Health

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 review Lykos' clinical data, along with public comments and staff analyses, to make recommendatio...

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. She, like Mr. Biden, is in recovery. I write about addiction for the New York Times and have spoken to countless families who have shared harrowing experiences. I'm working on an article about how the Biden...

“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 University and IMPACT, a non-profit organization born out of a Brandeis initiative, found that creative sector efforts tackling tough challenges “are not adequately understoo...

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 help now.” Amy Emerson, chief executive officer of Lykos Therapeutics, said the company stood by the data and design of its studies, which were developed in cons...

In a statement, MultiPlan said it is working with Senate committees "to answer their questions and explain the costs and complexity patients may face" when choosing expensive care outside their networks. “We are committed to helping make healthcare transparent, fair and affordable for all,” the statement read. The commission's investigation reflects growing scrutiny of the New York-based company, which has remained largely out of the spotlight even as it has gained a dominant position in a lucrative healthcare sector. Another senator, Amy Klobuchar of Minnesota, this month asked federal antitrust authorities to investigate whether insurers and MultiPlan were conspiring to fix prices, and several health systems have sued the company, accusing it of such anticompetitive behavior. Separatel...