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Tag: pharmaceutical industry

  • Novo Nordisk wants to keep its crown leading the weight loss drugs pack—despite outlook downgrades and lawsuits, its CFO has a plan | Fortune

    When Ozempic and Wegovy launched, their bombshell success was only going to be exclusive to their maker—Novo Nordisk—for a matter of time. While the Danish pharma giant holds the patents to these GLP-1s for the time being, some are due to expire as early as next year.

    The success of these drugs, used to treat diabetes and obesity, has naturally caught the attention of Novo’s competitors. America’s Eli Lilly, for example, is seeing growing demand for its Mounjaro product and is keen for a pill form of the medication to be pushed speedily through the U.S. approvals process.

    Novo Nordisk has a pill form of its own products to come, but the fact remains that until it can conjure its next rabbit from the hat, the outlook is weakening. In its Q3 2025 results released November 5, Novo reported expected sales growth for the year of between 8 and 11% at constant exchange rates, and operating growth profit now between 4% and 7%. Compared to the same time last year, Novo was predicting 22% operating profit growth and sales growth of 24%.

    Novo Nordisk shares dropped on the update before quickly rebounding, but its stock remains on a downward trajectory. Its share price has fallen more than 50% year to date.

    After a company-wide restructuring costing some DKK 9 billion ($1.38 billion), Novo’s path to success lies in its ability to create the next healthcare-altering drug. This, says Novo CFO Karsten Munk Knudsen, will be the “silver bullet” to defending key markets from competitors.

    “The ultimate defence in our industry is in innovation,” Knudsen told Fortune in an exclusive interview. “So clearly we do everything we can to push innovation forward: That could be the Wegovy pill that we hope to launch next year in the U.S., that could be our third-generation product CagriSema that we hope to submit in the coming months, and then push and increasing forward also amycretin. So innovation is really the silver bullet here.”

    CagriSema is an obesity medication to be taken once weekly, and amycretin is a daily oral medication used to fight diabetes.

    For the patents on some of Novo Nordisk’s hero products in certain regions to be running out is an inevitable headache—companies can only hold them for so long before competitors are able to launch their own products. To win a patent is the prize for pushing the needle, Knudsen said, and after a period of breathing room companies must go to battle for consumers: “This is how it is for our industry. The way we deal with it vis-a-vis our shareholders, first and foremost, is that we’ve been very transparent with the impact from countries where our patent … lapses into next year.”

    The company sees a low single-digit negative impact because of the expirations next year, Knudsen added: “In those specific markets then we adapt our strategies and we do not intend to leave these markets whatsoever, and intend to defend our market position.”

    The real snag will come in the next decade: The U.S. represents 50% of group sales for Novo, and while there is a “good runway” until the early 2030s, that’s when patents in America run out and the true battle begins.

    Legal issues

    Another side-effect of the phrama industry is legal issues, and Novo has plenty on its plate. These include an anticompetition lawsuit from a major competitor, claims about Novo-manufactured drugs leading to significant medical side-effects, and the pharma giant itself launching suits over copies of its product.

    Most recently, New York-based Pfizer launched a case against Novo Nordisk over the Danish brand’s bid to buy obesity start-up Metsera. Both Metsera and Novo have fired back, with the latter saying in a statement: “We are confident this transaction does not raise any antitrust issues.”

    Knudsen also said he doesn’t see consumers moving away from Novo products following cases alleging serious side effects from taking the medication. “This class of products has been around, just in our portfolio, for more than 15 years, and we are reaching millions of patients with our products,” he said. “Clearly that would not be the case if there are any material concerns around safety around our products.”

    Nonetheless, the suits could prove costly and lengthy—potentially having a material impact on the company’s bottom line.

    “First and foremost, I do believe that we have a highly capable global legal function and the best way to deal with legal situations is to prevent them from occurring in the first place,” Knudsen said. “The best defence is prevention and from there it’s really about the legal capabilities both with our in-house function and with our external legal advisors that we use.”

    Financially, he added, risks are evaluated on a rolling basis: “We have a reasonable risk profile on that front. It’s something that … we assess on an ongoing basis … and then what insurance coverage do we have, how strong is our legal position, and I think we’re in a reasonable position.”

    Eleanor Pringle

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  • FDA’s top drug regulator resigns after federal officials probe ‘serious concerns’

    The head of the Food and Drug Administration’s drug center abruptly resigned Sunday after federal officials began reviewing “serious concerns about his personal conduct,” according to a government spokesperson.Dr. George Tidmarsh, who was named to the FDA post in July, was placed on leave Friday after officials in the Department of Health and Human Services’ Office of General Counsel were notified of the issues, HHS press secretary Emily Hilliard said in an email. Tidmarsh then resigned Sunday morning.“Secretary Kennedy expects the highest ethical standards from all individuals serving under his leadership and remains committed to full transparency,” Hilliard said.The departure came the same day that a drugmaker connected to one of Tidmarsh’s former business associates filed a lawsuit alleging that he made “false and defamatory statements,” during his time at the FDA.The lawsuit, brought by Aurinia Pharmaceuticals, alleges that Tidmarsh used his FDA position to pursue a “longstanding personal vendetta” against the chair of the company’s board of directors, Kevin Tang.Tang previously served as a board member of several drugmakers where Tidmarsh was an executive, including La Jolla Pharmaceutical, and was involved in his ouster from those leadership positions, according to the lawsuit.Messages placed to Tidmarsh and his lawyer were not immediately returned late Sunday.Tidmarsh founded and led a series of pharmaceutical companies over several decades working in California’s pharmaceutical and biotech industries. Before joining the FDA, he also served as an adjunct professor at Stanford University. He was recruited to join the agency over the summer after meeting with FDA Commissioner Marty Makary.Tidmarsh’s ouster is the latest in a string of haphazard leadership changes at the agency, which has been rocked for months by firings, departures and controversial decisions on vaccines, fluoride and other products.Dr. Vinay Prasad, who oversees FDA’s vaccine and biologics center, resigned in July after coming under fire from conservative activists close to President Donald Trump, only to rejoin the agency two weeks later at the behest of Health Secretary Robert F. Kennedy Jr.The FDA’s drug center, which Tidmarsh oversaw, has lost more than 1,000 staffers over the past year to layoffs or resignations, according to agency figures. The center is the largest division of the FDA and is responsible for the review, safety and quality control of prescription and over-the-counter medicines.In September, Tidmarsh drew public attention for a highly unusual post on LinkedIn stating that one of Aurinia Pharmaceutical’s products, a kidney drug, had “not been shown to provide a direct clinical benefit for patients.” It’s very unusual for an FDA regulator to single out individual companies and products in public comments online.According to the company’s lawsuit, Aurinia’s stock dropped 20% shortly after the post, wiping out more than $350 million in shareholder value.Tidmarsh later deleted the LinkedIn post and said he had posted it in his personal capacity, not as an FDA official.Aurinia’s lawsuit also alleges, among other things, that Tidmarsh used his post at FDA to target a type of thyroid drug made by another company, American Laboratories, where Tang also serves as board chair.The lawsuit, filed in U.S. District Court of Maryland, seeks compensatory and punitive damages and “to set the record straight,” according to the company.

    The head of the Food and Drug Administration’s drug center abruptly resigned Sunday after federal officials began reviewing “serious concerns about his personal conduct,” according to a government spokesperson.

    Dr. George Tidmarsh, who was named to the FDA post in July, was placed on leave Friday after officials in the Department of Health and Human Services’ Office of General Counsel were notified of the issues, HHS press secretary Emily Hilliard said in an email. Tidmarsh then resigned Sunday morning.

    “Secretary Kennedy expects the highest ethical standards from all individuals serving under his leadership and remains committed to full transparency,” Hilliard said.

    The departure came the same day that a drugmaker connected to one of Tidmarsh’s former business associates filed a lawsuit alleging that he made “false and defamatory statements,” during his time at the FDA.

    The lawsuit, brought by Aurinia Pharmaceuticals, alleges that Tidmarsh used his FDA position to pursue a “longstanding personal vendetta” against the chair of the company’s board of directors, Kevin Tang.

    Tang previously served as a board member of several drugmakers where Tidmarsh was an executive, including La Jolla Pharmaceutical, and was involved in his ouster from those leadership positions, according to the lawsuit.

    Messages placed to Tidmarsh and his lawyer were not immediately returned late Sunday.

    Tidmarsh founded and led a series of pharmaceutical companies over several decades working in California’s pharmaceutical and biotech industries. Before joining the FDA, he also served as an adjunct professor at Stanford University. He was recruited to join the agency over the summer after meeting with FDA Commissioner Marty Makary.

    Tidmarsh’s ouster is the latest in a string of haphazard leadership changes at the agency, which has been rocked for months by firings, departures and controversial decisions on vaccines, fluoride and other products.

    Dr. Vinay Prasad, who oversees FDA’s vaccine and biologics center, resigned in July after coming under fire from conservative activists close to President Donald Trump, only to rejoin the agency two weeks later at the behest of Health Secretary Robert F. Kennedy Jr.

    The FDA’s drug center, which Tidmarsh oversaw, has lost more than 1,000 staffers over the past year to layoffs or resignations, according to agency figures. The center is the largest division of the FDA and is responsible for the review, safety and quality control of prescription and over-the-counter medicines.

    In September, Tidmarsh drew public attention for a highly unusual post on LinkedIn stating that one of Aurinia Pharmaceutical’s products, a kidney drug, had “not been shown to provide a direct clinical benefit for patients.” It’s very unusual for an FDA regulator to single out individual companies and products in public comments online.

    According to the company’s lawsuit, Aurinia’s stock dropped 20% shortly after the post, wiping out more than $350 million in shareholder value.

    Tidmarsh later deleted the LinkedIn post and said he had posted it in his personal capacity, not as an FDA official.

    Aurinia’s lawsuit also alleges, among other things, that Tidmarsh used his post at FDA to target a type of thyroid drug made by another company, American Laboratories, where Tang also serves as board chair.

    The lawsuit, filed in U.S. District Court of Maryland, seeks compensatory and punitive damages and “to set the record straight,” according to the company.

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  • Donald Trump’s Big Pharma Showdown Ends with a Whimper

    It’s hard to find things that Donald Trump and Bernie Sanders agree on, but one point of consensus is that pharmaceutical companies have long been ripping off Americans by charging extortionate prices for prescription medications. “Americans are being screwed, and it’s no good. They’re not going to put up with it,” Trump said in February, at a White House event. In May, he issued an executive order declaring that the Administration would impose lower prices by fiat if drugmakers didn’t align their U.S. prices with what they charge in other countries. “I agree with President Trump,” Sanders commented in a statement. “It is an outrage that the American people pay, by far, the highest prices in the world for prescription drugs.”

    In addition to threatening to introduce price controls, the Trump Administration was preparing the way for tariffs on drugs and their ingredients, many of which come from abroad. Wall Street paid attention to these threats. Between Trump’s election last November and the beginning of April, a period in which the stock market as a whole rose sharply, drug stocks fell by about twenty per cent. That was then. Last week, the President, standing alongside the C.E.O. of Pfizer, Albert Bourla, announced plans for a government-run website, TrumpRx, on which Pfizer would list some of its drugs at prices discounted up to eighty-five per cent. A White House fact sheet said the Administration and Pfizer, the world’s fourth-largest pharmaceutical company by revenue, had reached an agreement to “bring American drug prices in line with the lowest paid by other developed nations (known as the most-favored-nation, or MFN, price).” Wasn’t this more bad news for drugmakers? Investors didn’t think so. In two days, Pfizer’s shares jumped up by fourteen per cent. The stocks of other pharmaceutical companies also rose strongly based on predictions that they would strike similar deals. By the end of the week, the S. & P. Pharmaceuticals Select Industry Index had surpassed its November high.

    A closer inspection of the Pfizer agreement shows that Trump has turned out to be a paper tiger. “It’s a lot of nothing,” Craig Garthwaite, the director of the health-care program at Northwestern’s Kellogg School of Management, told me. “For most people, it will have very little effect on drug prices.” Rena Conti, an economist and expert on the biopharmaceutical industry who works at Boston University’s Questrom School of Business, issued a similar assessment: “Top line is: it’s a win for Pfizer, but not a win for American patients.” Rather than radically restructuring drug pricing and distribution, the agreement amounted to “fiddling around the edges,” she said.

    In the American drug industry, practically anything that preserves the status quo is a victory for Big Pharma firms, which, according to a study by the Journal of the American Medical Association, boast a net profit margin of 13.8 per cent compared to 7.7 per cent for S. & P. 500 companies in other sectors. Years ago, I asked a senior executive at a prominent drugmaker why it employed so many lobbyists in Washington. After looking at me as if I were a naïf, he explained that the industry generated most of its revenues and the vast majority of its profits in the U.S. In other countries, such as Britain and France, companies were forced to negotiate the prices they charged with government-run or single-payer health-care systems that have a lot of bargaining leverage. But in this country—where health care is balkanized and the largest public drug-buyer in the U.S., Medicare, was legally prevented from negotiating with drugmakers—the industry was able to charge much higher prices. It was well worth paying an army of lobbyists to try to preserve this privileged position.

    Between 1998 and the middle of this year, according to data from OpenSecrets, a public-interest group that tracks money in politics, Big Pharma spent more than $6.3 billion on lobbying. During that period, the most significant reform related to drug pricing came in the Inflation Reduction Act of 2022, which empowered Medicare to haggle prices with drug companies. In principle, this was a landmark development, but the negotiated prices won’t go into effect until next year and will initially apply to just ten prescription drugs, out of thousands. (In subsequent years, the number is scheduled to grow.) If Trump was really determined to stand up to Big Pharma, he would be pressing for a rapid expansion of this initiative, but he isn’t doing that. And, even if he did, he would have to corral Republicans in Congress to support the new legislation required, which certainly wouldn’t be easy: the I.R.A. was passed without a single G.O.P. vote.

    In place of real reform, we now have the Pfizer agreement, and its headline proposal to launch TrumpRx. In a press release about the deal, Pfizer said it would offer many of its primary-care medications at prices averaging half their list prices. This sounded promising, but industry analysts quickly pointed out that about ninety per cent of Americans get their prescribed medications through insurance plans. For these people, it would still likely be cheaper to get the drugs the traditional way and pay the co-payment. Garthwaite said buying drugs through TrumpRx could conceivably benefit “a small subset of people,” principally among the population that doesn’t have any insurance coverage. But many medications would still be prohibitively expensive. Conti calculated that, even with Pfizer’s announced forty-per-cent discount for Xeljanz, a popular treatment for arthritis and other inflammatory diseases, it could still cost patients more than fifteen thousand dollars a year.

    John Cassidy

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  • All bark, no bite: Trump’s latest trade war turns into another TACO salad for Wall Street | Fortune

    When President Donald Trump made his “Liberation Day” speech on April 2, announcing sweeping tariffs across a range of sectors, markets reacted sharply. Investors feared a replay of the disruptive trade battles of his first term, and stocks dropped as they tried to assess how new levies might ripple through global supply chains.

    But six months on, the story looks different. Much of the initial panic has faded, replaced by recognition that the real economic impact of Trump’s tariffs has been softened by carve-outs, negotiated deals, and exemptions. In fact, stocks snapped out of a multi-day losing streak on Friday, reacting almost with disregard to the latest surprise from Trump’s social media account.

    Now, as Trump tries to reignite the trade war with an overnight announcement of a slew of tariffs, including a 100% tariff on branded and patented pharmaceuticals and a 50% tariffs on furniture imports, markets are barely reacting. 

    Michael Browne, global investment strategist at Franklin Templeton, said that the markets regard tariffs as “over.”

    “The real level of tariffs is much lower, which is one of the reasons the impact has been muted,” Browne told The Financial Times.

    The other reason could be that consumers have proven far more resilient to higher prices than economists once expected.

    Pharma scare eases quickly

    At first, the news rattled European and Asian drugmakers. Zealand Pharma dropped nearly 3%, Novo Nordisk lost 1.6%, and India’s Sun Pharmaceutical and Divi’s Laboratories fell more than 3% in early trading. The Stoxx 600 Healthcare index swung between gains and losses before closing flat.

    Yet European equities as a whole closed higher, underscoring how investors now discount Trump’s tariff announcements. 

    The pan-European Stoxx 600 finished the day up 0.8%, with the CAC 40 in Paris up 0.97%, the DAX in Frankfurt up 0.87%, and Madrid’s IBEX 35 leading gains with a 1.3% rise.

    JPMorgan strategists quickly told clients the pharma tariff was “largely avoidable” for companies that expand U.S. manufacturing. 

    “We continue to see a very manageable overall impact from tariffs to our large-cap coverage,” the note said, according to CNBC.

    The resilience reflects the numerous carveouts from the pharma tariffs. Generics — which account for nine out of ten U.S. prescriptions — are excluded from the new levies. A U.S.–EU trade agreement limits duties on most European drug exports to 15%. And companies actively investing in U.S. manufacturing, such as Eli Lilly, AstraZeneca, Roche, GSK, and Amgen, are exempt as soon as they break ground on new facilities.

    Analysts were quick to highlight those caveats.

    “Many large-cap biopharmaceutical companies should not be exposed because they are engaged in some sort of U.S. facility construction activity,” Leerink Partners’ David Risinger told BioPharma Dive.

    The White House pushed back on the “carve-out” framing, saying these are Section 232 national-security tariffs aimed at reshoring critical manufacturing.

    The exemptions for companies “building” U.S. plants are temporary, intended to give firms runway to relocate production without immediately hiking prices, spokesperson Kush Desai told Fortune. He added that the 15% caps on many European (and Japanese) pharma exports reflect broader trade agreements that included “significant concessions that favor the U.S.,” not a softening of the tariff stance.

    Resilient consumers 

    For investors, the reaction was familiar. Initial volatility gave way to a recognition that tariffs rarely land as broadly as advertised. 

    Imports account for only around 10% of the U.S. economy, giving businesses and consumers room to adjust. Many companies stocked up on goods ahead of deadlines, while others shifted to alternative suppliers.

    “It may be that inflation comes through, but there is no sign of that yet,” Browne told Financial Times.

    The muted market response also reflects a larger truth: consumers have been much more resilient than most economists expected. Commerce Department data released Thursday showed the U.S. economy grew at a 3.8% annual pace last quarter, its strongest stretch since 2023, powered by robust household spending and business investment.

    Economists note that Americans’ willingness to keep shopping, even amid high borrowing costs, has repeatedly surprised forecasters.

    As Boston wealth manager Gina Bolvin put it, the real lesson may be that “don’t fight the Fed” has become “don’t fight the U.S. consumer.”

    TACO

    Markets’ calm also reflects a trade they’ve come to rely on — what analysts call the TACO trade (Trump Always Chickens Out). After April’s “Liberation Day” shock, investors assumed Trump would follow his familiar pattern: issue sweeping tariff threats, then pull back once markets started to wobble. That confidence helped stocks rebound to record highs.

    Exemptions have reinforced that bet. The effective average tariff rate has stayed well below headline figures, thanks to carve-outs fand exemptions for companies breaking ground on U.S. plants.

    Economists caution that tariffs often take months to ripple through supply chains, so some price pressure could still emerge later this year. But so far, inflation data has remained stable, undercutting predictions that trade policy would deliver a consumer shock.

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    Eva Roytburg

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  • Trump plans a hefty tax on imported drugs, risking higher prices and shortages

    WASHINGTON (AP) — President Donald Trump has plastered tariffs on products from almost every country on earth. He’s targeted specific imports including autos, steel and aluminum.

    But he isn’t done yet.

    Trump has promised to impose hefty import taxes on pharmaceuticals, a category of products he’s largely spared in his trade war. For decades, in fact, imported medicine has mostly been allowed to enter the United States duty free.

    That’s starting to change. U.S. and European leaders recently detailed a trade deal that includes a 15% tariff rate on some European goods brought into the United States, including pharmaceuticals. Trump is threatening duties of 200% more on drugs made elsewhere.

    “Shock and awe’’ is how Maytee Pereira of the tax and consulting firm PwC describes Trump’s plans for drugmakers. “This is an industry that’s going from zero (tariffs) to the potentiality of 200%.’’

    Trump has promised Americans he’ll lower their drug costs. But imposing stiff pharmaceutical tariffs risks the opposite and could disrupt complex supply chains, drive cheap foreign-made generic drugs out of the U.S. market and create shortages.

    “A tariff would hurt consumers most of all, as they would feel the inflationary effect … directly when paying for prescriptions at the pharmacy and indirectly through higher insurance premiums,’’ Diederik Stadig, a healthcare economist with the financial services firm ING, wrote in a commentary last month, adding that lower-income households and the elderly would feel the greatest impact.

    The threat comes as Trump also pressures drugmakers to lower prices in the United States. He recently sent letters to several companies telling them to develop a plan to start offering so-called most-favored nation pricing here.

    But Trump has said he’d delay the tariffs for a year or a year and a half, giving companies a chance to stockpile medicine and shift manufacturing to the United States — something some have already begun to do.

    Leerink Partners analyst David Risinger said in a July 29 note that most drugmakers have already increased drug product imports and may carry between six and 18 months of inventory in the U.S.

    Jefferies analyst David Windley said in a recent research note that tariffs that don’t kick in until the back half of 2026 may not be felt until 2027 or 2028 due to stockpiling.

    Moreover, many analysts suspect Trump will settle for a tariff far lower than 200%. They also are waiting to see whether any tariff policy includes an exemption for certain products like low-margin generic drugs.

    Still, Stadig says, even a 25% levy would gradually raise U.S. drug prices by 10% to 14% as the stockpiles dwindle.

    In recent decades, drugmakers have moved many operations overseas – to take advantage of lower costs in China and India and tax breaks in Ireland and Switzerland. As a result, the U.S. trade deficit in medicinal and pharmaceutical products is big — nearly $150 billion last year.

    The COVID-19 experience – when countries were desperate to hang onto their own medicine and medical supplies — underscored the dangers of relying on foreign countries in a crisis, especially when a key supplier is America’s geopolitical rival China.

    In April, the administration started investigating how importing drugs and pharmaceutical ingredients affects national security. Section 232 of the Trade Expansion Act of 1962 permits the president to order tariffs for the sake of national security.

    Marta Wosińska, a health policy analyst at the Brookings Institution, says there is a role for tariffs in securing U.S. medical supplies. The Biden administration, she noted, successfully taxed foreign syringes when cheap Chinese imports threatened to drive U.S. producers out of business.

    Trump has bigger ideas: He wants to bring pharmaceutical factories back to the United States, noting that U.S.-made drugs won’t face his tariffs.

    Drugmakers are already investing in the United States.

    The Swiss drugmaker Roche said in April that it will invest $50 billion in expanding its U.S. operations. Johnson & Johnson will spend $55 billion within the United States in the next four years. CEO Joaquin Duato said recently that the company aims to supply drugs for the U.S. market entirely from sites located there.

    But building a pharmaceutical factory in the United States from scratch is expensive and can take several years.

    And building in the U.S. wouldn’t necessarily protect a drugmaker from Trump’s tariffs, not if the taxes applied to imported ingredients used in the medicine. Jacob Jensen, trade policy analyst at the right-leaning American Action Forum, notes that “97% of antibiotics, 92% of antivirals and 83% of the most popular generic drugs contain at least one active ingredient that is manufactured abroad.’’

    “The only way to truly protect yourself from the tariffs would be to build the supply chain end to end in the United States,’’ Pereira said.

    Brand-name drug companies have fat profit margins that provide flexibility to make investments and absorb costs as Trump’s tariffs begin. Generic drug manufacturers do not.

    Some may decide to leave the U.S. market rather than pay tariffs. That could prove disruptive: Generics account for 92% of U.S. retail and mail-order pharmacy prescriptions.

    A production pause at a factory in India a couple years ago led to a chemotherapy shortage that disrupted cancer care. “Those are not very resilient markets,” Brookings’ Wosińska said. “If there’s a shock, it’s hard for them to recover.”

    She argues that tariffs alone are unlikely to persuade generic drug manufacturers to build U.S. factories: They’d probably need government financing.

    “In an ideal world, we would be making everything that’s important only in the U.S.,’’ Wosińska said. “But it costs a lot of money … We have offshored so much of our supply chains because we want to have inexpensive drugs. If we want to reverse this, we would really have to redesign our system … How much are we willing to spend?”

    ___

    Murphy reported from Indianapolis. AP Health Writer Matthew Perrone contributed to this report.

    Paul Wiseman, Tom Murphy, The Associated Press

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  • The Maker of Ozempic Is Trying to Block Compounded Versions of Its Blockbuster Drug

    The Maker of Ozempic Is Trying to Block Compounded Versions of Its Blockbuster Drug

    Drugmaker Novo Nordisk is taking action to curb the massively popular compounded semaglutide industry, which provides copies of its blockbuster weight-loss drugs Ozempic and Wegovy to patients—often for much lower prices.

    The Danish pharmaceutical company is lobbying the US Food and Drug Administration to add semaglutide to the agency’s Demonstrable Difficulties for Compounding (DDC) lists, which would block compounding pharmacies from producing dupes of the drug. In a filing posted by the agency on Tuesday, lawyers for Novo Nordisk reason that semaglutide belongs on these lists “due to the complexities associated with their formulations,” among other reasons.

    “These drugs are inherently complex to compound safely, and the risks they pose to patient safety far outweigh any benefits. Novo Nordisk’s aim with this nomination is to ensure that patients receive only FDA-approved, safe, and effective semaglutide product,” says Novo Nordisk director of media relations Jamie Bennett.

    FDA press officer Amanda Hils told WIRED via email that the agency “is reviewing the petition and will respond directly to the petitioner.”

    If granted, the designation would have seismic implications for the compounding industry—and for the likely millions of people currently taking compounded GLP-1 drugs.

    Injectable GLP-1 drugs including semaglutide and tirzepatide have been in shortage since 2022 because of their huge popularity. In the US, when the FDA declares that a drug is in shortage, certain licensed pharmacies are permitted to make “compounded” versions of the medication, which are mixed in-house and are supposed to contain the same active ingredients as the original drug.

    Telehealth providers have capitalized on the GLP-1 drug shortage, offering patients compounded versions via quick virtual appointments. The practice has created tension with the pharmaceutical companies that make the brand-name drugs, since the compounded versions are sold at much lower prices. Ozempic and Wegovy can cost around $1,000 a month without insurance, while compounded semaglutide is advertised for as low as $100 a month online.

    Unlike generic medications, which are manufactured after drug patents expire, compounded medications are not subject to FDA approval before hitting the market. This means that the FDA cannot vouch for the safety, effectiveness, or quality of compounded drugs before they’re sold to patients. The FDA has received multiple reports of adverse side effects, including hospitalization, related to possible dosing errors associated with compounded semaglutide products.

    Kate Knibbs, Emily Mullin

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  • The FDA Just Rejected a Bid for MDMA’s Approval to Treat PTSD

    The FDA Just Rejected a Bid for MDMA’s Approval to Treat PTSD

    The US Food and Drug Administration has rejected a first-of-its-kind proposal to use the psychedelic drug MDMA, also known as ecstasy or Molly, as a treatment for post-traumatic stress disorder.

    Drugmaker Lykos Therapeutics had asked the FDA to approve the drug in combination with talk therapy. The company said Friday that the regulatory agency has requested an additional Phase 3 trial so that the safety and efficacy of the therapy can be further studied. The decision comes after an FDA advisory panel in June concluded that there wasn’t enough evidence to recommend its approval.

    Lykos said it plans to request a meeting with the FDA to ask for reconsideration of the decision and to further discuss the agency’s recommendations. “The FDA request for another study is deeply disappointing, not just for all those who dedicated their lives to this pioneering effort, but principally for the millions of Americans with PTSD, along with their loved ones, who have not seen any new treatment options in over two decades,” said Lykos CEO Amy Emerson in a company statement. She added that conducting another Phase 3 trial would take several years.

    As many as 13 million Americans suffer from PTSD in any given year, according to the National Center for PTSD. Just two drugs have been specifically approved to treat the disorder, with the latest being greenlit by the FDA in 2000. The lack of options has turned combat veterans into unlikely advocates for MDMA-assisted therapy. In the days leading up to the FDA decision, veterans groups and members of Congress from both parties pressed for its approval.

    In a letter to President Biden, more than 300 veterans and representatives of veterans service organizations wrote that MDMA-assisted therapy “offers desperately needed hope for veterans and their families, with the potential to save and drastically improve countless lives over the coming years.”

    A bipartisan group of more than 60 members of the House of Representatives and 19 senators also voiced their support for the therapy this week. “Given the substantial burden of PTSD and the current treatment limitations, the possibility of new, more effective therapies is particularly meaningful,” the lawmakers wrote in a letter to FDA commissioner Robert Califf.

    There has been increasing interest in recent years in using MDMA and other psychedelics to treat severe mental illness. But with the FDA decision, MDMA will remain a federally prohibited substance listed as Schedule I drug, defined as those that have “no currently accepted medical use and a high potential for abuse.”

    During a nine-hour meeting on June 4, Lykos representatives made their case to an independent panel of FDA advisers. The company’s clinical trial data showed that more than 86 percent of study participants who underwent MDMA-assisted therapy experienced a measurable reduction in the severity of their PTSD symptoms, and 71 percent improved enough that they no longer met the criteria for a diagnosis. In a placebo group, 69 percent improved and nearly 48 percent no longer qualified for a PTSD diagnosis.

    Despite the positive results, advisory committee members cited concerns about the reliability of the clinical trial data, the long-term efficacy of the treatment, and the standardization of the talk therapy given during the MDMA sessions. One major question raised by the advisory committee was the extent to which the talk therapy contributes to the treatment benefit.

    The panel overwhelmingly voted that there wasn’t enough evidence to recommend approval. Just two of the 11 committee members agreed that MDMA-assisted therapy is effective based on the evidence Lykos presented, and only one thought its benefits outweighed the risks. The FDA usually follows the recommendations of advisory committees but is not obligated to do so.

    Lykos said it will “work diligently in the coming months to address FDA’s concerns and to take advantage of agency processes to resolve scientific disagreements.”

    Emily Mullin

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  • It’s Shockingly Easy to Buy Off-Brand Ozempic Online, Even if You Don’t Need It

    It’s Shockingly Easy to Buy Off-Brand Ozempic Online, Even if You Don’t Need It

    Eli Lilly and Novo Nordisk have both recently taken legal action against companies selling compounded versions of drugs, often alleging trademark infringement. Novo Nordisk has filed 21 lawsuits since last summer. This June, Eli Lilly initiated six lawsuits, following 10 other lawsuits that the pharmaceutical company began last fall. In one, filed against a company selling compounded GLP-1s online, it alleged that passing compounded drugs off as having identical active ingredients as its products was “not merely deceptive—it’s dangerous.”

    “Telehealth providers and compounding pharmacies that are claiming to offer or sell unapproved compounded products claiming to contain ‘semaglutide’ are sourcing their ingredients from entities other than Novo Nordisk,” Novo Nordisk spokesperson Jamie Bennett told WIRED. “As the FDA has cautioned, unapproved compounded ‘semaglutide’ drugs do not have the same safety, quality, and effectiveness assurances as Novo Nordisk’s FDA-approved semaglutide medicines, and patients should not use a compounded drug if an approved drug is available.”

    “There’s huge safety implications,” Ryder says. In 2012, a compounding pharmacy caused a fungal meningitis outbreak that killed at least 64 people, among the worst pharmaceutical drug-contamination disasters in the United States. The supervisory pharmacist who oversaw the manufacture of this medicine was sentenced to prison time, and the event led to tightened oversight and licensing requirements for compounders.

    Some of the leading compounding pharmacies that produce GLP-1 medications have landed in trouble for their practices. Hallandale Pharmacy, a popular supplier—two of my four vials came in its sleek blue packaging—has run into trouble with regulators for past infractions, which included concerns over record-keeping and facility conditions. It has received warning letters from the FDA, although the last one was closed out in May 2022, which means the FDA found that it had addressed outstanding issues. (Hallandale declined requests for comment.)

    The FDA has found issues with pharmaceutical companies, too, though. In 2023, FDA inspectors found bacterial contamination at a Novo Nordisk production plant in North Carolina. “Leadership addressed immediately, and the site received FDA approval for full production for market in August 2023,” Novo Nordisk’s Bennett says.

    Compounding advocates say that, although the drugs are not FDA-approved, they are still subject to rigorous quality control, in part due to post-2012 rule changes. Carroll, for example, says Hims did “due diligence” when choosing its pharmacy and that it has been satisfied with the medication quality. “We’ve seen an extremely good response from our customers,” he says. “No untoward side effects that we didn’t anticipate.” According to Carroll, Hims has not had to report any adverse effects to the FDA.

    What’s Next?

    As researchers continue to discover new potential use cases for GLP-1 drugs, and public interest and demand remains high, these drugs may be on the FDA’s official shortage list for months or even years to come. If the shortage ends, one type of compounding pharmacy (called 503a) would be required to stop production immediately, while 503b pharmacies, which typically produce on a larger scale, would have 60 days. An end to the shortage would require some substantial pivots within this booming cottage industry. None of the telehealth companies that sent compounded semaglutide to WIRED made mention of what might happen in this scenario during the intake process.

    Many people who take compounded drugs may be taken by surprise if they are told they must switch to brand names—and pay much higher prices—within a matter of months.

    However, even when the shortage does officially end, at least some of the telehealth companies do not plan to pivot from compounding. “We believe there’s going to be more and more demand for the medication, so that may actually prolong the shortage list,” says Hims’ Pat Caroll. “We are convinced there’s a pathway, even when it comes off the shortage list, to supply these compounded medications.”

    Even compounding skeptics suspect that it’s not going away anytime soon. With demand so high, Ryder suspects pharmaceutical companies will need to ramp up production to serve “basically 40 percent of the US population” before shortages end. Until then, Ryder suspects this telehealth boom will continue unabated.

    For now, the vials of compounded semaglutide WIRED ordered are sitting in the back of a fridge untouched.

    Kate Knibbs

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

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



    CNN
     — 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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



    CNN
     — 

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

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

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

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

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

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

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

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

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

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

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

    sanjay pkg vpx

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    Dr. Robert

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    VS Phages Sanjay Steffanie

    How naturally occurring viruses could help treat superbug infections

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

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

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

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

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  • Rite Aid files for bankruptcy | CNN Business

    Rite Aid files for bankruptcy | CNN Business


    New York
    CNN
     — 

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

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

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

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

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

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

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

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

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

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

    Rite Aid has had an interim CEO since January 2023.

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

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

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

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

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

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

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

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

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

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

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


    Washington
    CNN
     — 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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



    CNN
     — 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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



    CNN
     — 

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

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

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

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

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

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

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

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

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

    She was 54.

    Video shows Lisa Marie Presley on the Golden Globes red carpet

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

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

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

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



    CNN
     — 

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

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

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

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

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

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

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

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

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

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



    CNN
     — 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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



    CNN
     — 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    Records show Pletcher plans to appeal the ruling.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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


    San Francisco
    CNN
     — 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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



    CNN
     — 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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



    CNN
     — 

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

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

    CNN has not independently confirmed his cause of death.

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

    Here’s what your teen could see on TikTok

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

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

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

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

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

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

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

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

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

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

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

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