1s known as compounded tirzepatide.The active ingredient in Mounjaro and Zepbound is tirzepatide, one type of <a target="_blank" class="" href="https://www.businessinsider.com/weight-loss-glp-1-drugs-ozempic-wegovy-mounjaro-effects-future-2023-12">GLP-1 drugs</a>, which mimic hormones that our bodies naturally produce to control appetite and blood sugar. (Ozempic and Wegovy contain a similar drug called <a target="_blank" class="" href="https://www.businessinsider.com/how-weight-loss-meds-injections-compare-costs-results-side-effects">semaglutide</a>.)<a target="_blank" class="" href="https://www.businessinsider.com/buy-compounded-semaglutide-online-risks-wegovy-ozempic-2023-1">Compounded medications</a> are custom formulations of drugs provide by specialized pharmacies. Since brand name GLP-1 drugs have long been in shortage, drug compounders are legally allowed to fill the gap in demand with their own versions of the same active ingredients, semaglutide or tirzepatide.While regulated, these compounded drugs aren't FDA-approved, raising concerns from doctors about variations in quality.The grey market of weight-loss drugs is vast and complicated.Some weight-loss clinics or med spas offer injections for as little as $20, with way of vetting what you're getting, and some online clinics are simply money scams, a <a target="_blank" class="" href="https://www.businessinsider.com/scientist-cheaper-ozempic-sold-online-contains-dangerous-ingredients-2024-8">recent study found</a>.Rothenhoefer contacted a telehealth company with a verified, credentialed compounding pharmacy.The price for her dose of the compounded version is $329 monthly, compared to the brand name's list price of more than $1,000 per month.Pharmaceutical companies are pushing back against their low-cost competitors in the GLP-1 market.In August, Eli Lilly halved the price of its <a target="_blank" class="" href="https://www.businessinsider.com/eli-lilly-cut-price-zepbound-tirzepatide-weight-loss-drug-copycats-2024-8">weight-loss drug Zepbound </a>through single-dose vials — a bid to lure customers back to brand-name drugs, analysts said.But Rothenhoefer said that if manufacturers want people to buy their products, prices need to keep dropping."I think everyone would be on the branded if it were accessible and affordable. But there are people out there that are alive now that might not have been or might have been in five years if they didn't get their health under control," she said of patients like her who are now using compounded medications.<h2 id="bc1e401f-b010-4062-a1c7-ffc442cacc15">A huge relief</h2>Previously, Rothenhoefer said she was constantly worried about protecting the dwindling stockpile of medication in her refrigerator.Now, with reliable access, a huge burden has been lifted, Rothenhoefer said. She is no longer fixated on rushing to get ice in a cooler for her meds as a first priority, and is free to think about everything else that matters."I don't have any fear at all anymore," she said. "My mind has been totally put at ease and I can now focus on the rest of my life."

Weight-loss drugs are life-changing — and expensive. Here's one woman's solution.

<keyword id="19894886" type="General" weightage="20" keywordseo="china" source="keywords">China</keyword>'s top drug regulator has cleared a mpox vaccine developed by local drug firm Sinopharm for clinical trials which could be the country's first experimental dose to battle the deadly disease. The domestic vaccine candidate, created by the Shanghai Institute of Biological Products and administered by Sinopharm, is expected to play an important role in preventing and controlling mpox infections, the company said in a statement released on Monday afternoon. There is currently no approved mpox vaccine in China. Globally, a few vaccines have been approved in the United States, Canada, the European Union, Japan and Russia. In China, a vaccine candidate typically goes through three phases of clinical trials before gaining market approval. The process can take years, even decades. However, the National Medical Products Administration, China's top drug regulator, has launched a number of accelerated or streamlined channels to facilitate applications of novel drugs and vaccines or those in urgent need, state-run China Daily reported on Tuesday. According to the company, the new vaccine is a replication-deficient vaccine based on a strain called MVA. The description is the same as <keyword id="22925756" type="General" weightage="20" keywordseo="jynneos" source="keywords">Jynneos</keyword>, the world's first mpox vaccine approved by the <keyword id="20256595" type="General" weightage="20" keywordseo="food-and-drug-administration" source="keywords">Food and Drug Administration</keyword> in the United States in 2019. The <keyword id="19902256" type="General" weightage="20" keywordseo="world-health-organisation" source="keywords">World Health Organisation</keyword> said on August 14 that the mpox outbreak in <keyword id="19924003" type="General" weightage="20" keywordseo="africa" source="keywords">Africa</keyword> constitutes a public health emergency of international concern - its highest form of alert. Previously, in July 2022, the WHO declared a global emergency but then lifted it in May last year because of a sustained decline in international cases. So far, more than 120 countries and regions across the world have reported more than 100,000 confirmed infections and 226 related deaths. China reported its first imported case in September 2022 and the first domestic case in June last year. By the end of July, the nation had reported 2,567 confirmed cases, according to the China Daily report. SEE ALSO: <a href="https://www.businessinsider.in/business/auto/news/ather-energy-looks-to-raise-3100-crore-files-ipo-papers-with-sebi/articleshow/113214971.cms">Ather Energy looks to raise ₹3,100 crore, files IPO papers with SEBI</a> <a href="https://www.businessinsider.in/tech/mobile/news/iphone-16-pro-iphone-16-pro-max-india-price-specifications/articleshow/113204340.cms">iPhone 16 Pro and iPhone 16 Pro Max with bigger displays, A18 Pro chipset launched starting at ₹1,19,900</a> <a href="https://www.businessinsider.in/tech/mobile/news/apple-iphone-16-iphone-16-plus-price-specs/articleshow/113203568.cms">iPhone 16, iPhone 16 Plus with A18 chipset launched starting at ₹79,900</a>

China's drug regulator clears mpox vaccine; to undergo clinical trial

<ul class="summary-list"><li><keyword id="21230020" type="General" weightage="20" keywordseo="weight-loss-drugs" source="keywords">Weight loss drugs</keyword> like <keyword id="19918897" type="General" weightage="20" keywordseo="Ozempic" source="keywords">Ozempic</keyword> are overtaking keto in popularity, a new report shows.</li><li><keyword id="20037811" type="General" weightage="20" keywordseo="GLP-1-drugs" source="keywords">GLP-1 drugs</keyword> lead to significant weight loss and are changing consumer habits.</li></ul>Hold the butter — the <a target="_blank" class="" href="https://www.businessinsider.com/weight-loss-glp-1-drugs-ozempic-wegovy-mounjaro-effects-future-2023-12">rise of weight loss medications</a> may be signaling an end to popular high-fat, <keyword id="21752741" type="General" weightage="20" keywordseo="low-carb-diet" source="keywords">low-carb diet</keyword> trends. Americans are now looking up Ozempic more frequently than keto on Google, according to the <a target="_blank" class="" href="https://newconsumer.com/2024/07/introducing-the-consumer-trends-2024-mid-year-report/">2024 mid-year Consumer Trends report</a> from The New Consumer and Coefficient Capital. The <a target="_blank" class="" href="https://www.businessinsider.com/guides/health/diet-nutrition/keto-diet">keto diet</a>, based on eating a whopping 70% to 80% of daily calories from fat sources and as little as 5% from carbs, has been a dominant force in the diet world for over a decade. Along the way, consumers' hunger for low-carb alternatives to their favorite treats has sparked a massive market of ostensibly better-for-you snacks, from zero-sugar candy to high-protein chips and cookies. The global market for keto products <a target="_blank" class="" href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9312449/#b2-ms119_p0084">was valued at</a> more than $9 billion in 2019. But among Americans, interest appears to have stalled out in recent years: In surveys commissioned by the International Food Information Council, the share of self-identified dieters who reported following a keto or high-fat diet in the past year dropped to 4% in 2023 from 7% in 2022. At the same time, Ozempic has emerged — a brand name for <a target="_blank" class="" href="https://www.businessinsider.com/ozempic-treat-addiction-alzheimers-depression-2023-5">the drug semaglutide,</a> which has become the eponym for a class of medications called GLP-1s that can lead to unprecedented weight loss. As keto fades away, it's making room for a lucrative market catering to GLP-1 users' smaller but more refined appetites instead. <h2>Some doctors have called keto the worst diet for health</h2>Despite hitting its stride in the mid-2010s, the <keyword id="21521371" type="General" weightage="20" keywordseo="keto-diet" source="keywords">keto diet</keyword> has been around for at least a century. Whether branded as Atkins, the Zone diet, or just called low-carb, keto promised that you could shed pounds and boost health by eating the foods conventional wisdom had forbidden, from juicy burgers with cheese to steaks slathered in butter. But for doctors, the potential weight loss boon comes with major caveats, prompting keto to earn the title of "<a target="_blank" class="" href="https://www.businessinsider.com/keto-low-carb-diet-ranked-worst-healthy-eating-2022-1">worst diet for healthy eating</a>" several years in a row. Eating too much <a target="_blank" class="" href="https://www.businessinsider.com/guides/health/diet-nutrition/saturated-vs-unsaturated-fat">saturated fat</a> and cholesterol has been linked to a higher risk of heart disease and other illnesses. Consuming <a target="_blank" class="" href="https://www.businessinsider.com/reducing-processed-meat-intake-lower-disease-risk-study-2024-7">processed meats</a> like sausages and ham has been tied to higher odds of developing cancer. Both saturated fat and processed meats are popular in low-carb diet variations like "<a target="_blank" class="" href="https://www.businessinsider.com/lazy-keto-diet-easier-to-follow-but-experts-dont-recommend-2021-6">dirty keto</a>," full of junk food. Still, the allure of losing weight while eating bacon and burgers has persisted, and research has uncovered <a target="_blank" class="" href="https://www.businessinsider.com/keto-diet-could-help-people-with-diabetes-control-blood-sugar-2020-12">promising benefits of low-carb diets</a> for controlling blood sugar levels, managing diabetes, and potentially aiding weight loss. <h2>Weight loss meds offer a new way to stop cravings and shed pounds</h2><a target="_blank" class="" href="https://www.businessinsider.com/weight-loss-obesity-drug-fda-approved-wegovy-2021-6">Semaglutide</a>, the active ingredient in Ozempic, received FDA approval as a weight management treatment in 2021. Now, between 8 million to 20 million Americans are using some type of GLP-1 medication, according to estimates from The New Consumer report. There could be another 25 million to 50 million users over the next few years, the report suggests. GLP-1 drugs work for weight loss by mimicking various hormones that naturally occur in the human body and help regulate appetite. For patients, the medications help to combat "food noise," a persistent preoccupation with food and eating that can make long-term dieting difficult. GLP-1s can even make crave-able treats like <a target="_blank" class="" href="https://www.businessinsider.com/semaglutide-ozempic-disgusted-favorite-foods-2022-11">fried foods or sweets seem less delicious</a>. As a result, weight loss drugs are changing the way we eat, and the food industry is taking note. GLP-1 users make up the biggest share of people trying <a target="_blank" class="" href="https://www.businessinsider.com/ozempic-wegovy-users-about-to-get-own-frozen-foods-nestle-2024-5">new grocery products,</a> and they're more willing to splurge on expensive items, according to the recent trend report. The race is on among pharmaceutical companies to develop medications with even more powerful benefits and fewer side effects. <h2>But low-carb diets still have a major advantage over Ozempic</h2>While semaglutide and other GLP-1s have been called a "game changer" for <a target="_blank" class="" href="https://www.businessinsider.com/how-weight-loss-meds-injections-compare-costs-results-side-effects">weight loss</a>, they're still largely unavailable to many people who might benefit. The medications can cost $1,000 or more a month, making affordability the biggest barrier for people seeking <a target="_blank" class="" href="https://www.businessinsider.com/how-much-ozempic-costs-with-insurance-2023-6">GLP-1 treatment</a>, followed by a lack of insurance coverage. Frequent shortages have also prompted a booming gray market for <a target="_blank" class="" href="https://www.businessinsider.com/buy-compounded-semaglutide-online-risks-wegovy-ozempic-2023-1">compounded GLP-1s</a>, which the FDA has warned can be ineffective and potentially risky. Even the brand name drugs come with <a target="_blank" class="" href="https://www.businessinsider.com/mounjaro-vs-ozempic-side-effects-2023-5">side effects</a>, most commonly mild to moderate symptoms like nausea or vomiting. In contrast, a major draw of low-carb diets has always been ease of access, offering a means for people to try fixing their health at home without a doctor's visit, dietitian-approved meal plan, or calorie-counting app. Combined with an emerging trend of <a target="_blank" class="" href="https://www.businessinsider.com/doctor-shares-foods-prescribed-to-fight-disease-2024-5">food-as-medicine</a>, tackling health issues at the grocery store instead of the pharmacy is still attractive to many people. Ozempic's star is still rising, but as long as the steep costs and healthcare hurdles persist, low-carb diets are likely to linger, even if only on the fringes. Correction: July 24, 2024 — An earlier version of this story misrepresented a keto-related finding of a survey. The survey, from the International Food Information Council, found that the share of respondents who said they'd followed a keto diet fell by 3 percentage points, to 4%, from 2022 to 2023; it did not fall by 4% in 2023.

Forget keto — Ozempic might finally kill the low-carb diet trend 

<ul class="summary-list"><li>Sean Combs isn't scheduled to leave his Brooklyn jail until his next court date in two months. </li><li>Meanwhile, teams of lawyers and prosecutors, plus a trio of judges, are working on the case.</li></ul>Sean "Diddy" Combs isn't due back in court on <a target="_blank" class="" href="https://www.businessinsider.com/sean-diddy-combs-arrested-grand-jury-indictment-2024-9">his Manhattan sex-trafficking indictment</a> until December 18.Meanwhile, Combs' future is being charted behind the scenes by federal prosecutors, defense lawyers, and a trio of judges tasked over the coming days with drafting possible new charges, a gag order, and a bail decision.Here's what's expected next in the case, which alleges that since 2009, the <a target="_blank" class="" href="https://www.businessinsider.com/sean-combs-diddy-business-income-dried-up-ciroc-music-deleon-2024-10">millionaire rap entrepreneur</a> used force and threats to sexually abuse "women and others around him," including at drug-fueled <a target="_blank" class="" href="https://www.businessinsider.com/sean-diddy-combs-indictment-allegations-freak-off-sex-performances-2024-9">parties called "freak-offs."</a>An attorney for Combs declined to comment on the pending matters. The US Attorney's office in Manhattan did not respond to a request for comment.<div type="image" title="An evidence photo from the Sean Combs sex-trafficking case shows a magazine for an AR-15 loaded with large caliber .233 ammunition. Federal prosecutors allege it was found in Combs' Miami bedroom closet." height="302" width="334" msid="114292368" hostid="261" sizebytes="4698"></div><h2 id="ff8cdb75-43ba-49bb-89a1-227ee1fff66c">Possible new charges: weapons and drugs</h2>Combs maintains his innocence and pleaded not guilty to three federal charges: racketeering, sex trafficking, and transportation to engage in prostitution (for allegedly causing female victims and commercial sex workers to cross state lines). The charges carry a mandatory minimum of 15 years in prison, and the top possible sentence is life.Twice denied bail on a defense offer of home confinement and a $50 million bond, Combs remains for now in a federal jail in Brooklyn, where he can strategize with his lawyers about <a target="_blank" class="" href="https://www.businessinsider.com/sean-diddy-combs-judge-gag-order-trial-date-2024-10">his scheduled May 5 criminal trial</a> and a growing number of <a target="_blank" class="" href="https://www.businessinsider.com/sean-combs-diddy-new-allegations-lawsuits-2024-10">sexual abuse lawsuits</a>.Last week, at his third and most recent court appearance, prosecutor Emily Anne Johnson hinted that Combs could be summoned out of jail and back to court at any time before his next date — for a second arraignment."Our investigation is continuing," Johnson told <a target="_blank" class="" href="https://www.businessinsider.com/sean-diddy-combs-new-judge-sex-trafficking-ticketmaster-2024-10">US District Judge Arun Subramanian</a>. "There is a possibility that there will be a superseding indictment."Johnson did not say if a grand jury is hearing new evidence, and she gave no specifics on the potential new charges. Federal prosecutors have signaled they are looking at weapons and drug charges.<div type="image" title="This evidence photo from the Sean Combs sex-trafficking case shows a drum magazine loaded with 59 rounds of large capacity .223 caliber ammunition. Federal prosecutors say it was seized from Combs' Los Angeles home." height="344" width="386" msid="114292369" hostid="261" sizebytes="9802"></div>Prosecutors alleged at a bail hearing last month that federal agents seized three AR-15 rifles with defaced serial numbers when search warrants were executed at Combs' homes and a Florida airport back in March. Two of the weapons were found broken down into parts in the bedroom closet of <a target="_blank" class="" href="https://www.businessinsider.com/p-diddy-miami-mansion-on-star-island-paid-off-mortgage-2024-9#:~:text=Combs'%20legal%20team%20cited%20a,Island%20Drive%2C%20at%20%2448.5%20million.">Combs' $48.5 million Miami mansion,</a> they said. Two magazines with a total of 29 rounds of high-caliber ammo were also in the closet, they allege.When <a target="_blank" class="" href="https://www.businessinsider.com/sean-diddy-combs-lawyer-nyc-sex-trafficking-charges-2024-7">defense attorney Marc Agnifilo</a> suggested during bail arguments that the weapons belonged to Combs' security, Johnson, the prosecutor, had this to say:"I don't dispute that Mr. Combs has used armed security," she said. "But it is incredulous that armed security in a professional security company would use defaced AR-15s and store them in pieces in the defendant's personal closet.""That," she added, "is absurd."During the same September 17 bail hearing, Johnson also told the judge that when Combs was arrested at his Manhattan hotel on the previous night — "at a time when he should be on his very, very best behavior" because he knew he was under investigation — agents recovered from his room "bags of pink powder that are visually similar to bags of pink powder that we have seized before from the defendant that have tested positive for ecstasy and other drugs."Combs' indictment alleges he gave ecstasy, ketamine, GHB, and other so-called party drugs to his victims "to keep them obedient and compliant."Agnifilo suggested the drugs were for Combs' personal use, telling the judge that his client had previously checked himself into rehab for drug treatment and, at the time of his arrest, was undergoing "therapy for things that, most respectfully, he needs treatment and therapy for."<div type="image" title="This evidence photo from the Sean Combs sex-trafficking case shows a defaced serial number on an AR-15 rifle. Federal prosecutors say this is one of three defaced weapons seized from Combs in March." height="316" width="476" msid="114292366" hostid="261" sizebytes="9012"></div><h2 id="bec9a333-2f01-4a2a-bcc4-8af66309c481">Possible new defendants: Combs' "associates"</h2>A new, or superseding, indictment, if one comes, could name new defendants, a possibility that prosecutors have also alluded to in court filings and bail arguments.The indictment's racketeering charge alleges the Bad Boy Records founder ran a conspiracy prosecutors call "The Combs Enterprise.""The defendant arranged Freak Offs with the assistance of members and associates of the Enterprise, including employees of <a target="_blank" class="" href="https://www.businessinsider.com/sean-combs-diddy-business-income-dried-up-ciroc-music-deleon-2024-10">his business,</a>" prosecutors wrote in a September 17 bail memo.Over the years, these unnamed assistants used bribes, violence, and threats to keep victims and potential witnesses in line, including "resorting to kidnapping and arson when the defendant's power and control were threatened," the bail memo alleges.Prosecutors say these associates also purchased and distributed drugs, made sure the freak-offs were stocked with lubricants and extra linens, and then cleaned up afterward.Ample supplies were stocked away for future freak-offs, prosecutors allege."Over 1,000 bottles of baby oil and personal lubricant" were seized at one search warrant location, federal prosecutors said in one of the bail memo's most memorable details.<h2 id="a27d9dab-78a9-43e4-b5fe-23973061c2f0">A gag order</h2>Prosecutors and defense lawyers <a target="_blank" class="" href="https://www.businessinsider.com/sean-diddy-combs-judge-gag-order-trial-date-2024-10">have accused each other </a>of making or condoning potentially jury-tainting public statements. One of the few things they now agree on is that a gag order is a good idea.The judge last month ordered the sides to work together on the wording of such an order for his consideration.In a related matter, the defense has accused prosecutors of looking the other way as Department of Homeland Security agents involved in executing the Combs search warrants in March <a target="_blank" class="" href="https://www.businessinsider.com/sean-diddy-combs-accuses-doj-grand-jury-leaks-2024-10">leaked explicit and prejudicial details to the press.</a>Prosecutors have countered that they are not involved in any leaks and that Agnifilo has himself made prejudicial statements to the press, including by telling TMZ last month that the Combs prosecution is "the takedown of a successful Black man."The judge has ordered the sides to file briefs on the defense's demand for an evidentiary hearing on the leaks.Agnifilo wants the hearing so that allegedly "leaked" evidence can be excluded from trial. That would include hallway surveillance footage from the Intercontinental Hotel in LA revealed by CNN in May. The footage shows <a target="_blank" href="https://www.businessinsider.com/sean-diddy-combs-apologizes-video-cassie-ventura-assault-2024-5">Combs punching and kicking his then-girlfriend, singer Cassandra "Cassie" Ventura,</a> after a freak-off in March 2016.<h2 id="6bc431cd-51df-4e23-b890-2330f1a7bc97">A bail decision</h2>On October 2, Combs filed a sealed motion with a federal appellate court in Manhattan seeking to overturn his two lower-court bail denials.Agnifilo argued that Combs and his family members preemptively gave him their passports and that Combs cooperated with prosecutors pending his arrest. He has also <a target="_blank" class="" href="https://www.businessinsider.com/sean-diddy-combs-attack-cassie-sex-trafficking-case-could-backfire-2024-9">challenged the credibility</a> of key witnesses and argued that the conduct charged in the indictment was consensual."There's 30 million reasons for this to be depicted as a one-sided thing — one for each dollar that he was being sued for," Agnifilo told a magistrate judge at Combs' first court appearance, referring to<a target="_blank" class="" href="https://www.businessinsider.com/sean-combs-diddy-sex-trafficking-rape-abuse-lawsuit-cassie-venutura-2023-11#:~:text=The%20lawsuit%2C%20which%20was%20reviewed,to%20The%20New%20York%20Times."> a quickly-settled lawsuit</a> filed against him by Ventura in November.In fighting pretrial release, prosecutors have countered that Combs is a flight risk due to his wealth and his access to his private plane. They have also argued that he is a danger to the community due to his volatile temper and past violence, and that he has a history of contacting witnesses. They have yet to file a response to Combs' bail appeal.The appellate court has already denied Combs' request to remain free while a three-judge panel decides the appeal.

What's next in Diddy sex-trafficking case: possible gun and drug charges, a gag order, and a bail decision

The government has waived the requirement for clinical trials of certain categories of drugs in <keyword id="19895063" type="General" weightage="20" keywordseo="India" source="keywords">India</keyword> if they are approved in the <keyword id="19899478" type="General" weightage="20" keywordseo="US" source="keywords">US</keyword>, the <keyword id="19922618" type="General" weightage="20" keywordseo="UK" source="keywords">UK</keyword>, Japan, Australia, Canada and the European Union. The waiver only covers five categories -- orphan drugs for rare diseases, gene and cellular therapy products, <keyword id="22559447" type="General" weightage="20" keywordseo="new-drugs" source="keywords">new drugs</keyword> used in pandemic situations, new drugs used for special defence purposes and new drugs having significant therapeutic advances over the current standard care. This waiver would ensure expeditious availability of the latest medicines for treating diseases like cancers, rare diseases like Spinal Muscular Atrophy (SMA) and Duchenne Muscular Dystrophy (DMA), and autoimmune conditions in India. "As per Rule 101 of New Drugs and Clinical Trials Rules, 2019, the Central Licensing Authority, with the approval of the Central Government, may specify, by an order, the name of the countries, from time to time, for considering waiver of local clinical trial for approval of new drugs under Chapter X and for grant of permission for conduct of clinical trial under Chapter V of the said rules," the Drugs Controller General of India (<keyword id="20559042" type="General" weightage="20" keywordseo="DGCI" source="keywords">DGCI</keyword>) said in an order issued on August 7. "In exercise of the powers conferred under Rule 101 of the said rules with the approval of the Central Government, the countries namely USA, UK, Japan, Australia, Canada and EU are hereby specified for following categories of new drugs," it said. Presently, several medicines already approved by other regulatory authorities in the US, the UK and the EU are not immediately available for Indian patients because of certain regulatory requirements under the Drugs and Cosmetics Act and rules made thereunder. These include the requirement of conducting a local clinical trial and generating safety and efficacy data before marketing authorisation in India, an official explained. However, Rule 101 of the New Drugs and Clinical Trials, 2019, allows the DCGI to specify certain countries for considering waiver of local clinical trials for approval of new drugs. "The advantages of operationalising this rule are that the latest medicines to treat diseases like cancers, rare diseases like SMA and DMA, and autoimmune conditions will become available expeditiously in India. "Presently, the delay in launching a new or novel medicine in India is anywhere between 5-20 years when compared to western markets. With the waiver of Rule 101, the scope of parallel launches of medicines in India along with the West will be opened up," the official explained. Besides, there will be a considerable reduction in the cost of various advanced medicines. Also, there will be a substantial reduction in the public procurement costs of the central and state governments under various schemes like the Central Government Health Scheme (CGHS) and Ayushman Bharat. Another advantage is that the resources which would have gone into approving the Indian clinical trials could now be utilised productively elsewhere, the official said. The costs of conducting local clinical trials will be reduced for pharmaceutical firms, therefore passing on these savings to patients. This is especially true for cases of rare diseases where firms have logistical difficulties in finding participants. The change will promote further research in these areas as there will be access to patient data in the Indian context much earlier, ultimately promoting indigenous innovation and shift from volume to value, the government's mission for the pharmaceutical industry, the official said. SEE ALSO:<a href="https://www.businessinsider.in/business/news/ola-wants-to-re-enter-the-quick-commerce-business-to-take-on-blinkit-and-swiggy-instamart/articleshow/112364583.cms" target="_blank"></a> <a href="https://www.businessinsider.in/business/news/ola-wants-to-re-enter-the-quick-commerce-business-to-take-on-blinkit-and-swiggy-instamart/articleshow/112364583.cms" target="_blank">Ola wants to re-enter the quick commerce business to take on Blinkit and Swiggy Instamart</a><a href="https://www.businessinsider.in/finance/banks/news/rbi-mpc-meet-cheque-clearing-time-reduced-upi-limit-increased-for-tax-payment/articleshow/112366099.cms" target="_blank"></a> <a href="https://www.businessinsider.in/finance/banks/news/rbi-mpc-meet-cheque-clearing-time-reduced-upi-limit-increased-for-tax-payment/articleshow/112366099.cms" target="_blank">RBI MPC meet – Cheque clearing time reduced, UPI limit increased for tax payment</a><a href="https://www.businessinsider.in/business/auto/news/tata-curvv-ev-with-up-to-585-km-range-launched-starting-at-17-49-lakh/slidelist/112342769.cms" target="_blank"></a> <a href="https://www.businessinsider.in/business/auto/news/tata-curvv-ev-with-up-to-585-km-range-launched-starting-at-17-49-lakh/slidelist/112342769.cms" target="_blank">Tata Curvv EV with up to 585 km range launched starting at ₹17.49 lakh</a>

Govt waives clinical trial requirement for several drugs approved in select countries

<ul class="summary-list"><li>A 3-year-study of Zepbound and Mounjaro found the GLP-1 drugs can help prevent diabetes.</li><li>The weekly injections cut the risk of developing diabetes by 94% among adults with high blood sugar.</li></ul>First, these new injectable drugs were meant to treat diabetes. Then, they became approved for weight loss. And now, a new study suggests losing weight with some <a target="_blank" class="" href="https://www.businessinsider.com/weight-loss-glp-1-drugs-ozempic-wegovy-mounjaro-effects-future-2023-12">GLP-1 drugs</a> can also prevent diabetes.Results from a three-year study of over 1,000 patients, funded by drugmaker Eli Lilly, suggest that taking <a target="_blank" class="" href="https://www.businessinsider.com/eli-lilly-mounjaro-zepbound-approved-weight-loss-stronger-than-wegovy-2023-11">Zepbound</a> or Mounjaro may reduce the risk of developing diabetes by 94% among patients at risk. Those patients were both overweight and had pre-diabetes — higher-than-normal blood sugar readings put them at greater risk of developing type 2 diabetes in the near future."These data reinforce the potential clinical benefits of long-term therapy for people living with obesity and pre-diabetes," Dr Jeff Emmick, senior vice president of product development at Eli Lilly, said in a release.<h2 id="ce50f17b-ef75-4c48-9639-252137ecba17">Patients on the drug lost a lot of weight — lowering their risk of developing diabetes</h2><div type="image" title="a close up of a person measuring their waist size " height="1414" width="2121" msid="112660673" hostid="261" sizebytes="139486"></div>The weight loss benefits of taking Eli Lilly's dual-agonist drug, (generically called tirzepatide) were profound.Patients on the highest dose of the drug lost, on average, more than 22% of their body weight in this study, while patients on the lowest dose lost around 15%. Patients in a control group on a placebo jab only lost about 1%.Weight loss, along with eating healthy and exercising more, is already a well-known strategy for reducing the risk of developing diabetes among people with pre-diabetes.Hormone-mimicking shots like Zepbound, Mounjaro, Ozempic, and Wegovy make your body feel full with less food; they slow down digestion and improve blood sugar control. Tirzepatide tends to be a more powerful medication than semaglutide (the drug branded as Ozempic and Wegovy from Novo Nordisk), because it acts on two separate hormone receptors (GLP-1 and GIP) rather than one.<h2 id="29c21add-aa70-4d9e-a9ac-a10698deeb61">The big unanswered question</h2>How long people will need to remain <a target="_blank" class="" href="https://www.businessinsider.com/how-long-do-you-have-to-take-ozempic-probably-forever-2023-6">on these drugs</a> is unclear. If someone on Zepbound or Mounjaro loses a substantial amount of weight, to the point that they no longer have pre-diabetes or obesity, can they stop taking their drug?That is something doctors and researchers can't answer. Studies suggest that most people who do that will rebound, <a target="_blank" class="" href="https://www.businessinsider.com/quit-wegovy-ozempic-no-evidence-stop-taking-works-2023-12">regaining all they've lost</a>, and often more. Plus, insurers tend not to cover a drug that costs more than $1,000 a month for someone without any diagnosable health conditions.These weekly injectables for weight loss and diabetes are also being tested as prevention and treatment tools for various other conditions including <a target="_blank" class="" href="https://www.businessinsider.com/glp-1-for-dementia-alzheimers-early-study-looks-promising-2024-7">dementia</a>, liver disease, and drug and alcohol <a target="_blank" class="" href="https://www.businessinsider.com/ozempic-treat-addiction-alzheimers-depression-2023-5">addictions.</a>But it's unclear how often the drugs will be covered by insurance, and whether people will want to deal with common side effects like nausea and gastrointestinal issues for life.

Eli Lilly's weight-loss drug may prevent diabetes — but there's 1 unanswered question

<ul class="summary-list"><li>Lykos Therapeutics is cutting 75% of staff after FDA rejected its MDMA drug for mental health.</li><li>The FDA's decision marks the first time the agency considered a psychedelic for medical use.</li></ul>US <a target="_blank" class="" href="https://www.businessinsider.com/wegovy-maker-novo-nordisk-employers-weight-loss-drugs-restrictions-coverage-2024-2">drugmaker</a> Lykos Therapeutics is cutting most of its staff after the Food and Drug Administration <a target="_blank" class="" href="https://www.businessinsider.com/mdma-therapy-maps-lykos-rick-doblin-fda-legalization-trials-2024-5">rejected its MDMA drug</a> for mental health treatments.Lykos will lay off 75% of its staff, or about 100 employees, and the remaining team will focus on ongoing development and working with the FDA, the company said in a statement on Thursday. Its founder, Rick Doblin, will also exit the privately-held company's board."As we prepare to address the FDA decision, we need to focus on delivering the FDA the robust clinical data necessary to support the approval of this potential <a target="_blank" class="" href="https://www.businessinsider.com/psychedelics-better-leaders-business-executives-2024-3">new treatment</a>," Amy Emerson, the CEO of Lykos, said in the statement.The company said it is planning to resubmit its research to the FDA because it believes that MDMA, which is also commonly known as ecstasy or molly, can help people with post-traumatic stress disorder, including veterans and survivors of sexual violence.This is the first time the agency has considered a psychedelic for medical use.If the FDA ruled in its favor, Lykos had the <a target="_blank" class="" href="https://www.businessinsider.com/mdma-therapy-maps-lykos-rick-doblin-fda-legalization-trials-2024-5">potential</a> to become a multibillion-dollar company.Johnson &amp; Johnson sells an esketamine nasal spray called Spravato for depression. It's one of the few new treatments for mental illness approved in recent years, and it had global sales of about $500 million in the first half of the year, per the company's latest <a target="_blank" class="" href="https://www.investor.jnj.com/news/news-details/2024/Johnson--Johnson-reports-Q2-2024-results/default.aspx">financials</a>.<a target="_blank" class="" href="https://www.businessinsider.com/what-is-mdma-mental-physical-effects-in-body-and-brain-2023-3">MDMA is a Schedule I drug</a> under the Controlled Substances Act, along with heroin and cannabis. The classification is given to drugs with a high potential for abuse and no currently accepted medical use in treatment in the United States, according to the Drug Enforcement Administration.Possible effects of using MDMA include depression, anxiety, and paranoia, while overdose effects include heart and liver failure and death, per the DEA.

The drugmaker that hopes to legalize MDMA is cutting 75% of its staff after the FDA rejected the drug

<ul class="summary-list"><li>Eli Lilly is cutting the price of its popular weight-loss drug to compete with counterfeit weight-loss drugs.</li><li>Zepbound will be sold for $399-$549 per month, compared to a previous list price of $1,059.</li></ul>One of the biggest weight-loss drugs on the market will now be available at half the cost, as its manufacturer hopes to reclaim the market from booming counterfeit sales.Pharmaceutical giant Eli Lilly announced in a press early Tuesday that Zepbound, its brand of the drug tirzepatide designed specifically for weight loss, would be sold in single-dose bottles.Tirzepatide is part of a <a target="_blank" class="" href="https://www.businessinsider.com/how-weight-loss-meds-injections-compare-costs-results-side-effects">class of medications called GLP-1s</a>, which act on a hormone receptor that controls appetite. Research suggests it can lead to even more weight loss than similar GLP-1 drugs like Wegovy and Ozempic (which contain semaglutide) because tirzepatide works on two hunger-related hormones instead of just one. It was <a target="_blank" class="" href="https://www.businessinsider.com/eli-lilly-mounjaro-zepbound-approved-weight-loss-stronger-than-wegovy-2023-11">FDA-approved</a> for weight loss in November 2023.Previously, Zepbound was only sold in pre-filled injector pens for a list price of $1,059 per month.This move could curb shortages, patient advocates say, since vials are cheaper and easier to get hold of than pens.The new single-dose vials will be available to customers who pay out of pocket and cost $399-$549 for month's supply, depending on dose, though they do require patients to use a needle and syringe.The move is intended to increase access to the wildly popular medication, according to Lilly's executive vice president Patrik Jonsson."These new vials not only help us meet the high demand for our obesity medicine, but also broaden access for patients seeking a safe and effective treatment option," he said in the press release.<h2 id="31e963f5-8ff6-4b21-839a-d6de8e2b317f">How copycats took over the weight-loss drugs market</h2>By offering a cheaper alternative, Lilly is pushing back against a massive market of counterfeit weight loss drugs, many of which are illegal and potentially risky.Versions of tirzepatide and semaglutide are sold online without a prescription through a legal loophole, but can have a <a target="_blank" class="" href="https://www.businessinsider.com/scientist-cheaper-ozempic-sold-online-contains-dangerous-ingredients-2024-8">serious risk of contamination or overdose</a>, a researcher previously told Business Insider.Another class of copycat drugs, known as <a target="_blank" class="" href="https://www.businessinsider.com/buy-compounded-semaglutide-online-risks-wegovy-ozempic-2023-1">compounded medications</a>, does require a prescription and offers some quality control, but still isn't FDA approved or regulated, so doctors say it can be risky too.The latest move from Lilly is aimed to recapture consumers looking for cheaper options, and hit counterfeiters with a one-two punch alongside its efforts to crack down on knockoff providers via <a target="_blank" class="" href="https://investor.lilly.com/news-releases/news-release-details/lilly-warns-patients-about-counterfeit-and-compounded-medicines">lawsuits </a>announced earlier this year.

Eli Lilly just halved the price of its weight-loss drug — declaring war on the booming market of knock-offs

<ul class="summary-list"><li>Stephanie Noble, 37, felt as though her shopping was getting out of hand.</li><li>In June, she decided to start a 'no-spending' journey.</li></ul>This as-told-to essay is based on a conversation with Stephanie Noble. It has been edited for length and clarity.For over a year, I had been slowly realizing that I needed to change my <a target="_blank" href="https://www.businessinsider.com/gen-z-men-women-leisure-spending-habits-differ-report-shows-2024-9">spending habits</a>, but I wouldn't do anything about it.I constantly saw new makeup products influencers were trying out on platforms like <a target="_blank" href="https://www.businessinsider.com/gen-z-tiktok-user-quit-mental-health-productivity-us-ban-2024-4">TikTok</a> and heard the messaging that told me, "You need this. It will change your life."Influencer culture and chasing <a target="_blank" href="https://www.businessinsider.com/i-tried-dopamine-restricting-for-procrastination-motivation-productivity-strategy-2022-6">dopamine hits</a> contributed to my spending habits getting out of control. I don't think you have to be an addict to fall into unhealthy spending habits. But I'm personally in recovery for drug and alcohol use, and I think another factor influencing my shopaholic nature was just following into addiction easily. Since June, I've been on a no-spending journey that's not only saved me money but also given me time back.<h2 id="790b08a3-cd9b-4a7a-aa9c-20db007b3b44">I felt overwhelmed with how much stuff I had and knew I needed a change</h2>This June, I was <a target="_blank" href="https://www.businessinsider.com/how-to-declutter-workspace-expert-2024-9">cleaning out my office</a>, and it was overwhelming to see not only how much stuff I had but also how many brand-new products I had with tags still on them.Something clicked in me, and I knew I had to make a change. I had to allow my internal voice to be louder than any influencer taglines I was hearing and center the fact that my worth is not tied to how many makeup products I have or <a target="_blank" class="" href="https://www.businessinsider.com/things-millennials-spend-too-much-money-on-2024-9">how much money I can spend</a>, regardless of the narratives being sold to me.I haven't shopped since June 20. My no-spend journey includes makeup, skincare, hair care, clothes, shoes, purses, and jewelry. I don't repurchase any new products until I've used what I have. For example, there's a tinted sunscreen I really like, and I recently ran out. But I already had a tinted sunscreen in my collection I could give use, so I'm doing that instead of replacing the one I ran out of. Although I don't like the one I'm trying now as much, I'm still going to use it until it's gone. Then, when I run out of it and repurchase a new tinted <a target="_blank" href="https://www.businessinsider.com/why-sunscreen-is-not-enough-to-protect-you-from-sun-2023-9">sunscreen</a>, I'll choose the brand I know I love. That's my mental system, so to speak.Since June, I did buy a $7 body lotion on Amazon because mine was completely out — I was quite literally scraping the product out of the sides. Later I found a body lotion in my closet and was like, "Oh crap, I already had one," but beyond that accidental purchase, I haven't had any slip-ups, and I haven't run out of that many products.<h2 id="b14212e5-b21a-408f-bc81-3b02ec3dcad6">I've also stopped spending as much on food</h2>My no-spend journey with products has also made me pay more attention to my food spending habits. My husband and I are vegans, so it's not necessarily easy to eat out. We <a target="_blank" href="https://www.businessinsider.com/stopped-ordering-grocery-delivery-shop-with-kids-save-money-2024-6">order groceries online </a>every week and eat out maybe twice a month. Luckily my husband is a great chef, so he makes dinner for us every night.We've prioritized <a target="_blank" href="https://www.businessinsider.com/only-ate-home-cooked-food-for-a-month-what-happened-2019-8">eating at home</a> since the start of the pandemic, so our food routine isn't new. But I did take DoorDash off my phone. I realized ordering one sushi roll would cost around $35 with delivery and tip included, and I had to ask myself, "What am I doing?"<h2 id="7f72d96d-56f9-4e21-89bd-77e68c1893fa">It's not always easy, but I've learned to get my dopamine hits elsewhere</h2>But watching the recent fall decor and clothing haul content has been difficult. I had to look in my closet at my sweaters and pull out my fall decor. I realized that not only is my stuff still so cute, but the trends have not changed much from last year. It's the same pattern, colors, and vibe.I used to get a dopamine hit from shopping, but now I've been getting a dopamine hit from going on walks, listening to new songs, getting out with nature, sharing memes with my husband, and doing just about anything with my dogs. I don't just let those moments of joy pass me by. I intentionally sit with them, wire them into my brain, and make a list of those <a target="_blank" href="https://www.businessinsider.com/happiness-gratitude-journal-depression-2019-4">moments of gratitude</a>. Journaling has also been a helpful tool I've used for years when wanting to make a change.<h2 id="ec63ce4d-ffdb-4124-894a-f4a58a6bec62">Saving money has been great, but getting time back has been better</h2>After paying bills, with the way I used to shop, I normally wouldn't have much to put in savings. I'm starting to notice what I have left over since I've stopped shopping and moving it into a different account, and I've saved a little over $5,000 at this point. I plan to add the money to a <a target="_blank" href="https://www.businessinsider.com/use-several-high-yield-savings-accounts-reach-goals-2024-7">high-yield savings account</a>, but beyond that, I haven't decided what I want to do with the extra money. My husband's great with finances, and I want to talk more with him about it. But what I do know is that I want to spend the money on experiences.While saving money has been great, the biggest benefit of my no-spend journey has been getting time back. I've been <a target="_blank" href="https://www.businessinsider.com/revenge-bedtime-procrastination-going-to-bed-early-2021-9">going to bed earlier</a>, waking up earlier, journaling every morning, taking longer walks, and just being more present overall.Time can't be bought, and I'm being more intentional about how I spend mine.

I realized my spending was out of control and started a 'no-spend era.' Since June, I've saved over $5,000. 

<ul class="summary-list"><li>Sierra Leone declared a state of emergency over widespread drug abuse.</li><li>One drug causing particular concern in the West African nation is the synthetic drug "kush."</li></ul>Sierra Leone's capital, Freetown, is a<a target="_blank" href="https://www.wewillnomad.com/destination/sierra-leone"> bustling African port city</a> on the Atlantic Ocean, where even the dead can't rest, say its residents.Cemeteries are bolstering their security measures because gravediggers are stealing human bones to make powerful synthetic drugs, local journalists told Business Insider.Sierra Leone, in West Africa, declared a state of emergency in April over rising cases of synthetic drug abuse due to the spread of "kush," which contains ground human bones, locals say.Addressing the nation on April 4, Sierra Leone's president, Julius Maada Bio, said the country was facing "an existential threat" from "the ravaging impact of drugs and substance abuse, particularly the devastating synthetic drug kush."<div type="image" title="A vendor sells daily necessities at a market in Freetown, Sierra Leone, Feb. 21, 2024." height="3648" width="5472" msid="109861396" hostid="261"></div>As with the rise of synthetic drug use in other parts of the world, such as the <a target="_blank" href="https://www.businessinsider.com/how-brutal-sinaloa-cartel-flooded-us-fentanyl-los-chapitos-2023-5">fentanyl crisis in the US</a>, kush could be set to spread.International expansion is "almost inevitable," Michael Cole, a professor of forensic science at Anglia Ruskin University in the UK, told BI.While there are no official statistics on the number of users of the drug, they are not hard to spot, reports say.The streets of Freetown, the country's capital, are said to be awash with young men, often sitting or lying in the spot where they lost consciousness after smoking the drug, Sally Hayden reported for <a target="_blank" href="https://www.irishtimes.com/world/africa/2023/07/17/people-love-kush-more-than-food-west-africas-growing-drug-problem/">The Irish Times</a>.<h2>Why locals say kush is sometimes made with ground human bones</h2><div type="image" title="A man sleeps on a motorbike inside a drug den at the Kington landfill site in Freetown on June 21, 2023." height="2401" width="3600" msid="109861400" hostid="261"></div>Kush has been around for years in Sierra Leone, but its exact origin and composition remain unclear.Cole told BI that kush was a mixture of tobacco, cannabis, tramadol, and fentanyl — but he noted that some believe it can also contain formaldehyde, a preservative used in embalming fluid for corpses.Formaldehyde also has <a target="_blank" class="editor-rtfLink" href="https://pubmed.ncbi.nlm.nih.gov/18720671/">euphoric properties</a>, says the National Library of Medicine, which explains why kush users could be raiding Freetown's cemeteries.Mabinty Magdalene Kamar, the editor of a local news outlet, Politico SL, said that kush users had claimed to her that the drugs did indeed contain bones."We heard stories about boys breaking into cemeteries and tombs and then taking out the bones of dead bodies, grinding them just to produce kush," she told BI.The drug has a ravaging effect on users' physical health. Abdul Jalloh, a mental health expert and hospital care manager at the Sierra Leone Psychiatric Teaching Hospital, told BI he had observed kush users suffering from issues such as skin necrosis, ulcers, wounds, oral issues, kidney and liver problems, and eye infections.It can also be fatal, with <a target="_blank" class="editor-rtfLink" href="https://www.bbc.co.uk/news/world-africa-68742694">one doctor telling the BBC </a>that "in recent months," hundreds of men had died in Freetown after suffering organ failure caused by the drug.<h2>Police guard Freetown's cemeteries</h2><div type="image" title="Headstones line the Waterloo Ebola graveyard in Waterloo, Sierra Leone on December 14, 2017." height="3333" width="5000" msid="109861403" hostid="261"></div>Local media outlets have <a target="_blank" href="https://sierraloaded.sl/local/police-human-bones-kush/">reported cases of gravedigging</a> for bones to extract formaldehyde and make the drug.Thomas Dixon, the editor of the Salone Times newspaper in Freetown, told BI that while his publication had not been able to confirm the use of human bones in the drug, "you will see missing bones" if you go to cemeteries in the city.Fears over grave robbing for kush production have become so widespread in the city that some cemeteries have requested <a target="_blank" href="https://www.bbc.co.uk/news/world-africa-68742694">police protection,</a> the BBC reported.Business Insider contacted the Freetown Police Force for comment.<h2>"It makes you forget"</h2>Jalloh said most kush users were "between the ages of 20 to 34."Sierra Leonians face soaring unemployment rates, and much of its population lives in poverty — and some seem to be turning to kush in a bid to forget such problems.<div type="image" title="Two men relax on a car at the Kington landfill site in Freetown on June 21, 2023. In recent years Kush, a mix of various chemicals and plants that mimic the natural properties found in cannabis, according to the National Drug Agency, is increasingly being used by youth in Sierra Leone." height="2401" width="3600" msid="109861405" hostid="261"></div>Jalloh said that many of the patients he had dealt with cited unemployment, stress, and peer pressure among the reasons they had started using the drug."It makes you forget," Salifu Kamara, a 21-year-old kush user, told <a target="_blank" href="https://www.npr.org/sections/goatsandsoda/2024/02/10/1229662975/kush-synthetic-drug-sierra-leone">NPR</a>. "We're under such strain. There's no work. There's nothing here."Dixon said he believed it pointed to a "systemic failure" in the country, adding that kush turned young people into "zombies.""Young people don't believe in the authorities anymore. The people don't believe in the political system anymore - they are sliding into taking drugs," he said.<div type="image" title="People gather in a Kush drug den in Freetown on June 26, 2023." height="2401" width="3600" msid="109861407" hostid="261"></div>Jalloh noted that the use of synthetic drugs was not unique to Sierra Leone."It's a global crisis everywhere," he said.<h2>Synthetic cannabinoids</h2>Authorities have likened kush to synthetic cannabinoids, the <a target="_blank" href="https://www.theguardian.com/global-development/2023/sep/13/its-like-smoking-poison-sierra-leones-youth-battle-addiction-to-a-mystery-drug">Guardian</a> reports.Synthetic cannabinoids are chemically engineered substances that mimic the effects of cannabis but can be much more harmful and unpredictable.The <a target="_blank" href="https://www.cdc.gov/nceh/hsb/chemicals/sc/default.html">Centers for Disease Control and Prevention (CDC)</a> warns that toxic synthetic cannabinoids can cause rapid heart rate, vomiting, agitation, confusion, and hallucinations."Synthetic marijuana" can be up to 100 times as potent as traditional marijuana, inducing extreme physical effects like seizures, psychosis, and even death.<div type="image" title="Packets of synthetic marijuana illegally sold in New York City put on display at a news conference in New York." height="2001" width="2961" msid="109861409" hostid="261"></div>Recent years have seen a worldwide <a target="_blank" href="https://www.businessinsider.com/what-is-k2-or-spice">growth of synthetic drugs, </a>marketed as<a target="_blank" href="https://www.facebook.com/watch/?v=1790253157707430"> "spice,"</a> "K2," "black mamba," or "crazy clown."Drugmakers change the specific ingredients so fast — and produce the drugs in such massive quantities — that enforcement agencies can't keep up.In 2021, Kensington, a low-income neighborhood in North Philadelphia, became notorious for abuse of a sedative called "tranq."Also known as "xylazine," the animal sedative was often cut with other drugs. A side-effect of this drug can be struggling to stand upright, which is why users are commonly described in the media as "zombies."Last month, the Financial Times reported that <a target="_blank" href="https://www.ft.com/content/93e07d74-c379-41fb-87e2-06280031d167">tranq had reached the UK.</a>

The global synthetic drugs crisis has hit West Africa, where people are digging up human bones to make a drug called 'kush'

Elon Musk can be cagey about his <a target="_blank" href="https://www.businessinsider.com/elon-musk-drug-use-cringeworthy-spacex-meeting-wsj-2024-1">purported drug use</a>. After bombshell reports about internal concerns over the Tesla-SpaceX-Twitter-Neuralink executive using LSD, cocaine, ecstasy, and ketamine, Musk's line has typically been that <a target="_blank" href="https://www.businessinsider.com/elon-musk-tesla-ceo-denies-drug-use-allegations-2024-1">it's not happening</a>. More recently, he's shifted: OK, fine, it is happening, but it's just ketamine for depression, and actually <a target="_blank" href="https://www.businessinsider.com/elon-musk-don-lemon-small-amount-ketamine-every-other-week-2024-3">it's good for shareholders</a>. If his companies are doing well, Musk argued recently, and he's taking drugs while running those companies, then he should stick with the drugs, for capitalism's sake. One might pause at the logic, but Musk is hardly the only person making that calculation — plenty of people have come around to the idea that drugs are a decent work tool.Professionals are increasingly using substances like LSD, psilocybin, and ketamine as mechanisms to improve their performance. <a target="_blank" href="https://www.businessinsider.com/microdosing-psilocybin-mushrooms-for-creativity-startups-2024-3">Startup hustlers</a> and working women say they're turning to "magic" mushrooms to be more productive and creative, to take the edge off, or maybe just to get a bit of a hangover-free after-hours buzz. Some executives are attending <a target="_blank" href="https://www.businessinsider.com/photos-see-inside-luxury-psilocybin-magic-mushroom-retreat-2022-9">luxury psychedelic retreats</a>, where they spend a few days tripping in a forest, trying to expand and unlock their minds in ways that they hope will expand and unlock business opportunities, à la <a target="_blank" href="https://www.businessinsider.com/steve-jobs-lsd-daniel-kottke-cnn-2015-1">Steve Jobs</a>. The psychedelics market is a lucrative one and <a target="_blank" href="https://jamanetwork.com/journals/jamapsychiatry/article-abstract/2787968#:~:text=The%20market%20for%20psychedelic%20substances,the%20legal%20US%20cannabis%20market.&amp;text=In%20the%20Table%2C%20we%20summarize,offerings%20in%202020%20or%202021.">expected to reach $11 billion</a> by 2027.Drugs used to be viewed as dangerous, a hindrance to life success, or, you know, just something you did for fun. Now they're increasingly seen as a useful tool for work. Instead of trying to get high, people are using them to try to get ahead."It's not uncommon for the public view on things to flip-flop, going from negative to, 'Oh, wow, these things are great,' and viewing them as potentially good for everything," Greg Fonzo, a codirector of the Center for Psychedelic Research &amp; Therapy at the University of Texas at Austin's Dell Medical School, told me. "The truth lies somewhere in between, right? No drug is for everything, and most drugs are not purely negative."<a target="_blank" href="https://www.businessinsider.com/what-is-microdosing-2019-1">Microdosing</a> — which means taking, say, one-tenth of a normal dose of a drug — is a trend popular among moms on the playground and workers in the office. Anecdotally, people say it helps with creativity, focus, productivity, and just feeling better on the job. Scientifically, the story gets more complicated.The jury is still out on whether and how microdosing works, said Matthew Johnson, a senior researcher for the Center of Excellence for Psilocybin Research and Treatment at Sheppard Pratt. There hasn't been a ton of research, and while people say in surveys that microdosing helps improve cognitive function and reduce anxiety, some <a target="_blank" href="https://www.imperial.ac.uk/news/216134/citizen-scientists-show-placebo-effect-explain/">placebo-controlled</a> <a target="_blank" href="https://journals.sagepub.com/doi/full/10.1177/02698811211050556">trials</a> suggest that, in actuality, it may not do much."The science of microdosing is: So far, we don't really know what's going on, whether it's all placebo effect," Johnson said. In theory, microdosing is subperceptual. It's not like sipping a glass of wine to relax or having a cup of coffee to wake yourself up, both of which hit pretty immediately. The idea is instead to take tiny doses over time you don't notice, which hopefully benefit you in the long run.If people are indeed feeling something off what they ingest, it's possible they're not technically microdosing — they're just getting a little bit high on the job. A <a target="_blank" href="https://www.reddit.com/r/bartenders/comments/13wy1ke/should_i_microdose_before_work/">glance at Reddit</a> would indicate that unintentional at-work "oops" highs happen, which is because measuring these drugs precisely is hard."You could get a mushroom that has a little bit more or a little bit less psilocybin, and then you would end up having a perceptual experience, which, depending on the activity of the day, might be more than you bargained for," said Katrina Michelle, a clinical therapist in New York and the former director of harm reduction for the Multidisciplinary Association for Psychedelic Studies.Of course, not everyone is looking for a micro experience to improve work performance. Some people are experimenting with psychedelics on the macrodose level. Some corporate elites are seeking out psychedelic retreats to improve their leadership skills, shift their perceptions, and, in some cases, even bond with their teams.Rob Grover and Gary Logan, the founders of the Journeymen Collective, which offers luxury guided magic-mushroom retreats in Vancouver, British Columbia, told me their company worked with a multitude of executives, entrepreneurs, and visionaries to help them elevate their businesses to "conscious businesses," which they recognize sounds fluffy."When leaders become conscious leaders so that they're aware of what's going on around them, they have greater precision of thought, greater clarity, greater creativity that they can lead in a different way and they can lead in a more effective and efficient way," Grover said. "So that's where we come in and help people with a massive reset of their consciousness so that they can impact their company, their boards, their vision of what they're here to do in a deeply impactful way."They work with people for a minimum of four months — one month of preparation leading up to two days of "ceremonies," followed by three months of "integration" post-retreat. Their experiences, which start at $15,000 a person for a group session, have seen a huge boom over the past couple of years: Bookings increased 183% from 2022 to 2023.The deal sounds pretty great: Go to the mountains, have your experience, and kill it at work. But that's not a guaranteed outcome. Someone might trip and discover that they love their job again, but they could also decide they actually hate the corporate world and are over it."These medicines are not something we can necessarily have superconsistent expectations about," Michelle said. "It's really hard to ever say with any psychedelic medicine that this is going to have this one effect when it comes to your psycho-emotional health."Some executives appear to have such strong convictions about the power of psychedelic retreats that they're <a target="_blank" href="https://fortune.com/well/article/psychedelic-leadership-retreat-magic-mushrooms-mdma-ayahuasca/">bringing their colleagues and business partners along</a>, hoping that it will bring them all closer together and push them forward. The issue of team retreats and drug use is a complicated one. Psychedelic experiences can be deeply intense and personal, not something everyone wants in a work environment. There are also questions of pressure and power dynamics in play. People around Musk, including some of his board directors, <a target="_blank" href="https://www.businessinsider.com/elon-musk-company-directors-drug-use-report-wsj-2024-2#:~:text=Elon%20Musk%20is%20said%20to,participate%20in%20or%20enable%20his">reportedly felt pressured</a> to take drugs with him to avoid upsetting him. My boss is lovely, but I don't really want to vomit in front of him at an ayahuasca retreat as I share my deepest, darkest secrets, nor do I want to feel like I have to in order to keep my job. Justin Townsend, the CEO and head facilitator of MycoMeditations, which offers psilocybin-assisted retreats in Jamaica, told me that many of his clients say his services, which can run from $6,500 to $23,000, help them to be better leaders and perform better professionally. He's working on launching retreats for business leaders, but it's a prospect that entails some special considerations. If a company calls and says it wants to send five executives down, it might get awkward and difficult if not handled correctly."We're all aware of corporate etiquette, and no matter how close and tight that team is, if you come to a psychedelic retreat, there's nowhere to hide," he said.I asked him for advice on what to do if such a situation landed at someone's feet. He said to look into the safety, efficacy, and legal status of the proposal, think about what your boss wants to achieve and whether there are alternative solutions, and consider your personal boundaries. If it's not for you, he said, "just say no."Some of these dynamics aren't novel. Social pressures at work have always existed — just look at <a target="_blank" href="https://www.businessinsider.com/pressure-socializing-with-coworkers-debate-viral-2023-9">happy hour</a>. So has the idea of performance enhancement, whether via coffee (legal), Adderall (legal, depending on how you get it), or cocaine (illegal). The type of psychedelic substances in vogue in the workplace also have a socioeconomic slant to them. <a target="_blank" href="https://www.businessinsider.com/legal-marijuana-states-2018-1">Marijuana has been decriminalized</a> in many more parts of the country than <a target="_blank" href="https://www.businessinsider.com/oregon-legal-magic-mushroom-psilocybin-cubensis-need-to-know-2022-4">psilocybin</a>, but you're still likelier to lose your employment over smoking a joint on the job than you are if you eat a square of a magic-mushroom chocolate bar. You can still be fired over psychedelics, though — in 2021, <a target="_blank" href="https://www.businessinsider.com/iterable-ceo-fired-justin-zhu-lsd-report-2021-4">a startup CEO was axed</a> after saying he'd microdosed LSD at work. Regardless, all three are still federally illegal. With hidden <a target="_blank" href="https://www.businessinsider.com/how-to-recognize-the-signs-of-fentanyl-overdose-could-kill-2022-12">fentanyl</a> sometimes in the mix, many drugs may be extra dangerous. There are also questions about the effects that long-term psychedelic use has on the heart."My main concern is that people understand the risk, any risk — bad-trip risk, psychiatric risk, or legal risk," Johnson said.Whatever the risks and benefits, given our optimization-obsessed corporate world, some elements of drugs as a work-enhancement tool appear to be here to stay. Not to mention that there's money to be made in the psychedelics industry, and plenty of boring or annoying jobs could stand to be made more tolerable by whatever means possible.A lot of executives and workers have a little bit of Elon Musk in them. Figuring a little microdose here, a little trip there, might not hurt performancewise. Townsend, who runs the Jamaica retreats, told me that if anything, he thought Musk might want to pay him a visit, given how much he seems to be working and his use of ketamine for depression."I'd say give me Elon for a week," he said, "and I'll give you a different man."<a target="_blank" href="https://www.businessinsider.com/author/emily-stewart">Emily Stewart</a> is a senior correspondent at Business Insider, writing about business and the economy.

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