Patient Dies Weeks After Kidney Transplant From Genetically Modified Pig

Richard Slayman received the historic procedure in March. The hospital said it had “no indication” his death was related to the transplant.Richard “Rick” Slayman, who made history at age 62 as the first person to receive a kidney from a genetically modified pig, has died about two months after the procedure.Massachusetts General Hospital, where Mr. Slayman had the operation, said in a statement on Saturday that its transplant team was “deeply saddened” at his death. The hospital said it had “no indication that it was the result of his recent transplant.”Mr. Slayman, who was Black, had end-stage kidney disease, a condition that affects more than 800,000 people in the United States, according to the federal government, with disproportionately higher rates among Black people.Surgeons performing the world’s first kidney transplant from a genetically modified pig into a living human in March.Michelle Rose/Massachusetts General Hospital, via Agence France-Presse — Getty ImagesThere are far too few kidneys available for donation. Nearly 90,000 people are on the national waiting list for a kidney.Mr. Slayman, a supervisor for the state transportation department from Weymouth, Mass., had received a human kidney in 2018. When it began to fail in 2023 and he developed congestive heart failure, his doctors suggested he try one from a modified pig.“I saw it not only as a way to help me, but a way to provide hope for the thousands of people who need a transplant to survive,” he said in a hospital news release in March.His surgery, which lasted four hours, was a medical milestone. For decades, proponents of so-called xenotransplantation have proposed replacing ailing human organs with those from animals. The main problem with the approach is the human immune system, which rejects animal tissue as foreign, often leading to serious complications.Recent advances in genetic engineering have allowed researchers to tweak the genes of the animal organs to make them more compatible with their recipients.The pig kidney that was transplanted into Mr. Slayman was engineered by eGenesis, a biotech company based in Cambridge, Mass. Scientists there removed three genes and added seven others to improve compatibility. The company also inactivated retroviruses that pigs carry and could be harmful to humans.“Mr. Slayman was a true pioneer,” eGenesis said in a statement on social media on Saturday. “His courage has helped to forge a path forward for current and future patients suffering from kidney failure.”Mr. Slayman was discharged from the hospital two weeks after his surgery, with “one of the cleanest bills of health I’ve had in a long time,” he said at the time.In a statement published by the hospital, Mr. Slayman’s family said he was kind, quick-witted and “fiercely dedicated to his family, friends and co-workers.” They said they had taken great comfort in knowing that his case had inspired so many people.“Millions of people worldwide have come to know Rick’s story,” they said in the statement. “We felt — and still feel — comforted by the optimism he provided patients desperately waiting for a transplant.”

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Washington University Stops Offering Gender Medications to Minors

The NewsWashington University in St. Louis will stop prescribing gender medications to minors, the school said on Monday, citing “unacceptable” legal liability under a new Missouri law banning such treatments.The change comes seven months after a former employee of the university’s youth gender clinic claimed that doctors there were hastily prescribing the treatments, throwing the center into the cross hairs of politicians trying to outlaw so-called gender affirming care for adolescents.Current patients under 18 will be referred to other providers for these medications, which include puberty blockers and hormones, the university said in a statement.“We are disheartened to have to take this step,” the statement said.St. Louis Children’s Hospital, part of the Washington University hospital system, where the gender clinic opened in 2017.Bryan Birks for The New York TimesBackgroundIn June, Gov. Mike Parson, Republican of Missouri, signed into law the ban on gender-affirming care for new patients under 18, part of a wave of more than 20 laws across the country severely restricting such care.Under the new law, existing patients of Washington University’s youth gender clinic were still allowed to receive the treatments. But the law includes a provision allowing patients to make legal claims against doctors who prescribe hormonal medications to minors. The university said this part of the law made it “untenable” to continue providing this care.Since it opened in 2017, the St. Louis clinic had seen a sharp increase in patient demand, overwhelming its small staff, The New York Times reported last month. Many patients and their families told The Times that the clinic’s doctors provided excellent care, and that the hormonal treatments profoundly improved patients’ mental health.But the clinic’s staff members struggled to give thorough psychological evaluations to patients with serious mental health problems, highlighting tensions among experts over how much screening should be required before giving adolescents access to hormones.This nuanced medical debate has run in parallel to a sweeping political movement to ban gender treatments for minors. Major medical groups have opposed bans on gender-affirming care for minors, as have many of the clinicians who have raised concerns that some children are being rushed into treatment.What’s NextWashington University said that its gender clinic would still provide hormonal treatments to adult patients, and that it would offer education and mental health support to patients of all ages.“Our medical practitioners have cared for these patients with skill and dedication,” the school’s statement said. “They have continually provided treatment in accordance with the standard of care and with informed consent of patients and their parents or guardians.”After the clinic’s former employee, Jamie Reed, went public, Missouri’s attorney general, a Republican, opened an investigation into the clinic’s operations, which is continuing. Senator Josh Hawley, Republican of Missouri, is conducting a similar inquiry.Civil rights groups are challenging Missouri’s ban, which has a “sunset” provision and will be in effect for four years. Last month, a judge declined the groups’ request for an injunction that would have temporarily blocked enforcement of the law.

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How to Change Minds? A Study Makes the Case for Talking It Out.

Researchers found that meaty conversations among several people can align beliefs and brain patterns — so long as the group is free of blowhards.Co-workers stuck on a Zoom call, deliberating a new strategy for a crucial project. Roommates at the kitchen table, arguing about how to split utility bills fairly. Neighbors at a city meeting, debating how to pay for street repairs.We’ve all been there — in a group, trying our best to get everyone on the same page. It’s arguably one of the most important and common undertakings in human societies. But reaching agreement can be excruciating.“Much of our lives seem to be in this sort of Rashomon situation — people see things in different ways and have different accounts of what’s happening,” Beau Sievers, a social neuroscientist at Dartmouth College, said.A few years ago, Dr. Sievers devised a study to improve understanding of how exactly a group of people achieves a consensus and how their individual brains changed after such discussions. The results, recently published online but not yet peer-reviewed, showed that a robust conversation that results in consensus synchronizes the talkers’ brains — not only when thinking about the topic that was explicitly discussed, but related situations that were not.The study also revealed at least one factor that makes it harder to reach accord: a group member whose strident opinions drown out everyone else.“Conversation is our greatest tool to align minds,” said Thalia Wheatley, a social neuroscientist at Dartmouth College who advises Dr. Sievers. “We don’t think in a vacuum, but with other people.”Dr. Sievers designed the experiment around watching movies because he wanted to create a realistic situation in which participants could show fast and meaningful changes in their opinions. But he said it was surprisingly difficult to find films with scenes that could be viewed in different ways. “Directors of movies are very good at constraining the kinds of interpretations that you might have,” he said.Reasoning that smash hits typically did not offer much ambiguity, Dr. Sievers focused on films that critics loved but did not bring blockbuster audiences, including “The Master,” “Sexy Beast” and “Birth,” a 2004 drama in which a mysterious young boy shows up at a woman’s engagement party.None of the study’s volunteers had seen any of the films before. While lying in a brain scanner, they watched scenes from the various movies without sound, including one from “Birth” in which the boy collapses in a hallway after a tense conversation with the elegantly dressed woman and her fiancé.Part of a scene from the 2004 film “Birth,” that was used in a study of how brain patterns are affected by group conversations that yield a consensus agreement.After watching the clips, the volunteers answered survey questions about what they thought had happened in each scene. Then, in groups of three to six people, they sat around a table and discussed their interpretations, with the goal of reaching a consensus explanation.All of the participants were students in the same master of business administration program, and many of them knew each other to varying degrees, which made for lively conversations reflecting real-world social dynamics, the researchers said.After their chats, the students went back into the brain scanners and watched the clips again, as well as new scenes with some of the same characters. The additional “Birth” scene, for example, showed the woman tucking the little boy into bed and crying.After groups reached a consensus explanation about the first film clip, volunteers watched more material, including part of this second scene from “Birth.”The study found that the group members’ brain activity — in regions related to vision, sound, attention, language and memory, among others — became more aligned after their conversation. Intriguingly, their brains were synchronized while they watched the scenes they had discussed, as well as the novel ones.Groups of volunteers came up with different interpretations of the same movie clip. Some groups, for example, thought the woman was the boy’s mother and had abandoned him, whereas others thought they were unrelated. Despite having watched the same clips, the brain patterns from one group to another were meaningfully different, but within each group, the activity was far more synchronized.The results have been submitted for publication in a scientific journal and are under review.“This is a bold and innovative study,” said Yuan Chang Leong, a cognitive neuroscientist at University of Chicago who was not involved in the work.The results jibe with previous research showing people who share beliefs tend to share brain responses. For example, a 2017 study presented volunteers with one of two opposite interpretations of “Pretty Mouth and Green My Eyes,” a short story by J.D. Salinger. The participants that had received the same interpretation had more aligned brain activity when listening to the story in the brain scanner.And in 2020, Dr. Leong’s team reported that when watching news footage, brain activity in conservatives looked more like that in other conservatives than that in liberals, and vice versa.The new study “suggests that the degree of similarity in brain responses depends not only on people’s inherent predispositions, but also the common ground created by having a conversation,” Dr. Leong said.The experiment also underscored a dynamic familiar to anyone who has been steamrollered in a work meeting: An individual’s behavior can drastically influence a group decision. Some of the volunteers tried to persuade their groupmates of a cinematic interpretation with bluster by barking orders and talking over their peers. But others — particularly those who were central players in the students’ real-life social networks — acted as mediators, reading the room and trying to find common ground.The groups with blowhards were less neurally aligned than were those with mediators, the study found. Perhaps more surprising, the mediators drove consensus not by pushing their own interpretations, but by encouraging others to take the stage and then adjusting their own beliefs — and brain patterns — to match the group.“Being willing to change your own mind, then, seems key to getting everyone on the same page,” Dr. Wheatley said.Because the volunteers were eagerly trying to collaborate, the researchers said that the study’s results were most relevant to situations, like workplaces or jury rooms, in which people are working toward a common goal.But what about more adversarial scenarios, in which people have a vested interest in a particular position? The study’s results might not hold for a person negotiating a raise or politicians arguing over the integrity of our elections. And for some situations, like creative brainstorming, groupthink may not be an ideal outcome.“The topic of conversation in this study was probably pretty ‘safe,’ in that no personally or societally relevant beliefs were at stake,” said Suzanne Dikker, a cognitive neuroscientist and linguist at New York University, who was not involved in the study.Future studies could zero in on brain activity during consensus-building conversations, she said. This would require a relatively new technique, known as hyperscanning, which can simultaneously measure multiple people’s brains. Dr. Dikker’s work in this arena has shown that personality traits and conversational dynamics like taking turns can affect brain-to-brain synchrony.Dr. Wheatley agreed. The neuroscientist said she has long been frustrated with her field’s focus on the isolated brain.“Our brains evolved to be social: We need frequent interaction and conversation to stay sane,” she said. “And yet, neuroscience still putters along mapping out the single brain as if that will achieve a deep understanding of the human mind. This has to, and will, change.”

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Does Social Media Make Teens Unhappy? It May Depend on Their Age.

A large study in Britain found two specific windows of adolescence when some teenagers are most sensitive to social media.Over the past few years, as the cold glow of a smartphone has followed more and more adolescents from bedroom to school and back again, parents have fretted over the technology’s influence. And no wonder, with Facebook researchers covertly studying how its apps erode girls’ body image, doctors describing TikTok-induced tic disorders, and prosecutors and lawmakers pledging to hold social media companies responsible for harming children.But in the background, a quieter scientific discussion has questioned whether social media is doing much harm at all. While a few researchers have claimed that digital technology is a powerful, causal factor in the rising rates of mental health problems, others have countered that the risk of harm for most teenagers is tiny — about the equivalent influence on well-being as wearing eyeglasses or regularly eating potatoes, one group calculated.Now, the authors of the eyeglass paper have published a large, multiyear study providing what independent experts said was an unusually granular and rigorous look at the relationship between social media and adolescents’ feelings about life.Analyzing survey responses of more than 84,000 people of all ages in Britain, the researchers identified two distinct periods of adolescence when heavy use of social media spurred lower ratings of “life satisfaction”: first around puberty — ages 11 to 13 for girls, and 14 to 15 for boys — and then again for both sexes around age 19.Like many previous studies, this one found that the relationship between social media and an adolescent’s well-being was fairly weak. Still, it suggested that there were certain periods in development when teenagers may be most sensitive to the technology.“We actually considered that the links between social media and well-being might be different across different ages — and found that that is indeed the case,” said Amy Orben, an experimental psychologist at Cambridge University, who led the study.For most adolescents in the United States, screens are a big part of life. Nine out of 10 American teenagers have a smartphone, and they are spending many hours a day staring at it — watching videos, playing games and communicating through social media, recent surveys show.As social media use among teenagers has exploded over the past two decades, so too have rates of depression, anxiety and suicide, leading scientists to wonder if these striking trends could be related.Some have suggested that social media may have an indirect effect on happiness by displacing other activities, like in-person interactions, exercise or sleep, that are crucial for mental and physical health. Heavy social-media use seems to disturb adolescent sleep patterns, for example.Still, research looking for a direct relationship between social media and well-being has not found much.“There’s been absolutely hundreds of these studies, almost all showing pretty small effects,” said Jeff Hancock, a behavioral psychologist at Stanford University who has conducted a meta-analysis of 226 such studies.What is notable about the new study, said Dr. Hancock, who was not involved in the work, is its scope. It included two surveys in Britain totaling 84,000 people. One of those surveys followed more than 17,000 adolescents ages 10 to 21 over time, showing how their social media consumption and life-satisfaction ratings changed from one year to the next.“Just in terms of scale, it’s fantastic,” Dr. Hancock said. The rich age-based analysis, he added, is a major improvement over previous studies, which tended to lump all adolescents together. “The adolescent years are not like some constant period of developmental life — they bring rapid changes,” he said.The study found that during early adolescence, heavy use of social media predicted lower life-satisfaction ratings one year later. For girls, this sensitive period was between ages 11 and 13, whereas for boys it was 14 and 15. Dr. Orben said that this sex difference could simply be because girls tend to hit puberty earlier than boys do.“We know that adolescent girls go through a lot of development earlier than boys do,” Dr. Orben said. “There are a lot of things that could be potential drivers, whether they’re social, cognitive or biological.”Both the boys and girls in the study hit a second period of social media sensitivity around age 19. “That was quite surprising because it was so consistent across the sexes,” Dr. Orben said. Around that age, she said, many people go through major social upheaval — like starting college, working in a new job or living independently for the first time — that might change the way they interact with social media, she said.Although the new report drew from richer data sets than previous studies did, it nevertheless lacked some information that would be helpful in interpreting the results, experts said. Waiting a whole year between responses is not ideal, for example. And although the surveys asked how much time the participants spent communicating on social media, they did not ask how they used it; talking to strangers while simultaneously playing a video game might lead to different effects than texting with a group of friends from school.Taken together with past work, the findings suggest that while most teenagers are not affected much by social media, a small subset could be significantly harmed by its effects. But it is impossible to predict the risks for an individual child.“For your 12-year-old, what does that mean for them? It’s hard to know,” said Michaeline Jensen, a clinical psychologist at the University of North Carolina at Greensboro. Given the small effect seen in the study, “very few of these kids would be going from normal functioning to clinical levels of depression,” she said. But “that’s not to say that none of them would.”Dr. Jensen pointed out that the study also found a link in the opposite direction: For all ages, participants who felt bad about their lives wound up spending more time on social media a year later. This suggests that for some people the technology may be a coping mechanism rather than the cause of their gloom.All these experts said that they were often frustrated by the public debates about social media and children, which so often inflate the platforms’ harms and ignore the benefits.“It carries risks — peer influence, contagion, substance use,” Dr. Jensen said. “But it can also carry lots of positive things,” like support, connection, creativity and skill mastery, she added. “I think a lot of times that does get overlooked because we’re so focused on risks.”

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F.D.A. Approves GHB, a ‘Date Rape’ Drug, for Rare Sleeping Disorder

Jazz Pharmaceuticals brought in more than $1.7 billion last year selling GHB to narcolepsy patients. With the new approval, sales could soar.In the 1960s, the drug was given to women during childbirth to dampen their consciousness. In the 1990s, an illicit version made headlines as a “date rape” drug, linked to dozens of deaths and sexual assaults.And for the last two decades, a pharmaceutical-grade slurry of gamma-hydroxybutyrate, or GHB, has been tightly regulated as a treatment for narcolepsy, a disorder known for its sudden sleep attacks.Now, the Food and Drug Administration has approved the drug for a new use: treating “idiopathic hypersomnia,” a mysterious condition in which people sleep nine or more hours a day, yet never feel rested. Branded as Xywav, the medication is thought to work by giving some patients restorative sleep at night, allowing their brains to be more alert when they wake up. It is the first approved treatment for the illness.But some experts say the publicly available evidence to support the new approval is weak. And they worry about the dangers of the medication, which acts so swiftly that its label advises users to take it while in bed. Xywav and an older, high-salt version called Xyrem have a host of serious side effects, including breathing problems, anxiety, depression, sleepwalking, hallucinations and suicidal thoughts.GHB “has serious safety concerns, both in terms of its abuse liability and its addictive potential,” said Dr. Lewis S. Nelson, the director of medical toxicology at Rutgers New Jersey Medical School.An estimated 40,000 people in the United States have been diagnosed with idiopathic hypersomnia, but Dr. Nelson said that many more people with daytime drowsiness might wind up with this diagnosis now that it has an F.D.A.-approved treatment. The disorder’s hallmark symptoms — sleep cravings, long naps and brain fog — overlap with many other conditions.The more people who take the drug, the more opportunity for abuse. “The potential for the scope of use to expand is very real,” Dr. Nelson said. “So that is concerning to me.”The new approval is a boon for Jazz Pharmaceuticals, based in Dublin, which brought in more than $1.7 billion last year selling Xyrem and Xywav to about 15,300 people, most with narcolepsy.“We’re really excited about bringing the benefit of this effective medication to more patients,” said Bruce Cozadd, the chairman and chief executive of Jazz, which announced the new approval on Thursday.On the black market, homemade GHB — also known as liquid ecstasy, goop and G — can be bought by the capful for $5 to $25. But nightly treatments of Xyrem and Xywav cost roughly $100,000 a year. The new approval will make it much easier for hypersomnia patients to get insurance coverage for Xywav.Many doctors and patients have never heard of idiopathic hypersomnia, Mr. Cozadd said, but Jazz will aim to change that. “There’s an educational effort that we’ll be part of,” he said, “which is really making sure there’s a better understanding among treaters and among patients of the condition and its treatment.”The F.D.A. did not immediately respond to a request for comment.In March, Jazz and the Hypersomnia Foundation, a patient advocacy group, began an awareness campaign — “I have IH” — which included an online survey of health care providers’ knowledge of the condition (it was low), and advertisements in Times Square.“I never thought I’d live to see that day — it was very emotional,” said Betsy Ashcraft, the treasurer of the foundation’s board of directors, whose adult son has idiopathic hypersomnia. (Jazz paid the foundation’s board members, who are volunteers, for their time consulting on the campaign, she said.)GHB is an old drug, first synthesized by a Russian chemist in 1874. A century later, it was sold as a dietary supplement in the United States, and academic researchers began reporting that it greatly improved the nighttime sleep of people with narcolepsy and curbed their daytime sleep attacks, called cataplexy.In 1994, the F.D.A. approached a Minnesota drug company called Orphan Medical to investigate GHB as a treatment for narcolepsy. The government gives incentives — including tax credits and seven years of market exclusivity — to develop drugs for diseases that have small patient markets.But at the same time, illicit GHB was becoming a big problem. At low doses, the odorless powder can trigger euphoria and sexual arousal, making it popular at parties and raves. At high doses, especially when mixed with other downers like alcohol, it can knock a person out without any memory of what happened.In 2000, after GHB had been linked to sexual assaults and deaths, Congress passed a law that made the drug illegal, but allowed for future medical uses. Later that year, Orphan Medical sought F.D.A. approval of Xyrem for narcolepsy..css-1xzcza9{list-style-type:disc;padding-inline-start:1em;}.css-rqynmc{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:0.9375rem;line-height:1.25rem;color:#333;margin-bottom:0.78125rem;}@media (min-width:740px){.css-rqynmc{font-size:1.0625rem;line-height:1.5rem;margin-bottom:0.9375rem;}}.css-rqynmc strong{font-weight:600;}.css-rqynmc em{font-style:italic;}.css-yoay6m{margin:0 auto 5px;font-family:nyt-franklin,helvetica,arial,sans-serif;font-weight:700;font-size:1.125rem;line-height:1.3125rem;color:#121212;}@media (min-width:740px){.css-yoay6m{font-size:1.25rem;line-height:1.4375rem;}}.css-1dg6kl4{margin-top:5px;margin-bottom:15px;}#masthead-bar-one{display:none;}#masthead-bar-one{display:none;}.css-1pxllx6 header h4{font-family:nyt-cheltenham,georgia,’times new roman’,times,serif;font-weight:500;font-size:1.25rem;line-height:1.5625rem;margin-bottom:5px;}@media (min-width:740px){.css-1pxllx6 header h4{font-size:1.5625rem;line-height:1.875rem;}}.css-1pd7fgo{background-color:white;border:1px solid #e2e2e2;width:calc(100% – 40px);max-width:600px;margin:1.5rem auto 1.9rem;padding:15px;box-sizing:border-box;}@media (min-width:740px){.css-1pd7fgo{padding:20px;width:100%;}}.css-1pd7fgo:focus{outline:1px solid #e2e2e2;}#NYT_BELOW_MAIN_CONTENT_REGION .css-1pd7fgo{border:none;padding:20px 0 0;border-top:1px solid #121212;}.css-1pd7fgo[data-truncated] .css-rdoyk0{-webkit-transform:rotate(0deg);-ms-transform:rotate(0deg);transform:rotate(0deg);}.css-1pd7fgo[data-truncated] .css-eb027h{max-height:300px;overflow:hidden;-webkit-transition:none;transition:none;}.css-1pd7fgo[data-truncated] .css-5gimkt:after{content:’See more’;}.css-1pd7fgo[data-truncated] .css-6mllg9{opacity:1;}.css-1rh1sk1{margin:0 auto;overflow:hidden;}.css-1rh1sk1 strong{font-weight:700;}.css-1rh1sk1 em{font-style:italic;}.css-1rh1sk1 a{color:#326891;-webkit-text-decoration:underline;text-decoration:underline;text-underline-offset:1px;-webkit-text-decoration-thickness:1px;text-decoration-thickness:1px;-webkit-text-decoration-color:#ccd9e3;text-decoration-color:#ccd9e3;}.css-1rh1sk1 a:visited{color:#333;-webkit-text-decoration-color:#ccc;text-decoration-color:#ccc;}.css-1rh1sk1 a:hover{-webkit-text-decoration:none;text-decoration:none;}A subsequent meeting of an F.D.A. advisory committee brought charged testimony both for and against the drug. A lawyer who had taken GHB for narcolepsy for 19 years testified that his cataplexy “disappeared almost overnight,” with no side effects. The next speaker described how her daughter had bought GHB as a supplement for bodybuilding and became addicted. “I am here today to tell you how GHB killed my daughter,” she said.The advisory committee recommended the agency approve Xyrem for narcolepsy with cataplexy, which it did in 2002. Three years later, Orphan was acquired by Jazz.Xyrem contains a lot of salt, increasing a user’s risk of hypertension. The low-sodium Xywav was approved for narcolepsy last year, and Jazz has been urging doctors — with much success — to switch patients to the new brand. As executives pointed out in a recent earnings call, the shift is good news for Jazz’s business: Xyrem will most likely begin to compete with generic versions of the drug next year, whereas Xywav will have market exclusivity until at least 2027.Both prescriptions are tightly controlled through a safety program (known as a REMS) in which a single pharmacy ships the drug and regularly monitors patients and their doctors. Through this strict program, Jazz receives regular reports about any negative drug experiences reported by patients, and must disclose such cases to the F.D.A.Xyrem, left, and Xywav, the low-sodium version of the drug.As of June 30, the F.D.A. had recorded more than 27,000 “serious adverse events” for patients taking Xyrem or Xywav, including 753 deaths, according to the agency’s public database of such reports. (The F.D.A. defines serious events as those that were life threatening or led to hospitalization, serious medical consequences or death. However, these reports could be inaccurate or incomplete, the agency notes. Some of the events happened to people taking multiple drugs, and no single report can prove a drug caused illness.)“For some years I’ve had questions about whether this drug has benefits that exceed its high risks,” said Thomas Moore, a researcher at the Center for Drug Safety and Effectiveness at Johns Hopkins University, who in 2014 published a report recommending that the F.D.A. re-evaluate Xyrem.“F.D.A. approval of Xywav is based on both its benefit and its risks,” said Mr. Cozadd of Jazz. “Clearly F.D.A. believes, as we do, that used properly the drug is very beneficial for these patients.”In the years after Xyrem was approved for narcolepsy, Jazz ran afoul of the federal government for inappropriately marketing the drug for unapproved conditions, including insomnia, depression and fibromyalgia, a chronic condition involving pain and fatigue that affects at least four million people in the United States. The transgression cost the company $20 million in fines.In 2010, Jazz tried to get the drug approved to treat fibromyalgia, but an F.D.A. advisory committee voted overwhelmingly against the idea.“The data to support its benefit was infinitesimally small,” said Dr. Nelson of Rutgers, who was on that panel. Given the large size of the fibromyalgia population, the committee deemed the risks too high, he said: “Even with REMS, it just seemed like a potentially catastrophic idea.”The F.D.A. granted the new approval for hypersomnia without asking an advisory panel to weigh in. Jazz’s application was based on a small clinical trial in which 115 patients were given Xywav for 12 to 16 weeks, leading to decreases in scores on a sleepiness scale. After that acclimation period, about half of the volunteers were switched to a placebo for two weeks, which led to marked increases in their sleepiness scores.“Those under placebo deteriorated very rapidly,” said Dr. Isabelle Arnulf, a sleep disorder specialist at the Pitié-Salpêtrière University Hospital in Paris, who has studied hypersomnia for 25 years and helped carry out Jazz’s clinical trial. (She has not taken any payments from the company, she said.)Although many of the volunteers reported side effects like nausea, anxiety and dizziness, the change in sleepiness scores was “extremely high,” Dr. Arnulf said. “That’s why we are so enthusiastic with this drug.” These results align, she said, with a 2015 study of a few dozen hypersomnia patients from her clinic who were helped by Xyrem.Other scientists were skeptical of the new trial’s results, which were presented at a scientific conference but not yet published in a journal. Some pointed out that the placebo group’s worsening scores might be at least partly explained by the negative effects of chemical withdrawal from the drug.“Some, or possibly most, of the treatment difference could be contaminated by withdrawal effects,” Mr. Moore of Johns Hopkins said after reviewing a poster presentation of the data the company provided to The New York Times.A senior scientist at Jazz, Dr. Jed Black, said that the volunteers who were switched to placebo did get sleepier, but that their scores were still better than they were before starting the trial, which you wouldn’t expect if they were in the throes of withdrawal. “There’s absolutely no evidence of withdrawal, or any evidence of physical or psychological dependence,” he said.Other experts said it was also hard to tease apart the possible effects of other drugs. More than half of the volunteers had been taking stimulant medications and were allowed to continue those drugs during the study.“Based on what they presented, you cannot say it’s a study that supports approval,” said ​Stanley Edlavitch, an epidemiologist at the University of Missouri Kansas City School of Medicine and former F.D.A. official.But with few other options, many hypersomnia patients are willing to take their chances on the drug. Rebecca King, a board member of the Hypersomnia Foundation, said she long struggled with daytime sleepiness, taking hourslong naps in the morning and afternoon but never feeling like she had slept — until Xyrem, which her doctor legally prescribed “off label” four years ago, before it was approved by the F.D.A.“The doctor actually said to me, ‘Rebecca, are you sure you want to try this? You are messing with your brain,’” she recalled. But the drug, she said, “was a huge, dramatic improvement for me.”Still, it isn’t for everyone. Ms. Ashcraft’s son, for example, saw no benefit when he tried Xyrem.“If you gave me a list of medicines and said, ‘Which one do you want approved for idiopathic hypersomnia?’ I don’t know that I would have picked Xywav,” said Dr. Lynn Marie Trotti, a sleep neurologist at Emory University School of Medicine who has studied the condition.Still, Dr. Trotti is pleased that there is now an approved choice for people with such a debilitating illness.“For some patients, it is going to be the right medication,” she said, “and they should be able to access it.”

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Two New Laws Restrict Police Use of DNA Search Method

Maryland and Montana have passed the nation’s first laws limiting forensic genealogy, the method that found the Golden State Killer.New laws in Maryland and Montana are the first in the nation to restrict law enforcement’s use of genetic genealogy, the DNA matching technique that in 2018 identified the Golden State Killer, in an effort to ensure the genetic privacy of the accused and their relatives.Beginning on Oct. 1, investigators working on Maryland cases will need a judge’s signoff before using the method, in which a “profile” of thousands of DNA markers from a crime scene is uploaded to genealogy websites to find relatives of the culprit. The new law, sponsored by Democratic lawmakers, also dictates that the technique be used only for serious crimes, such as murder and sexual assault. And it states that investigators may only use websites with strict policies around user consent.Montana’s new law, sponsored by a Republican, is narrower, requiring that government investigators obtain a search warrant before using a consumer DNA database, unless the consumer has waived the right to privacy.The laws “demonstrate that people across the political spectrum find law enforcement use of consumer genetic data chilling, concerning and privacy-invasive,” said Natalie Ram, a law professor at the University of Maryland who championed the Maryland law. “I hope to see more states embrace robust regulation of this law enforcement technique in the future.”Privacy advocates like Ms. Ram have been worried about genetic genealogy since 2018, when it was used to great fanfare to reveal the identity of the Golden State Killer, who murdered 13 people and raped dozens of women in the 1970s and ’80s. After matching the killer’s DNA to entries in two large genealogy databases, GEDmatch and FamilyTreeDNA, investigators in California identified some of the culprit’s cousins, and then spent months building his family tree to deduce his name — Joseph James DeAngelo Jr. — and arrest him.Ms. Ram subsequently published an article in a law journal calling on Maryland lawmakers to act against the practice. Granting police access to a suspect’s genome, she argued, including markers of sensitive health information, was akin to an unreasonable search, which is banned by the Fourth Amendment. In 2019, she testified to a state House committee after a delegate, Charles Sydnor, who is now a state senator, introduced legislation that would have banned the method outright.The ban did not pass. But it prompted discussions with legal experts, public defenders, prosecutors and police officers that led to a compromise bill, which passed unanimously this term in the state House and Senate.“This bill strikes a balance between this very important technology to identify people that do the very worst things to our Marylanders, yet it balances that against the privacy concerns and the trust that we need from the public,” John Fitzgerald, the chief of the Chevy Chase Village Police Department, testified to the Maryland House Judiciary Committee in February.But some experts said that the law could put a damper on the technology’s use in Maryland. For one thing, the law states that by 2024, genealogists working on such cases must be professionally certified — a credential that does not yet exist.Another sticky provision: Investigators may use only genealogy companies that have explicitly informed the public and their customers that law enforcement uses their databases, and that have asked for their customers’ consent to participate. Currently, customers of GEDmatch and FamilyTreeDNA are given a choice about whether to participate in these searches. But the companies provide little information about what those searches entail, and the opt-in settings are turned on by default.“We know well that most people do not read these kinds of forms closely,” Ms. Ram said. “This is likely to generate unwitting inclusion rather than actual consent.”Unlike 23andMe and Ancestry, which have kept their immense genetic databases unavailable to law enforcement without a court order, GEDmatch and FamilyTreeDNA are eager to cooperate. If other states do not follow Maryland’s lead, it seems unlikely that either company would make changes that would shrink the pool of DNA profiles available for these searches. Both companies said in statements that they had no plans to update their policies.“If the rest of the nation doesn’t have that requirement, why would they bow to Maryland’s needs?” said Paul Holes, a critic of the bill and a retired cold-case investigator who was on the team that found Mr. DeAngelo. “Now they’re serving the greater good at the expense of one state.”In the three years since Mr. Holes’s team found Mr. DeAngelo, likely several hundred cases, many of them decades old, have been solved nationwide with genetic genealogy. The method has been used to solve crimes, exonerate the innocent and find the names of unidentified remains. The Defense Department may use the technique to identify World War II soldiers.Joseph James DeAngelo Jr., also known as the Golden State Killer, appearing before the court during a sentencing hearing in August.Pool photo by Santiago MejiaIn some cases, customers may never know that the DNA markers they have uploaded into a database are being used by the police to identify culprits — or that using the database may bring trouble to their relatives. In 2018, police in Orlando, Fla., asked a woman for a DNA test, telling her that they believed she was related to a dead person they were trying to identify. She complied, only to find out that they were investigating her son, who was subsequently arrested and charged with murder.In other cases, detectives might surreptitiously collect the DNA of a suspect’s relative by testing an object that the relative discarded in the trash.Maryland’s new law states that when police officers test the DNA of “third parties” — people other than the suspect — they must get consent in writing first, unless a judge approves deceptive collection.Investigators cannot use any of the genetic information collected, whether from the suspect or third parties, to learn about a person’s psychological traits or disease predispositions. At the end of the investigation, all of the genetic and genealogical records that were created for it must be deleted from databases.And perhaps most consequential, Maryland investigators interested in genetic genealogy must first try their luck with a government-run DNA database, called Codis, whose profiles use far fewer genetic markers.Mr. Holes said that this part of the law could have tragic consequences. For old cases, he pointed out, DNA evidence is often highly degraded and fragile, and every DNA test consumes some of that precious sample. “In essence, the statute could potentially cause me to kill my case,” he said. And given the speed that DNA technology evolves, he added, it is unwise for a law to mandate use of any particular kind of test.But other experts called this provision crucial, because the potential privacy breach is far more severe for genetic genealogy, which gives law enforcement access to hundreds of thousands of genetic markers, than it is for Codis, which uses only about two dozen markers.These searches are “the equivalent of the government going through all of your medical records and all of your family records just to identify you,” said Leah Larkin, a genetic genealogist who runs a consulting business in the San Francisco Bay Area that is largely focused on helping adoptees and others find their biological relatives. “I don’t think people fully appreciate how much is in your genetic data.”

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Scientists Drove Mice to Bond by Zapping Their Brains With Light

The study, a tour de force in bioengineering, comes after two decades of research on brain-to-brain synchrony in people.Mice with tiny devices implanted in their brains showed a great affinity to one another in an experiment when the signals were synchronized.Northwestern UniversityLate one evening last March, just before the coronavirus pandemic shut down the country, Mingzheng Wu, a graduate student at Northwestern University, plopped two male mice into a cage and watched as they explored their modest new digs: sniffing, digging, fighting a little.With a few clicks on a nearby computer, Mr. Wu then switched on a blue light implanted in the front of each animal’s brain. That light activated a tiny piece of cortex, spurring neurons there to fire.Mr. Wu zapped the two mice at the same time and at the same rapid frequency — putting that portion of their brains quite literally in sync. Within a minute or two, any animus between the two creatures seemed to disappear, and they clung to each other like long-lost friends.“After a few minutes, we saw that those animals actually stayed together, and one animal was grooming the other,” said Mr. Wu, who works in the neurobiology lab of Yevgenia Kozorovitskiy.Mr. Wu and his colleagues then repeated the experiment, but zapped each animal’s cortex at frequencies different from the other’s. This time, the mice displayed far less of an urge to bond.The experiment, published this month in Nature Neuroscience, was made possible thanks to an impressive new wireless technology that allows scientists to observe — and manipulate — the brains of multiple animals as they interact with one another.“The fact that you can implant these miniaturized bits of hardware and turn neurons on and off by light, it’s just mind-blowingly cool,” said Thalia Wheatley, a social neuroscientist at Dartmouth College who was not involved in the work.For centuries, she noted, most neuroscientists have been focused on the individual brain and the function of its various parts. “The whole field is built on looking at a brain in a jar — Where’s memory? Where’s vision?” Dr. Wheatley said. But to understand nuanced social behaviors, which by definition can’t be observed in isolation, “it’s very important that we’re beginning to look at more than one brain at the same time.”The new study also raises questions about a tantalizing phenomenon that has been observed in humans for decades, with potential implications for everything from social anxiety disorders to pandemic isolation: When two people interact, their brain patterns align in intriguing ways.An optogenetic device used a tiny LED light, implanted into the mice’s brains, to activate groups of neurons.Northwestern UniversityFrom ghosts to batsWhen research on so-called interbrain synchrony emerged in the 2000s, some scientists dismissed it as parapsychology, a trippy field of the 1960s and ’70s that claimed to find evidence of ghosts, the afterlife and other wonders of the paranormal.In 1965, for example, two ophthalmologists published in the prestigious journal Science an absurd study of 15 pairs of identical twins. Each twin, with electrodes on their scalps, was placed in a separate room and asked to blink on command. In two of the pairs, the study reported, one twin showed distinctive patterns of brain activity while the sibling was blinking in the other room. The doctors called it “extrasensory induction.”“The paper is hilarious,” said Guillaume Dumas, a social physiologist at the University of Montreal who has studied brain-to-brain synchrony for more than a decade. In that far-out era, he said, “there were many papers with methodologically questionable conclusions claiming to demonstrate interbrain synchronization with two people.”Since then, however, many sound studies have found brain synchronies emerging during human interactions, starting with a paper in 2002 that described how to collect and merge data from two brain scanners simultaneously as two people played a competitive game. This enabled researchers to observe how both brains were activated in response to each other. In a Science paper in 2005, this “hyperscanning” technique showed correlations of activity in two people’s brains when they played a game based on trust.In 2010, Dr. Dumas used scalp electrodes to find that when two people spontaneously imitated each other’s hand movements, their brains showed coupled wave patterns. Importantly, there was no external metronome — like music or a turn-taking game — that spurred the pairs to “tune in” to each other; it happened naturally in the course of their social interaction.“There’s no telepathy or spooky thing at play,” Dr. Dumas said. Interacting with someone else is complicated, requiring an ongoing feedback loop of attention, prediction and reaction. It makes sense that the brain would have some way of mapping both sides of that interaction — your behaviors as well as the other person’s — simultaneously, although scientists still know very little about how that happens.Later research showed that brain synchrony depended on the social relationship of the two people. Strangers and couples seem to have differing levels of brain synchrony, for instance. Another study found greater brain synchrony between a leader and a follower than between two followers.A test of the devices showing synchronized and desynchronized signals.Northwestern UniversityWeizhe Hong didn’t know about any of these human studies when, a few years ago, his team stumbled upon the same sort of synchrony while recording from brain cells of interacting mice. “For about six months, we were very puzzled by it,” said Dr. Hong, a neuroscientist at the University of California Los Angeles. “I just found it too good to be true, too surprising to me.”In most social interactions, after all, the two interacting animals aren’t doing the same thing at the same time; in a conversation, one person may listen while the other talks. So it did not immediately make sense to him why his mice would show such robust neural synchrony. But after digging into the scientific literature, he said, “I realized, oh actually, there’s 15 years of history of studying human synchrony.”In their experiments, Dr. Hong’s team recorded this synchrony in a part of the brain called the medial prefrontal cortex, which had been linked to a range of social behaviors. Certain neurons in each animal’s brain seemed to encode the animal’s own behavior, whereas other cells’ activity correlated with the behavior of the other animal. There was some overlap between the two groups, suggesting that certain cells were responsive to both animals. These findings could be related to previous studies of “mirror neurons,” which fire when an animal acts or when it observes that action in another animal, although that link is far from clear, Dr. Hong said. “Whether they’re mirror neurons or not is definitely something we’re very interested in,” he added.When his team went to the large Society for Neuroscience meeting to share their preliminary mouse data, in 2018, they discovered that scientists from the University of California, Berkeley, had found stunningly similar results in socially interacting bats. The mouse and bat studies were both published in Cell in 2019.“We were amazed and encouraged,” Dr. Hong said. “This hadn’t been done for years, and now somebody else did it in another species.”Manipulating miceWhen the signals were issued at a different frequencies, the mice showed far less interest in one another.Northwestern UniversityThe Northwestern researchers who carried out the new study in Nature Neuroscience were familiar with these human and animal experiments on interbrain synchrony. “It seemed interesting and a little bit strange,” Dr. Kozorovitskiy said. She thought the phenomenon could be further probed with a new tool they had developed to manipulate the brains — and activities — of animals.Their tool involves optogenetics, a technique that uses a tiny LED light, implanted into an animal’s brain, to activate discrete groups of neurons. (A gene that encodes a light-sensitive protein derived from algae is first inserted into the neurons of interest, to make them responsive.)But studying social behavior with optogenetics had historically been difficult because the light source was typically attached to the animal’s head through fiber-optic cables, which interfered with the animal’s normal behavior. So John Rogers, a biomedical engineer at Northwestern who specializes in bioelectronics, developed tiny wireless devices that, once implanted, can be controlled remotely by a nearby computer.“Because everything is implanted, mice can behave naturally and they can socially interact with one another naturally,” Dr. Rogers said. “You don’t have the cables that get tangled up, and there’s no head-mounted gear” for the mice to gnaw on.The tool also allowed researchers to independently control multiple devices — and multiple animals — at once. Dr. Rogers and Dr. Kozorovitskiy began looking for a way to test it. Dr. Kozorovitskiy had seen the Cell study showing that interacting mice produce synchronies in the medial prefrontal cortex. Perhaps, she thought, the optogenetic device could test the converse relationship: If two animals’ brains were synchronized, would the animals become more social?The answer, as Mr. Wu discovered that late night last spring, was yes. The results may suggest that brain synchrony is a causal driver of social behavior — and is more than just a byproduct of brains performing similar activities, or thinking similar thoughts, in a shared environment.But many more experiments will be needed before scientists can reach that conclusion with confidence. Almost all of the data in people, too, is ambiguous: Neural synchrony seems to be tightly linked with behavior, but that doesn’t mean it is the root cause. That uncertainty has led many researchers to wonder whether synchrony really matters.“There is an overwhelming amount of evidence that we synchronize our behaviors and physiological rhythms spontaneously, and when we do so, we cooperate more and like each other better,” said Ivana Konvalinka, a cognitive scientist at the Technical University of Denmark who studies two-person neuroscience. But, she said, “despite working within this field, I am still not entirely convinced that the fact that our brains sync up has any functional significance at all.”And yet, if brain-to-brain synchrony does turn out to be a real driver of social interaction, it could have some meaningful applications for people who struggle with social anxiety disorders, for example. Several noninvasive techniques, like transcranial magnetic stimulation, can stimulate people’s brain activity and are being tested as treatments for a range of psychiatric disorders.“I don’t want to be too prescriptive or fantastical about it, but the human sociality spectrum is very broad, and there’s probably a subset of people who wouldn’t mind if it was possible to influence their level of sociality,” Dr. Kozorovitskiy said, pointing out that many of us already do this every time we meet friends at a bar.Still, she said, “we cannot even start thinking about those kinds of experiments in clinical context until we understand much more about what’s happening.”

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