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What is the framework for approval? In 2017, the FDA granted “breakthrough” status to MDMA-assisted therapy. Status, the recognition of a drug's therapeutic promise, aims to shorten regulatory times. The original application was sponsored by the nonprofit Multidisciplinary Association for Psychedelic Studies, which earlier this year created a for-profit entity, Lykos Therapeutics, to commercialize MDMA if it gained approval. FDA approval. The request presents an unusual challenge for the FDA, which typically does not regulate drug treatments associated with talk therapy, an essential part of Lykos' regimen for treating post-traumatic stress disorder. On June 4, an expert advisory panel will…

Hunter Biden, the president's son, is on trial in federal court for falsely claiming in a gun application that he had not used illicit drugs. Testimonies from his ex-wife and his ex-girlfriends describe his drug-fueled character; look for his dealer on the streets; his large cash withdrawals from the bank. Hallie Biden, his brother Beau's widow who was dating him in the fall of 2018 when the gun purchase occurred, spoke of his erratic behavior, possession of rocks of crack and cocaine "the size of ping-pong balls, or bigger, maybe” and how she frantically urged him to go to rehab.…

“In a creative environment there is an encounter with yourself, an awakening to your unconscious, to your experiences,” said Tammy Federman, a filmmaker whose new documentary “Memory Game” centers on a theater troupe of survivors of Holocaust in Israel managed by AMCHA, an Israeli social support services organization. “But there's also a group meeting because one person talks about this very traumatic experience and another person can relate to it. It gives you the courage to open up, to share your experience, and there is also joy, there is humor, there is movement and creativity.” And while research from Brandeis…

Research like the current research into MDMA therapy has blocked support from various groups and lawmakers in both parties for the treatment of post-traumatic stress disorder, a condition that affects millions of Americans, particularly military veterans who are at enormous risk of suicide . No new treatments for PTSD have been approved for more than 20 years. “What's happening is really a paradigm shift for psychiatry,” said David Olson, director of the Institute for Psychedelia and Neurotherapy at UC Davis. “MDMA represents an important step for the industry because there is a real lack of effective treatments and people need…

In one of those emails, from June 2021, Greg Folkers, Dr. Fauci's former chief of staff, was discussing global biosafety practices and referenced an EcoHealth fact sheet. Folkers rendered the group's name as "Ec~Health," a misspelling that lawmakers said appeared to be a deliberate attempt to prevent the email from being caught in keyword searches to satisfy FOIA requests related to EcoHealth . In a separate email the same month, Folkers rendered the last name of Kristian Andersen, a prominent virologist who has investigated the origins of the pandemic and faced scrutiny from lawmakers, as “anders$n.” Experts on records retention…