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The initial application from Lykos presented positive data from two late-stage clinical trials that used MDMA in combination with talk therapy to treat PTSD. The advisers said it was also difficult to parse how much the accompanying talk therapy — an area that the FDA does not regulate — contributed to outcomes. Advocates for the treatment, including some veterans groups, said they were “incredibly disappointed” by the FDA decision. Dozens of clinical trials involving psychedelics are in various stages, and additional scrutiny can help strengthen the findings and build confidence. Psychopharmacology did not allow the study authors to publish a correction with data that excluded findings from one study site, said Allison Feduccia, an author in all three retracted studies.
Persons: Lykos, , ” Martin Steele, Brett Waters, , Rachel Yehuda, , , Michael Bogenschutz, Yehuda, It’s, Lori Bruce, Psychopharmacology, caressed, “ it’s, Amy Emerson, ” Lykos, Allison Feduccia, Dr, Sanjay Gupta, Brian Barnett, ” Bruce, Nadia Kounang Organizations: CNN, Food and Drug Administration, Lykos Therapeutics, FDA, Veteran Mental Health Leadership Coalition, Hope, Center, Psychedelic Psychotherapy, Mount, Icahn, of Medicine, NYU Langone Center, Psychedelic Medicine, Oxford, NUS, Neuroethics, Interdisciplinary Center, Bioethics, Yale University, , Multidisciplinary Association for Psychedelic Studies, Health Canada, Institutional, Board, CNN Health, Cleveland Clinic Locations: Canada,
Making matters worse, kidneys from Black donors in the U.S. are more likely to be thrown away as a result of a flawed system that erroneously considers all Black donor kidneys as more likely to stop working after a transplant than kidneys from donors of other races. Research on previous transplants shows that some kidneys donated by Black people are more likely to stop working sooner after transplantation than kidneys donated by people from other races. This could explain the data on Black donor kidney failure rate. And since Black kidney recipients are more likely to receive kidneys from Black donors, this approach could perpetuate transplant disparities. One way researchers are working to identify higher risk kidneys is using the APOLLO study, which assesses the impact of key variants on donated kidneys.
Organizations: CNN, Black, American, Research, Americans Locations: U.S, Africa, West, Saharan Africa
This week, the pope is due to make an historic intervention in the debate around AI at the G7 summit in southern Italy’s Puglia region. AI, the pope believes, can make the world a better place only if it serves the “common good” and does not increase inequalities. European Union lawmakers have already passed a law regulating AI, while a bipartisan group of US senators have set out plans for AI regulation that could lead to federal legislation. “AI and emerging technologies are on Pope Francis’ radar screen,” Larrey, now a professor of philsophy at Boston College, told CNN. It’s clear that Francis sees AI as part of what he called the “epochal change” taking place at the beginning of the 21st century.
Persons: Pope Francis, Francis, Joe Biden, , , Paolo Benanti, Benanti, ” Benanti, Vincenzo Paglia, Giorgia, Francis ’, Father Antonio Spadaro, Philip Larrey, Larrey, Pope Francis ’ Organizations: CNN, Catholic, Pontifical Academy for Life, Microsoft, IBM, Cisco Systems, United Nations, Food, Agriculture Organization, Union, Philosophy Department, Pontifical Lateran University, Boston College Locations: Italy’s Puglia, ” Italy, Puglia “, Puglia, Rome, Nevada
Opinion | Ethical Lapses in the Medical Profession
  + stars: | 2024-05-14 | by ( ) www.nytimes.com   time to read: +1 min
To the Editor:Re “Moral Dilemmas in Medical Care” (Opinion guest essay, May 8):It is unsettling, and dismaying, to read Dr. Carl Elliott’s account of moral lapses continuing to exist, if not thrive, in medical education. As a neurology resident in the early 1970s, I was assigned a patient who was scheduled to have psychosurgery. He was a prisoner who had murdered a nurse in a hospital basement, and the surgery to remove part of his brain was considered by the department to be a therapeutic and even forward-looking procedure. This was despite its being widely discredited, and involving a prisoner who could not provide truly informed consent. It is lamentable that even though bioethics programs are widely incorporated into medical education, moral and ethical transgressions remain a stubborn problem as part of medical structures’ groupthink.
Persons: Carl Elliott’s
“Now, post-surgery and post recovery, I am able to see in dimmer lighting with my left eye,” Cook said. A treatment that used CRISPR was found to be safe and efficacious in improving vision among a small sample of patients with inherited blindness in the Phase 1/2 clinical trial that Cook participated in. Months following the treatment, Cook was sitting with friends on a balcony that had Christmas lights wrapped around the railing. Courtesy Olivia CookBefore the treatment, Cook said that she sometimes could conceal the vision challenges she has had. Mass Eye and EarKalberer described the CRISPR treatment as “groundbreaking,” but warned it’s not a cure.
Persons: Olivia Cook, Cook, , ” Cook, , I’ve, “ I’d, you’d, CRISPR, Eric Pierce, Brigham, “ We’re, ” Pierce, Jason Comander, , Michael Kalberer, Kalberer, it’s, “ It’s, It’s, Pierce, Editas, We’re, Art Caplan, ” Caplan, , Vlad Diaconita, ” Diaconita, Dr, Sanjay Gupta, Aliaa Abdelhakim Organizations: CNN, Missouri State University, New England, of Medicine, Mass, Harvard Medical School, Editas Medicine, Perelman School of Medicine, University of Pennsylvania, University of Michigan, University of Miami, Oregon Health & Science University, US Food and Drug Administration, CEP290, pharma, NYU Grossman School, Medicine’s Department of Population Health, Columbia University Vagelos College of Physicians and Surgeons, CNN Health Locations: Springfield, United States, CEP290
A Montana rancher was charged with illegally selling offspring from a cloned sheep across state lines. There's nothing illegal about selling sheep for exorbitant prices — unless those animals are Marco Polo argali sheep, or in Schubarth's case, hybrids of Marco Polo argali sheep. Marco Polo argali sheep are native to central Asia and are considered threatened under the US Endangered Species Act. Shortly thereafter, Schubarth allegedly got his hands on some of those sheep parts and, in 2015, paid a deposit of $4,200 to produce cloned sheep embryos from the dead argali's remains. AdvertisementIn May 2017, a pure argali sheep was born from one of those cloned embryos.
Persons: , Arthur, Jack, Schubarth, Marco Polo, George Schaller, Joyce Tischler, Lacey, King, Matthew Polak, Dolly, it's, Alison Van Eenennaam, Davis, Van Eenennaam, Gregory Kaebnick, isn't, Rula Rouhana, Reuters It's, Kaebnick, didn't Organizations: Service, Department, Lewis & Clark Law School's Center for Animal Law, European Union, Getty, University of California, and Wildlife Service, The Hastings Center, Reproductive Biotechnology, Reuters Locations: Montana, Asia, Kyrgyzstan, Dubai
Paris CNN —France became the world’s first country to enshrine abortion rights in its constitution on Monday, the culmination of an effort that began in direct response to the US Supreme Court’s decision to overturn Roe v. Wade. The amendment states that there is a “guaranteed freedom” to abortion in France. While abortion is a highly divisive issue in US politics that often falls along party lines, in France it is widely supported. The measure’s passage is a clear victory for the French left, which has been pushing for years to guarantee abortion rights in the constitution. The vote marks the 25th time the French government has amended its constitution since the founding of the Fifth Republic in 1958.
Persons: Roe, , Gabriel Attal, ” Attal, Emmanuel Macron, Simone Veil, Emmanuel Macron’s, , Wade, Eric Dupond, Moretti, perviously, CNN’s Joseph Ataman, Christopher Lamb Organizations: Paris CNN —, Wade, French Senate, National Assembly, ” Lawmakers, France, Health, US, Fifth, Catholic, Pontifical Academy for Life Locations: Paris CNN — France, of Versailles, Paris, France, United States, Europe, Hungary, Fifth Republic
The need for more transplant organs is immense and growing. Researchers have transplanted genetically modified pig kidneys and hearts into people who were brain-dead to test whether they work in humans. Although Larry Faucette was too sick for a human heart transplant, University of Maryland doctors said he seemed physically strong enough for a genetically modified pig heart. It was more than a decade after the first heart transplant but long before such procedures became relatively routine. “We learned that the pig heart is an adequate substitute for a human heart.
Persons: Lawrence Faucette, Ann, he’d, ” Ann, Larry Faucette, Ann Faucette Ann, Larry, didn’t, , Robert Montgomery, , Shelby Lum, ” Montgomery, Xenotransplantation, Art Caplan, Caplan, Babe ”, ” Caplan, They’re, eGenesis, people’s, Dr, Mike Curtis, Sanjay Gupta, ” Curtis, hasn’t, Julie O’Hara, Jim Parsons, Jayme Locke, couldn’t, Locke, Parsons, NYU —, Montgomery —, O’Hara, ” Locke, David Bennett Sr, Mary, David Jr, Bartley Griffith, Bennett, they’ve, Muhammad M, Mohiuddin, Larry Faucette’s, David Bennett’s, ” Griffith, xenotransplantation Ann Faucette, Wilbur, White’s, Ann Faucette, NYU ethicist Caplan, they’re, NYU’s Montgomery, UAB’s Locke, Steve Wood, ’ Curtis, “ I’m, it’s, ” O’Hara, Bennett’s, Larry Faucette —, ” Bennett’s, Faucette, who’d, Griffith, would’ve, Kate, Lucy, Nadia Kounang Organizations: CNN, Food and Drug Administration, University of Maryland, FDA, National Institute of Allergy, NYU Langone Transplant Institute, NYU Langone's Transplant, NYU Grossman School, Medicine’s Department of Population Health, “ Disney, University of Alabama, Transplant Institute, Parsons Family, Birmingham, NYU, University of Maryland School of Medicine, Doctors, University of Maryland Medical Center, Uno, UAB, CNN Health, NFL Locations: Frederick , Maryland, United States, Montgomery, , Midwest, Yucatan, Maryland
His knowledge came in handy for a 2023 meeting at the Vatican between Francis and Microsoft President Brad Smith that focused on how AI could help or hurt humanity. Microsoft first reached out to Benanti several years ago for his thoughts on technology, the friar said. “It is a problem not of using (AI) but it is a problem of governance,'' the friar said. The European Union became a trailblazer late last year when negotiators secured a deal that paves the way for legal oversight of AI technology. For his part, Benanti said that regulating artificial intelligence shouldn't mean limiting its development.
Persons: — Friar Paolo Benanti, Benanti, Pope Francis, Francis, , , Brad Smith, Smith, , . Francis of Assisi, , Giorgia Meloni Organizations: ROME, Associated Press, Pontifical Gregoriana University, United Nations, Intelligence, Vatican’s Pontifical Academy for Life, Microsoft, Rome's Sapienza University, European Union, trailblazer Locations: Italian, Rome, West, Italy
He appealed the court order, which has been stayed, throwing Kate Cox's abortion in flux. Hours later, Paxton swooped in with an appeal to the Texas Supreme Court and an ominous threat to prosecute any doctor that provides an abortion to Cox. On Friday, the Texas Supreme Court put a temporary hold on the Travis County judge's order, preventing Cox's doctors from proceeding with the abortion. The Texas Supreme Court has yet to issue a ruling on the case. The Center for Reproductive Rights, which is representing Cox, released a statement saying they hope the Texas Supreme Court ultimately rules in Cox's favor.
Persons: Ken Paxton, Kate Cox's, , Kate Cox, Cox, Paxton swooped, Kate, Molly Duane, Paxton, Debbie McNabb, McNabb, — hysterectomies Organizations: Service, Texas, Texas Supreme, Reproductive Rights, Center for Reproductive Rights, National Institute of Health, for Reproductive, NIH Locations: Texas, Travis
“I’ve seen dozens of people killed in accidents or shootings, but this was the hardest thing I’ve done in my life,” Daphna-Tekoah told CNN by telephone. “I asked ‘Would you like me to find out about sperm preservation?’”Medical social worker Shir Daphna-Tekoah suggested the idea of sperm extraction to bereaved families on October 7. “The demand has been very high,” she told CNN in a video call, adding that dozens of families have accessed the service since October 7. It isn’t that they want a baby instead of their son - it’s the grandchild,” she told CNN by telephone. PSR can be the easy part, Rosenblum told CNN.
Persons: Shir Daphna, “ I’ve, , Tekoah, , , Noga Fuchs, Dr, Shimi Barda, Noga, Barda, Shaylee Atary, Atary, Fuchs, Irit Oren Gunders, Irit Rosenblum, Lawyer Irit Rosenblum, Irit Rosenblum Rosenblum, Rosenblum, “ We’ve, ” Rosenblum, “ I’m, ” Yulia, Vlad Poznianski, Baruch, Yulia, Shira, Liat Malka, Baruch Pozniansky, Yulia Pozniansky, she’s, Malka, She’s, won’t, isn’t, Soldiers, ” Israel ‘, Gil Siegal Organizations: CNN, Kaplan, of Health, PSR, Ichilov, Israel Defense Forces, Noga Fuchs, Noga, Israel’s Ministry of Foreign Affairs, Ministry of Health, New, Center for Health Law, Kiryat Ono, Israel, University of Virginia Law School Locations: Tel, Kfar Aza, Gaza, Israel
But ethics classes alone are insufficient to help students develop a clear moral compass so that they can rise above ideological catchphrases and wrestle intelligently with moral dilemmas. Instead, colleges and universities need to be more self-critical and rethink what it means for students to be educated. At the same time, academia has become more hesitant: We often avoid challenging our students, avoid putting hard questions to them, avoid forcing them to articulate and justify their opinions. This flies in the face of what a “liberal education” should be. Liberal education should be built around honing critical thinking skills and moral and logical reasoning so students can emerge as engaged citizens.
Persons: Georgetown —, ” M.I.T, , Organizations: Georgetown, Liberal, The American Association of Colleges, Universities
July 13 (Reuters) - The U.S. Food and Drug Administration on Thursday approved the first over-the-counter contraceptive pill, paving the way for millions of women in the country to purchase birth control without prescription. Perrigo will next week share its pricing plan for the pill, which will be available in stores and online in the first quarter of next year. Women should take a progestin-only pill within the same three hours every day to avoid pregnancy. The National Catholic Bioethics Center and other groups have opposed making Opill available without prescription, saying physicians should be involved in health decisions, especially for teenagers, along with parental supervision, to avoid harm. Perrigo gained the daily-use pill first through its $2.13 billion acquisition of Paris-based HRA Pharma in 2021.
Persons: Roe, Wade, Xavier Becerra, Opill, Jeffrey Singer, Perrigo, Manas Mishra, Sriparna Roy, Arun Koyyur Organizations: U.S . Food, Drug Administration, Perrigo, Human Services, Cato Institute, FDA, Catholic Bioethics Center, HRA Pharma, Thomson Locations: U.S, Paris, Bengaluru
Authorities in China took multiple steps to tighten rules and ethical standards affecting human gene editing in the wake of the revelations about his previous research. But the scientist’s release of a new proposal involving gene editing of embryos has scientists and medical ethics experts concerned – and confused. Genetic manipulation of human embryos – both viable and nonviable ones – is typically tightly controlled globally and some countries ban all such research, experts say. But there is robust global debate around allowing genome editing of human embryos to treat serious genetic conditions or expanding research. Chinese law does not allow gene-edited human embryos used in research to be implanted into humans, or developed for more than 14 days.
Persons: , It’s, Peter Dröge, , “ I’m, ” Joy Zhang, bioethicists, There’s, He’s, He’s “, Françoise Baylis, ” Baylis Organizations: Hong Kong CNN, Authorities, Nanyang Technological University, Centre for Global Science, University of Kent, CNN, bioethicists, Twitter, China’s Ministry of Science, Technology, National Health Commission, Southern University of Science, China’s biosciences, Dalhousie University Locations: Hong Kong, China, Beijing, Singapore, Britain, USA, Europe, Shenzhen
The research raises critical legal and ethical questions, and many countries, including the US, don’t have laws governing the creation or treatment of synthetic embryos. “Unlike human embryos arising from in vitro fertilization (IVF), where there is an established legal framework, there are currently no clear regulations governing stem cell derived models of human embryos. “I just wish to stress that they are not human embryos,” Zernicka-Goetz said. Right now, the synthetic model human embryos are confined to test tubes. “There is much work to be done to determine the similarities and differences between synthetic embryos and embryos that form from the union of an egg and a sperm.”
Persons: CNN —, ” James Briscoe, Francis Crick, Dr, Magdalena Zernicka, Goetz, Zernicka, , ” Zernicka, , haven’t, Sanjay Gupta, ” Roger Sturmey Organizations: CNN, Francis, Francis Crick Institute, International Society for, CalTech, University of Cambridge, The Guardian, CNN Health, University of Manchester Locations: United States, United Kingdom, Boston, Israel
CNN —Scientists have pieced together a new draft of the human genome that better captures humanity’s genetic diversity. The scientists involved say it will improve our ability to diagnose disease, discover new drugs and understand the genetic variants that lead to ill health or a particular physical trait. The pangenome, a digital amalgamation of sequences that can be used to compare, construct and study other human genome sequences, is still a draft. The first draft of the human genome was released in 2001 and was only fully completed in 2022. The new pangenome reference is an amalgamation of different genomes from 47 people with ancestry from around the world.
Elon Musk's Neuralink is testing its brain implant on animals ahead of plans for human trials. 19 of the 22 members of the animal-research oversight board are also Neuralink staff, per Reuters. Elon Musk's Neuralink has reportedly filled its committee overseeing animal testing with staff who stand to profit if the brain implant is approved by regulators, according to Reuters. Federal law requires certain animal research facilities to have a regulatory board called an Institutional Animal Care and Use Committee, or IACUC. That's because Neuralink staff typically receive equity in the company, five current and former workers told Reuters.
The membership of the panel at Musk’s company, Neuralink, raises questions about potential violations of conflict-of-interest regulations aimed at protecting research integrity, a dozen animal-research and bioethics experts told Reuters. Autumn Sorrells has chaired an oversight board approving animal experiments by Elon Musk’s brain-chip startup, Neuralink, and also run the company’s animal care program. Reuters couldn’t determine the compensation terms of the Neuralink IACUC members who are also company employees. The independence of such boards, Nicolelis said, is critical to protecting the integrity of animal research that could impact humans in future clinical trials. These institutions generally prohibit people with direct financial interests from serving on IACUCs or voting on animal experiments.
A messy legal fight over the Food and Drug Administration's approval of the abortion pill mifepristone poses risks to the biopharma industry that go beyond the single drug. If a subsequent decision tosses out the pill's approval, it could potentially stifle innovation in the sector and deter investments in the development of life-changing drugs, biopharma companies and experts in law and economics say. More than 200 biopharma companies made a similar claim Monday in an open letter calling for the reversal of Kacsmaryk's decision. But Hastings said biopharma companies still respect the FDA when the agency turns down their drugs. Suliman offered a more hopeful take on how the legal fight could affect biopharma innovation.
REUTERS/Nacho DoceMADRID, April 5 (Reuters) - A 68-year-old Spanish TV actress said that her newly adopted daughter was conceived using her dead son's frozen sperm and is in fact her granddaughter, reigniting a debate over the bioethics of surrogacy and children's right to privacy in Spain. The weeks-old baby, named Ana Sandra, was born to a surrogate mother identified on Wednesday by the Lecturas magazine as a Cuban woman living in Miami, Florida. "This girl isn't my daughter, but my granddaughter," TV actress Ana Obregon told celebrity magazine ¡Hola! Obregon's only biological child, her son Aless Lequio, died of cancer in 2020 at the age of 27. Obregon rose to prominence in the 1980s and starred in Spanish sitcoms in the late 1990s and early 2000s.
But that's futile, experts say, because the AI of today can't feel empathy, let alone love. We've spent years trying to get AI to love us back. Experts told Insider that it's futile to expect the AIs that exist right now to love us back. During a simulation in October 2020, OpenAI's GPT-3 chatbot told a person asking for psychiatric help to kill themselves. Halpern, the UC Berkeley professor, told Insider AI-based relationships are perilous also because the entity can be used as a money-making tool.
The video, which has nearly 60,000 likes, is among a proliferation of TikTok posts tagged with the names of semaglutide weight-loss drugs, including Wegovy and Ozempic. "What drives the video to go viral is if you can generate some kind of discussion," he told Insider. Unlike official ads, partnerships, or promotions, TikTok posts receive little oversight from government agencies or medical boards. All four said the TikTok posts are driving an influx of patients to their clinics. Oden told Insider that her videos are "drumming up quite a bit of new business" among patients of all ages.
But for a few thousand people, the mental health support they received wasn’t entirely human. About 4,000 people got responses from Koko at least partly written by AI, Koko co-founder Robert Morris said. Academics, journalists and fellow technologists accused him of acting unethically and tricking people into becoming test subjects without their knowledge or consent when they were in the vulnerable spot of needing mental health support. “There are millions of people online who are struggling for help.”There’s a nationwide shortage of professionals trained to provide mental health support, even as symptoms of anxiety and depression have surged during the coronavirus pandemic. In June, the World Health Organization included informed consent in one of its six “guiding principles” for AI design and use.
A digital mental health company is drawing ire for using GPT-3 technology without informing users. Koko co-founder Robert Morris told Insider the experiment is "exempt" from informed consent law due to the nature of the test. "The participants should have given informed consent and this should have passed through an IRB [institutional review board]." A women seeks mental health support on her phone. Beatriz Vera/EyeEm/Getty ImagesChatGPT and the mental health gray areaStill, the experiment is raising questions about ethics and the gray areas surrounding the use of AI chatbots in healthcare overall, after already prompting unrest in academia.
The U.S. Department of Homeland Security has approved research that will use artificial intelligence to delve into drug supply chains and probe for weaknesses, including foreign influence. Any overreliance on foreign inputs in drug supply chains could leave the U.S. open to dire shortages in the event of conflict or natural catastrophe. PREVIEWThe DHS-backed dive into drug supply chains will examine to what extent the supply of drugs might be susceptible to disruption. The new DHS-backed study will try to map out supply chains several layers deep, and potentially uncover previously hidden issues, Mr. Tuchman said. Consultant Steven Lynn says the pandemic opened people’s eyes to issues inherent in far-flung pharmaceutical supply chains.
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