The legalization of cannabis in the United States—the biggest change in policy for an illegal substance since Prohibition ended—has been an unqualified success for approximately no one. True, the drug is widely available for commercial purchase, many marijuana-related charges have been dropped, and stoner culture has become more aligned with designer smoking paraphernalia featured on Goop than the bumbling spaciness of Cheech and Chong. But a significant part of the market is still underground, medical research is scant, and the aboveground market is not exactly thriving. Longtime marijuana activists are unhappy. Entrepreneurs are unhappy. So are people who buy weed, as well as those who think weed should never have been legal in the first place. The country is now poised to change the legal status of a new class of psychoactive drugs: psychedelics. They have shown early promise in treating mental-health issues, even though some enthusiasts are concerned that easing regulations without a better understanding of these drugs could put patients in a degree of danger. Oregon is now licensing centers that can administer psilocybin, and MDMA is moving toward FDA approval. In some ways, the fate of legalized pot could be read as a cautionary tale for how these drugs, too, could be left in a limbo that hardly anyone really likes. But as psychedelics enter the mainstream—becoming decriminalized, state-legal, or even FDA-approved—they will be dispensed and sold differently from marijuana. The process is unlikely to please everyone, but if advocates, manufacturers, and lawmakers can keep psychedelics from falling into the same traps that marijuana did, they have a chance of creating an industry that serves at least some Americans well. Despite its wide availability, cannabis is still illegal under federal law. Since 1970, it’s been listed as a Schedule I drug, meaning the government believes it carries a high likelihood of abuse and no medical value. Starting in the 1970s, states began passing laws lowering penalties for cannabis possession and allowing it for medical purposes and, eventually, recreational use. In 2013, U.S. Deputy Attorney General James M. Cole issued a memo declaring that the Justice Department would not strictly enforce federal marijuana laws in states that legalized it. Americans were eager to buy marijuana as states launched legalization programs, but in most states, cannabis hasn’t proved to be a great legal business. Because cannabis is still illegal at the federal level, many entrepreneurs don’t benefit from many of the tax breaks that other businesses do, meaning the industry essentially pays billions in extra taxes, according to an analysis by a cannabis-research firm. In most states, big corporations dominate the industry while small-business owners struggle to afford high licensing fees. One promise of legalization was its potential benefit to Black and Latino communities, who were disproportionately affected by the War on Drugs, but as of 2017, members of these communities accounted for single-digit percentages of state-sanctioned cannabis entrepreneurs. Because legal weed is sometimes more expensive than old-school dealer prices, plenty of people simply stick with the unregulated underground. In states like New York, the gap between what’s legal and what’s enforced has allowed illicit stores to pop up among the legitimate ones. [Read: America loves its unregulated wellness chemicals] That’s all in places where recreational use is legal. In the 14 states where only medical use is allowed, dispensaries must make a different calculus: They serve patients in need, but others treat them only as a loophole to access the drug—and are likely to go elsewhere if recreational access becomes available. In the 12 states where even medical marijuana is illegal, the only cannabis products legally available are a handful of medications that have been approved by the FDA, all for a narrow set of indications, such as vomiting among chemotherapy patients, AIDS-related anorexia, and certain kinds of seizures. Active clinical trials to study cannabis are few and far between, which means that the drug currently has no clear pathways to be federally approved for other indications. Psychedelics are much further behind in their journey to wider availability, but on the surface, they appear poised to mimic marijuana. The drugs are undergoing a sea change in public sentiment; Aaron Rodgers has a trip story, and so does Michael Bublé. Half of state governments have introduced psychedelics-related bills, some of them to form working groups that will dig into the science of psychedelics, and some to launch full-blown psilocybin industries. Assuming that reform moves at a comparable speed to cannabis, researchers have estimated that 25 states could legalize psychedelics in the next decade or so. Voters in Oregon and Colorado have already passed ballot initiatives that opened the way for psilocybin industries in their states. But instead of following marijuana’s trajectory for reform—first decriminalization, then medical legitimacy, followed by recreational use—psychedelics are barreling down all those avenues at once. State-regulated psilocybin centers are shaping up to be less like cannabis dispensaries and more like a hybrid of a psychotherapy office, a medical clinic, and a spa. Rules in the psilocybin industry are much more restrictive than those for cannabis ever were, because many people believe unlocking the possible benefits of these drugs requires more careful support and perceive the risks of a bad trip as higher. Whereas Oregonians over 21 can pop into a dispensary, flash an ID, and take their bud (or gummies, or soda, or cookies) home, adults seeking psilocybin must undergo a comprehensive mental- and physical-health screening, then ingest their dose under the supervision of a trained and licensed facilitator. Meanwhile, researchers and start-ups are pushing psychedelics forward on the medical front. We might see the first MDMA approval to treat PTSD as soon as August. [Read: What if psychedelics’ hallucinations are just a side effect?] This air of legitimacy—the idea that psychedelics could be more serious drugs than cannabis—gives drugs like MDMA and psilocybin certain advantages. Psychedelics research is booming in a way that marijuana research never really has. Few scientists have overcome the hurdles of studying cannabis; for instance, by most accounts, the government-grown weed that researchers have to use is less potent than what’s sold at dispensaries, and has been known to arrive in labs already moldy. And with the thriving black market, pharmaceutical companies have seemed uninterested in sponsoring cannabis clinical trials. But for psychedelics, which support much less illegal trade, start-ups and nonprofits are leaning hard into the clinical-trial route. Sue Sisley, a physician and marijuana researcher who previously developed clinical trials for marijuana, says psychedelics have moved toward legalization so quickly in large part because they’re following Big Pharma’s traditional drug-development playbook. In some ways, the FDA-forward approach is a gamble for people hoping to create a psychedelics industry. For one thing, Ariel Clark, an Anishinaabe cannabis and psychedelics attorney, worries that this pathway could put the drugs firmly out of (legal) reach for the people who could most benefit from the protections that come with legalization, including the Indigenous communities that already use some psychedelics in traditional ceremonies. Currently, a single psilocybin session at an Oregon service center costs thousands; companies that receive FDA approval could possibly further inflate the prices of approved psychedelics and treatment. (That has already happened with ketamine.) Additionally, FDA approval of proprietary psychedelics might still leave growers paying the same high taxes that have caused small-cannabis-business owners to fold. “Farmers already have really low margins,” and taxes don’t help, says Hadas Alterman, a partner at Plant Medicine Law Group and a member of Oregon’s Psilocybin Advisory Board’s equity subcommittee. But even in a scenario that leaves small-time entrepreneurs in the dust, some advocates argue that medicalization would be a net good. Medicalization might not lead the United States to a hallucinogenic utopia, but compared with underground use, it very well could increase access to psychedelics, improve patient safety, and build a functional (if inequitable) industry. Psychedelics manufacturers and people with the means to afford their pricey treatments might be perfectly happy with that outcome. [Read: Psychedelics open your brain. You might not like what falls in.] Psychedelics are still in uncharted territory in the U.S. Even though start-ups are investing millions on the assumption that they’ll be approved as medicines, and state-run programs are charging ahead with developing their own psychedelic industries, research on the drugs is still in early days, and their exact path to legalization remains murky. But at the very least, lawmakers have a great model of what not to do. “Folks sitting in government saw what happened with cannabis,” Clark told me. One can only assume that they don’t want to repeat the experience. from https://ift.tt/8K5RvFb Check out http://natthash.tumblr.com
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Within the next couple of decades, a new generation of contraceptives could hit the American market. One, a pill that blocks certain cells from accessing vitamin A, might be able to limit fertility without flooding the body with hormones; another is an injection that temporarily blocks up the reproductive plumbing. The method that’s furthest along in trials is a topical gel that promises to induce temporary infertility when smeared daily on the shoulders and upper arms—without affecting mood or libido. “Overall, we don’t have any serious adverse events at all,” Christina Wang, a contraceptive researcher at the Lundquist Institute in California, and one of the developers of the gel, told me. This coming slew of treatments will be notable not only for their imaginative delivery methods, but for their target audience: men. For decades, men hoping to manage their fertility have been limited to just two imperfect options—condoms or vasectomies. But in recent years, researchers have taken massive steps toward developing simple, convenient, and effective contraceptive options for men with virtually zero side effects. Soon, women may not be forced to bear nearly the entire burden of preventing pregnancy. But the coming innovations won’t just be about expanding the menu of options for men. Better male contraception wouldn’t be on the way if not for the many scientific paths that female contraception has paved. Now women’s birth control—much of which still comes with plenty of irksome, sometimes risky, side effects—seems due for some kickbacks. True, the logistics of keeping an egg from exiting an ovary don’t completely overlap with the mechanics of keeping sperm out of the female reproductive tract. But in principle, “there are a lot of similarities,” Diana Blithe, the chief of the NIH’s Contraceptive Development Program, told me, which means one can easily inform the other. With an eye on what’s now being accomplished for male contraception, researchers may soon be able to deliver to women new forms of birth control that aren’t just more tolerable, but also more on-demand, less invasive, or even usable on male and female reproductive systems alike. In the six-plus decades since the debut of the birth-control pill, the list of contraceptive choices for women has lengthened impressively. People can opt for barrier methods, or choose among pills, patches, and implants; they can receive injections a few times a year, or select an intrauterine device that can last up to 10 years. “We have so many options, it’s almost like you’re in a cereal aisle,” Amy Alspaugh, a nurse and reproductive-health researcher at the University of Tennessee at Knoxville, told me. Read: The calendar of human fertility is changing Many methods are also ever-improving: IUDs, implants, and injections now have longer lifespans and are easier to insert and remove; doses of hormonal contraception have dramatically decreased. “We used to give basically like a horse dose of estrogen and progestin,” Alspaugh told me. “Now we give the lowest dose that we know we can give and still have it be effective,” in order to minimize side effects. Some researchers have been exploring new ways to deliver contraception--microneedles, for instance, or even microchip technology that might allow women to remotely tune their birth control. (The latter idea has raised privacy concerns galore.) The Population Council, an NGO based in New York, has been working on a multipurpose vaginal ring that will, in addition to preventing pregnancy, release an antiviral to protect women against HIV, Régine Sitruk-Ware, a reproductive endocrinologist and contraception researcher at the nonprofit, told me. By and large, though, the changes to female contraception have been incremental—more ingredient swaps than whole new recipes. Categorically, “we’ve had the same offerings for pretty much 30 years now,” Heather Vahdat, the executive director of the Male Contraceptive Initiative, told me. And plenty of women remain dissatisfied with the inconveniences and risks that come with the choices at hand. Some experience weight gain, acne, or nasty mood swings, or worry about the risk of stroke that can come with hormone-based pills. Others balk at the often-painful placement process for IUDs. Manually inserting a device into the lower abdomen probably wouldn’t be acceptable in other contexts without anesthesia, and yet, for women’s contraception, “we’ve socialized that into something acceptable,” Brian Nguyen, an ob-gyn and contraception researcher at the University of Southern California, told me. Nonhormonal methods such as condoms, diaphragms, and spermicide are easy to come by, but generally less effective than hormonal ones. They can also come with their own side effects. And women could certainly benefit from a greater variety of on-demand methods, Vahdat told me—contraception for when you have sex, “not just in case you have sex”—that would save them the trouble of weathering side effects all month, year, or decade long. Over the years, some researchers have argued that significant inconveniences and side effects are acceptable for female contraception. Women, after all, are weighing those costs against pregnancy, itself a risky condition that can come with life-threatening complications; men, meanwhile, take contraception to prevent pregnancy in someone else. I asked Vahdat whether the typical side-effect profile of currently available female contraceptives would pass muster in any of the male methods in trials. “Based on history,” she told me, “I think that it would not.” Several other experts agreed. In 2011, a worldwide trial for an injectable hormonal contraceptive for men was halted when an independent safety-review committee determined that the drug’s side effects “outweighed the potential benefits.” The side effects in question included mood swings and depression, both of which are frequently experienced by women on birth control. And yet, most of the participants who stuck with the study said that they wanted to keep using the injection. In recent years, Nguyen has heard more and more of the men in contraceptive trials cite their female partners’ negative experiences with birth control as reason for their participation. “Many think of risk to their partner as a risk themselves,” he said. [Read: The different stakes of male and female birth control] Still, the strict standards for the tolerability of male birth control could raise the floor for female methods too. Such crossover advances are already in the works. Researchers took care to formulate the topical contraceptive for men with a dose of natural testosterone, alongside progestin, the active ingredient that halts sperm production; the idea, experts told me, is to better recapitulate what’s naturally seen in men’s bodies, to minimize unnecessary side effects. Many female hormonal contraceptives, meanwhile, rely on a synthetic compound called ethinylestradiol that incompletely mimics the estrogen women’s bodies make—and appears to raise the risk of blood clots. The Population Council is now working on another vaginal ring that replaces ethinylestradiol with hormones better matched to female biology. Other conveniences may be trickier to translate. For example, researchers hope to someday offer men a more easily reversible vasectomy, in which a dissolvable or removable hydrogel is inserted into the vas deferens. But experts told me that temporarily stopping up the fallopian tubes is simply harder. Plus, whereas sperm are churned out constantly, eggs are released for fertilization on a cycle that can be tricky to measure and predict—which can make side effects frustratingly tough to control too, Nguyen told me. Targeted interventions are also more easily delivered to the testes than the ovaries. And their success is easier to verify: Men have long been able to check their own sperm count with a device that’s similar to an at-home COVID test, but no parallel exists for women, Wang told me. And because sperm take months to produce, male hormonal contraceptives might be more forgiving to users who miss a day of treatment—unlike many pills designed for women, which tend to be less flexible, Mitchell Creinin, a contraceptive researcher at UC Davis Health, told me. [Read: A vaccine for birth control?] The difficulty of wrangling eggs, though, doesn’t have to mean limiting options for women. Conception can’t happen unless egg and sperm actually meet—which means that just about any drug designed to waylay the functionality or motility of sperm could play a role in the female reproductive tract. The options go way beyond spermicide: The Population Council is working on a product that will modify the vagina’s acidity to stop sperm from swimming properly, Sitruk-Ware told me. And Deborah Anderson, an immunologist and reproductive-health researcher at Boston University, has been working on a dissolvable film imbued with sperm-blocking antibodies that can be placed into the vagina before sex, and seem to persist at high enough levels to provide contraception for 24 to 48 hours, she told me. A couple of drugs being trialed for men could even someday be marketed to women in some form—among them, a sperm-motility-blocking drug that, experts told me, might be deployable in the female reproductive tract too. With all the attention now being paid to men’s contraceptive preferences, some researchers worry that women’s needs will fall even further to the wayside. Jeffrey Jensen, a contraception researcher at Oregon Health & Science University, told me that even as grants for male methods continue to be green-lighted, his team has had to pause work on some female-contraceptive projects because of lack of funding in recent years. “Policy makers think that we’ve checked the box and that we can move on,” he said. And Sitruk-Ware said that, although researchers had at one point started developing a topical contraceptive gel for women, “donors were more interested in the gel for men.” Still, the arrival of male contraception is unlikely to dampen women’s enthusiasm for using their own methods, Allison Merz, an ob-gyn at UC San Francisco, told me. If anything, when those ultrasafe, ultra-effective products for men come to market, they’ll ignite more discussions over female contraception—and inspire more questions about why convenience and tolerability weren’t prioritized for women from the start. from https://ift.tt/cTpdsFX Check out http://natthash.tumblr.com A man comes to Northwell Health’s hospital on Staten Island with a sprained ankle. Any allergies? the doctor asks. How many alcoholic drinks do you have each week? Do you have access to firearms inside or outside the home? When the patient answers yes to that last question, someone from his care team explains that locking up the firearm can make his home safer. She offers him a gun lock and a pamphlet with information on secure storage and firearm-safety classes. And all of this happens during the visit about his ankle. Northwell Health is part of a growing movement of health-care providers that want to talk with patients about guns like they would diet, exercise, or sex—treating firearm injury as a public-health issue. In the past few years, the White House has declared firearm injury an epidemic, and the CDC and National Institutes of Health have begun offering grants for prevention research. Meanwhile, dozens of medical societies agree that gun injury is a public-health crisis and that health-care providers have to help stop it. Asking patients about access to firearms and counseling them toward responsible storage could be one part of that. “It’s the same way that we encourage people to wear seat belts and not drive while intoxicated, to exercise,” Emmy Betz, an emergency-medicine physician and the director of the University of Colorado’s Firearm Injury Prevention Initiative, told me. An unsecured gun could be accessible to a child, someone with dementia, or a person with violent intent—and may increase the chance of suicide or accidental injury in the home. Securely storing a gun is fundamental to the National Rifle Association’s safety rules, but as of 2016, only about half of firearm owners reported doing so for all of their guns. Some evidence shows that when health-care workers counsel patients and give them a locking device, it leads to safer storage habits. Doctors are now trying to figure out the best way to broach the conversation. Physicians talk about sex, drugs, and even (if your earbuds are too loud) rock and roll. But to many firearm owners, guns are different. Not so long ago, powerful physicians argued that if guns were causing so much harm, people should just quit them. In the 1990s, the director of the CDC’s injury center said that a public-health approach to firearm injury would mean rebranding guns as a dangerous vice, like cigarettes. “It used to be that smoking was a glamor symbol—cool, sexy, macho,” he told The New York Times in 1994. “Now it is dirty, deadly—and banned.” In the 2010s, the American Academy of Pediatrics’ advice was to “NEVER” have a gun in the home, because the presence of one increased a child’s risk of suicide or injury so greatly. (“Do not purchase a gun,” the group warned bluntly.) And when asked in 2016 whom they would go to for safe-storage advice, firearm owners ranked physicians second to last, above only celebrities. In the past couple of decades, some states have toyed with laws that curtail doctors’ ability to talk with patients about firearms and the information they can collect, to assuage gun owners’ privacy concerns. Only in Florida did the most restrictive version—what physicians call a “gag law”—pass, in 2011; six years later, a federal court struck it down. But “I think the gag orders, even though they’re not in effect now, really scared people,” Amy Barnhorst, an emergency psychiatrist and firearm-injury-prevention researcher at UC Davis, told me. A smattering of studies have found that doctors—particularly pediatricians—generally think talking with their patients about firearm safety is important, but most of the time, they’re not doing it. As of 2019, only 8 percent of firearm owners said their doctor had ever brought it up. That year, in California, Barnhorst launched the state-funded BulletPoints Project, a free curriculum that teaches health-care workers how and when to talk about firearms with their patients. The program instructs them to keep politics and personal opinions out of the conversation, and to ask only those patients who have particular reasons for extra caution—including people with children, those experiencing domestic violence, or those living with someone with a cognitive impairment. It also suggests more realistic advice than “Do not purchase a gun.” Maybe a patient has a firearm for self-defense (the most common reason to have one), so they’d balk at the idea of storing a gun unloaded and locked, with the ammunition separate. A health-care worker might recommend a quick-access lockbox instead. Researchers are now testing whether these firearm conversations have the best outcome if doctors broach them only when there’s a clear reason or if they do it with every patient. Johns Hopkins is trialing a targeted approach, talking about firearms and offering gun locks in cases where pediatric patients have traumatic injuries. Meanwhile, Northwell Health, which is New York State’s largest health system, asks everyone who comes into select ERs about gun access and offers locks to those who might need them. Both of these efforts are federally funded studies testing whether doctors feel confident enough to actually talk with patients about this, and whether those conversations lead people to store their firearms more securely. For doctors, universal screening means “there’s no decision point of who you’re going to ask or when you’re going to ask,” Sandeep Kapoor, an assistant professor of emergency medicine who is helping implement the program at Northwell Health, told me. So far, Northwell’s trial has screened about 45,000 patients, which signals that the approach can be scaled up. Kapoor told me that with this strategy, gun-safety conversations could eventually become as routine for patients as having their blood pressure taken. When she was in primary pediatrics, Katherine Hoops, a core faculty member at Johns Hopkins’s Center for Gun Violence Solutions, worked firearm safety into every checkup, as she would bike helmets and seat belts. (The American Academy of Pediatrics still maintains that the safest home for a child is one without a gun, but the organization now recommends that pediatricians talk about secure storage with every family, and offers a curriculum on how to have this conversation.) Universal screening can also find people whom a targeted approach might miss: The team at Northwell recently learned through screening questions that a 13-year-old who came in with appendicitis had been threatened with guns by bullies, and brought in his parents, a team of social workers, and the school to help. But a patient in the ER for a sprained ankle may understandably wonder why a doctor is asking about firearms. “There’s no context,” Chris Barsotti, an emergency-medicine physician and a co-founder of the American Foundation for Firearm Injury Reduction in Medicine, told me. The firearm community, he said, remembers when “the CDC wanted to stigmatize gun ownership,” so any movement for health care workers to raise these questions needs nuance. To his mind, these should be tailored conversations. Betz, of the University of Colorado, raises the question only when a patient is at risk, and believes that firearm safety can otherwise be in the background of a practice—for example, in a waiting room where secure-storage brochures are displayed alongside pamphlets on safe sex and posters on diabetes prevention. About half of firearm-owning patients agree that it’s sometimes appropriate for a doctor to talk with them about firearms, according to a 2016 study by Betz and her colleagues. They’re even more okay with it if they have a child at home. The physicians I asked said that the majority of the time, these conversations go smoothly. But Betz’s study also found that 45 percent of firearm-owning patients thought doctors should never bring up guns. Paul Hsieh, a radiologist and a co-founder of the group Freedom and Individual Rights in Medicine, wrote in an email that gun owners he’s spoken with “find the question about firearms ownership intrusive in a different way than questions about substance use or sexual partners.” Chethan Sathya, a pediatric trauma surgeon and the director of Northwell Health’s Center for Gun Violence Prevention, pointed out that those topics used to be contentious for physicians to talk about. To treat guns as a public-health issue, “we can’t be uncomfortable having conversations,” he told me. But doctors have more power in this situation than they do in others. They might tell someone with diabetes to stop having soda three times a day, but they can’t literally take soda away from a patient. With guns, they might be able to. In states with extreme-risk laws, if a health-care provider believes that their patient poses an immediate threat to themselves or others, they can work with law enforcement to petition the court to temporarily remove someone’s firearms; a handful of states allow medical professionals to file these petitions directly. There are many people “across America right now who own guns and won’t come to counseling, because they don’t want their rights taken away for real or imagined reasons,” Jake Wiskerchen, a mental-health counselor in Nevada who advocates for such patients, told me. They worry that if their doctor includes gun-ownership status in their medical record, they could be added to a hypothetical national registry of firearm owners. And if questions about guns were to become truly routine in a doctor’s office—such as on an intake form—he said owners might just lie or decide they “don’t want to go to the doctor anymore.” Physicians accordingly choose their words carefully. They talk about preventing firearm injury instead of gun violence—both because the majority of gun deaths are suicides, not homicides, and because it’s a less loaded term. Telling a diabetic patient to cut back on soda might work, but people “are not just going to throw their guns in the trash,” Barnhorst, of UC Davis, told me. “There’s a lot more psychological meaning behind firearms for people than there is for sodas.” Barsotti says a public-health approach to firearm safety requires more engagement with the upwards of 30 percent of American adults who own a firearm. Owners of shooting ranges and gun shops are already “practicing public health without the benefit of medical or public-health expertise,” he told me. They’re running their own storage programs for community members who don’t want their guns around for whatever reason; they’re bringing their friends for mental-health treatment when they might be at risk. Betz’s team collaborated with gun shops, shooting ranges, and law-enforcement agencies in Colorado to create a firearms-storage map of sites willing to hold firearms temporarily, and she counsels gun clubs on suicide prevention, as a co-founder of the Colorado Firearm Safety Coalition. Exam-room conversations can be lifesaving, but in curbing gun injury, Betz told me, health-care workers “have one role to play. We’re not the solution.” from https://ift.tt/3kmNL9l Check out http://natthash.tumblr.com For something that isn’t candy, Zyn nicotine pouches sure look a lot like it. The packaging, a small metal can, looks more than a little like a tin of mints. The pouches come in a wide variety of flavors: citrus, cinnamon, “chill,” “smooth.” And they’re consumed orally, more like jawbreakers or Warheads than cigarettes. America has found itself in the beginnings of a Zyn panic. As cigarette and vape use have trailed off in recent years, Zyn and other nicotine pouches are gaining traction. The absolute pouch-usage numbers are still not that high, but sales have more than quadrupled from late 2019 to early 2022. Although only adults 21 and older can legally purchase them—a fact that the product’s website directly points out—they are reportedly catching on with teens. “I’m delivering a warning to parents,” Senate Majority Leader Chuck Schumer said in January, calling for a crackdown, “because these nicotine pouches seem to lock their sights on young kids.” Earlier this month, a group of plaintiffs filed a class-action lawsuit accusing the tobacco giant Philip Morris International (PMI), which also makes Zyn, of purposefully targeting kids. (“We believe the complaints are without merit and will be vigorously defended,” a PMI spokesperson told me over email, adding that Zyn offers “adult-orientated flavors.”) On their surface, nicotine pouches seem to be a fad like any other, but they are the end result of a century of nicotine marketing and development that began with cigarettes and has now moved beyond. “It’s basically part of the long history of the candification of nicotine,” Robert Proctor, a Stanford historian who has written multiple books on tobacco, told me. Over the years, the tobacco industry has gradually introduced more and more products flavored and packaged like sweet treats. Now, with Zyn, the industry has finally devised a near-perfect one. [Read: The easy way for Joe Biden to save lives] Once, nicotine wanted to be the opposite of candy. In the 1920s, weight loss—or “reducing,” as it was then known—became a major craze, and the tobacco industry moved to market its products as a healthier alternative to candy. “Reach for a Lucky instead of a sweet!” read one ad. Candymakers were understandably aggrieved about this slight, but the industries made nice in 1930, when Lucky’s maker dropped “instead of a sweet!” from its slogan. Candy and cigarettes had commonalities. Both relied on sugar—candy because, well, obviously, and cigarettes to cut the bitter taste of tobacco. Both were placed near the checkout register, to encourage impulse purchases. Soon, the makers of both products established joint trade journals and labor unions, at least one of which exists to this day. (Yes, some of the workers who make Ghirardelli chocolate and Marlboro cigarettes are represented by the same union.) Around this time, tobacco companies warmed up to the potential of cigarettes made out of chocolate, bubblegum, or pure sugar. Candy cigarettes, they seem to have realized, were free advertising, a gateway for kids into the world of smoking. (“Just Like Daddy!” read the slogan on one brand’s boxes.) The more similar the candy replicas looked to the real deal, the better. By the 1950s, most of the top cigarette brands—Lucky Strike, Chesterfield, Philip Morris—had their candy equivalent made by other companies, with packaging that very closely matched the real thing. This was roughly the equivalent of a modern apple-juice maker packaging its product in a Jack Daniel’s bottle. These tobacco companies claim never to have encouraged this, but as Proctor details in his 2011 book, Golden Holocaust, they did nothing to discourage it either. The goal, he writes, was to “create Philip Morris in the minds of our future smokers.” (That Philip Morris and the current Philip Morris International are not technically the same company, having since rebranded and then split apart.) Over time, cigarettes themselves became more and more candylike—and the government has responded by cracking down. Menthol cigarettes went big in the 1950s and ’60s, and starting in the ’70s, companies introduced a wider range of even more candylike flavors: chocolate,strawberry, Twista Lime, Warm Winter Toffee. Flavored cigarettes were eventually banned in 2009—with the exception of menthol—because of their disproportionate popularity among kids. But flavored e-cigarettes such as Juul took their place just a few years later and quickly became the most popular tobacco product among American youth—until they, too, were mostly banned in 2020. Now, with products such as Zyn, the candification of nicotine is pretty much complete. Pouches don’t just taste like candy; they’re also packaged like candy and consumed like candy (don’t swallow them, though). Proctor told me he’s talked with people for hours before realizing they had a nicotine pouch in their mouth. “It’s the ultimate merger of two of the leading hazards of modernity,” he said. Other companies such as Velo and Lucy are selling nicotine pouches too. Lucy even calls one of its special pouch lines “Breakers” (which sounds suspiciously close to Icebreakers, though a spokesperson for the company told me in an email, “They are in no way intended to resemble ice breakers the mints or any other type of candy.”). And it’s not just pouches: Nicotine chewing gum and lozenges have become available in wide varieties of flavors and are packaged in candy-colored pastels. Nicotine gummies have been on the rise as well. [Read: Gummy vitamins are just candy] Unlike with cigarette-shaped candies or candy-flavored cigarettes, both of which were uncomplicatedly bad, there actually is a legitimate, good-faith argument to be had about the merits of Zyn and similar flavored products. On the one hand, they do not contain tobacco and are not smoked, which is largely what makes cigarettes so deadly. The tobacco industry has positioned these products as a way for adults to wean themselves off of cigarettes, and they sure seem to be much safer than cigarettes, which kill more than 480,000 Americans each year—more than the combined deaths from COVID and car-crash fatalities in 2021. So the more people popping flavored pouches or gummies rather than smoking cigarettes, the better. On the other hand, they are addictive, and flavored products have been shown to play a major role in hooking kids. The PMI spokesperson told me, “If you’re worried about your health, the best thing is to never start using nicotine or”—if you already do—“stop using it.” Whether the increase in the number of kids using nicotine is worth the decrease in the number of adults using cigarettes is hotly debated. There’s a dark irony to the fact we’re having this debate at all. A hundred years ago, tobacco companies invoked the idea, if not the specific language, of harm reduction when they marketed their cigarettes as a healthy alternative to candy. Now they’re making their own nicotine products more candylike and marketing them as a healthy alternative to cigarettes. The harm reducer has become the harm to be reduced. After all this, flavored nicotine pouches might end up banned, just like flavored cigarettes and vapes before them. But in the cat-and-mouse game that the tobacco industry has been playing with regulators, Zyn may have a better chance of persisting than anything before it. from https://ift.tt/MIW3yGT Check out http://natthash.tumblr.com When a new RSV vaccine for pregnant people arrived last fall, Sarah Turner, a family-medicine physician at Lutheran Hospital, in Indiana, couldn’t help but expect some pushback. At most, about half of her eligible pregnant patients opt to get a flu vaccine, she told me, and “very few” agree to the COVID shot. But to Turner’s surprise, patients clamored for the RSV shot—some opting in even more eagerly than they did for Tdap, which protects newborns against pertussis and had previously been her easiest sell. For once, expectant parents were the ones starting conversations about immunizations. Each year in the U.S., respiratory syncytial virus hospitalizes an estimated 58,000 to 80,000 kids under the age of 5; the risks are highest for infants, for whom the virus is “enemy No. 1,” says Sallie Permar, an immunologist and pediatrician in chief at NewYork-Presbyterian/Weill Cornell Medical Center. But this past season marked the first time that the U.S. had two tools that could substantially shrink that toll: a vaccine for pregnant people, who can then pass antibodies to their child, and a monoclonal antibody, known as nirsevimab, that is given directly to infants. Their arrival feels akin “to the end of polio,” Anne-Marie Rick, a pediatrician and clinical researcher at Children’s Hospital of Pittsburgh, told me: With both shots in widespread use, the risks of winter illness could forever look different for the youngest Americans. But some experts worry that these powerful shots are being squandered. The CDC’s seasonal recommendations governing their use may simply be “too strict,” Permar told me. In keeping with those guidelines, many practices stopped giving the maternal vaccine at the end of January; the main window for administering the monoclonal antibody is expected to close at the end of this week. The next eligibility windows won’t open for months. The U.S has two brand-new shots that protect extraordinarily well against a deadly respiratory virus—and that people actually want to take—and it is holding them back. The guiding principle behind the CDC’s recommendations has logic to it. RSV is a seasonal virus, and both injections are thought to offer protection for about six months. For the maternal vaccine, which is administered between 32 and 36 weeks of pregnancy, the clock on the baby’s protection starts after birth. So if a pregnant person gets the vaccine in June—outside of the CDC’s recommended window—and has their baby in July, their child may be vulnerable again come February, before RSV season typically ends. In theory, spring and summer infants might be better protected by getting nirsevimab starting in October, when RSV usually arrives. Current guidelines also require a choice between the two options: Most infants that benefit from maternal vaccination are not eligible to also receive nirsevimab. [Read: The worst pediatric-care crisis in decades] This past season, though, nirsevimab was in severely short supply—in large part because drug companies seem to have underestimated demand, William J. Muller, a pediatric-infectious-disease expert at Northwestern who helped trial the monoclonal antibody, told me. Many hospital systems also balked at the cost of the new drug, which is pricier than the maternal vaccine, wasn’t yet bundled into the expense of delivering infants, and wasn’t consistently covered by insurance. The shortfalls became so dire that Sanofi, nirsevimab’s manufacturer, stopped taking new orders for certain doses of the monoclonal antibody as early as October. The CDC issued a health alert, calling on providers to restrict administration of those doses to only the highest-risk infants. “In our hospital system, we had some for the NICU babies, and that was literally it,” Turner, of Lutheran Hospital, told me. Nirsevimab should be more available this year: Spokespeople from AstraZeneca and Sanofi told me that the companies are “confident we will meet the global demand” for the antibody in 2024. But last year set quite a low bar. And when the window for administration opens in October—potentially already coinciding with RSV’s rise—supplies could go fast, as parents who haven’t been able to get shots for themselves or their babies rush to catch up, Grace Lee, a pediatrician at Stanford, who advised the CDC on its RSV guidance, told me. (The CDC did not respond to a request for comment.) Opening the administration window earlier for either the vaccine or the monoclonal antibody could ease that burden: The U.S. starts immunizing people against the flu well ahead of the season’s start, Lee said, because “it’s just not feasible to vaccinate the entire U.S. population in a week.” For several years, too, “RSV has been on the move,” Permar told me, thanks in large part to pandemic mitigations. The virus was virtually absent in 2020, only to come roaring back for a bizarrely early season that began during the summer of 2021 and had mostly concluded by the end of January 2022. In the past two seasons, the virus has also arrived somewhat early, starting with a September rise. If that pattern holds, waiting until September to vaccinate pregnant people or until October to immunize infants might leave many newborns more vulnerable than they need to be for weeks or months. Many experts do anticipate that RSV’s pattern will quickly settle back to its norm. Over the decades, its consistency “has been remarkable,” says Sarah Long, a pediatrician at Drexel University who advised the CDC on its guidelines for both new RSV interventions. But even in more predictable years, RSV transmission varies across regions—sometimes kick-starting during the summer in the South and lingering until spring further north. The recommendations “can’t be a one-size-fits-all” across the U.S., says Shabir Madhi, a vaccinologist at the University of the Witwatersrand, in South Africa, who helped lead clinical trials of the maternal vaccine. These are judgment calls: France opens its nirsevimab window earlier than the U.S.; Belgium will allow some pregnant people to receive a vaccine as early as the spring. The U.K. is weighing whether to offer both injections at any time of year. One argument for the current seasonal window is that giving a vaccine or a monoclonal antibody injection too early might mean recipients miss out on protection at the end of the season, Karen Acker, a pediatrician at Weill Cornell, told me. But Permar and others are hopeful that the effects of the new RSV interventions might last longer than five or six months, which is about when clinical trials stopped directly testing their effects. Early data for nirsevimab, for instance, suggests that a little bit of protection may even trickle into subsequent seasons, Muller told me. [Read: Fall’s vaccination routine didn’t have to be this hard] RSV is also of greatest threat to children within the first few months of life, when their respiratory tracts are still tiny and developing. Given the choice between offering the maternal vaccine a little early—which could leave an older infant a bit more vulnerable at the season’s end—and waiting to administer nirsevimab to a young infant after RSV season has started, the former might actually be the safer strategy. Plus, summer babies who don’t get nirsevimab at the hospital are less likely to get it later, especially if their parents aren’t regularly taking them to see a pediatrician. Giving a shot on the early side is better than never giving one all, Joshua Salomon, a health-policy researcher at Stanford, told me. In theory, the CDC’s guidelines do make room for adjustments in administration windows, in accordance with local RSV trends. But those decisions can be difficult to execute when providers have to place orders ahead of time and store vials in limited space. So far, many doctors’ offices and hospitals have stuck to the months outlined by the CDC guidance. “The cutoff dates have been taken very dogmatically,” Rick told me. At the start of the past season, infants just one day over the recommended dosing age of eight months or younger were denied nirsevimab, Turner told me. Then, a lot of providers simply stopped offering the maternal vaccine after January 31, or simply ran out. When both the need and the enthusiasm for a vaccine or drug is strong, taking every opportunity for protection makes sense. Several experts I talked with supported wider windows; Permar thinks the U.S. should even consider offering the maternal vaccine year-round. To her mind, restrictions regarding both seasonality and gestational age too strongly limit the chances that a baby will be protected. Some providers also noted that, given all the uncertainties, they would recommend the maternal vaccine as primary defense, leaving nirsevimab as the backup—simply because the vaccine can be delivered first. A maternal shot can set babies up with protection from the moment of birth, a sort of insurance policy that can guard against nirsevimab supply or delivery issues. A wider window of vaccine eligibility might not be a perfect solution. But it could get more infants protected when they most need it—putting to best use a shot that people are actually willing to get. from https://ift.tt/bwi2spJ Check out http://natthash.tumblr.com Recently, a balmy spring day left me feeling parched. I needed a beverage—stat!—and had forgotten my water bottle at home. I ducked into a nearby CVS to pick up a drink. The choices were so overwhelming, I nearly forgot my thirst. The drink aisle included a bevy of the usual thirst-quenching options—and some that looked like they belonged in an apothecary rather than next to the LaCroix. Row upon row of multicolored cans and bottles held drinks with purposes beyond mere hydration and flavor. Some promised to improve my energy, immunity, or gut health. Others claimed to stimulate mind states such as clarity, balance, or calm. Fizzy or flat, juice or tea, high in protein or in probiotics? Drinks with a purpose, known as “functional beverages,” have become unavoidable in many supermarkets, drugstores, and gas stations across the country. On top of Vitamin Water and traditional energy drinks like Red Bull and Monster, you can find options such as BRĒZ, a supposedly mood-shifting elixir infused with mushrooms and cannabis and SkinTē, a “collagen sparkling tea.” Kin Euphorics, a line of drinks launched by the supermodel Bella Hadid that’s available at Target, sells one meant to boost energy, level up immunity, and make your skin glow. Simply picking out a drink has never been harder. Drinks have always been about more than taste and hydration—think of coffee, alcohol, and soda. Energy drinks first appeared in stores inthe 1960s, before exploding in popularity in the 2000s. Yet the expansion of a drink’s promised effects beyond inebriation or energy is “a little bit newer,” Ernest Baskin, a food-marketing professor at Saint Joseph’s University, told me. Some of the products I spotted at the pharmacy included an caffeinated shot called Tru Energy and its extra-strength sibling, Tru Power; pastel-colored cans of Recess, a seltzer with magnesium and adaptogens to promote calmness; and Poppi, a soda for gut health. Even the energy drinks are no longer just a few hyper-sweet, hyper-caffeinated options: Newer brands tout health benefits, such as added vitamins, and come in a wider variety of formulations, including seltzers, coffees, and teas. These functional beverages are booming. By one estimate, the industry is expected to be worth $54 billion in North America alone this year. Grocers report that functional beverages are vying for prime shelf space traditionally occupied by sodas, bottled water, and even alcohol. Encountering the staggering range of supplements, nutrients, and other additives now present in the drink aisle can make choosing a drink feel deeply stressful, more like picking up medication than grabbing a bottle on the go. Part of the reason functional drinks have exploded is the same reason that there are lots of protein bars and low-sugar snacks: If it sounds healthy, more people will buy it. Americans are “increasingly interested in health,” Baskin said. That’s how you end up with something like Bai—a line of “water beverages” infused with antioxidants and electrolytes—and prebiotic sodas that contain ingredients including live bacteria and fiber. Even Nestlé’s Nesquik, a chocolate drink I enjoyed as a child, comes in a “protein power” version. The fact that these drinks can be sold at a premium has endeared them to stores, Baskin said. A single can of Celsius energy drink or Olipop prebiotic soda costs $3 at Target. Of course, as in all things wellness, whether any of these products actually does what it says to do is far from guaranteed. Certainly, a drink stuffed with huge amounts of caffeine will be energizing. Others are more suspect. A sparkling water brand called Good Idea goes so far as to claim to balance blood sugar. Safety Shot, packaged in cans labeled with a blue medical cross, is sold as a hangover cure, promising to rapidly lower blood-alcohol levels. (Products marketed as supplements, as opposed to beverages, are less rigorously regulated by the FDA.) Drink makers have swooped in to capitalize on the ongoing cultural obsession with hydration—one in which Stanley Cups are a must-have item and influencers suggest that clear skin is just a bottle of water away. That has created an opening for more fantastical functional beverages that promise to be a quick fix for all kinds of health concerns—stress, anxiety, insomnia, and unhappiness. Read: It’s just a water bottle Recess, one of the drinks I saw at CVS, is positioned as an antidote to a hectic world, helping sippers feel “calm cool collected.” Among the ingredients it highlights are hemp and adaptogens, a category loosely defined as substances that help the body deal with stress. Some drinks claim to promote a shift in mood, equating health with happiness; others, to induce sleep. An energy shot called Magic Mind, touting buzzy ingredients such as nootropics, lion’s-mane mushrooms, and the calming plant ashwagandha, is marketed as a path to a clear mind. Maybe it’s not surprising that people crave products claiming to bottle some form of respite. Younger adults, to whom most of these drinks are targeted, are drinking less booze but also using more marijuana: They want altered states, if just not in alcohol form. In lieu of happy-hour drinks at a bar, some functional beverages are positioned as something to gather around. One called hiyo describes itself as a “mindful social tonic”; another, called Three Spirit, is meant to “make moods and enhance connections.” Yet as I stood in the drink aisle, with its shelves of mood elixirs and wellness tonics, these products strangely made me feel worse. Passing on these drinks can seem like a missed opportunity; after all, who doesn’t need some kind of boost these days? Perhaps the appeal of these beverages is less about their actual effect and more about the feeling they sell—that you can take a step toward self-optimization one sip at a time. I had walked into the grocery store just wanting a drink, but being confronted with all those options made me anxious that I didn’t want enough—as if my current state was unacceptable. After spotting a bottle of Kin Euphorics, I pulled up its website and filled out an online quiz: “How do you want to feel?” it asked. Energized, rejuvenated, balanced, or calm? All I wanted to feel was hydrated. from https://ift.tt/AZg7TGt Check out http://natthash.tumblr.com I first met Daniel Kahneman about 25 years ago. I’d applied to graduate school in neuroscience at Princeton University, where he was on the faculty, and I was sitting in his office for an interview. Kahneman, who died today at the age of 90, must not have thought too highly of the occasion. “Conducting an interview is likely to diminish the accuracy of a selection procedure,” he’d later note in his best-selling book, Thinking, Fast and Slow. That had been the first finding in his long career as a psychologist: As a young recruit in the Israel Defense Forces, he’d assessed and overhauled the pointless 15-to-20-minute chats that were being used for sorting soldiers into different units. And yet there he and I were, sitting down for a 15-to-20-minute chat of our own. I remember he was sweet, smart, and very strange. I knew him as a founder of behavioral economics, and I had a bare familiarity with the work on cognitive biases and judgment heuristics for which he was soon to win a Nobel Prize. I did not know that he’d lately switched the focus of his research to the science of well-being and how to measure it objectively. When I said during the interview that I’d been working in a brain-imaging lab, he began to talk about a plan he had to measure people’s level of delight directly from their brain. If neural happiness could be assessed, he said, then it could be maximized. I had little expertise—I’d only been a lab assistant—but the notion seemed far-fetched: You can’t just sum up a person’s happiness by counting voxels on a brain scan. I was chatting with a genius, yet somehow on this point he seemed … misguided? I still believe that he was wrong, on this and many other things. He believed so, too. Daniel Kahneman was the world’s greatest scholar of how people get things wrong. And he was a great observer of his own mistakes. He declared his wrongness many times, on matters large and small, in public and in private. He was wrong, he said, about the work that had won the Nobel Prize. He wallowed in the state of having been mistaken; it became a topic for his lectures, a pedagogical ideal. Science has its vaunted self-corrective impulse, but even so, few working scientists—and fewer still of those who gain significant renown—will ever really cop to their mistakes. Kahneman never stopped admitting fault. He did it almost to a fault. Whether this instinct to self-debunk was a product of his intellectual humility, the politesse one learns from growing up in Paris, or some compulsion born of melancholia, I’m not qualified to say. What, exactly, was going on inside his brilliant mind is a matter for his friends, family, and biographers. Seen from the outside, though, his habit of reversal was an extraordinary gift. Kahneman’s careful, doubting mode of doing science was heroic. He got everything wrong, and yet somehow he was always right. In 2011, he compiled his life’s work to that point into Thinking, Fast and Slow. Truly, the book is as strange as he was. While it might be found in airport bookstores next to business how-to and science-based self-help guides, its genre is unique. Across its 400-plus pages Kahleman lays out an extravagant taxonomy of human biases, fallacies, heuristics, and neglects, in the hope of making us aware of our mistakes, so that we might call out the mistakes that other people make. That’s all we can aspire to, he repeatedly reminds us, because mere recognition of an error doesn’t typically make it go away. “We would all like to have a warning bell that rings loudly whenever we are about to make a serious error, but no such bell is available, and cognitive illusions are generally more difficult to recognize than perceptual illusions,” he writes in the book’s conclusion. “The voice of reason may be much fainter than the loud and clear voice of an erroneous intuition.” That’s the struggle: We may not hear that voice, but we must attempt to listen. Kahneman lived with one ear cocked; he made errors just the same. The book itself was a terrific struggle, as he said in interviews. He was miserable while writing it, and so plagued by doubts that he paid some colleagues to review the manuscript and then tell him, anonymously, whether he should throw it in the garbage to preserve his reputation. They said otherwise, and others deemed the finished book a masterpiece. Yet the timing of its publication turned out to be unfortunate. In its pages, Kahneman marveled at great length over the findings of a subfield of psychology known as social priming. But that work—not his own—quickly fell into disrepute, and a larger crisis over irreproducible results began to spread. Many of the studies that Kahneman had touted in his book—he called one an “instant classic” and said of others, “Disbelief is not an option”—turned out to be unsound. Their sample sizes were far too small, and their statistics could not be trusted. To say the book was riddled with scientific errors would not be entirely unfair. If anyone should have caught those errors, it was Kahneman. Forty years earlier, in the very first paper that he wrote with his close friend and colleague Amos Tversky, he had shown that even trained psychologists—even people like himself—are subject to a “consistent misperception of the world” that leads them to make poor judgments about sample sizes, and to draw the wrong conclusions from their data. In that sense, Kahneman had personally discovered and named the very cognitive bias that would eventually corrupt the academic literature that he cited in his book. In 2012, as the extent of that corruption became apparent, Kahneman intervened. While some of those whose work was now in question grew defensive, he put out an open letter calling for more scrutiny. In private email chains, he reportedly goaded colleagues to engage with critics and to participate in rigorous efforts to replicate their work. In the end, Kahneman admitted in a public forum that he’d been far too trusting of some suspect data. “I knew all I needed to know to moderate my enthusiasm for the surprising and elegant findings that I cited, but I did not think it through,” he wrote. He acknowledged the “special irony” of his mistake. Kahneman once said that being wrong feels good, that it gives the pleasure of a sense of motion: “I used to think something and now I think something else.” He was always wrong, always learning, always going somewhere new. In the 2010s, he abandoned the work on happiness that we’d discussed during my grad-school interview, because he realized--to his surprise—that no one really wanted to be happy in the first place. People are more interested in being satisfied, which is something different. “I was very interested in maximizing experience, but this doesn’t seem to be what people want to do,” he told Tyler Cowen in an interview in 2018. “Happiness feels good in the moment. But it’s in the moment. What you’re left with are your memories. And that’s a very striking thing—that memories stay with you, and the reality of life is gone in an instant.” The memories remain. from https://ift.tt/0fcrXBY Check out http://natthash.tumblr.com “In my lifetime, I never dreamed that we would be talking about medicines that are providing hope for people like me,” Oprah Winfrey says at the top of her recent prime-time special on obesity. The program, called Shame, Blame and the Weight Loss Revolution, is very clear on which medicines she means. At one point, Oprah stares into the camera and carefully pronounces their brand names for the audience: “Ozempic and Wegovy,” she says. “Mounjaro and Zepbound.” The class of drugs to which these four belong, called GLP-1 receptor agonists, is the reason for the special. For a brief and telling moment, though, Oprah’s story of the revolution falters. It happens midway through the program, when she’s just brought on two obesity doctors, W. Scott Butsch and Amanda Velazquez, to talk about the GLP-1 wonder drugs. “Were you all surprised in your practices when people started losing weight?” she asks. Butsch gets a little tongue-tied: “Yeah, I mean, I think we have—we’ve already been using other medications for the last 10, 20 years,” he says. “But these were just a little bit more effective.” Oprah is nonplussed. She didn’t know about these other drugs, before Ozempic, that were already helping people with obesity. “Where was I?” she cries. “Where was the announcement?” Velazquez milks the moment for a laugh—“We didn’t have TikTok; that was our problem,” she says—and the show moves on. Whatever the identity of these medicines that came before, these almost-as-effective ones, they will not receive another mention. The show proceeds as if they don’t exist. And yet: They do. Amid the hype around the GLP-1s, with their multibillion-dollar sales and corresponding reputation as a modern miracle of medicine, a sort of pharmaco-amnesia has taken hold across America. Patients and physicians alike have forgotten, if indeed they ever knew, that the agents of the “weight-loss revolution”—Ozempic and Wegovy, Mounjaro and Zepbound—are just the latest medications for obesity. And that older drugs—among them Qsymia, Orlistat, and Contrave—are still available. Indeed, the best of these latter treatments might produce, on average, one-half the benefit you’d get from using GLP-1s in terms of weight loss, at less than one-30th the price. That result should not be ignored. Given the lack of widespread insurance coverage for the newer drugs, as well as marked lapses in supplies, many people have been left out of Oprah’s revolution. For last week’s special, she interviewed a mother and her daughter who say, to pursed-lipped expressions of concern, that they’d love to be on a drug like Wegovy or Zepbound, but “cannot access it financially.” Although the Centers for Medicare and Medicaid Services has just announced that GLP-1 drugs for obesity may now be covered for seniors who also have cardiovascular disease, insurers have been pulling back. Next week, the North Carolina state workers’ health plan will cut off GLP-1 coverage for close to 25,000 people. Other, older drugs could help curb this crisis. [Read: Older Americans are about to lose a lot of weight] The newer drugs are much more potent. Semaglutide, the active ingredient in Ozempic and Wegovy, produced an additional 12 percent loss of body weight, on average, compared with placebos in clinical trials; the equivalent result for the highest dose of tirzepatide, which is in Mounjaro and Zepbound, was 18 percent. Meanwhile, the most popular of the older drugs for treating obesity, an amphetamine derivative called phentermine, has been shown to produce, on average, a 3 or 4 percent loss of total body weight. When phentermine is prescribed along with another older drug called topiramate—they’re sold in combination as Qsymia—the effect is stronger: more than 9 percent additional weight loss as compared with placebo, according to one trial. The newer drugs have also been investigated in very large numbers of patients and been shown to measurably reduce obesity-related complications such as strokes, heart attacks, and death. “We have all this data showing that GLP-1 drugs are reducing cardiovascular events and having other benefits,” Eduardo Grunvald, the medical director of the weight-management program at UC San Diego Health, told me, “and we have no data on the other drugs on those issues.” (Like many prominent obesity doctors, including Butsch and Velazquez, Grunvald has received thousands of dollars in consulting fees and honoraria from the maker of Wegovy. He has also received payments from the company behind Contrave.) All else being equal, the GLP-1s are the better option. But all else is rarely equal. For one thing, the average weight-loss effects reported in the literature can’t tell you how each specific patient will respond to treatment. When people take Wegovy or Zepbound, more than half of them are strong responders, according to the published research, with weight loss that amounts to more than 15 percent. At the same time, roughly one in seven people gets no clear benefit at all. The older drugs also have a diversity of outcomes. Qsymia doesn’t seem to work for about one-third of those who take it, but another third finds Ozempesque success, losing at least 15 percent of body weight. “I’ve had patients who have lost as much or more weight with Qsymia as they do with GLP-1s,” Grunvald said. “It’s about finding that lock and key for a particular individual.” [Read: Ozempic can turn into No-zempic] Depending on that fit, a patient may end up saving quite a bit of money. Since 2016, Sarah Ro, a primary-care physician based in Hillsborough, North Carolina, has run a weight-management program that serves rural communities. She’s been treating patients with the older drugs, she told me, and getting good results: “I regularly have people losing 50 pounds on phentermine alone, or phentermine-topiramate.” These drugs are generally covered by insurance, but Ro prescribes them as generics that are cheap enough to pay for out of pocket either way. “It’s like 10 to 11 bucks for phentermine, and 12 bucks for topiramate,” she said. A similar month’s supply of Wegovy or Zepbound injections is listed at more than $1,000. “I have to be honest with you, the whole craze and wave of uptake of the GLP-1 medications was a little bit of a surprise to me,” Grunvald said. “We had this decade of drugs that were actually effective, but people really didn’t latch onto them.” Again, he emphasized the obvious fact that the GLP-1 medications work much better, overall, than the old ones. But he and other experts with whom I spoke suggested that the higher potency alone cannot explain an utter turnabout in patient demand, from nearly zero to almost unmanageable. Several noted that the older drugs are “stigmatized,” as Grunvald put it. In particular, a lot of people are wary of phentermine, on account of its status as an amphetamine derivative, and also its connection to the “fen-phen” scandal of the 1990s, when it was sold as part of an enormously popular (and effective) drug combination that turned out to have dangerous effects on people’s hearts. But as David Saxon of the University of Colorado’s Anschutz Medical Campus explained to me, the problems with fen-phen derived from the “fen” and not the “phen”—which is to say, a different drug called fenfluramine. “Phen,” for its part, has been prescribed as a weight-loss drug for more than half a century—far longer than any GLP-1 agonist has been on the market—and has shown no clear signs of causing serious problems. Its known side effects are similar to those of Adderall, a drug that is now used by more than 40 million Americans. Topiramate brings other risks, including birth defects, tingling sensations, and changes in mood. Especially at higher doses, it can lead to brain fog. But again, the specifics here will vary from one patient to the next. And GLP-1s have their own side effects, most notably gastrointestinal distress that can be quite unpleasant. About one-sixth of people taking semaglutide are forced to stop; a guest on Oprah’s special said she had to quit after ending up in the emergency room, vomiting blood. Some of these patients may do just fine on phentermine or topiramate. “Honestly, I see more side effects with the GLP-1 drugs than with the other drugs,” Grunvald told me. “I get more messages and phone calls about side effects than I used to.” Some of the older drugs’ peculiar side effects can even wind up being useful, Ro suggested. Many of her patients with obesity are fond of Mountain Dew, she told me; some are drinking two liters every day. She counsels cutting back on sugary beverages, but topiramate can really help, because it can distort the taste of carbonation. In the clinical literature, this dysgeusia is deemed unwanted—it’s called a “taste perversion.” For Ro, it can be a tool for weaning off unhealthy habits. “We have such a wonderful response to using topiramate,” she said. Now she’s girding for the change in North Carolina’s health-insurance coverage for state workers. She tells her patients not to panic; if they can’t afford to pay for Wegovy or Zepbound out of pocket, she can switch them to different agents. “Everybody’s talking about GLP-1s, and it’s like, ‘GLP-1s or bust,’” she said. “And I’m going, ‘Hello! You know, my patients never had that much access to GLP-1s anyway.’” Those patients may not end up getting the best possible treatments for obesity—add this to the running list of health disparities—but they can have a drug that works. For anyone who is living with meaningful complications of obesity, having some weight loss will likely be better than having none at all. If Oprah never got the memo, the problem may have less to do with medicine than with expectation. The older drugs can work, but their average effects on body weight are in the range of 5 to 10 percent, which is about what some people can expect to achieve through major changes to their lifestyle. “Remember, you’re fighting against the cultural current that says, ‘What, you’re taking one of those medicines? That’s awful! You ought to be able to do that yourself,’” Ted Kyle, a pharmacist and an obesity-policy consultant, told me. “The efficacy is not enough to get you over that hump of cultural resistance, and of the stigma attached to taking medicines for obesity.” And then, when a patient on an older drug has reached their new plateau for body weight, which could be just 10 pounds less than where they were before, they may not be so inclined to keep up with their prescription. Are they really going to stay on a medication for the rest of their life, if its effects are not utterly transformative?
from https://ift.tt/uytOQDB Check out http://natthash.tumblr.com On Sunday evening, I fed a bowl of salmon, broccoli, and rice to my eight-month-old son. Or rather, I attempted to. The fish went flying; greens and grains splattered across the walls. Half an hour later, bedtime drew near, and he hadn’t eaten a thing. Exasperated, I handed him a baby-food pouch—and he inhaled every last drop of apple-raspberry-squash-carrot mush. For harried parents like myself, baby pouches are a lifeline. These disposable plastic packets are sort of like Capri-Suns filled with blends of pureed fruits and vegetables: A screw-top cap makes for easy slurping, potentially even making supervision unnecessary. The sheer ease of baby pouches has made them hyper-popular—and not just for parents with infants who can’t yet eat table food. They are commonly fed to toddlers; even adults sometimes eat baby pouches. But after my son slurped up all the goo and quickly went to sleep, I felt more guilty than relieved. Giving him a pouch felt like giving up, or taking a shortcut. No parent has the time or energy to make healthy, homemade food all the time, but that doesn’t stop Americans from still thinking “they need to try harder,” Susan Persky, a behavioral scientist at the NIH who has studied parental guilt, told me. That can leave parents stuck between a pouch and a hard place. Baby pouches have practically become their own food group. These shelf-stable time-savers debuted in 2008, and now come in a staggering range of blends: Gerber sells a carrot, apple, and coriander version; another, from Sprout Organics, contains sweet potato, white bean, and cinnamon. Containing basically just fruits and veggies, pouches are generally seen as a “healthy” option for kids. A 2019 report found that the product accounts for roughly a quarter of baby-food sales. Around the same time, a report on children attending day care showed that pouches are included in more than a quarter of lunch boxes, and some kids get more than half their lunchtime nutrition from them. But pouches should be just a “sometimes food,” Courtney Byrd-Williams, a professor at the University of Texas’s Houston School of Public Health, told me. When you stack up their drawbacks, relying on them can really start to feel dispiriting. Although pouches are generally produce-based, they tend to have less iron than fortified cereal does and more added sugars than jarred baby food. Excess sweetness may encourage kids to eat more than necessary and could promote a sweet tooth that could later contribute to diet-related chronic disease. If consumed in excess, pouches may also get in the way of kids learning how to eat real food. Unlike jarred baby food, which tends to contain a single vegetable or several, pouches usually include fruit to mask the bitter with the sweet. “If we’re only giving them pouches,” Byrd-Williams said, “are they learning to like the vegetable taste?” And because the purees are slurped, they don’t give infants the opportunity to practice chewing, potentially delaying development. In 2019, the German Society for Pediatrics and Adolescent Medicine went so far as to issue a statement against baby pouches, warning that eating them may delay eating with a spoon or fingers. And then, the scariest scenario: Earlier this month, the CDC reported that hundreds of kids may have lead poisoning from pouches containing contaminated applesauce. Perhaps more troubling, a recent analysis by Consumer Reports found that even certain pouches on the market that weren’t implicated in the contamination scandal also contain unusually high levels of lead. Naturally, these concerns can make parents anxious. Online, caregivers fret that their reliance on the products might leave their child malnourished. Some worry that their kid will never learn how to eat solid food or figure out how to chew. Pouches, to be clear, are hardly a terrible thing to feed your kid. They can be a reliable way to get fruits and vegetables into picky kids, offering a convenience that is unrivaled. But pouch guilt doesn’t stem entirely from health concerns. By making parenting easier, they also are a reminder of what expectations parents aren’t meeting. I wanted to be the kind of mom who would consistently make my son home-cooked food and persevere through a tough meal, but on Sunday, I was just too exhausted. Guilt is a fact of life for many parents. Virtually anything can trigger it: going to work, staying at home, spending too much time on your phone, not buying supersoftbamboo baby clothes. If parents can have unrealistic standards about it, it’s fair game. “There’s just a lot of guilt about what parents should be doing,” Byrd-Williams said. But feeding children is especially fraught. Parents are often told what they should feed their children—breast milk, fresh produce—but never how to do so; they’re left to figure that out on their own. About 80 percent of mothers and fathers experience guilt around feeding, Persky told me—about giving their kids sugary or ultra-processed foods or caving to requests for junk. Guilt might be an impetus for better food choices, but Persky said she has found the opposite: Parents who are made to feel guilty about the way they feed their kids end up choosing less healthy foods. “It’s hard to parent when you’re struggling with self-worth,” she said. Pouch guilt has less to do with the products themselves and more to do with what they represent: convenience, ease, a moment of respite. Asking for a break conflicts with the core expectations of American parenthood, particularly motherhood. At every turn, parents are pressured to do more for their kids: On social media, momfluencers tout home-cooked baby food and meticulously styled birthday parties. The American mentality is that the “moral and correct way to do things is to have infinite willpower,” Persky said, and in this worldview, “shortcuts seem like an inherently bad thing.” Raising children is supposed to be about hard work and self-sacrifice—about pureeing carrots at home instead of buying them in a plastic packet. But when parents are constantly short on time, sometimes the best they can do is scrape together as much as they can, one squeeze pouch after another. from https://ift.tt/RPwmiFo Check out http://natthash.tumblr.com America is in a funk, and no one seems to know why. Unemployment rates are lower than they’ve been in half a century and the stock market is sky-high, but poll after poll shows that voters are disgruntled. President Joe Biden’s approval rating has been hovering in the high 30s. Americans’ satisfaction with their personal lives—a measure that usually dips in times of economic uncertainty—is at a near-record low, according to Gallup polling. And nearly half of Americans surveyed in January said they were worse off than three years prior. Experts have struggled to find a convincing explanation for this era of bad feelings. Maybe it’s the spate of inflation over the past couple of years, the immigration crisis at the border, or the brutal wars in Ukraine and Gaza. But even the people who claim to make sense of the political world acknowledge that these rational factors can’t fully account for America’s national malaise. We believe that’s because they’re overlooking a crucial factor. Four years ago, the country was brought to its knees by a world-historic disaster. COVID-19 hospitalized nearly 7 million Americans and killed more than a million; it’s still killing hundreds each week. It shut down schools and forced people into social isolation. Almost overnight, most of the country was thrown into a state of high anxiety—then, soon enough, grief and mourning. But the country has not come together to sufficiently acknowledge the tragedy it endured. As clinical psychiatrists, we see the effects of such emotional turmoil every day, and we know that when it’s not properly processed, it can result in a general sense of unhappiness and anger—exactly the negative emotional state that might lead a nation to misperceive its fortunes. The pressure to simply move on from the horrors of 2020 is strong. Who wouldn’t love to awaken from that nightmare and pretend it never happened? Besides, humans have a knack for sanitizing our most painful memories. In a 2009 study, participants did a remarkably poor job of remembering how they felt in the days after the 9/11 attacks, likely because those memories were filtered through their current emotional state. Likewise, a study published in Nature last year found that people’s recall of the severity of the 2020 COVID threat was biased by their attitudes toward vaccines months or years later. [From the May 2021 issue: You won’t remember the pandemic the way you think you will] When faced with an overwhelming and painful reality like COVID, forgetting can be useful—even, to a degree, healthy. It allows people to temporarily put aside their fear and distress, and focus on the pleasures and demands of everyday life, which restores a sense of control. That way, their losses do not define them, but instead become manageable. But consigning painful memories to the River Lethe also has clear drawbacks, especially as the months and years go by. Ignoring such experiences robs one of the opportunity to learn from them. In addition, negating painful memories and trying to proceed as if everything is normal contorts one’s emotional life and results in untoward effects. Researchers and clinicians working with combat veterans have shown how avoiding thinking or talking about an overwhelming and painful event can lead to free-floating sadness and anger, all of which can become attached to present circumstances. For example, if you met your old friend, a war veteran, at a café and accidentally knocked his coffee over, then he turned red and screamed at you, you’d understand that the mishap alone couldn’t be the reason for his outburst. No one could be that upset about spilled coffee—the real root of such rage must lie elsewhere. In this case, it might be untreated PTSD, which is characterized by a strong startle response and heightened emotional reactivity. We are not suggesting that the entire country has PTSD from COVID. In fact, the majority of people who are exposed to trauma do not go on to exhibit the symptoms of PTSD. But that doesn’t mean they aren’t deeply affected. In our lifetime, COVID posed an unprecedented threat in both its overwhelming scope and severity; it left most Americans unable to protect themselves and, at times, at a loss to comprehend what was happening. That meets the clinical definition of trauma: an overwhelming experience in which you are threatened with serious physical or psychological harm. [Read: Why are people nostalgic for early-pandemic life?] Traumatic memories are notable for how they alter the ways people recall the past and consider the future. A recent brain-imaging study showed that when people with a history of trauma were prompted to return to those horrific events, a part of the brain was activated that is normally employed when one thinks about oneself in the present. In other words, the study suggests that the traumatic memory, when retrieved, came forth as if it were being relived during the study. Traumatic memory doesn’t feel like a historical event, but returns in an eternal present, disconnected from its origin, leaving its bearer searching for an explanation. And right on cue, everyday life offers plenty of unpleasant things to blame for those feelings—errant friends, the price of groceries, or the leadership of the country. To come to terms with a traumatic experience, as clinicians know, you need to do more than ignore or simply recall it. Rather, you must rework the disconnected memory into a context, and thereby move it firmly into the past. It helps to have a narrative that makes sense of when, how, and why something transpired. For example, if you were mugged on a dark street and became fearful of the night, your therapist might suggest that you connect your general dread with the specifics of your assault. Then your terror would make sense and be restricted to that limited situation. Afterward, the more you ventured out in the dark, perhaps avoiding the dangerous block where you were jumped, the more you would form new, safe memories that would then serve to mitigate your anxiety. Many people don’t regularly recall the details of the early pandemic—how walking down a crowded street inspired terror, how sirens wailed like clockwork in cities, or how one had to worry about inadvertently killing grandparents when visiting them. But the feelings that that experience ignited are still very much alive. This can make it difficult to rationally assess the state of our lives and our country. One remedy is for leaders to encourage remembrance while providing accurate and trustworthy information about both the past and the present. In the early days of the pandemic, President Donald Trump mishandled the crisis and peddled misinformation about COVID. But with 2020 a traumatic blur, Trump seems to have become the beneficiary of our collective amnesia, and Biden the repository for lingering emotional discontent. Some of that misattribution could be addressed by returning to the shattering events of the past four years and remembering what Americans went through. This process of recall is emotionally cathartic, and if it’s done right, it can even help to replace distorted memories with more accurate ones. President Biden invited the nation to grieve together in 2021, when American death counts reached 500,000, and again in 2022, when they surpassed 1 million. In his 2022 State of the Union address, he rightly acknowledged that “we meet tonight in an America that has lived through two of the hardest years this nation has ever faced,” before urging Americans to “move forward safely.” But in the past two years, he, like almost everyone else, has largely tried to proceed as if everyone is back to normal. Meanwhile, American minds and hearts simply aren’t ready—whether we realize it or not. [Read: The Biden administration killed America’s collective pandemic approach] Perhaps Biden and his advisers fear that reminding voters of such a dark time would create more trouble for his presidency. And yet, our work leads us to believe that the effect would be exactly the opposite. Rituals of mourning and remembrance help people come together and share in their grief so that they can return more clear-eyed to face daily life. By prompting Americans to remember what we endured together, paradoxically, Biden could help free all of us to more fully experience the present. from https://ift.tt/VHd5QZG Check out http://natthash.tumblr.com |
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