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These two alleged patients — both of whom exchanged messages with Hunterbrook Media — appear to be part of what Dr. The company is doing so through an FDA loophole that enables facilities called compounding pharmacies to sell their own versions of patented drugs during shortages. The GLP-1 drugs that Hims sells are produced by a Belcher-owned subsidiary — and Hims does not appear to be prescribing through a particularly rigorous process, according to conversations with multiple patients. A Hunterbrook Media reporter qualified as eligible for GLP-1 drugs with Hims after completing a four-minute survey and received a prescription under an hour after submitting it, without speaking to a doctor or submitting medical records. An FDA legal expert told Hunterbrook Media that Hims may have opened itself up to liability with its compounding business — risking litigation from Big Pharma and regulatory intervention from the federal government. The company is also risking the health of its patients, according to multiple obesity doctors who spoke with Hunterbrook. Fitch shared a similar sentiment. These injectable medications, which help patients shed body weight by suppressing appetite, have been labeled a medical miracle — and created a market potentially worth hundreds of billions of dollars. But the marketplace for these medications has gone haywire. As the supply shortfall has driven explosive growth in the black market for GLP-1 drugs, the FDA has temporarily allowed production of what are known as compounded versions of the drugs. These versions, unlike generics, are not FDA-approved. The loophole is Section B of the Federal Food, Drug, and Cosmetic Act, which enables compounding facilities to produce knockoff versions of drugs that are in shortage. This was the opening Hims needed. Logan, a year-old teacher from Iowa, told Hunterbrook Media he had been denied access to GLP-1 drugs by insurance four times — even though he had been prescribed Wegovy by a doctor. That is how he ended up purchasing the compounded version through Hims. In , two Belcher executives were convicted in a massive medical fraud scheme that ranged from paying kickbacks to physicians to repackaging over-the-counter medicines and vitamins as prescription-only drugs to boost pricing. The stock shot up, likely because the public assumed this new product was a drug. But it turned out the product was not a drug at all, but rather only FDA-approved as a medical device. GeoPharma went bankrupt in Shareholders then sued alleging that, prior to the bankruptcy, the Tanejas had sold Belcher at a suspiciously low valuation to a shell company owned and controlled by the Tanejas themselves. The company was subsequently sued by the U. Department of Labor for allegedly mismanaging retirement funds, which resulted in consent orders against two former GeoPharma executives, the CFO and Controller and Director of Human Resources. Belcher has since been accused of engaging in widespread fraud by former Chief Science Officer Darren Rubin, in a whistleblower suit filed in Taneja denied these claims but the parties appear to be headed towards a settlement. One stands out. Compounding pharmacies have for decades provided additional supply in shortage and customized dosages that are not available from other manufacturers. But injectables from some compounding pharmacies have proven deadly. In , the New England Compounding Center failed to maintain a sterile manufacturing facility. Fungal meningitis infected hundreds of people and killed at least Right to Your Inbox. No Paywalls. No Ads. On Reddit, for example, customers have reported that they did not have to consult with a doctor before being shipped the drug. A Hunterbrook Media reporter was able to order the drug from Hims in a matter of minutes after filling out a survey — without speaking to a doctor, sharing any of her medical records, or conducting blood testing. The first step was a survey that took four minutes to complete. The survey asked about weight, mental health history, and weight loss goals. There was an option to upload blood work but it was not required. The end of the survey suggested a treatment plan and offered a choice between 3-, 6-, and month supplies. About 20 minutes after the survey was submitted, Hims offered a prescription via text, and compounded semaglutide was on the way. In April, the agency warned that some compounded semaglutide products contain salts and impurities, unlike the approved formulations, and may be less safe and effective. Aggarwal told Hunterbrook Media that these drugs can be transformational — and he understands the imperative of finding more affordable ways for them to reach patients. Hims has entered the market at a time when companies selling knockoff GLP-1 drugs are facing mounting litigation from Big Pharma. While ramping up GLP-1 supplies to resolve the shortage, Lilly and Novo are aggressively suing sellers of compounded versions of their drugs. The formulation, Dr. In February, Novo announced settlements with two of the Florida defendants, which agreed to disclose that their compounded drugs have not been vetted by the FDA for safety and effectiveness. So far, neither Novo nor Lilly appear to have sued Hims. Belcher denied these claims. And Hims appears to be toeing the line. Unlike the clinics and medical spas targeted by Novo, Hims does reveal that the drugs it sells are not FDA approved — but in one ad seen by a Hunterbrook Media reporter, it does so only in barely visible font that blends into the background of its ads. Try to read the disclosure below. And while Hims does not claim to be selling Ozempic, as some of the spas Novo sued allegedly did, the company does use the name Ozempic in its advertising. In an interview with Hunterbrook Media, Upadhye said that even with a green light from the FDA to sell compounded drugs, Hims could still face future patent litigation. Is that worth it for Lilly and Novo to take their patents and sue in court? Maybe not. But what happens if a few dozen injections become a few hundreds and a few hundreds become a few thousands? If Novo sues, Hims could face a preliminary injunction and be forced to stop selling the compounded drugs immediately, Upadhye explained. And if a court declined a pretrial injunction — but later ruled in favor of Novo on the merits of the case — Hims could be mandated to pay damages on every injection of GLP-1 drugs it sold. Much will also depend on what patents are asserted against a B company. Compounders also have exposure to personal injury litigation. They would sue the compounder. Compounding pharmacies face another existential threat: Once shortages ease, the FDA will close the loophole that allows compounding. Within 60 days of an announcement that a shortage is over, compounders would no longer have a right to sell the drugs, said Upadhye. Some experts who spoke with Hunterbrook, including Dr. Fitch and Dr. Aggarwal, said that they believe the shortage could last significantly longer. Even with the loophole still open, and safety issues aside, the stock gains of jumping on the GLP-1 bandwagon have proved ephemeral. While the stocks of producers of GLP-1 drugs, including Lilly and Novo, have soared, downstream players in the weight-loss space have quickly lost gains. The problem is that the market has commoditized nearly as rapidly as it has grown. And rather than holding the stock for a year, which could have potentially unlocked a lower long-term capital gains tax rate, they sold right away. In combination, these three executives sold The transactions were made pursuant to 10 b plans and disclosed in SEC filings. We note that the CCO also registered Sam is based in New York. Michelle Cera is a sociologist specializing in digital ethnography and pedagogy. She is a Ph. Matthew Termine is a lawyer with nearly five years of experience leading the legal team at a mortgage technology company. In , Matt was credited by the Wall Street Journal, among others, for identifying suspicious mortgage loan transactions that led to several successful criminal prosecutions, including that of a prominent political operative and the chief executive officer of a federally chartered bank. He grew up in Old Saybrook, Connecticut and now lives in Brooklyn with his wife and two sons. Jim Impoco , who edited this article, is the award-winning former editor-in-chief of Newsweek who returned the publication to print in Nick Gibbons , a Hunterbrook Media advisor, also contributed reporting. His experience includes a blend of qualitative and quantitative investment roles at Two Sigma, Norges Bank Investment Management, and Citadel. He began his career in forensic accounting at independent equities research provider Gradient Analytics. Hunterbrook Media publishes investigative and global reporting — with no ads or paywalls. Subscribe here. Learn more here. Please contact ideas hntrbrk. When using this website, you acknowledge and accept that such usage is solely at your own discretion and risk. Hunterbrook Media LLC, along with any associated entities, shall not be held responsible for any direct or indirect damages resulting from the use of information provided in any Hunterbrook publications. It is crucial for you to conduct your own research and seek advice from qualified financial, legal, and tax professionals before making any investment decisions based on information obtained from Hunterbrook Media LLC. The content provided by Hunterbrook Media LLC does not constitute an offer to sell, nor a solicitation of an offer to purchase any securities. Furthermore, no securities shall be offered or sold in any jurisdiction where such activities would be contrary to the local securities laws. We strive to ensure the accuracy and reliability of the information provided, drawing on sources believed to be trustworthy. Nevertheless, this information is provided 'as is' without any guarantee of accuracy, timeliness, completeness, or usefulness for any particular purpose. Hunterbrook Media LLC does not guarantee the results obtained from the use of this information. All information presented are opinions based on our analyses and are subject to change without notice, and there is no commitment from Hunterbrook Media LLC to revise or update any information or opinions contained in any report or publication contained on this website. The above content, including all information and opinions presented, is intended solely for educational and information purposes only. Hunterbrook Media LLC authorizes the redistribution of these materials, in whole or in part, provided that such redistribution is for non-commercial, informational purposes only. Redistribution must include this notice and must not alter the materials. Any commercial use, alteration, or other forms of misuse of these materials are strictly prohibited without the express written approval of Hunterbrook Media LLC. Unauthorized use, alteration, or misuse of these materials may result in legal action to enforce our rights, including but not limited to seeking injunctive relief, damages, and any other remedies available under the law. A graphic produced by Hunterbrook Media summarizing what we believe to be the state of affairs for Hims Background: Hims enters the knockoff GLP-1 market Hims launched in selling generic versions of Viagra and hair loss treatments online.
Bottled: How Coca-Cola Became African
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Travel to virtually any African country and you are likely to find a Coca-Cola, often a cold one at that. Bottled asks how this carbonated drink became ubiquitous across the continent, and what this reveals about the realities of globalisation, development and capitalism. A beverage in Atlanta and a beverage in Johannesburg pull us all towards the same end narrative. This story matters for more than just the local reasons, enhancing our understanding of our globalised, integrated world. Access to content on Oxford Academic is often provided through institutional subscriptions and purchases. If you are a member of an institution with an active account, you may be able to access content in one of the following ways:. Typically, access is provided across an institutional network to a range of IP addresses. This authentication occurs automatically, and it is not possible to sign out of an IP authenticated account. Choose this option to get remote access when outside your institution. 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