Soy, Oat and Almond Drinks Can be Called Milk: FDA

Plant-based beverage makers hailed the agency’s decision but objected to the recommendation for labels to specify the nutritional differences with cow’s milk.Oat, soy and almond drinks can keep the word milk in their names, the Food and Drug Administration proposed this week, in an effort to end a long-running battle between the powerful dairy industry and the plant-based upstarts that have been changing the way Americans consume cereal and flavor their coffee.Most consumers, the agency noted in its draft proposal, are aware that liquid extracts from plants have no relationship to the udder of a cow.But in a concession to the nation’s traditional milk producers, the F.D.A. also recommended that the packaging for plant-based drinks make clear the key nutritional differences between their products and cow’s milk. If a carton of rice milk contains less vitamin D or calcium than dairy milk does, for example, the label should provide that information to consumers, the agency said.Although the new labeling recommendations are described as voluntary, industry experts predicted that most companies would comply. The agency plans to issue a final decision after another period of public comment.“Today’s draft guidance was developed to help address the significant increase in plant-based milk alternative products that we have seen become available in the marketplace over the past decade,” Dr. Robert M. Califf, the F.D.A. commissioner, said in a statement. “The draft recommendations issued today should lead to providing consumers with clear labeling to give them the information they need to make informed nutrition and purchasing decisions on the products they buy for themselves and their families.”The F.D.A.’s guidance had been eagerly anticipated by dairy producers and the expansive plant-based food sector, which have been at loggerheads over whether the word “milk” on products that are derived from nuts and grains confuses consumers. The debate, which was kicked off four decades ago by the introduction of soy-based beverages, has taken on greater urgency amid a seismic shift in dietary habits. Products like oat milk continue to enjoy robust growth, while milk consumption has been on a downward trajectory for decades. Americans on average drink nearly half as much milk as they did in 1970, according to the U.S. Department of Agriculture.The growing embrace of beverages made from cashews, quinoa or flaxseed has been fueled in part by health concerns; some people buy them because they are lactose intolerant. And an increasing number of Americans cite either the desire for a vegan diet or dairy production’s contribution to climate change through the manure and methane produced by cows. Animal rights activists have sought to portray dairy farming as inherently cruel, a claim that has been rejected by the industry. For some consumers, the turn toward plant-based products is simply a matter of taste.Executives in the plant-based food sector had been anticipating a less favorable ruling, given the skepticism expressed by one of Dr. Califf’s recent predecessors, Dr. Scott Gottlieb. In 2018, he famously declared that “an almond doesn’t lactate” — comments that suggested the agency might seek a ban on the word “milk” for nondairy beverages.Madeline Cohen, a regulatory lawyer with the Good Food Institute, which promotes plant-derived food products, said the F.D.A.’s guidance was a welcome acknowledgment that consumers were savvy enough to know that coconut milk was not produced by lactating animals. “We know that consumers are going out and purposely buying these products,” she said. “No one is purchasing them by accident.”But she expressed disappointment with the new labeling recommendations, saying they were unnecessary and potentially confusing, especially given that some nutritional components in milk, such as protein and magnesium, are not lacking in the typical adult’s diet. “If anything, some groups of Americans are consuming too much protein,” she said, adding that people who care about the nutritional content of a plant-based drink can read the product’s existing back-of-the-carton label.Dairy producers had a similarly mixed reaction to the F.D.A.’s proposals. Alan Bjerga, a spokesman for the National Milk Producers Federation, expressed disappointment that the word “milk” could remain on cartons of plant-derived beverages. However, he said he thought the new nutritional labeling recommendations might persuade some companies to switch to words like “beverage” or “drink” rather than have to acknowledge that their products have less protein and calcium than plain, old-fashioned milk.“The fact that the F.D.A. is finally doing something after 40 years is positive for us,” he said.

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FDA Seeks More Authority to Oversee CBD Products

The agency wants Congress to intervene, saying it does not have adequate oversight powers to ensure the safety of the myriad cannabidiol products derived from hemp.Four years after Congress legalized hemp, spawning a vast, unregulated market for cannabidiol-infused beverages, gummies and lotions, the Food and Drug Administration said on Thursday it lacked the authority to regulate such products. Instead, the agency called on federal lawmakers to give it a stronger regulatory framework to address the health claims and safety concerns that have dogged the prolific CBD industry.Dr. Janet Woodcock, the F.D.A.’s principal deputy commissioner, said the agency’s existing regulatory methods governing the sale of food additives and dietary supplements were inappropriate for products containing CBD, the hemp-derived chemical whose promoters ascribe to it a dizzying welter of health benefits.Unlike tetrahydrocannabinol, or THC, the cannabis component that gets users high, CBD is not psychoactive. But there is little data to back up marketing claims that CBD can prevent diabetes, soothe anxiety or ease menstrual cramps.In a statement, Dr. Woodcock said an internal committee that she led at the agency was concerned about the overall paucity of scientific literature on CBD, and that some research suggested long-term use might be associated with liver toxicity and damage to men’s reproductive systems. Also unclear, she said, was whether CBD was safe for pregnant women and children. “For example, we have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm,” she said.The agency, which has a stricter review process for prescription drugs, has very relaxed oversight powers for consumer products like cosmetics and dietary supplements. It does not vet such products before they reach the market, but mainly responds to complaints of dangerous ingredients before investigating or trying to get them removed from store shelves.More About CannabisWith recreational marijuana becoming legal in several states, cannabis products are becoming more easily available and increasingly varied.A Weed Pioneer: Roland Conner is the first person with a criminal conviction to open a licensed cannabis dispensary with the state’s help.Risk for Children: A new study found that the ingestion of edibles by children under 6 has risen rapidly since the start of the pandemic, contributing to a “significant increase” in hospitalizations.Marijuana Pardons: President Biden pardoned thousands of people convicted of marijuana possession under federal law. But many others, including those convicted on state charges, are not eligible.A New Competition: The New York Growers Cup showcases small craft growers who are hoping to come up with the next big strain in weed.While waiting for Congress to decide whether to give it more control, the agency will continue to take action against companies that make specific health claims about CBD products, she said. “We will remain diligent in monitoring the marketplace,” Dr. Woodcock said.Industry groups expressed disappointment with the decision. They said they worried that the matter could languish in a closely divided Congress, despite bipartisan support for an industry that grew to nearly $6 billion in the four years since lawmakers removed hemp from the federal list of controlled substances.“The idea that we need to start from scratch on a completely new regulatory pathway is of great concern to us,” said Jonathan Miller, counsel for the U.S. Hemp Roundtable, a trade association.He and other industry supporters had been urging the F.D.A. to use existing regulatory frameworks for CBD. On Thursday, the agency definitively quashed that idea by rejecting petitions from three groups that had asked the F.D.A. to regulate CBD products the way it oversees dietary ingredients like caffeine, ginseng and echinacea.Jonathan Havens, a former legal counsel at the F.D.A. who now represents companies in the CBD industry, said many growers and manufacturers had grown frustrated with the F.D.A.’s inaction, which has contributed to a chaotic marketplace that has created confusion for consumers and financial uncertainty for businesses.“The F.D.A. has never wanted to deal with this issue,” he said. “And although that’s regrettable, it would be less regrettable if we knew that in 2018 and Congress could have dealt with it, particularly at a time when Congress wasn’t so sharply divided and bills more regularly emerged from both houses and reached the president’s desk.”Amid the regulatory vacuum, more than two dozen states have taken up CBD legislation, producing a patchwork of laws.Members of Congress have long expressed impatience with the F.D.A. on CBD regulation. Last September, a bipartisan group of legislators sent a letter to the agency complaining about its lack of cooperation on proposed legislation aimed at resolving the matter.On Thursday, several lawmakers who have worked on the issue expressed guarded optimism that Congress would be able to tackle the issue.“I’m encouraged by the F.D.A.’s announcement today and looking forward to finding a path forward,” Representative Angie Craig, Democrat of Minnesota, said in a statement, echoing remarks from Representative Morgan Griffith, a Virginia Republican who previously joined Ms. Craig to sponsor CBD legislation in the House.But other legislators struck a more combative tone. Representative James Comer, a Republican from Kentucky and the new chairman of the House Oversight and Accountability Committee, said he would use his committee position to investigate the F.D.A.’s decision to shift the matter to Congress.“The F.D.A. failed for too long to take steps to ensure the safety of hemp-derived dietary products, putting the health and safety of the American people at risk,” he wrote. “We need to be sure that the F.D.A. is not using this as an opportunity simply to leverage more authority and resources from Congress.”

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Legal Use of Hallucinogenic Mushrooms Begins in Oregon

On Jan. 1, Oregon became the first state to allow adult use of psilocybin “magic” mushrooms. Licensed guides will likely determine whether the program is a success.PORTLAND, Ore. — The curriculum was set, the students were enrolled and Oregon officials had signed off on nearly every detail of training for the first class of “magic” mushroom facilitators seeking state certification.But as the four-day session got underway inside a hotel conference room in early December, an important pedagogical tool was missing: the mushrooms themselves.That’s because state officials, two years after Oregon voters narrowly approved the adult use of psilocybin, were still hammering out the regulatory framework for the production and sale of the tawny hallucinogenic fungi.Instead, the students, most of them seasoned mental health professionals, would have to role play with one another using meditation or intensive breathing practices that could lead to altered states of consciousness — the next best thing to the kind of psychedelic trip they would encounter as licensed guides.Not that anyone was complaining.Like many of the two dozen students who paid nearly $10,000 for the course, Jason Wright, 48, a hospital psychiatric nurse in Portland, said he was thrilled to be part of a bold experiment with national implications. “It’s incredible to be on the front lines of something that has the potential to change our relationship with drugs that should never have been criminalized in the first place,” he said.On Jan. 1, Oregon became the first state in the nation to legalize the adult use of psilocybin, a naturally occurring psychedelic that has shown significant promise for treating severe depression, post-traumatic stress disorder and end-of-life anxiety among the terminally ill, among other mental health conditions.Although scientists are still working to understand their therapeutic dynamics, psilocybin and other psychedelics are thought to promote neuroplasticity, a rewiring of the brain that gives patients fresh perspectives on longstanding psychiatric problems.One recent study on alcohol-use disorder, for example, found that two doses of psilocybin paired with talk therapy led to an 83 percent decline in heavy drinking among participants, and that nearly half of them had stopped drinking entirely by the end of the eight-month trial.The long-term benefits, however, remain unclear.Measure 109, as it’s called, authorized the creation of psilocybin service centers where anyone over 21 can consume the mushrooms in a supervised setting. One key requirement is that a state-certified facilitator must be present during drug-induced journeys, which can last five or six hours.Unlike cannabis, which can be sold at dispensaries, Oregon will not allow the retail sale of psilocybin; consumption must take place at a licensed service center.“It’s incredible to be on the front lines of something that has the potential to change our relationship with drugs,” said Jason Wright, a psychiatric nurse from Portland.Amanda Lucier for The New York TimesFor drug reform supporters, Oregon’s approval of Measure 109 is nothing short of revolutionary, a seismic policy shift they hope will inspire other states and municipalities — and persuade federal authorities to ease longstanding prohibitions.Oregon voters also made history in 2020 by decisively voting to decriminalize the personal possession of small amounts of hard drugs like heroin, cocaine and methamphetamine.Although psilocybin and the other drugs remain illegal at the federal level — a regulatory clash that complicates the state’s headlong embrace of decriminalization — Oregon’s decision to overhaul its relationship with mind-altering compounds is already influencing other jurisdictions.In November, Colorado voters approved a ballot measure that removes criminal penalties for possessing certain psychedelics, and similar ballot measures and reform legislation have been introduced in New York, Washington and a dozen other states. Over the past three years, Washington D.C., Seattle and a score of American cities have also moved to decriminalize psilocybin.Mounting scientific interest in psychedelics has reached the highest levels of government. The Food and Drug Administration in 2018 granted psilocybin “breakthrough therapy” status for major depressive disorder, a designation that paved the way for clinical trials. Researchers say they expect full F.D.A. approval in the coming year or two. Another drug with strong therapeutic potential, MDMA, or Ecstasy, is likely to win F.D.A. approval even sooner for treating post-traumatic stress disorder.“Psychedelic medicine is starting to transcend partisan politics in a way that few issues have,” said Sam Chapman, executive director of the Healing Advocacy Fund, a nonprofit organization that backed Measure 109 and has been working to guide its implementation. “It’s our responsibility to create a golden standard that’s worthy of wider implementation.”Oregon’s experiment has not been without hiccups. The ballot measure’s passage created a backlash in rural, more conservative parts of the state. A subsequent ballot measure in November resulted in 25 of the state’s 36 counties voting to opt out of the program for now.The 120-hour course run by Fluence was open to anyone with a high school diploma but the program largely chose applicants with experience in the field of mental health.Amanda Lucier for The New York TimesThe prolonged regulatory vacuum provided an opening for entrepreneurs who jumped the gun. In early December, police raided Shroom House, a retailer in Portland that the authorities said was illegally selling psilocybin mushrooms and drawing long lines of customers.State officials say they are undaunted, even while acknowledging the gantlet of novel regulatory and logistical challenges. Psilocybin use is legal in a handful of countries, among them Brazil, Nepal and the Bahamas, but none have sought to create a system of supervised use.Angela Allbee, a policy analyst at the Oregon Health Authority who oversees the state’s psilocybin services section, said the process had been slow and bumpy at times, in part because officials sought to maximize public participation through advisory panels, public hearings and meetings with law enforcement officials.The biggest tensions erupted over the issue of affordability, given that psilocybin sessions will not be covered by insurance, at least as long as the federal government lists the drug as a Schedule 1 substance with “no currently accepted medical use.”A single session is likely to cost hundreds, if not thousands of dollars.One debate centered on whether to embrace a therapeutic model that would require more intensive, and costly, oversight by a psychotherapist, or a less rigorous approach that would allow anyone over 21 to access the drug, with or without a mental health diagnosis, as long as trained facilitators were present during the session. Health officials opted for the latter, which they are calling a “non-directed” approach.“Being the first in the nation means we have a responsibility to get this right and that sometimes means learning on the fly,” Ms. Allbee said.There was a palpable sense of excitement as the inaugural cohort of students gathered at the Dossier Hotel in downtown Portland for a 160-hour course run by Fluence, an education and training consultancy that offers certification in the nascent field of psychedelic-assisted therapy.Officials seeking to maximize public participation in the legalization debate said the biggest tensions were over affordability, since psilocybin will not be covered by insurance, at least for the time being.Amanda Lucier for The New York Times“It feels like I’m dreaming,” said Brian Pilecki, 43, a psychotherapist who was one of the instructors. “I never imagined this would happen in my lifetime.”The trainees included an ordained rabbi/clinical therapist who lives at an off-the-grid ranch near the town of Bend; a young psychiatrist disillusioned by the limitations of conventional psychotropic medications; and a trauma specialist who sheepishly described herself as a Christian fundamentalist shaped by a lifetime of antidrug sentiment.But the trauma therapist, Sherry Beckmann, 52, said her recent experience with deeply troubled war veterans convinced her to reconsider that antipathy after some of her patients had breakthroughs after a hallucinogenic experience. “The patients don’t lie,” said Ms. Beckmann, who has come to see the drugs as “spiritual gifts” from God. “It’s part of my own journey too. I mean I don’t know why I’m here today other than trusting a gut feeling.”The certification programs are open to anyone with a high school diploma who has passed a background check. Licensure is limited to Oregon residents until 2025. But the Fluence program largely chose applicants with previous experience in the field of mental health — social workers, hospice nurses and psychiatrists.The curriculum included significant emphasis on nontherapeutic matters, including Indigenous traditions involving hallucinogens, the negative social effects of U.S. drug policy and the impacts of systemic racism on marginalized populations.Although psilocybin is widely considered safe and serious adverse reactions are rare, the practical aspects of the course sought to prepare facilitators for potentially difficult moments, including sexual arousal or intense emotional eruptions, especially among those with repressed trauma.Nathan Howard, the director of operations at InnerTrek, another training company approved by the state, said the company was especially interested in applicants with a quality known as equanimity, or the ability to maintain calm in difficult situations. “You are going to be sitting with people undergoing perhaps one of the most intimate, intense experiences of their lives,” he said. “You don’t want to direct the experience — you’re there to observe — but you also might need to hold their hand at certain moments.”The first day of the Fluence course was largely devoted to self-reflection, with many students voicing frustration with the limitations of psychotropic drugs like Xanax or Zoloft that are used to treat the symptoms of mental illness, not the underlying causes. Others spoke reverentially about their own experiences with psychedelics.At one point, an instructor asked the students to close their eyes, meditate and think about what brought them to the hotel conference room. Later, they broke into small groups to share personal stories about times in their life they felt oppressed or marginalized. They also spoke about the lack of diversity within their ranks, prompting a round of soul-searching about their role in promoting a therapy that, for the time being, will likely only be available to the privileged few.But mostly there was elation that the long-awaited moment of legalized psychedelics had finally arrived. Mr. Wright, the hospital psychiatric nurse, said he had personally experienced the healing power of psychedelics and wanted his patients to experience those benefits as well.The prevailing model of psychiatric care, he said, was focused on calming patients who show up at the emergency room in the throes of a psychotic or manic episode. The drugs, Mr. Wright said, were effective at stabilizing patients, but many of them simply returned again because the underlying trauma or depression remained untreated. “I’m happy to be here,” he told the group, “so I can stop pushing ineffective drugs to my patients.”

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Can a Federally Funded ‘Netflix Model’ Fix the Broken Market for Antibiotics?

Shortages and drug-resistant germs have renewed attention on a $6 billion proposal in Congress that would reconfigure the way antimicrobial drugs are developed and sold.Recent shortages of amoxicillin, an effective antibiotic that pediatricians have long relied upon to treat strep throat and ear infections in children, have put a spotlight on an urgent global threat: the world’s shrinking arsenal of potent antibiotics and the lack of incentives to develop them.The broken marketplace for new antimicrobial drugs has stirred debate over a bill, languishing in Congress, that would dramatically reconfigure the way antibiotics are discovered and sold in the United States.The $6 billion measure, the Pasteur Act, would upend the conventional model that ties antibiotic profits to sales volume by creating a subscription-like system that would provide pharmaceutical companies an upfront payment in exchange for unlimited access to a drug once it is approved by the Food and Drug Administration.Some call it the Netflix model for antibiotics.The measure attempts to address the vexing economics of antibiotics: Promising new drugs often gather dust on pharmacy shelves because health providers would rather save them for patients whose infections don’t respond to existing ones. That’s because the more frequently an antibiotic is used, the more quickly it will lose its curative punch as the targeted bacteria develop the ability to survive.New antibiotics also tend to be expensive, a disincentive for hospital-based prescribers who will often turn to cheaper ones, making it even harder for drug companies to earn back their initial investmentAside from the shortages of drugs that still work, the shrinking toolbox of effective antimicrobials has become a silent global crisis that claims nearly 1.3 million lives a year. By 2050, the United Nations estimates that drug-resistant pathogens could kill 10 million people annually.“If we want antibiotics to work for our kids, our grandkids or ourselves in 10 years, we have to invest in the infrastructure today,” said Kevin Outterson, executive director of CARB-X, a nonprofit that provides funding for small biotechs developing novel antibiotics.By separating profits from sales volume, supporters of the bill hope that prescribers will save new drugs for patients whose infections are resistant to existing medications. Limiting their use, experts say, can help extend the life of a new antibiotic before evolutionary pressure creates a “superbug” all but impervious to available antimicrobials.The bill, a decade in the making, has bipartisan support and is widely backed by researchers, health care policy experts and drug company executives. But as momentum for the bill has gained steam, opposition has emerged from a small group of doctors and health care advocates, many of them critics of Big Pharma. They say the bill is a drug-industry giveaway — and unlikely to address the problem of antibiotic resistance.Senator Todd Young, a Republican of Indiana, is one of the bill’s co-sponsors. Michael A. McCoy for The New York TimesThe legislation’s prospects seemed grim in the final weeks of a lame duck session during which lawmakers often race to push through unfinished legislation. Concerns over cost had already prompted mainly Republican lawmakers to reduce its price tag by $5 billion, and Congress has been anxious to push through a final spending deal before the holidays.“The Covid-19 pandemic demonstrated America’s vulnerability to catastrophic public health crises, and it highlighted the urgency of taking reasonable measures to prevent them in the future,” Senator Todd Young, an Indiana Republican and one of the bill’s co-sponsors, said in an email. “The next public health crisis is already here: the emergence of bacteria resistant to antibiotic treatment.”In a letter to Congress in November, opponents of the measure said it would encourage the development of ineffective drugs, in part because of what they describe as flaws in the F.D.A.’s existing approval process for antibiotics. “Under the Pasteur Act, taxpayer dollars will be wasted as a blank check to pharmaceutical manufacturers for antimicrobials of limited benefit,” they wrote.One of the signers, Dr. Reshma Ramachandran, an assistant professor at the Yale School of Medicine, said the bill leaves in place a regulatory regimen for antibiotics that she and others contend allows companies to market drugs of questionable value. Her objection to the status quo centers on a central tenet of the F.D.A.’s antibiotics review process: New drugs can be approved under a concept known as noninferiority, which allows novel medications to be less effective than existing ones. Dr. Ramachandran, whose work focuses on antimicrobial resistance and health policy, and other critics of the bill said that the F.D.A. should adopt a system that requires drugmakers to prove that new antibiotics are superior to current ones.“As a clinician, it’s a huge concern for me that we could have new costly drugs on the market without regulatory oversight to actually ensure these drugs are clinically meaningful or that they even address resistant infections,” Dr. Ramachandran said.Many experts, however, say that such an approach is impractical and raises ethical questions. To establish whether a new antibiotic is superior to existing ones, researchers would have to conduct clinical trials that test the new therapy against a placebo or a drug they know to be less effective. For study participants battling an infection, getting a placebo or an inferior drug could prove deadly.“This whole superiority notion makes no sense. We don’t hold any drug to that standard,” said Kenneth E. Thorpe, a health policy official in the Clinton administration who is an adviser to the advocacy group Partnership to Fight Infectious Disease. “We need to spur innovation and get as many novel antibiotics as we can given the diversity of infections and the threat to human health if we fail.”Mr. Thorpe and others say that criticism of the legislation overlooks a key provision: The decision to fund any antibiotic must consider whether the drug meets a critical need. Such a determination will be guided by a panel of experts from the Department of Health and Human Services, the Centers for Disease Control and Prevention and a half-dozen other federal health agencies. The system would mirror the advisory committees that guide decision making at the F.D.A.“Components of the bill are designed to ensure this valuable funding goes to the right drugs,” said Dr. David Hyun, who directs the Antibiotic Resistance Project at the Pew Charitable Trusts.Diane Shader Smith, right, with her daughter, Mallory Smith, as seen in the documentary “Salt in My Soul.” Mallory Smith died in 2017 from a drug-resistant infection when she was 25.Giant PicturesOver the 10-year life of the legislation, the federal government would make payments ranging from $750,000 to $3 billion to companies making “critical need antimicrobials.” An analysis by the Center for Global Development estimated that the $6 billion price tag for the legislation would yield $32 billion in savings over a decade and save 20,000 lives in the United States and 518,000 around the world.It can cost a $1 billion or more to bring a new drug to market, but earning back that investment has proved increasingly elusive. Unlike blockbuster medications for chronic conditions like diabetes or high blood pressure, most antibiotics are prescribed for just days or weeks. Many hospitals, unwilling to pay the high prices that accompany new therapies, prefer to rely on cheaper but less effective options, experts say.A number of antibiotic start-ups have gone bankrupt in recent years, sending a chill through the industry.The crisis has barely pierced the public’s consciousness, in part because many of those who succumb to drug-resistant infections are already battling other health problems. When a cancer patient dies from drug-resistant bacterial pneumonia, family members are likely to blame the cancer, not the infection.Diane Shader Smith has a firsthand appreciation for the challenges of trying to draw attention to abstract threats like antimicrobial resistance. Five years ago her daughter, Mallory, who had cystic fibrosis, died at 25 from a drug-resistant lung infection she contracted at age 12. The coroner noted her cause of death as cystic fibrosis.“I know what it’s like to live with a superbug and the damage it does to patients and their families,” said Ms. Shader Smith, a writer from California who has spent the past few years raising awareness about resistant infections.“I may end up in the hospital one day for a hip replacement, melanoma or some other illness, and I don’t want to contract an untreatable superbug,” said Ms. Shader Smith, who last month wrote a column in USA Today, urging Congress to pass the Pasteur Act. “The truth is that drug-resistant infections are a threat many of us will face at some point in our lives. The hard part is getting that threat to penetrate the consciousness of Americans.”Emily Cochrane contributed reporting from Washington, D.C.

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WHO Lists Top Fungi Health Threats

The pathogens cause infections that kill millions of people each year and often go undiagnosed. Even when identified, a growing number of infections is resistant to the current crop of drugs.The World Health Organization has released a ranking of fungi that threaten human health in its most ambitious effort to draw attention to a constellation of pathogens that are largely overlooked, even as they have become increasingly widespread, resistant to treatment and deadly.The health agency listed 19 invasive fungal diseases, including four it described as a “critical priority,” that collectively kill 1.3 million people and contribute to the death of five million others each year. Many of those deaths occur among people with H.I.V., cancer, tuberculosis and other underlying health conditions that leave them vulnerable to infection.Health officials say the death toll from fungal infections is likely much higher because many hospitals and clinics, especially in poorer countries, lack the diagnostic tools for detecting them.“The bottom line is that invasive fungal infections are becoming more prevalent, but frequently they are not recognized in patients and not correctly treated,” Dr. Carmem L. Pessoa-Silva, a W.H.O. official focused on disease surveillance and control, said at a news conference on Tuesday. “We do not have a real sense of the size of the problem.”The W.H.O. framed the report as a call to action, and officials said they hoped it would help lead to a greater sense of urgency among governments, drug developers, doctors and health policy experts.Climate change has helped to increase geographic range and prevalence of some infections, the W.H.O. said. The coronavirus pandemic has also led to a spike in fungal infections among Covid patients who end up in intensive care units, where stubborn pathogens like Candida auris sometimes flourish, then invade the body through breathing tubes and intravenous lines.In India, Mucormycosis, a rare but aggressive pathogen often referred to as “the black fungus,” has stalked thousands of Covid patients, some of whom have required disfiguring facial surgeries to remove the infections.Much like pernicious bacteria that evolve and become resistant to antibiotics through their overuse in people and agriculture, antifungal medications have been losing their curative punch in recent years. Scientists have said that rising rates of resistance to Aspergillus fumigatus, a common mold that can be fatal to those with weakened immunities, have been tied to the prodigious use of fungicides on cash crops like grapes, corn and cotton.Once a fungal infection enters the bloodstream, treatment becomes exponentially more difficult: Bloodstream infections with fungi in the candida family, for example, have a mortality rate of 30 percent. That figure is substantially higher among patients with Candida auris, one of the four “critical priority” fungi cited in the W.H.O. report. The fungus, a yeast first identified in Japan in 2009, has spread to four dozen countries and is often resistant to more than one drug.There are only four classes of drugs that treat fungal infections, “and very few new ones in the pipeline,” said Dr. Hatim Sati, another W.H.O. official who helped to write the report. Many of the existing drugs are so toxic, he said, that some patients cannot safely take them.Doctors and researchers said they were encouraged by the W.H.O.’s decision to turn a spotlight onto fungal infections. “This is long overdue given that fungal diseases have long been neglected even as the problem grows at an exponential rate,” said Dr. Cornelius J. Clancy, an infectious diseases doctor at the VA Pittsburgh Health Care System who did not contribute to the report.Dr. David Denning, chief executive of the advocacy group Global Action for Fungal Infections, said that in some ways, poor surveillance was the root of that neglect.The failure to diagnose fungal infections means that patients often go untreated, he said, citing research in Kenya, which found that better surveillance efforts for fungal meningitis would save 5,000 lives annually among people with H.I.V.The annual cost for widespread testing, he said, would be around $50,000.The lack of diagnosis has other unseen consequences, Dr. Denning said. He offered the hypothetical example of a leukemia patient who develops a fungal infection that proves fatal. “If that person dies from a fungal infection, their relatives might want to give money to a leukemia charity,” he said. “They aren’t going to give it to the fungal disease charity because the leukemia is the thing they knew about.”

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With Promise of Legalization, Psychedelic Companies Joust Over Future Profits

One patent application for psilocybin therapy claimed its treatment rooms were unique because they featured “muted colors,” high-fidelity sound systems and cozy furniture. Another sought exclusivity on a therapist reassuringly holding the hand of a patient. Then there’s the patent seeking a monopoly on nearly all methods of delivering the drug to patients, including vaginally and rectally.Humans have been consuming psilocybin, or “magic,” mushrooms for millenniums, and most synthetic hallucinogens have been around for decades. But as excitement about the promise of psychedelic medicine reaches a fever pitch, drawing hundreds of millions in investment, there is a growing scrum of psychedelic companies seeking to gain a financial edge through a blizzard of patent claims — or at least to scare off potential competitors.The patent application that described therapy room décor and drug delivery methods was filed by Compass Pathways, a psychedelic medicine company valued at $450 million, that, with at least 50 claims, has been especially aggressive with its intellectual property filings. Over the past three years, its competitors have collectively filed more than a hundred applications with the U.S. Patent and Trademark Office, some of which have been granted and others rejected.George Goldsmith, the co-founder and executive chairman of Compass, said the company’s patent strategy was necessary to ensure that psilocybin therapy would one day be available to people across the globe. He said that required raising hundreds of millions of dollars to conduct clinical trials at 150 sites in Europe and North America, the key to winning over regulators in multiple countries and for convincing both private and government insurers to cover psychedelic therapies. “It’s hard, tedious work that can’t be done as a philanthropic venture,” he said.Granted developing new drugs, proving their efficacy and safety through clinical trials and then winning approval from regulators is hugely expensive, and patents are often necessary to protect a company’s investment in that process.But the patent claims by Compass and other companies have provoked howls of derision from some scientists and patient advocates, who warn that corporate efforts to profit from existing drugs like psilocybin, LSD and Ecstasy could chill academic research and throttle public access by making new therapies prohibitively expensive.A treatment room of Compass Pathways, which is described in the patent, at King’s College Hospital in London.Tom Jamieson for The New York Times“I’m not anticapitalist or anti-profit making, but I am opposed to patent trolling, which is when you claim you invented something you didn’t invent,” said Carey Turnbull, who founded two psychedelic companies and now runs Freedom to Operate, an advocacy group that has been challenging psychedelic patent claims it views as flawed, including those filed by Compass. The clash over psychedelic-related intellectual property highlights the soaring expectations of investors, philanthropists and researchers who are rushing to shape an emerging field that many believe could revolutionize the treatment of depression, substance abuse, post-traumatic stress disorder and other mental health conditions.Robin Feldman, an expert on pharmaceutical intellectual property at the University of California Hastings College of Law, said the conflict over psychedelics reflects the larger problems of a patent system that saddles Americans with some of the highest prescription drug prices in the world. “It’s not pretty when you look under the hood,” she said. “With psychedelics, what we’re seeing is a clash of cultures between the altruism of those who want to use existing compounds in new and exciting ways crashing up against the realities of the patent system.”Though most psychedelic drugs remain illegal under federal law, the Food and Drug Administration has become more receptive to new uses for them. The agency is weighing approval of the therapeutic uses of MDMA, better known as Ecstasy, and psilocybin, which is undergoing accelerated review. Three years ago, the F.D.A. approved esketamine, a nasal spray derived from the anesthetic ketamine, for depression that is resistant to other types of treatment.For the first time in decades, the National Institutes of Health has begun funding psychedelic research, and many of the country’s premier universities have been racing to set up psychedelic research centers. A number of them have also entered into partnerships with drug companies, which are seeking to patent new therapies — and share any future profits.Seattle, Denver, Oakland, Calif., and Washington, D.C. are among a score of municipalities that have decriminalized psilocybin mushrooms. In January, Oregon will become to first state to offer psilocybin therapy in a clinical setting.Investment has been pouring into the three dozen publicly listed companies — most of which didn’t exist four years ago. According to InsightAce Analytic, a market research firm, the psychedelic therapeutics market was worth $3.6 billion in 2021 and is expected to reach $8.3 billion by 2028, though many companies, like their biotech start-up cousins and the overall market, have been buffeted by declining stock prices in recent months.“It feels like it came out of nowhere with a very powerful, attention-grabbing debut,” said Ritu Baral, an analyst who follows the psychedelics sector for the investment bank Cowen.The shifting terrain is bracing for veteran psychedelic researchers who kept the flame alive during the nation’s concerted war on drugs, when funding evaporated. On one hand, they are thrilled by the gush of promising new studies, positive media coverage and unexpected support from conservative politicians moved by the stories of traumatized combat veterans healed by psychedelic-assisted therapy.A lab-grown Psilocybe mushroom in Canada.Alana Paterson for The New York TimesBut like many longtime researchers, Robert Jesse, who helped start the psilocybin research division at Johns Hopkins University over two decades ago, sees potential pitfalls. To him, psychedelics are spiritual tools that belong to all of humanity, not just those wealthy enough to afford a $5,000 psychedelic retreat.“While I’m not a conventionally religious person, my early experiences with psychedelics changed my worldview in religious ways,” said Mr. Jesse, who in 2005 filed an amicus brief to the U.S. Supreme Court on behalf of a religious group that was seeking to import the natural hallucinogenic ayahuasca for its ceremonies. The court ruled unanimously in the group’s favor.Mr. Jesse said corporatization threatens to take the psychedelic field in potentially troubling directions. The surge of money is luring away talented scientists from research at academic institutions. The promise of hefty returns for investors, he and other experts have said, has also led to a decline in the philanthropic largess that has sustained psychedelic research in recent years.But it’s the flood of patent filings that most worries Mr. Jesse, given the time and the millions of dollars it can take to fight a patent claim, even one that a court eventually dismisses as meritless. “It’s a scorched-earth approach, in that a company can generate intellectual property that scares others from entering the field,” he said.Mr. Goldsmith, the Compass executive, looks visibly pained when he hears such criticisms. In a video interview, he spoke about why he and his wife started the company: their frustration over the failure of existing drugs to treat their college-age son when he was struggling with depression. “Do we try to change the system, or do we try to help those people in an imperfect system?” Mr. Goldsmith asked. “We chose the latter.”The company’s patent strategy, Mr. Goldsmith said, has been instrumental in coaxing more than $400 million from investors, among them the PayPal co-founder Peter Thiel. Compass is headquartered in London, though its stock trades on the Nasdaq.Other drug company executives disputed the idea that patent filings were cynical attempts to gain a monopoly over existing drugs. Doug Drysdale, the chief executive of Cybin, a three-year-old psychedelics company based in Canada, said patents protect the work of scientists trying to enhance the therapeutic value of existing drugs.He cited DMT, or dimenthyltryptamine, a naturally occurring hallucinogen known to produce intense experiences. The problem, he said, is that they are notably brief, sometimes lasting just five minutes to 10 minutes — perhaps not quite long enough to disrupt ingrained ways of thinking and help people with severe depression find new ways to apprehend their illness.Mr. Drysdale said the company had recently obtained a patent for an altered version of DMT that opened up the possibility of sessions lasting 30 minutes to 40 minutes. “It’s not modifying the molecule for modification’s sake,” he said. “If you’re asking investors for hundreds of millions of dollars, you need to have the intellectual property, otherwise there’s no way to get a return on investment.”A number of companies, including Cybin, have been working to create psilocybin analogues that produce experiences lasting two to three hours, roughly half the time required for the current therapy. Here, the goal is to lower the cost of treatment, given that many psychedelic sessions require the participation of two licensed professionals, a safeguard against potential patient abuse that markedly increases costs.Robert Jesse, who has studied psilocybin for twenty years, worried about the surge of patent filings. “It’s a scorched-earth approach,” he said.Brian L. Frank for The New York TimesDr. Stephen Ross, a founding member of New York University’s Psychedelic Research Group, said he feared that efforts to create much shorter psychedelic episodes without requiring psychotherapy could lead to bad experiences for patients and negative media attention, potentially spurring the kind of backlash that strangled the nascent field four decades ago during the nation’s war on drugs. “It could completely destroy all the progress of the past few years,” he said.In some ways, the business model for psychedelics is deeply problematic, analysts say. Most psychedelic therapies are based on just a handful of sessions, a potential obstacle to big profits. By contrast, many of the most lucrative drugs on the market — like those that treat diabetes, hypertension or kidney failure — are taken over the course of a lifetime.Psychedelic medicine is also complicated in another way: Most researchers are not seeking F.D.A. approval for the compounds alone, but rather for a package that pairs the drugs with talk therapy.The therapy, which often includes preparing patients for taking the drugs and helping them process the experience, is key to successful treatment, researchers say. Giving short shrift to it or overlooking the mind-set of the patient and the place where the sessions take place can lead to bad trips, especially for those with pre-existing psychiatric conditions like schizophrenia or bipolar disorder.Dr. Yvan Beaussant, a palliative care specialist at the Dana Farber Cancer Institute who has been studying psilocybin therapy for terminally ill patients, said that he worried the profit-driven model of drug development would shortchange psychotherapy.He and other researchers say they struggle to obtain grant money for clinical trials to determine the kind of talk therapy that works best. “Psychotherapy is not where the profit is for these companies,” he said.For now, the effort to rein in excessive patent claims is led by a group of four dozen intellectual property wonks and archivists who volunteer to trawl university libraries and scour long-forgotten research papers. Their database, Porta Sophia, or “Doorway to Wisdom,” aims to help U.S. patent officials assemble what’s known as “prior art,” evidence about a drug or therapy that has been overlooked or lost to time that patent examiners can use to reject a flawed or excessively broad patent application.David Casimir, a patent lawyer who started Porta Sophia, said that much of the earlier research on psychedelics was done before the advent of electronic databases, much of it by researchers who abandoned the field amid the government crackdown of the 1970s and 1980s.“We’re talking about sources of information that would be challenging for a patent reviewer to find on their own,” said Mr. Casimir, who began the project two years ago after becoming alarmed by what he saw as questionable patent claims. “If we’re doing our job correctly, the worst, most egregiously overreaching patents will have prior art available on our website for examiners to find.”In some cases, the organization itself challenges patent approvals. Mr. Casimir laughed when recalling one claim by a company that a combination of MDMA and LSD was novel. As any psychedelic aficionado well knows, he said, that combination has been around for decades and is fondly referred to as “candy flipping.”A month after Porta Sophia challenged the application, the company voluntarily scaled back its claims. Earlier this year, Porta Sophia also challenged the claims filed by Compass Pathways, the company that had described room décor and music in its patent application. In August, Compass withdrew the claims.The company, however, is still pursuing them abroad.

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Animal Rights Activists Await Verdict in Smithfield Piglet Case

The Utah trial has highlighted what the defendants argue is a lack of transparency for the treatment of animals at large corporate farms.As a matter of dollars and cents, the theft of two piglets from a sprawling farm in rural Utah was not a huge loss for its owner, Smithfield Foods, the world’s largest pork producer.But several weeks after a group of animal rights activists posted a video online of their nighttime incursion into the Circle Four Farms in Beaver County, local and federal law enforcement officials began a multistate investigation. F.B.I. agents raided animal sanctuaries in Utah and Colorado, and at one of them, government veterinarians sliced off a portion of a piglet’s ear in their search for DNA evidence of the crime.The stolen piglets were never recovered, and the federal government declined to pursue any charges. But Utah prosecutors filed felony burglary and theft charges against five of the activists, three of whom pleaded guilty to less serious misdemeanors in exchange for agreeing not to trespass on Smithfield property in Utah or to criticize the company online for three years.On Saturday, a jury began deliberating the fate of the two others, Wayne Hsiung and Paul Darwin Picklesimer, who face six years in prison in a case that has become a cause célèbre among activists focused on the plight of hogs, chickens and cows who spend their lives in so-called concentrated animal feeding operations.Animal welfare advocates say the trial has also become a showcase of corporate power, testing whether the meat industry can prevent the public from glimpsing behind the curtain and viewing the sometimes unsavory aspects of modern mass food production.Even the jury has been prevented from learning about the conditions on Circle Four Farm, which processes more than one million pigs a year and is one of the largest hog-producing facilities in the country. In a series of rulings, the judge has excised any testimony about animal welfare, blocked the jury from viewing the footage that the defendants filmed that day and even banned from the trial any mention of why the defendants trespassed in the first place.“This is a clear case of government overreach,” said Mary Corporon, a lawyer for Mr. Picklesimer, who filmed the raid. “Let’s face it, Joe Sixpack citizen can’t get the F.B.I. to try and solve the burglary of their TV or their grandmother’s ring because they’re not a major multinational corporation with immense political pull.”Smithfield declined to comment on the case, citing the continuing trial.The stolen piglets were worth at most $42.50 each, according to testimony from a state official.Prosecutors have rejected the suggestion they are acting on behalf of Smithfield, noting that a crime is a crime and that investigators acted only after the defendants publicized footage of their 2017 raid, which they had dubbed “Operation Deathstar.”But in court documents, prosecutors argued that the company’s reputation was harmed by the footage and other similar videos, including one published by The New York Times, as well as by protests by animal rights activists that targeted Costco, one of Smithfield’s biggest buyers.“The defamation campaign has caused reputation and public image damage to Costco and Smithfield,” prosecutors wrote.Justin Marceau, a law professor at the University of Denver and author of the book “Beyond Cages: Animal Law and Criminal Punishment,” said the prosecution was an unsubtle attempt to chill the growing movement of activists who use subterfuge and hidden cameras to document conditions on factory farms.Agricultural-producing states have been particularly aggressive in their efforts to quash the use of undercover footage by activists and whistle-blowers. In recent years, nearly a dozen states have passed so-called “ag-gag” laws that criminalize the taking of unauthorized video or photos on animal farms, though courts in recent years have struck down five of them as unconstitutional. Professor Marceau led the legal effort that overturned Utah’s law in 2017.“Prosecutors would have you believe this case is about burglary, but in reality, it’s a case about whether people can rescue animals in dire conditions that are now commonplace in our food system,” he said. “I can’t think of a more significant animal law case in recent history.”The defendants, members of the group Direct Action Everywhere, or DxE, were seeking to document the farm’s use of gestation crates, the metal enclosures for pregnant sows that critics say are cramped and inherently cruel. Smithfield had vowed to end their use by 2017, but Mr. Hsiung said the group encountered hundreds of them at Circle Four Farms.“The agonizing screams of pigs confined to these cages were so loud we couldn’t hear each other talk,” Mr. Hsiung said. The two piglets they took on their way out, he said, were sick and malnourished and would have most likely ended up in a dumpster.Jim Monroe, a Smithfield spokesman, said the company had largely phased out the use of gestation crates and was committed to improving the welfare of the tens of millions of pigs it raised each year. “Any deviation from our high standards for animal care is counterproductive to this mission,” he said in an email.Richard Piatt, a spokesman for Sean Reyes, the Utah attorney general, said the defendants had invited prosecution by publicly posting evidence of a crime. “Prosecutors feel there’s an obligation to acknowledge there was a burglary and theft,” he said.Indeed, Mr. Hsiung, a lawyer and a founder of DxE, has long embraced the kind of guerrilla tactics he knows can garner public attention from sympathizers and law enforcement officials. He has been arrested more than a dozen times in recent years, and he said he viewed the current trial as something of a teaching moment.“My goal is more transparency, so the American public can really see how their food is produced,” he said.It’s unclear whether the defendants have much support in Beaver County, a sparsely populated swath of high desert along the Nevada border where Smithfield is one of the largest employers. Emotions there have been especially high since last summer, when the company announced it was planning to shut down most of its operations there. Executives have blamed the downsizing on what they have described as onerous regulations in California, where many of its pigs are processed.In August, the judge granted a defense request to move the trial to a larger, adjacent county.The jurors will not be deliberating the fate of the two stolen piglets. Now full-grown, the piglets, known as Lucy and Ethel, are living at an animal sanctuary in Utah. According to activists, they are doing just fine.

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Psilocybin Therapy Sharply Reduces Excessive Drinking, Small Study Shows

Researchers said the results offered promise to the millions of Americans with alcohol use disorder.A small study on the therapeutic effects of using psychedelics to treat alcohol use disorder found that just two doses of psilocybin magic mushrooms paired with psychotherapy led to an 83 percent decline in heavy drinking among the participants. Those given a placebo reduced their alcohol intake by 51 percent.By the end of the eight-month trial, nearly half of those who received psilocybin had stopped drinking entirely compared with about a quarter of those given the placebo, according to the researchers.The study, published Wednesday in JAMA Psychiatry, is the latest in a cascade of new research exploring the benefits of mind-altering compounds to treat a range of mental health problems, from depression, anxiety and post-traumatic stress disorder to the existential dread experienced by the terminally ill.Although most psychedelics remain illegal under federal law, the Food and Drug Administration is weighing potential therapeutic uses for compounds like psilocybin, LSD and MDMA, the drug better known as Ecstasy.Dr. Michael Bogenschutz, director at NYU Langone Center for Psychedelic Medicine and the study’s lead investigator, said the findings offered hope for the nearly 15 million Americans who struggle with excessive drinking — roughly 5 percent of all adults. Excessive alcohol use kills an estimated 140,000 people each year.“These are exciting results,” Dr. Bogenschutz said. “Alcohol use disorder is a serious public health problem, and the effects of currently available treatments and medications tend to be small.”The double-blind randomized trial followed 93 participants for 32 weeks and divided them into two groups: One received psilocybin and the other a placebo in the form of antihistamine pills. The participants, all of whom struggled with excessive drinking, also took part in 12 therapy sessions that began several weeks before they received their first doses and continued for a month after the final dose. The psilocybin dosage was determined according to participants’ weight, and their heart rate and blood pressure were monitored during the eight-hour sessions.Although none of the participants who received psilocybin reported serious adverse effects, the study had one notable limitation: After each session, nearly all the study subjects were able to successfully guess whether they had received psilocybin or the placebo. “Biased expectancies could have influenced results,” the authors wrote, “so this issue remains a challenge for clinical research on psychedelics.”Mary Beth Orr of Burien, Wash., used to have five or six drinks every evening and more on the weekends before enrolling in the psilocybin study.Ted S. Warren/Associated PressMary Beth Orr, one of the study participants who received psilocybin, said the treatments helped alter her destructive relationship with alcohol. Although she never blacked out and described herself as a “classy drinker,” her life was nonetheless diminished by nightly boozing that left her feeling miserable in the morning.“I spent a lot of time every day thinking about not drinking in the evening,” said Ms. Orr, 69, a retired museum art technician who lives near Seattle. “I wanted to stop but couldn’t.”The psilocybin sessions, she said, were at times unnerving but ultimately illuminating. The mystical, dreamlike journeys included vivid splashes of color, fantastical creatures and an emotional encounter with her deceased father. “It was like a gorgeous show, with jewels and the sense of rushing through a tunnel with deity figures looking down at me from niches in the walls,” she said. Two therapists served as her guides as she lay on a sofa, her eyes masked while soothing music was piped into her headphones.Though less colorful and exhilarating, the second session was anchored by a pivotal, underwater conversation with a family member who she said had caused her immense pain over the years. At the end, she wished the relative well, and they parted with a kiss.The takeaway message, she said, was one of forgiveness, understanding and love, both for others and herself. “I’m no longer afraid of feelings, and I’m living a deeper life,” she said.More than three years after her last session, Ms. Orr said that she seldom drinks but allows herself the occasional glass of wine. “It’s not that I monitor my drinking, it’s just that I don’t think about it, which is the glorious part for me.”Scientists do not fully understand how psilocybin and other psychedelics work on the mind, but the drugs are thought to promote neuroplasticity, or a rewiring of the brain, enabling those with psychiatric problems to find new ways to address their illness and self-destructive behaviors.Dr. Matthew W. Johnson, a psychedelic researcher at Johns Hopkins Medicine who was not involved with the JAMA study, said he was encouraged by the results, in part because of the study’s comparatively large size and double-blind design. A previous, promising trial on psilocybin and alcoholic use disorder, he noted, had just 10 participants.“This really moves the field forward,” said Dr. Johnson, a professor of psychiatry and behavioral sciences who is conducting a federally funded study on the use of psilocybin for smoking cessation.He said the promise of psychedelics was especially exciting, given the current crop of anti-addiction therapies, most of which take aim at the cravings, withdrawal or drug-mediated reward receptors in the brain. Psilocybin and other psychedelic compounds, by contrast, appear to affect the psychological underpinnings of addiction, Dr. Johnson said.“This study adds to the literature suggesting that psychedelics may have general anti-addiction efficacy, which is really an odd thing because it’s rare for a potential medication to be effective for multiple forms of addiction,” he said.Dr. Bogenschutz, the study’s lead author, said a subsequent trial would include more than 200 participants and test the efficacy of a single dose of psilocybin. The trial will also use a different placebo, the vitamin niacin.On Monday, the F.D.A. approved the trial, which will be the largest to study the use of psilocybin-paired therapy for the treatment of alcohol use disorder.

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Use of Marijuana and Psychedelics Is Soaring Among Young Adults, Study Finds

The annual U.S. survey of substance use captures the growing mainstream acceptance of cannabis and hallucinogenic compounds.Marijuana and hallucinogen use among young adults reached an all-time record last year after having leveled off during the first year of the coronavirus pandemic, according to federal survey data.The findings, part of the government’s annual survey of drug use among young Americans, also found that nicotine vaping and excessive alcohol consumption continued to climb in 2021 after a brief pause. Another worrying trend among young people, ages 19 to 30: mounting consumption of alcoholic beverages suffused with THC, the psychoactive ingredient in cannabis.But there were some bright spots in the survey. Cigarette smoking and opioid abuse among young adults dropped last year, a continuing trend that has heartened public health experts.Taken in its entirety, the report provides a mixed picture of substance use in the United States that experts say reflects a number of disparate trends affecting young Americans: the devastating mental health effects of the pandemic; the increased availability of legal marijuana; and the emerging therapeutic embrace of psychedelics to treat depression, post-traumatic stress disorder and other psychological problems.“Overall, the results are very concerning,” said Dr. Nora Volkow, director of the National Institute on Drug Abuse, which publishes the annual Monitoring the Future survey. “What they tell us is that the problem of substance abuse among young people has gotten worse in this country, and that the pandemic, with all its mental stressors and turmoil, has likely contributed to the rise.”More About CannabisWith recreational marijuana becoming legal in several states, cannabis products are becoming more easily available and increasingly varied.An Aphrodisiac?: The data is scarce, but anecdotal evidence suggests that the right dose of cannabis can make a woman’s orgasms more satisfying and increase sex drive.Risks of Driving High: Research suggests that marijuana may be less likely than alcohol to lead to deadly car crashes. But experts still urge caution.Delta-8: This popular cannabis product claims to be milder than regular marijuana. But is it legal? And is it safe? Here is what you should know.Edibles and Kids: A growing number of children are inadvertently consuming marijuana-infused foods. This is what to do if it happens to the young ones in your life.The online survey of people ages 19 to 60 was conducted from April to October 2021.Substance use research experts said the mounting use of marijuana in young adults was especially notable. The survey found that 43 percent in the 19-30 age group had used cannabis 20 or more times over the previous month, up from 34 percent. In 2011, that figure was 29 percent. Daily marijuana consumption also jumped significantly, to 11 percent from 6 percent in 2011.Increases in use also occurred among people ages 35 to 50, according to the survey.Not surprisingly, the surge in marijuana use has been occurring in tandem with a rise in the number of states that have legalized recreational use — 19 in the past decade. (Another 13 states allow the medical use of cannabis.) Experts say the normalization of marijuana has helped persuade many young people that it is harmless.A similar dynamic, experts say, is also at play with psychedelics. The use of hallucinogens had been stable for decades, but in 2021, 8 percent of young adults reported using psychedelics compared with 3 percent in 2011, a record high since the category was first surveyed in 1988.Over the past few years, researchers say, increasing media coverage and social media chatter about the potential therapeutic value of ketamine, psilocybin mushrooms and ecstasy have helped chip away at long-held taboos that were fostered during the nation’s failed war on drugs.“It’s about availability, but also about peer acceptability,” said Dr. Kevin M. Gray, a professor of psychiatry and behavioral sciences at the Medical University of South Carolina. “Generally speaking, young people don’t see these substances as dangerous, but the consequences of using them are still there.”Although the risks associated with psychedelics tend to be short-lived — overdoses are rare and most compounds are not addictive — experts stress the importance of using them with professional guidance. Some states have decriminalized psilocybin, but it and other popular psychedelics remain prohibited under federal law, though the Food and Drug Administration is expected to grant approvals for some therapeutic uses in the coming years.With marijuana use, the dangers include the risks of impaired driving, the potential for addiction and the effects on mental health such as heightened anxiety, depression and temporary psychosis.Many of those risks have increased alongside the potency of THC levels in cannabis, and more so with vaping products, said Sion Kim Harris, co-director of the Center for Adolescent Substance Abuse Research at Boston Children’s Hospital. Some vaping concentrates contain THC levels of 90 percent or higher and the increased potency, she said, has contributed to a spike in cannabinoid hyperemesis syndrome, a condition that causes recurrent vomiting in heavy marijuana users.Overall, Professor Harris said she was encouraged by some of the survey’s trends, including the continued declines in tobacco use, especially among teenagers. The drop in smoking, she noted, highlighted the benefits of sustained and consistent public health messaging about the perils of tobacco. But she said the rise in drug and alcohol use among college-age individuals was worrisome, especially given the potential to form lifelong habits during those pivotal years. “Stress is a real contributor to increased substance use and it’s really been a tough time for millennials and Gen Z,” she said.Dr. Volkow, the N.I.D.A. director, agreed. Given the normalization of formerly illicit substances, she said public health experts needed to come up with more nuanced and thoughtful ways of communicating the potential dangers of recreational drugs that also have therapeutic benefits.“As a society, we tend to be very categorical about these things,” she said. “We say drugs are so bad they will fry your brains like an egg and then we undermine the evidence that they can be harmful, depending on the dose and the person who takes them. By making everything black and white, we lose all credibility.”

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