The Long, Long Wait for a Diabetes Cure

In the three decades since she was first diagnosed with Type 1 diabetes, Lisa Hepner has clung to a vague promise she often heard from doctors convinced medical science was on the cusp of making her body whole again. “Stay strong,” they would say. “A cure is just five years away.”But the cure has yet to arrive, and Ms. Hepner, 51, a filmmaker from Los Angeles, remains hobbled by her body’s inability to make insulin, the sugar-regulating hormone produced by the pancreas. “I might look fine to you,” she said, “but I feel crappy 70 percent of the time.”Staying healthy can be exhausting for many of the 37 million Americans with some form of diabetes. There’s the round-the-clock monitoring of sugar levels; the constant, life-sustaining insulin injections; and the potential threats from diabetes’ diabolical complications: heart disease, blindness, kidney damage and the possibility of losing a gangrenous limb to amputation.“‘The cure is five years away’ has become a joke in the diabetes community,” Ms. Hepner said. “If it’s so close, then what’s taking so long? And in the meantime, millions of us have died.”That attenuated sense of hope drove Ms. Hepner to spend nearly a decade following the fortunes of ViaCyte, a small San Diego biotech company working to create what would essentially be an artificial pancreas. If successful, its stem-cell-derived therapy would eliminate the pin-pricks and insulin injections that circumscribe the lives of the 1.5 million Americans with Type 1 diabetes. Vertex Pharmaceuticals, a Boston biotech company developing a similar therapy, has already made significant headway.Since its theatrical debut in June, “The Human Trial,” the documentary she produced with her husband, Guy Mossman, has electrified the diabetes community, especially those with Type 1, a disease that the uninitiated often conflate with the more common Type 2.Unlike Type 2, which tends to emerge slowly in adulthood and can sometimes be reversed early on with exercise and dietary changes, Type 1 is an autoimmune disease that often strikes without warning in childhood or adolescence.Type 1 is also far less prevalent, affecting roughly 10 percent of those with diabetes. A pancreas transplant can cure the disease, but donated organs are in short supply and the surgery carries substantial risks. In most years, only a thousand transplants are done in the United States. To ensure the body does not reject the implanted pancreas, recipients must take immunosuppressant drugs all their lives, making them more susceptible to infections.Maren Badger, one of the first patients to have experimental cell colonies implanted under her skin, in a scene from the film.AbramoramaTherapies developed from human embryonic stem cells, many experts say, offer the best hope for a lasting cure. “The Human Trial” offers a rare glimpse into the complexities and challenges of developing new therapies — both for the patients who volunteer for the grueling clinical trials required by the Food and Drug Administration, and for the ViaCyte executives constantly scrambling to raise the money needed to bring a new drug to market. These days, the average cost, including the many failed trials along the way, is a billion dollars.At a time when the soaring price of insulin and other life-sustaining drugs has tarnished public perceptions of the pharmaceutical industry, the film is also noteworthy for its admiring portrayal of a biotech company whose executives and employees appear genuinely committed to helping humanity. (Limiting the cost of insulin remains politically volatile. On Sunday, during a marathon vote on the Democrats’ climate and health bill, Republicans forced the removal of a provision with a $35 cap on insulin prices for patients with private insurance, though the cap remained in place for Medicare patients.)“The Human Trial,” which can also be viewed online, has become a rallying cry for Type 1 patients, many of whom believe only greater visibility can unleash the research dollars needed to find a cure.Those who have seen the film have also been fortified by seeing their own struggles and dashed hopes reflected in the journeys of the film’s two main subjects, Greg Romero and Maren Badger, who became among the first patients to have the experimental cell pouches implanted under their skin.The despair that drives them to become human guinea pigs can be hard to watch. Mr. Romero — whose father also had the disease, went blind before he was 30 and then died prematurely — confronts his own failing vision while grappling with the pain of diabetes-related nerve damage. “I hate insulin needles, I hate the smell of insulin. I just want this disease to go away,” Mr. Romero, 48, says numbly at one point in the film.Type 1 can leave patients feeling alienated and alone, in part because of flawed assumptions about the disease. Tim Hone, 30, a medical writer in New York who has been living with Type 1 since he was 15, said friends and acquaintances sometimes suggested that he was responsible for causing his illness. “I’ve had people scold me and say that if I went on a diet and stopped eating Snickers bars I could reverse my disease,” Mr. Hone said.The stigma often drives people with Type 1 to hide the disease. In his quest to feel “normal” at college, Todd Boudreaux said, he avoided telling friends about his illness, a decision that could have had dangerous ramifications in the event of a seizure brought on by low blood sugar levels.Greg Romero, one of the subjects in the documentary. “I hate insulin needles, I hate the smell of insulin. I just want this disease to go away,” he said.Abramorama“I didn’t want to be defined by my illness, and I didn’t want to be seen as weak, but having Type 1 does make you different and it’s important that everyone around knows so they can help if you have severe low blood sugar,” said Mr. Boudreaux, 35, who lives in Monterey, Calif., and works for the nonprofit group Beyond Type 1.Ms. Hepner, too, has spent much of her life downplaying the disease, even with her husband, Mr. Mossman. She recalled his confusion early in their relationship when he awoke to find her discombobulated and drenched in sweat, the result of hypoglycemia, or low blood sugar. The more Mr. Mossman, a cinematographer, learned about the disease, the more he pressed her to make the film.For years, Ms. Hepner stood her ground, worried about drawing unwanted attention to her health. “It’s a competitive world out there and I just didn’t want people to think, ‘Oh, she’s not thinking straight because her blood sugar is high,’” she said.But over time, the ubiquity of pink-ribbon breast cancer awareness campaigns and highly publicized efforts to cure Alzheimer’s made Ms. Hepner realize her filmmaking skills could change public perceptions of Type 1, a disease that is nearly invisible, in part because many people who have it do not look sick.She hopes to change other misperceptions, including the notion that diabetes is a relatively inconsequential and “manageable” illness, one that has been popularized by Big Pharma’s feel-good drug television commercials that feature self-assured patients playing tennis and basketball and piloting hot air balloons.In fact, the industry spends a fraction of its research dollars on finding a cure, with the rest directed toward developing medications and devices that make it easier to live with the disease, according to the Juvenile Diabetes Cure Alliance.The payoff from those investments is undeniable. For those who can afford them, continuous glucose-monitoring devices can obviate the need for self-administered finger-prick testing, and the machines can be paired with iPhone-size insulin pumps that eliminate much of the guesswork over dosing.Ms. Hepner with her son Jack in a scene from the film. “We need to stop trying to normalize this disease because, let’s face it, having diabetes isn’t normal,” she said.AbramoramaMs. Hepner has profound appreciation for the wonders of insulin: At one point in the film she pays homage to its inventor, Frederick Banting, during a visit to his home in Canada. But she notes that insulin-dependent diabetes is no picnic. Many people without insurance cannot afford the thousands of dollars it costs annually for the drug, forcing some to skimp and ration. And a miscalculated or ill-timed dose can lead to seizures, unconsciousness and even death. Even with all the advances in care, only about 20 percent of adults with Type 1 are able to maintain healthy blood sugar levels, according to a 2019 study. On one occasion, Ms. Hepner woke up in the I.C.U. after her insulin pump failed.“We need to stop trying to normalize this disease because, let’s face it, having diabetes isn’t normal,” she said. “It’s the other pandemic, one that killed 6.7 million people last year around the world.”Despite her frustrations, it would be inaccurate to describe Mr. Hepner and her film as pessimistic. At the risk of giving away too much, “The Human Trial” ends on a hopeful note. And despite a number of near-brushes with bankruptcy, ViaCyte succeeded in gaining the funding to keep the laboratory lights burning.Then there is more recent news that did not make it into the film. Last month, ViaCyte was acquired by Vertex, the competing biotech company that has been developing its own stem-cell treatment. That treatment has shown early success, and last year the company announced that a retired postal worker who took part in clinical trials had been cured of Type 1 diabetes.After almost a lifetime of hearing a cure was just around the corner, Dr. Aaron Kowalski, chief executive of the JDRF (Juvenile Diabetes Research Foundation), the world’s biggest funder of Type 1 research, counts himself as an optimist. A dozen more drug companies are pursuing a cure than a decade ago, he said, and the organization this year plans to spend $100 million on cure research. “It’s not a matter of if this will happen, it’s a matter of when,” said Dr. Kowalski, who is a scientist and has had the disease since childhood, as has a younger brother. “Our job is to make sure it happens faster.”Until that day, he added, people with diabetes, both Type 1 and Type 2, could use a little empathy and understanding.

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Breaking Nicotine’s Powerful Draw

Millions of smokers could be forced to confront the agony of nicotine withdrawal as the F.D.A. weighs calling for a drastic reduction in the addictive lure of cigarettes.At some point in the next few years, the 30 million smokers in the United States could wake up one day to find that cigarettes sold at gas stations, convenience stores and smoke shops contain such minuscule amounts of nicotine that they cannot get their usual fix when lighting up.Would the smokers be plunged into the agonizing throes of nicotine withdrawal and seek out their favorite, full-nicotine brand on illicit markets, or would they turn to vaping, nicotine gum and other less harmful ways to get that angst-soothing rush?Such scenarios inched closer to the realm of possibility in June, when the Food and Drug Administration said that it would move toward slashing nicotine levels in cigarettes in an effort to reduce the health effects of an addiction that claims 480,000 lives a year.The agency set next May as its timetable for introducing a fully developed proposal. But many experts hope regulators will champion an immediate 95 percent reduction in nicotine levels — the amount federally funded studies have determined is most effective for helping smokers kick the habit.It could be years before any new policy takes effect, if it survives opposition from the tobacco industry. Even so, health experts say any effort to decrease nicotine in cigarettes to nonaddictive levels would be a radical experiment, one that has never been implemented by any other country.The science of nicotine addiction has come a long way since 1964, when a U.S. Surgeon General report first linked smoking to cancer and heart disease, although it would take another two decades for the mechanics of nicotine dependence to be understood and widely accepted.Tobacco contains more than 7,000 chemicals, many of them harmful when burned and inhaled, but it is nicotine that keeps smokers coming back for more. Nicotine stimulates a surge of adrenaline in the brain while indirectly producing a flood of dopamine, the chemical that promotes feelings of contentment and relaxation. The effects, however, are short-lived, which is why heavy smokers need a fresh injection a dozen or more times a day.Eric Donny, a tobacco expert at Wake Forest University School of Medicine who has conducted experiments with low nicotine cigarettes, says many scientists have come to embrace a 95 percent reduction in nicotine levels as ideal for helping study subjects smoke less. Anything higher, he said, can encourage participants to engage in so-called compensatory smoking — inhaling more deeply or smoking more frequently.The studies he and other scientists have run recently used genetically modified tobacco bred to express less nicotine; bringing nicotine down to zero is not an option under the Tobacco Control Act, a 2009 law that gave the F.D.A. the power to regulate the manufacture and marketing of tobacco.“When you get the nicotine in tobacco low enough, you just can’t get enough nicotine to maintain the dependence,” Dr. Donny said. “Smoking more creates adverse effects, like nausea, because the lungs can only handle so much of a burned substance.”But even as tobacco control researchers cheered the F.D.A. announcement, they acknowledged that any move to lower nicotine in cigarettes would be enormously challenging for inveterate smokers — even among the 70 percent who have said they would like to stop. As it is, fewer than one in 10 adults who try to quit smoking succeed, a reflection of nicotine’s addictive prowess and the limitations of nicotine replacement therapy.Low-nicotine VLN cigarettes, which use genetically modified tobacco, were sold at a Circle K store in Chicago, as part of a pilot project to see if they could help wean people off smoking.Taylor Glascock for The New York TimesDr. Nora Volkow, director of the National Institute on Drug Abuse, expressed confidence in the studies that backed an immediate cut in nicotine levels versus a gradual tapering. But she said that scientists and regulators still needed to address the welter of unforeseen consequences that could prove disruptive to determined smokers and could fuel the creation of underground markets for full-nicotine cigarettes. “You cannot completely predict outcomes based on a clinical randomized study,” she said. “Biology and life are not so precise.”Some scientists have urged caution for any plan that would drastically cut nicotine levels in one fell swoop, warning that the existing research on low-nicotine cigarettes is imperfect, given the high number of study participants who cheat. The skeptics, among them tobacco company executives, warn that banning conventional cigarettes would drive determined smokers to seek imports from Mexico and Canada. They also argue that some smokers, including teenagers, could develop a habit that pairs vaping or nicotine gum with low-nicotine cigarettes, which are just as carcinogenic as traditional cigarettes.Lynn T. Kozlowski, a tobacco researcher at the University at Buffalo who has contributed to four Surgeon General reports on smoking since 1981, said nicotine was a highly addictive drug, with a stranglehold on users that could rival cocaine and heroin, and that the F.D.A. needed to consider how a sweeping decrease of nicotine in cigarettes would affect smoker behavior.“What scares me is a national experiment with very low nicotine cigarette that is done without some testing in the real world,” he said. The studies many experts cite when promoting a 95 percent drop in nicotine levels relied upon paid participants, he noted, adding that some of them secretly smoked their own brands at the same time that researchers were plying them with low-nicotine cigarettes.In interviews, smokers who had heard about the F.D.A.’s announcement said they were conflicted by the prospect of being forced to abandon their addiction, despite knowing full well that it damaged their health and would likely shorten their life span. Mike Harrigan, an options trader who was taking a smoking break outside the Chicago Board of Trade, said he feared he might actually end up smoking more if cigarettes contained significantly lower amounts of nicotine. “It may help newer smokers, but it will hurt people who are used to a certain level of nicotine,” said Mr. Harrigan, 55, who has been a pack-a-day smoker for three decades.Dr. Kozlowski said he was especially concerned by the agency’s mixed messaging and seemingly conflicted stance on e-cigarettes, which deliver nicotine without the tar and many other toxins that are inhaled when tobacco is ignited. Even if the long-term impacts of vaping remain unknown — though health experts agree that teenagers should be discouraged from trying e-cigarettes — there is mounting consensus that such products are useful for helping adult smokers quit.The F.D.A. has so far approved just six vaping products and has denied more than a million others, including those made by Juul Labs. Earlier this summer, the agency ordered Juul off shelves, citing the potential harm from chemicals that could leach out of its e-liquid cartridges. But the F.D.A. has since granted the company further review.Dr. Judith Prochaska, an addiction specialist at Stanford University who runs a smoking cessation clinic for patients with cancer and their families, said lighting up during a stressful phone call, while sipping a cocktail or following a meal creates a powerful memory that conditions the mind into associating a cigarette with the stimulation or succor that it delivers via the rush of nicotine.“All these everyday behaviors cue your brain that nicotine is coming,” she said. “It’s basically the Pavlovian dog effect but conditioned here with a highly addictive drug.”Dr. Judith Prochaska, an addiction specialist at Stanford University, said certain activities that people associate with smoking can signal their brain that nicotine is coming, which deepens dependency.Mike Kai Chen for The New York TimesOver time, the dependency deepens. Regular smoking promotes the formation of additional dopamine receptors — sometimes millions more. When a smoker goes cold turkey, those unrequited receptors prompt the anxiety, irritability and depression that can make nicotine withdrawal so hard to bear.Nicotine patches, gum and vapes can help to satisfy some of the cravings, but they cannot replace the rituals of having a cigarette: the retreat outside with a co-conspirator, the crinkling of cellophane and foil as you open a new pack, the heady buzz of that first drag.Bruce Holaday, 69, a retired educator from Mill Valley, Calif., knows full well the power of nicotine. Over the past five decades, Mr. Holaday reckons he has tried to quit 100 times, often relying on nicotine replacement products. But he invariably returned to his lifelong, pack-a-day affair with Marlboro Lights.His last attempt in August, a cold turkey gambit without nicotine replacement therapy, triggered an excruciating maelstrom of cravings that lasted several months. “It was like a sudden earthquake of desire and need, and then there would be these tremors for the next 10 to 15 minutes,” he said.But this time, Mr. Holaday joined a support group at Stanford Health Care, which introduced a powerful social component into his quest. He described the effect as “not wanting to let the team down” and said he learned to avoid stressful situations, like watching the news. He discovered that if he could face down the initial waves of craving, they invariably subsided.In late June, he passed the one-year mark since taking his last drag.He gained weight but no longer gets easily winded on hikes. And he is confident he will never go back to smoking.Asked about the prospect of drastic government intervention to compel Americans to quit, Mr. Holaday paused and thought about the first puff he took a half-century ago as a college freshman. “Without that nicotine rush, I would have probably walked away and never smoked again,” he said. “It will be rough for smokers, but anything we can do to prevent a new generation from getting hooked is a good thing.”Robert Chiarito contributed reporting from Chicago.

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A Clunky Mask May be the Answer to Airborne Disease and N95 Waste

Experts say the U.S. government has unintentionally encouraged a dependency on imported masks by failing to promote elastomeric respirators, a reusable mask that is domestically produced.In the early 1990s, long before P.P.E., N95 and asymptomatic transmission became household terms, federal health officials issued guidelines for how medical workers should protect themselves from tuberculosis during a resurgence of the highly infectious respiratory disease.Their recommendation, elastomeric respirators, an industrial-grade face mask familiar to car painters and construction workers, would in the decades that followed become the gold standard for infection-control specialists focused on the dangers of airborne pathogens.The Centers for Disease Control and Prevention promoted them during the SARS outbreak of 2003 and the swine flu pandemic of 2009. A few studies since then have suggested that reusable elastomeric respirators should be essential gear for frontline medical workers during a respiratory pandemic, which experts predicted would quickly deplete supplies of N95s, the disposable filtration masks largely made in China.But when the coronavirus swept the globe and China cut off exports of N95s, elastomeric respirators were nowhere to be found in a vast majority of hospitals and health clinics in the United States. Although impossible to know for sure, some experts believe the dire mask shortage early on contributed to the wave of infections that killed more than 3,600 health workers.The pandemic has generated a bevy of painful lessons about the importance of preparing for public health emergencies. From the Trump administration’s tepid early response to the C.D.C.’s bungled coronavirus testing rollout and its mixed messaging on masking, quarantining and the reopening of schools, the federal government has been roundly criticized for mishandling a health crisis that has left one million Americans dead and dented public faith in a once-hallowed institution.Three years into the pandemic, elastomeric respirators remain a rarity at American health care facilities. The C.D.C. has done little to promote the masks, and all but a handful of the dozen or so domestic companies that rushed to manufacture them over the past two years have stopped making the masks or have folded because demand never took off.Most cost between $15 and $40 each, and the filters, which should be replaced at least once a year, run about $5 each. Made of soft silicone, the masks are comfortable to wear, according to health care worker surveys, and they have a shelf life of a decade or more.“It’s frustrating and frightening because a mask like this can make the difference between life and death, but no one knows about them,” said Claudio Dente, whose company, Dentec Safety, recently stopped making elastomeric respirators that were specifically redesigned at the request of federal regulators for health care workers.The government’s tentative approach to elastomeric respirators during the pandemic has largely escaped public scrutiny, even as American mask producers, health policy experts and nursing unions have been pressing federal officials to promote them more aggressively. The masks, they note, are an environmentally sustainable and cost-effective alternative to N95s. Worn properly, they offer better protection than N95s, which, as their name suggests, only filter out 95 percent of pathogens. Most elastomerics exceed 99 percent.The masks have another notable attribute: Most are made in the United States.Surgical masks are manufactured at a factory in central China. N95s are largely produced there, which has caused problems for mask supplies in the United States.Chinatopix, via Associated PressNow that hospitals have resumed buying cheap, Chinese-made face coverings and the resurgent American mask industry has imploded, experts warn of the perils of the nation’s continued dependency on foreign-made protective equipment. Many of the U.S. companies calling it quits are start-ups whose founders jumped into the P.P.E. business out of a sense of civic duty.“It’s sad to see all of this manufacturing capacity come online during a crisis, only to be shut down because hospitals and even our own government would rather save a few pennies buying from China,” said Lloyd Armbrust, president of the American Mask Manufacturers Association. Its membership includes just eight companies that are still producing masks, down from 51 a year ago. He said 17 of the companies have shut down.Some experts say the C.D.C.’s hands-off approach to elastomeric respirators is unintentionally encouraging a return to the nation’s reliance on disposable masks made overseas. Dr. Eric Feigl-Ding, an epidemiologist who heads the Covid-19 task force at the World Health Network, criticized federal officials for inaction despite compelling evidence that elastomerics provide the highest level of protection against aerosolized viruses. “At a certain point, you need to act on the existing science, and the failure to do otherwise is a dereliction of duty,” he said.To be clear, federal health experts back the use elastomerics but say they are awaiting additional study results before offering full-throated support for their widespread adoption by medical personnel. Emily Haas, a scientist at the C.D.C.’s National Institute for Occupational Safety and Health, or NIOSH, said researchers were still grappling with the need to regularly disinfect them and complaints about muffled communication, though some newer models make it easier for wearers to be heard.The bigger challenge, she says, is convincing hospitals and group purchasing organizations to embrace the masks given the abundance of N95s, which offer comparable protection during routine medical care and can be thrown away after each use.“There’s been so much research in the last 10 years that has really supported elastomerics, so in some ways the issue right now is cultural,” Dr. Haas said. “No one likes change, and introducing a whole new system of respiratory protection can be a heavy lift.”Experts say such obstacles could be overcome through more muscular federal leadership. Dr. Tom Frieden, who led an unsuccessful effort to fill the Strategic National Stockpile with elastomerics when he was C.D.C. director in 2009, said the advantages of providing them to frontline medical workers were clear, especially given the nation’s ruinous overreliance on single-use masks. He said health authorities could promote elastomerics by highlighting their cost savings for hospitals and the environmental benefits of a reusable mask to help reduce the tsunami of N95s that end up in landfills. “To me, it’s a puzzle why they haven’t become more widespread,” Dr. Frieden said.Providing an elastomeric respirator to each of the nation’s 18 million health care workers would cost roughly $275 million, according to Nicolas Smit, an expert on elastomerics and executive director of the American Mask Manufacturers Association. By comparison, he noted that the federal government spent $413 million on a disastrous effort to decontaminate N95 masks so they could be safely reused.N95s have posed environmental concerns since they have limited number of uses and end up in landfills.Cooper Neill for The New York TimesJames C. Chang, an industrial hygienist, has long been a fan of elastomerics. In 2018, he helped to produce a report on them for the National Academies of Sciences, Engineering and Medicine, and after the short-lived swine flu pandemic of 2009, he persuaded his employer, the University of Maryland Medical Center, to purchase 1,500 masks. The decision was based in part on research that predicted a respiratory pandemic lasting more than a few weeks would lead to catastrophic supply-chain shortages.“When you ran the numbers, it was pretty clear we’d burn through a six- or seven-digit cache of disposables pretty quickly,” he said. “It’s just not feasible for any hospital to stock that many masks.”Initially he had a handful of concerns — that their “Darth Vader” look would frighten patients or that disinfecting them would be burdensome. But those fears quickly faded in early 2020 as hospitals across the country scrambled to find N95s, and the C.D.C. issued guidelines saying N95s could be reused up to five times — guidance that evoked widespread skepticism among health professionals.To deal with the need to disinfect the masks, he set up a system that allowed workers to drop them off after each shift so they could be cleaned before being made available to others.“It was a real success story on our end because our staff had respirators to wear and they felt more reassured wearing elastomerics than wearing N95s,” Mr. Chang said.One of the only other hospital systems in the country to adopt the masks on a large scale was Allegheny Health Network of Western Pennsylvania, which early in the pandemic, distributed more than 8,000 respirators at its 14 hospitals. The decision to do so stemmed from a coincidence of geography: Allegheny’s headquarters in Pittsburgh was not far from the manufacturing plant of MSA Safety, a century-old company that got its start producing coal miner protective gear with help from Thomas Edison.Prompted by an appeal from hospital administrators, MSA began sending over the industrial-grade masks but they quickly ran into a problem. The protruding filters only screened inhaled air, which meant that exhaled air from an infected wearer could pose a potential health risk to those nearby, according to Dr. Zane Frund, executive director for materials and chemicals research at MSA Safety.The solution was not exactly rocket science: Product designers simply removed the masks’ exhalation valve, and NIOSH in late 2020 approved the new models. A subsequent design tweak added a mechanical voice amplifier to help ease communication.Dr. Sricharan Chalikonda, Allegheny’s chief medical operations officer, said he was surprised by just how popular they became among the 2,000 medical personnel who had been outfitted to wear them — a process aimed at ensuring air would not evade the mask’s tight face seal.Health experts have said they are awaiting additional studies on elastometric masks before throwing their weight behind them.Kirsten Luce for The New York TimesAccording to a paper he published in the Journal of the American College of Surgeons, none of the employees went back to wearing N95s. The cost benefit of relying almost entirely on elastomerics became irrefutable: Outfitting the workers was one-tenth as expensive than supplying them with disposable N95s. A separate study found that after one year, the filters were still 99 percent effective.“Elastomerics for us really were a game changer,” Dr. Chalikonda said. “When I think of all the millions of dollars wasted on N95s and then trying to reuse them makes you realize how much elastomerics are a missed opportunity.”Federal health officials say they are moving as fast as possible to produce stronger guidance on elastomerics. Maryann D’Alessandro, director of the National Personal Protective Technology Laboratory, said scientists were reviewing feedback from a study that distributed nearly 100,000 respirators to hospitals, nursing homes and first-responders across the country. “If we can get a tool kit together to serve as a guide for organizations and educate the users, we hope it can help move the needle,” she said.Many masks entrepreneurs are not likely to last that long. Max Bock-Aronson, the co-founder of Breathe99, which makes an elastomeric respirator that Time magazine included on its 2020 list of best inventions, has been winding down operations at the company’s Minnesota plant.He blamed the slump in sales on Covid fatigue and waning public interest in protective gear. The company’s fortunes, he added, were doomed early on by the C.D.C.’s mask guidance, which prompted Amazon, Google and Facebook to limit or bar the sale of medical-grade masks to consumers, even as P.P.E. imports once again began flooding the United States.“The whole industry has been gutted,” said Mr. Bock-Aronson. “Every time there’s a new variant, we get a small bump in sales, but I haven’t taken a nickel out of the company since last May,”For now, he is focused on finding a buyer for his company while selling off his inventory online. The masks cost $59 and can be sheathed in washable covers that come in eight colors, among them crimson, linen and royal blue.All sales, the website points out apologetically, are final.

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Psilocybin Spurs Brain Activity in Patients With Depression, Small Study Shows

The chemical derived from psychedelic mushrooms helped alleviate symptoms of depression and generated detectable neural responses that lasted weeks.Psychedelic compounds like LSD, Ecstasy and psilocybin mushrooms have shown significant promise in treating a range of mental health disorders, with participants in clinical studies often describing tremendous progress taming the demons of post-traumatic stress disorder, or finding unexpected calm and clarity as they face a terminal illness.But exactly how psychedelics might therapeutically rewire the mind remains an enigma.A group of neuroscientists at Kings College London thought advanced neuroimaging technology that peered deep into the brain might provide some answers. They included 43 people with severe depression in a study, giving them either psilocybin, the active ingredient in magic mushrooms, or a conventional antidepressant; the participants were not told which one they would receive. Functional magnetic resonance imaging, which captures metabolic function, took two snapshots of their brain activity — the day before receiving the first dose and then roughly three weeks after the final one.What they found, according to a study published Monday in the journal Nature Medicine, was illuminating, both figuratively and literally. Over the course of three weeks, participants who had been given the antidepressant escitalopram reported mild improvement in their symptoms, and the scans continued to suggest the stubborn, telltale signs of a mind hobbled by major depressive disorder. Neural activity was constrained within certain regions of the brain, a reflection of the rigid thought patterns that can trap those with depression in a negative feedback loop of pessimism and despair.By contrast, the participants given psilocybin therapy reported a rapid and sustained improvement in their depression, and the scans showed flourishes of neural activity across large swaths of the brain that persisted for the three weeks. That heightened connectivity, they said, resembled the cognitive agility of a healthy brain that, for example, can toggle between a morning bout of melancholia, a stressful day at work and an evening of unencumbered revelry with friends.Although the authors acknowledged the limitations of the study, including its small size and short time frame, they said psilocybin appeared to have a “liberating” effect on the brains of people with severe depression.Understand Post-Traumatic Stress DisorderThe invasive symptoms of PTSD can affect combat veterans and civilians alike. Early intervention is critical for managing the condition.Removing the Stigma: Misconceptions about how PTSD develops and its symptoms, can prevent people from seeking treatment. Psychedelic Drugs: As studies explore the therapeutic value of substances like MDMA, veterans are becoming unlikely advocates for their decriminalization. Virtual Reality: A treatment using new technology to immerse patients in a simulation of a memory could help them overcome trauma. Pandemic Trauma: Covid-19 has exacerbated mental health issues among medical workers, putting them at great risk of developing PTSD.“Psilocybin, it would seem, allows you to see things in an entirely new light, particularly when you have a psychotherapist who can help guide you through that experience,” said Richard Daws, a cognitive neuroscientist and a lead author of the study. “You can unpack difficult experiences that might define how you see the world, which is interesting because that’s exactly what traditional cognitive behavioral therapy is trying to do.”Experts not involved with the study said that the results were not entirely surprising but that they provided a possible biologic explanation for the anecdotal accounts about therapeutic breakthroughs with psychedelic medicine.Patrick M. Fisher, a neuroscientist at the Neurobiology Research Unit in Copenhagen who studies psilocybin’s affects on the brain, said the findings could help explain why study subjects in psychedelic research often report long-term relief from psychological ailments. “One or two doses of psychedelic drugs seem to impart lasting clinical benefits and changes in personality and mood, and that’s an unusual characteristic of drugs,” he said. “Although these brain imaging data are important for resolving the brain mechanisms that support these lasting changes, this study leaves prominent questions unanswered.”Other researchers agreed, saying the results highlighted the need for further study. Dr. Stephen Ross, associate director of the N.Y.U. Langone Center for Psychedelic Medicine, who has been studying the antidepressant effects of psilocybin on cancer patients, cautioned against drawing sweeping conclusions given the relatively brief monitoring period of participants’ brain activity. “It’s a little bit like looking out into the universe with a telescope and seeing interesting things and then starting to build theories based on that,” he said. “This is an important contribution though I’m more interested in what happens in three months or six months.”A separate, smaller experiment that was included in the Nature Medicine paper appeared to support the notion that psilocybin therapy could provide enduring benefits. In that trial, 16 patients were recruited with the knowledge that they would receive psilocybin for their treatment-resistant depression. Brain scans taken a day after the final doses were administered showed similar results to the other study. And when the researchers followed up six months later, many participants reported that the improvements to their depression had not subsided.“These results are very promising, but obviously no one should go out and try and procure psychedelics without speaking to a doctor or a therapist,” Dr. Daws said.The field of psychedelic medicine is still in its infancy following a decades-long gap in research, a direct result of antidrug policies that prevented most scientists in the United States from investigating mind-altering compounds. But as the stigma has faded and research funding has begun to flow more freely, a growing number of scientists have begun exploring whether such drugs can help patients suffering from a wide range of mental health conditions, including anorexia, substance abuse and obsessive-compulsive disorder.Along with psilocybin, MDMA, popularly known as Ecstasy, has been especially promising. A study last May in Nature Medicine found that the drug paired with talk therapy could significantly lessen or even eliminate symptoms of PTSD. Phase 3 clinical trials are now underway, and some experts believe the Food and Drug Administration could approve MDMA therapy for PTSD as soon as next year.Depression remains one of most common and intractable mental health challenges in the United States, with an estimated 21 million adults reporting a major depressive episode in 2020, according to the National Institute of Mental Health. Although Prozac and other antidepressants known as S.S.R.I.s have been effective for many, they have significant side effects and the drugs do no work for everyone.For that reason, the handful of small studies on psilocybin and depression have electrified mental health experts and patients.Another author of the Nature Medicine article published on Monday, Robin Carhart-Harris, director of the Neuroscape Psychedelics Division at the University of California, San Francisco, said the functional magnetic resonance imaging scans offered intriguing clues about the way depression inhabits the brain. The resulting images, he suggested, might be best compared to an undulating pastoral landscape marked by hills and deep valleys. People with depression, he said, often get stuck in a valley. Although S.S.R.I.s can make them feel better, the drugs do not appear to change the overall landscape of their brain, as it were, suggesting that the drugs do little more than ease the symptoms of their depression.But the psilocybin treatments, he said, seemed to provide a way out of those metaphorical valleys by inducing what scientists call global increases in brain network integration — essentially touching off activity across parts of the brain that were previously cut off from one another.“Psilocybin therapy seems to flatten the landscape so you move out of the valley,” Dr. Carhart-Harris said. “It makes you freer to move on.”Still, he acknowledged that the two trials raised a multitude of unanswered questions that he hoped researchers would explore. And he expressed caution against the headlong embrace of psychedelics without supervision, noting the acute vulnerability of patients experiencing a psychedelic journey.“It might sound trite to say, but I think psilocybin therapy opens up the mind, and that’s its strength,” Dr. Carhart-Harris said. “But that’s also arguably where the risk comes in, which is why it needs to be managed and to happen alongside psychological support.”

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Dr. Bronner’s, the Soap Company, Dips Into Psychedelics

Under the leadership of the founder’s grandsons, the company has become a big financial backer of efforts to loosen government restrictions on illegal drugs.VISTA, Calif. — Dr. Bronner’s, the liquid soap company best known for its teeny-font labels preaching brotherly love and world peace, would like you to consider the benefits of mind-altering drugs.The sentiment is promoted on limited-edition soap bottles that sing the praises of psychedelic-assisted therapies, and through the trippy pronouncements of David Bronner, grandson of the company’s founder and one of its top executives, who is not shy about sharing details of his many hallucinogenic journeys.“Let’s face it, the world would be a far better place if more people experienced psychedelic medicines,” said David, whose company in January became among the first in the United States to offer ketamine therapy as part of its employee health care coverage.Perhaps less well known is Dr. Bronner’s role as one of the country’s biggest financial supporters of efforts to win mainstream acceptance of psychedelics and to loosen government restrictions on all illegal drugs.Since 2015, Dr. Bronner’s Magic Soaps — yes, that’s its official name — has donated more than $23 million to drug advocacy and research organizations, according to corporate documents. They include scientists researching the healing properties of the club drug Ecstasy, activist groups that helped decriminalize psilocybin “magic mushrooms” in Oregon and Washington, D.C., and a small nonprofit working to preserve habitat for peyote, the hallucinogenic cactus central to some Native American spiritual traditions.Over the years, the company has also spent millions on efforts toward cannabis legalization, including litigation that in 2018 helped reverse a federal prohibition on the cultivation of industrial hemp.Soap on the assembly line bearing Dr. Bronner’s distinctive labels, which detail the philosophic ramblings of the company’s founder and the 18 uses for the concentrated liquid Castile soap.John Francis Peters for The New York TimesAlthough Open Society Foundations, the left-leaning philanthropy founded by George Soros, has quietly spent millions on drug policy changes, it is rare for a company to embrace an issue as contentious as loudly as Dr. Bronner’s has.“When it comes to corporate philanthropy, you’d be hard-pressed to find another company with the courage to publicly back an end to the war on drugs,” said Rick Doblin, who runs the Multidisciplinary Association for Psychedelic Studies, a research and advocacy group. It has received nearly $6 million from Dr. Bronner’s, with an additional $1 million pledged for each of the next five years.The Bronner family’s increasingly high-profile largess comes at a pivotal moment in the decades-long campaign to ease the nation’s just-say-no attitude toward illicit drugs. The changes have been seismic, from bipartisan congressional support for drug-sentencing reforms to the cascading state-by-state embrace of recreational marijuana.Ketamine therapy for depression has become a billion-dollar industry, and scores of states and municipalities are seeking to join Denver, Seattle and the dozen other cities that have decriminalized psychedelics. Researchers say another watershed moment is on the horizon: the Food and Drug Administration is considering approving MDMA, or Ecstasy, for the treatment of post-traumatic stress disorder.The University of Texas, Johns Hopkins and Yale are among the stolid institutions that have created divisions to explore whether psychedelic compounds can advance the treatment of anxiety, depression, addiction and a range of other mental health disorders. “We really are at an inflection point where the whole paradigm about these drugs is shifting,” said Dacher Keltner, a professor of psychology at the University of California, Berkeley, who is helping to set up the school’s new Center for the Science of Psychedelics.Emanuel Bronner, who founded the company in 1948, gave out bottles of his product after delivering lectures about mankind’s need to save “Spaceship Earth.” But he soon realized most people were more interested in the free soap.Dr. Bronner’sFounded in 1948 by Emanuel Bronner, a German-Jewish immigrant and a third-generation soap maker, Dr. Bronner’s tingly peppermint soap became a favorite in the 1960s among counterculture peaceniks who were enamored with its all-natural provenance and Bronner’s “All-One-God-Faith” dedication to ending the tribalism behind so much human suffering. One apocryphal origin story credits Woodstock for expanding its distribution. “The joke is that it left the festival in three times as many VW microbuses as it arrived in,” his grandson, Michael Bronner, said.Emil, as he was known, was a bracing, free-spirited renegade whose loquacious genius often danced on the edge of madness. (He was not, in any way, an actual doctor.) In 1945, not long after learning his parents had been murdered in Nazi death camps, Emil landed in a Chicago mental asylum, forcibly committed by his sister, where he was administered electric shock therapy, according to his family. After making an audacious escape, he hitchhiked to California, where he began his lifelong, peripatetic crusade to heal mankind.Bronner would hand out bottles of his product after delivering his idiosyncratic public lectures about humanity’s need to save “Spaceship Earth,” but he soon realized most people were more interested in his free soap than his spiritual ideology. His remedy? He began printing those philosophic ramblings on the labels, which also explained the 18-in-1 uses for his concentrated liquid Castile soap. (Teeth cleaning! Dishwashing! Dog shampoo!)Though a suggested birth-control use has since been discarded, the Bronners have left much of the label’s 3,000-word verbiage untouched, a decision that reflects the family’s deep reverence for a man whose zany presence is inescapable more than two decades after his death at age 89.The patriarch’s writings and his image are scattered throughout the company’s headquarters in Vista, Calif., about 40 miles north of San Diego. A frighteningly large blowup of his grinning face greets visitors in the lobby. Nearby a papier-mâché figure wearing a leopard-print Speedo is a goofy homage to his predilection for conducting business in skimpy swimming trunks. (Fun fact: For decades, the phone number printed on soap bottles rang through to a collection of red rotary phones that Emil Bronner answered at all hours from his living room recliner.)The workers behind Dr. Bronner’s All-One Magic Foam Experience played music during lunchtime at the company headquarters.John Francis Peters for The New York TimesThe company remains a family affair. Michael, the self-described “buttoned-up brother,” is president; his sister, Lisa, helps promote the brand’s work on environmental sustainability and fair-trade issues; and their mother, Trudy, is the chief financial officer. David, the eldest child, is C.E.O. — Cosmic Engagement Officer.Last year Dr. Bronner’s earned nearly $170 million in revenues, according to company documents, up from $4 million in 1998, several years after the company emerged from bankruptcy with an assist from Emil’s two sons, Jim and Ralph.That near brush with corporate death was tied to Emil’s decision to register his company, “All One God Faith, Inc.” as a religious nonprofit. The Internal Revenue Service was not pleased, and levied a crushing fine.But the founder’s unconventional approach to business lives on. Top salaries at the company cannot exceed five times that of the lowest-paid worker with five years on the job, which means Michael and David each earn roughly $300,000 a year. Their 300 employees receive an array of benefits, including up to $7,500 in child-care assistance and annual bonuses of up to 10 percent of their annual pay. The cafeteria’s vegan meals are free, as are the Zumba classes, back massages and solar-powered electric-vehicle charging stations.The company regularly spurns the kind of buyout offers that have claimed other independent brands like Burt’s Bees (now part of Clorox), Tom’s of Maine (Colgate-Palmolive) and Kiehl’s (L’Oréal). The offers, the brothers say, go right into the trash. In a good year, the company gives away 45 percent of its profits, or about $8 million, according to the company’s annual report. “If we cashed out, we’d be less effective as a charitable engine,” David said.His own love affair with psychedelics began shortly after college, at a dance club in Amsterdam, where he was introduced to candy flipping — the combination of LSD and Ecstasy. The journey included visions of Jesus, his grandfather and “a dialogue with deep self,” all of which helped him work through what he described as a crippling toxic masculinity and a troubled relationship. “I died five times but it got me out of my dark hole and set me on my path,” said David, 49, a vegan who favors hemp clothing and is especially fond of the adjective “rad.”He also has a showman’s eye for attention-grabbing gestures, which got him arrested twice; once for sowing hemp seeds on the front lawn of the Drug Enforcement Administration and the other for milling hemp oil while locked in a cage in front of the White House.A storage room at the company’s headquarters. The patriarch’s writings and image are scattered throughout the facility.John Francis Peters for The New York TimesThe company’s move to tether a large chunk of its corporate identity to psychedelics and the politics of drug reform have not always gone down well, especially with Trudy, 79, a former junior high school math teacher and regular Methodist churchgoer who winces when recalling the excesses of the 1960s. “I had friends who did the trippy stuff and it wasn’t always good,” she said. “On the other hand this country has a lot of mental health issues that need to be addressed.”Her lingering skepticism was dispelled by Michael’s recent turn to psychedelics. The shift came last year, when the medications he had long relied on to treat his anxiety and depression stopped working. It was then that he decided to try talk therapy paired with ketamine, a legal anesthetic and party drug that has been gaining increasing acceptance among mental health professionals.He compared the experience to a massage for the brain that helped cleared away much of his angst and despair. “I don’t want to oversell ketamine therapy as a miracle cure but it just stripped the rust away, gave me a reset and got me to a really good space,” he said.So far 21 employees or their dependents have signed up for the treatments, which can cost several thousand dollars.A battlefield anesthetic that is also used in veterinarian medicine, ketamine has only recently gained popularity as a therapy for hard-to-treat depression and suicidal ideation. Though the drug does not have F.D.A clearance for mental health conditions, doctors are allowed to prescribe it for so-called off-label use when they think it will provide benefits to a patient.Enthea, the health plan benefit administrator for the treatments, said 10 other companies were already following in Dr. Bronner’s footsteps. Many are driven by the prospect of reduced spending on mental health coverage and also with increasing employee productivity, Lia Mix, Enthea’s founder and chief executive, said.Emil Bronner didn’t do drugs, and he was distrustful of Western medicine, refusing to see a doctor even as he began losing his eyesight in his 60s. But his grandsons are sure he would have approved of their decision to make psychedelics a central component of the family business.“Our grandpa was all about shifting consciousness and opening hearts and minds,” David said, pausing for comic effect and flashing a mischievous grin: “He probably would have put LSD in his soaps.”The Bronner brothers vibing with a mural in front of a vat of sustainably sourced soap ingredients.John Francis Peters for The New York Times

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Avian Flu Spread in the U.S. Worries Poultry Industry

Though the risk to humans is low, scientists warn that outbreaks among farmed birds increase the potential for the virus to mutate and pose a threat to humans.A highly contagious and deadly form of avian influenza has been barreling across the eastern half of the United States in recent weeks, killing both wild birds and farmed poultry and raising fears that an unchecked outbreak could prove calamitous for an industry that was devastated by a similar virus seven years ago.Since early January, when it began killing chickens in northeast Canada, the virus has been identified in migratory waterfowl from Florida to Maine, and has infected backyard chickens in Virginia and New York and sickened thousands of turkeys in Kentucky and Indiana, prompting mass cullings and import bans.On Wednesday, federal officials announced that the virus, a so-called highly pathogenic avian influenza, had been found in a Delaware commercial chicken farm on the Delmarva Peninsula, home to one of the country’s largest concentrations of poultry farms.Experts suspect wild birds returning from winter feeding grounds are spreading the virus, most likely through contaminated droppings. With the peak springtime migration still weeks away, many fear the worst is yet to come.“It’s very concerning given how quickly this thing is accelerating,” said Henry Niman, a biochemist in Pittsburgh who studies the genetic evolution of viruses and has been tracking the outbreak’s spread across the country. “I think we could see historic levels of infections.”Federal officials have been urging poultry growers to report sick or dying birds and to tighten their farms’ biosecurity measures, which includes preventing contact between wild birds and domestic animals.“It’s important to note that avian influenza is not considered to be a risk to public health and it’s not a food-safety risk,” Mike Stepien, a spokesman for the Department of Agriculture’s Animal and Plant Health Inspection Service, said in an email.Although the danger to humans is low, scientists are keeping a close eye on the virus, the Eurasian H5N1, which is closely related to an Asian strain that has infected hundreds of people since 2003, mostly those who had worked with infected poultry. That virus does not spread efficiently among humans, but it is extremely deadly, with a fatality rate of 60 percent, according to the Centers for Disease Control and Prevention.The strain currently spreading across the United States has not jumped to humans, but virologists and epidemiologists say the mounting infections among birds is worrisome because it increases the possibility that the virus could mutate in ways that make it more infectious to people.Dr. Gail Hansen, a public health veterinarian who is the former state epidemiologist for Kansas, noted that influenza viruses have historically been behind the pandemics that affect humans. Some medical historians have traced the deadly influenza pandemic of 1918 to Army recruits in Kansas who may have caught the pathogen from farm animals and then spread it to military camps in Europe.“Scientists always assumed the next pandemic would be a respiratory influenza,” she said. “We were wrong with Covid, but it’s these kinds of viruses that keep us awake at night.”Young turkeys at an Iowa barn in 2015, after a devastating avian influenza outbreak that year. The avian flu circulating now has sickened thousands of turkeys in Kentucky and Indiana.Charlie Neibergall/Associated PressThe virus has also been coursing through Asia, the Middle East and Europe. In recent weeks, 300 outbreaks have been reported in 29 European countries. In Israel, an outbreak at a nature reserve killed thousands of cranes.At the moment turkey farmers, especially those in Indiana and Kentucky, are most worried. Over the past two weeks, several farms in those states have been shuttered after officials discovered the virus among birds that spend their entire lives crammed into massive sheds. Farmers say they have been stunned by how efficiently the virus kills, with animals dying hours after the initial infection.In Indiana, state officials have moved quickly, euthanizing more than 100,000 birds and throwing a six-mile cordon around affected farms — a containment area within which exports are halted and birds are tested daily.“Everyone is on super-high alert and trying to be as prepared as possible because we all remember the devastation of 2014 and 2015,” said Dr. Denise Heard, a veterinarian with the U.S. Poultry & Egg Association.The 2014-15 outbreak is considered the most destructive in the nation’s history. It sent poultry and egg prices soaring and cost the industry more than $3 billion — though the federal government compensated farmers for lost flocks. In the end, nearly 50 million birds were killed by the virus or destroyed to prevent its spread, a vast majority of them in Iowa and Minnesota.John Burkel, 54, a fourth-generation turkey grower in northern Minnesota, has been watching the spread with trepidation. In 2015, the virus tore through his farm in a matter of days, leaving just 70 survivors in a shed that had held 7,000 birds. The weeks that followed were spent culling, composting the dead and then repeatedly disinfecting the barns.As a precaution, health officials also advised that he and his son take a course of the antiviral drug Tamiflu. “We’ve never seen a virus that virulent,” said Mr. Burkel, a state legislator who works the farm with his wife and two children. “It was just horrible.”Since then, agriculture officials across the country have pushed farmers to embrace an array of biosecurity measures aimed at preventing outbreaks. They include sealing up tiny holes that might allow mice or sparrows to enter barns, disinfecting the tires of feed-delivery trucks before they enter a farm and creating “clean” and “dirty” zones where workers can change into fresh footwear and coveralls before stepping inside an animal containment shed.At the same time, experts say that federal officials have strengthened the nationwide system of surveillance that allows researchers to track, in almost real time, an avian flu’s spread within wild bird populations. “I think the crisis of 2015 made us realize it takes a village to prevent an outbreak and has left us much better prepared,” said Dr. Yuko Sato, a poultry veterinarian at Iowa State University who advises local farmers about improving their biosecurity practices.But hypervigilance has its limits, especially against a microscopic pathogen that can infiltrate a barn on the leg of a single housefly. For a growing number of scientists, the real threat is the nation’s industrialized system of meat and dairy production, with its reliance on genetically identical creatures packed by the thousands inside huge confinement sheds.Nearly all the nine billion chickens raised and slaughtered in the United States each year can trace their lineage to a handful of breeds that have been manipulated to favor fast growth and plump breasts. The birds are also exceptionally vulnerable to outbreaks of disease. “They all have the same immune system, or lack of an immune system, so once a virus gets inside a barn, it’s going to spread like wildfire,” said Dr. Hansen, the public health veterinarian.Andrew deCoriolis, the executive director of Farm Forward, a sustainable agriculture advocacy group, said the lack of genetic diversity isn’t just a threat to the nation’s food supply; it is also a potential threat to public health. More than half the 22 strains of novel influenza virus that the C.D.C. has identified as “of special concern” to human health are avian influenza viruses, he said, noting that a 2018 study examining the emergence of 39 highly pathogenic avian viruses found that all two of them had emerged on industrial poultry farms.He said the sector’s emphasis on biosecurity and infection containment obscures a larger, thornier issue that requires a fundamental rethinking of meat and egg production in the United States.“Instead of asking how factory farms can prevent infections that originate in the environment, which is how they frame it now, we should be asking how they can prevent infections that originate on factory farms,” he said. “If we keep raising more and more animals in these conditions, we should expect the exact outcome we’re getting because that’s how the system is set up.”

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Hedgehogs Are a Source of Drug-Resistant Bacteria, Study Finds

Scientists chart how a battle between fungus and bacteria living on the skin of hedgehogs led to the emergence of a strain of MRSA that can infect cows and humans.The tiny, spiny and adorable hedgehog is helping to upend conventional wisdom about the origins of drug-resistant bacterial infections that kill thousands of people each year.In a study published Wednesday in Nature, a group of international scientists found that the bacteria that cause a tough-to-treat infection existed in nature long before modern antibiotics began to be mass produced in the 1940s. The drugs have saved countless lives, but the wide distribution of antibiotics in the decades since then has also spurred an evolutionary arms race with the pathogens they target, leading to the emergence of dreaded superbugs that have evaded our efforts to vanquish them with pharmaceuticals.The key to the scientists’ paradigm-altering theory? Danish roadkill.When researchers examined hundreds of dead hedgehogs from Denmark and other countries in Western Europe, they found MRSA, or methicillin-resistant staphylococcus aureus, living on the skin of the vast majority of the animals. That was surprising, given that the animals had not been exposed to penicillin, though MRSA does colonize many mammals, including humans, where they can live harmlessly inside the nose or on the skin. The danger arises when these bacteria enter the bloodstream through a wound or intravenous tube, with potentially deadly consequences for those with weakened immune systems.The scientists were also intrigued by another pathogen they found on many of those same hedgehogs: a skin fungus that produces a penicillin-like substance which inhibits the growth of staphylococcus aureus. Like modern antimicrobials, this naturally occurring antibiotic is in constant battle with the staph bacteria that compete for nutrients on the hedgehog’s skin. Over time, some of those bacteria developed an ability to outsmart their fungal rivals and thrive on their hedgehog hosts, the study showed.What likely happened next is a familiar tale in the annals of infectious disease. The particular strain of MRSA that colonized the hedgehogs, known as mecC-MRSA, later found its way to dairy cows in rural areas where both creatures flourish, and eventually to humans. In Denmark, mecC-MRSA sickens 10 to 30 people a year.Through genetic coding of the hedgehog-borne mecC-MRSA, researchers were able to establish a timeline of its evolution back to the early 1800s, long before Alexander Fleming stumbled on a speck of mold in a petri dish that was repelling a spreading Staphylococcus colony.Anders Rhod Larsen, a microbiologist and a lead author of the paper, said the findings added a new wrinkle to the predominant narrative that the overuse of antibiotics was solely responsible for the rise of superbugs. “The main message is that MRSA predates antibiotic use in humans, but the broader theme is that we are not alone in this world,” said Dr. Larsen, who leads the National Reference Laboratory for Antimicrobial Resistance at Statens Serum Institut in Copenhagen. “Antibiotic resistance does not have any boundaries and it can be transmitted between species.”Anders Rhod Larsen, a microbiologist at Statens Serum Institut in Copenhagen, with samples of MRSA bacteria.Ciril Jazbec for The New York TimesResearchers not involved with the study said the findings helped to confirm long-held assumptions about the dynamics of antibiotic resistance. Antimicrobial substances, after all, are abundant in nature, and bacteria and fungi have long found ways to outsmart these compounds.Lance Price, who leads the Antibiotic Resistance Action Center at George Washington University, commended the research for documenting the process in the real world, and with such precision.“This is such an interesting story because who doesn’t love hedgehogs,” he said. “But what’s important about this paper is it shows the natural evolution of a drug-resistant human pathogen.”Tara C. Smith, an epidemiologist at Kent State University College of Public Health who studies livestock-associated MRSA, said the study helped highlight the role that animals played as reservoirs of antimicrobial resistance. “It really just steps up the need for better antibiotic stewardship and to take heed of what we’re using, both in human medicine and animal medicine,” she said.The MRSA that infected the hedgehogs did not appear to sicken them, but its overwhelming presence on the animals sampled from Denmark largely corresponded with mecC-MRSA’s prevalence among humans in that country. First discovered in 2011, mecC-MRSA has since spread to dairy herds across northern Europe and it can sometimes cause infections in cows but has rarely sickened humans.Jesper Larsen, another lead author of the paper and a senior researcher at Statens Serum Institut, said the results had already inspired him and other researchers to expand their focus on antibiotic resistance in wild animals. But he cautioned against any notion that naturally occurring resistance somehow lessened the urgency to curb the use of antimicrobial drugs to treat illness in humans.“The lesson here is that when we overuse antibiotics, we accelerate what is already happening in nature,” he said.There is perhaps another lesson from the study, Dr. Larsen added. Although the risks of humans contracting MRSA directly from hedgehogs are likely minimal, maintaining a healthy distance from the animals was always prudent.“If you see a hedgehog in your backyard,” he said, “you should probably avoid kissing it.”And responsible pet hedgehog owners already knew that it’s best not to snuggle with the animals.

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National Guard members take on new roles at nursing homes.

NEW HOPE, Minn. — Pfc. Shina Vang and his fellow soldiers in the Minnesota National Guard have had an exceptionally busy year. They helped process Afghan refugees fleeing Kabul for the United States, provided security at American military bases across the Horn of Africa and stood sentinel in Washington, D.C., following the Jan. 6 attacks on the U.S. Capitol. They also deployed across Minnesota during the civil unrest prompted by the police killings of George Floyd in Minneapolis and Daunte Wright in nearby Brooklyn Center.But none of those experiences prepared Private Vang and his fellow Guard members for their latest deployment: collecting bedpans, clipping toenails and feeding residents at North Ridge Health and Rehab, a sprawling nursing home in suburban Minneapolis that is the largest in the state.“I’ve had protesters throw apples and water bottles at me but that doesn’t compare to the challenge of giving someone a bed bath,” Private Vang said.Over the past two weeks, 30 Guard members have been working as certified nursing assistants at North Ridge, which has been so badly hobbled by an exodus of employees that administrators have been forced to mothball entire wings, severely limiting new admissions.As a result, hospitals cannot send patients to long-term care centers like North Ridge, creating a backup that is eroding Minnesota’s capacity to treat people with Covid-19 and other medical emergencies. Similar backlogs are choking health systems across the country.“It’s beyond a crisis,” said Katie Smith Sloan, the president of LeadingAge, an association of nonprofit long-term care facilities.On Tuesday, President Biden announced that 1,000 military medical professionals would be dispatched to hospitals across the country this winter to help overwhelmed doctors and nurses.Public health experts fear the worst is yet to come as the highly transmissible Omicron variant spreads to communities where health care workers are already straining to handle the surge of patients sickened by Delta. Maine, New Hampshire, Indiana and New York have deployed the National Guard to overburdened hospitals and nursing homes in recent weeks, but Minnesota’s initiative may be the most ambitious, with 400 guard members who have no previous nursing experience going through rapid-fire training before being sent to long-term care facilities across the state.

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National Guard Takes on New Roles in Understaffed Nursing Homes

In Minnesota, an ambitious initiative is training hundreds of Guard members to become certified nursing assistants and relieve burned out nursing home workers.NEW HOPE, Minn. — Pfc. Shina Vang and his fellow soldiers in the Minnesota National Guard have had an exceptionally busy year. They helped process Afghan refugees fleeing Kabul for the United States, provided security at American military bases across the Horn of Africa and stood sentinel in Washington, D.C., following the Jan. 6 attacks on the U.S. Capitol.Closer to home, they have been deployed across Minnesota during the civil unrest prompted by the police killings of George Floyd in Minneapolis and Daunte Wright in nearby Brooklyn Center.But none of those experiences prepared Private Vang and his fellow Guard members for their latest deployment: collecting bedpans, clipping toenails and feeding residents at North Ridge Health and Rehab, a sprawling nursing home in suburban Minneapolis that is the largest in the state.“I’ve had protesters throw apples and water bottles at me but that doesn’t compare to the challenge of giving someone a bed bath,” Private Vang said.Over the past two weeks, 30 Guard members have been working as certified nursing assistants at North Ridge, which has been so badly hobbled by an exodus of employees that administrators have been forced to mothball entire wings, severely limiting new admissions.As a result, hospitals cannot send patients to long-term care centers like North Ridge, creating a backup that is eroding Minnesota’s capacity to treat people with Covid-19 and other medical emergencies. Similar backlogs — hospital patients well enough to be discharged but too fragile to go home — are choking health systems across the country.“It’s beyond a crisis,” said Katie Smith Sloan, the president of LeadingAge, an association of nonprofit long-term care facilities. “For many providers across the country, it’s a collapse.”Minnesota National Guard member Nena Yochim on dish duty at North Ridge Health and Rehab.Tim Gruber for The New York TimesGuard member Gabriel Adepoju served a meal to Donald Pike, a resident at North Ridge. The nursing home has been hit especially hard by the pandemic, with more than 592 cases and 52 Covid deaths among its residents since March 2020.Tim Gruber for The New York TimesOn Tuesday, President Biden announced that 1,000 military medical professionals would be dispatched to hospitals across the country this winter to help overwhelmed doctors and nurses.Public health experts fear the worst is yet to come as the highly transmissible Omicron variant spreads to communities where health care workers are already straining to handle the surge of patients sickened by Delta. Maine, New Hampshire, Indiana and New York have deployed the National Guard to overburdened hospitals and nursing homes in recent weeks, but Minnesota’s initiative may be the most ambitious, with 400 guard members who have no previous nursing experience going through rapid-fire training before being sent to long-term care facilities across the state.Last week, chief executives from nine of the state’s largest hospital networks took out advertisements in Minnesota newspapers beseeching residents to get vaccinated and to take other steps to limit transmission of the coronavirus. “We’re overwhelmed,” the ads said.Gov. Tim Walz, a Democrat and National Guard veteran whose mother was a nursing assistant, said he conceived of the program as a stopgap measure.“Our health care work force is heartbroken and fatigued,” Governor Walz said in an interview on Tuesday, not long after learning that he and his wife and son had tested positive for the coronavirus. “Having the Guard provide a bit of a respite is a godsend but just to be clear, looking to the horizon we don’t see an end to the surge right now.”Staffing shortages have long been a problem for nursing homes in the United States, but the coronavirus has pushed many to the brink as low-wage aides retire early or quit for jobs that are better paid and less taxing. “The pandemic has underscored the system’s fragility, and the need for fundamental change,” said R. Tamara Konetzka, an expert in the economics of long-term care at the University of Chicago.In Minnesota, that means 23,000 nursing home positions were unfilled in October, up from 8,000 last March, according to a survey of providers.North Ridge has been hit especially hard by the pandemic, with more than 592 cases and 52 Covid deaths among its residents since March 2020, according to the Centers for Medicare and Medicaid Services, though the vast majority of those cases, 472, were among patients already sickened by Covid when they arrived. Over the past four years, North Ridge has been fined more than $180,000 by federal inspectors, and cited for a number of health and safety violations. It has received two out of five stars for overall care from C.M.S., a “below average” rating.A study guide for training National Guard members.Tim Gruber for The New York TimesColin Jones, center, and other Guard members getting briefed before a shift this month.Tim Gruber for The New York TimesAustin Blilie, the vice president of operations, said the two-star rating was based on surveys from 2018, and that North Ridge had greatly improved the quality of care since then. He noted that the most recent rating from earlier this year gave the facility five stars for staffing quality. The 8.5 percent mortality rate for Covid patients at North Ridge, he added, was less than half the state average for patients in congregate care settings.“Every time I look at the numbers of those who we lost, I am struck anew by the fact that every one represents an individual person, with a life and a history, and connections to other people,” he said. “Please know that we never lose sight of that here.”A low-slung collection of brown and tan brick buildings, North Ridge has 320 beds, but 100 of those are empty at the moment because of staff shortages. The employees that remain have been running ragged as they work overtime, and on some days, administrators, dietitians and physical therapists are forced to help with making beds and filling water pitchers. “We do what we can because the show must go on,” said Liz Ellenz, 37, the director of dining, who often works weekends and stays until 9 p.m. washing dishes. “Some days are really dark.”But on Thursday, Ms. Ellenz was positively giddy as five Guard members zipped around the kitchen with soldierly purpose and precision. They hosed down food carts, bagged trash and helped prepare the day’s lunch: ham and macaroni au gratin, stir-fried snow peas and citrus gelatin cubes.One of them, Staff Sgt. Nathan Madden, 47, whose civilian job is an assistant manager at a home improvement store, said the past two weeks had given him a newfound appreciation for those who care for the sick and the elderly. His past deployments have taken him to Kuwait, Croatia and, more recently, the Minneapolis courthouse where Derek Chauvin was on trial for the murder of Mr. Floyd. “This kind of work is humbling for sure,” Sergeant Madden said, adjusting the hairnet on his head. “It’s great to help out in the community, but I have older parents, so in a way this is preparing me for what I might have to do one day.”Certified nursing assistants, the workhorses of long-term care facilities, normally go through five weeks of training before taking final exams, but nursing school leaders condensed the program to eight 10-hour days. “It feels like we’re supporting a natural disaster,” said Traci Krause, the director of nursing at Minneapolis Community & Technical College, as a group of students practiced pulse taking and face washing on bed-bound mannequins.Isabella Ommodt, left, and Noah Perron of the National Guard trained with a dummy at the Minneapolis Community & Technical College in Minneapolis.Tim Gruber for The New York TimesMr. Jones with a device for moving patients in a North Ridge hallway.Tim Gruber for The New York TimesBesides gestures like providing free pizza and ice cream, there isn’t much North Ridge’s administrators can do to stem the exodus of staff members; the number of employees at the nursing home has dropped to 450 from 590 since the start of the pandemic. Although burnout and fears of infection have spurred some nursing assistants to quit, the root of the problem is money, employees and administrator say.North Ridge and other long-term care facilities in Minnesota that serve mostly patients on Medicaid pay around $16 an hour for newly hired nursing assistants. That’s comparable to what some fast-food outlets in and around New Hope have been offering. (Kitchen staff at North Ridge are paid even less: $11.25 an hour.)Such low wages are essentially tied to the state’s reimbursement rate for nursing home patients, which averages about $270 a day, according to the Minnesota Department of Human Services. Efforts by Governor Walz to raise reimbursement rates have stalled in the state’s politically divided legislature, as has his push to use some of the $1.2 billion in unspent Recovery Act funds on bonuses and raises for nursing aides.Fatimate Massquoi, a nursing manager at North Ridge, said meager pay coupled with the physical demands of the job, the anxieties of treating Covid patients and the unending loss, inevitably takes a toll. “People don’t know what it’s like to hold the hand of someone dying alone because their family isn’t allowed to be here,” she said. “Sometimes after a patient dies, I have to go into the bathroom to cry so no one will see me because I have to stay tough.”With Omicron racing across the country, staff and administrators worry about the weeks ahead. Only 60 percent of residents have received their booster shots, slightly higher than the national average, and a federal appeals court ruling last week means that North Ridge may have to fire the 10 percent of employees who remain unvaccinated.But last Thursday, Ms. Massquoi and her colleagues were feeling buoyant after learning that the National Guard would be staying an extra week, including 18 soldiers who had volunteered to work over the Christmas holiday. Having extra hands available does not mean North Ridge can increase its number of admissions, but it does allow exhausted workers to take a few days off.“The Guard has really given us the opportunity to take a breather, and allow people to spend time with their families and try to deal with the emotional burnout of the last 18 months,” said Mr. Blilie, the vice president of operations. “Hopefully, they’ll come back feeling a bit refreshed, and ready to go back at it.”

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Omicron and Vaccine Protection

Omicron and Vaccine ProtectionAndrew JacobsReporting on the coronavirusWhy are scientists worried?Early evidence suggests Omicron may be significantly more contagious than the highly contagious Delta variant. Because of a high number of mutations, scientists also worry Omicron might be able to dodge the immune system and vaccines more readily than previous variants. The makers of Regeneron have already indicated that their Covid antibody treatment might be less effective against Omicron but said tweaks to the drug can be made if necessary.

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