DIRS.INFO The most relevant business & tech news

☆ FDA rejection of MDMA-assisted therapy rattles advocates but doesn’t spell end of psychedelics in medicine, experts say
▼ + stars: | 2024-08-13 | by ( Deidre Mcphillips | Carma Hassan | ) edition.cnn.com time to read: +11 min

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, “

Courtesy Marian IppelHer lawsuit names as defendants the Grace Christian Reformed Church of Grand Rapids and affiliates, including the Christian Reformed Church in North America, a Protestant Calvinist Christian denomination also based in Grand Rapids. The Grace Christian Reformed Church did not immediately respond to requests for comment. “Recovered memory cases are difficult because you may need corroborating evidence, particularly when a child is very young,” Cadigan, who is not associated with Ippel’s case, said. The Christian Reformed Church in North America said it was unaware of any other complaints against the deacon, but said it investigates claims when people come forward. Abuse awarenessThe Christian Reformed Church, which counts about 230,000 followers in North America, has known of a history of abuse within its member churches, according to the suit.

Persons: Marian Ippel, ” Ippel, ” Marian Ippel, Ippel, Lynne Cadigan, ” Cadigan, ”, Marian, Ippel’s, Marian’s, “, wasn’t, Megan Bonanni, Larry Nassar, ” Bonanni, John Wixted, Wixted, James Hopper, Cadigan, they’re Organizations: Kent County Circuit, NBC News, Grace Christian Reformed Church, Christian Reformed Church, Catholic, “, Abuse Prevention, Catholic Church, University of California Locations: Grand Rapids , Michigan, Kent County, Grand Rapids, North America, Arizona, Guinea, Michigan, Manhattan Beach , California, San Diego

☆ This industry is defying America’s slowing job market
▼ + stars: | 2024-08-10 | by ( Bryan Mena | ) edition.cnn.com time to read: +6 min

Enter America’s top job creator: The mighty health care industry. Demand for health care workers remains red hot, according to recent government data on job openings. In June, the health care and social assistance industry had the highest seasonally adjusted job openings rate of any industry, at 7.6%, well above the total rate across the job market of 5.5% that month. That has translated into fatter paychecks for health care workers compared to the general private sector. “Virtually every nurse or health care tech in the country has a job,” Girard said.

Persons: Washington CNN —, there’s, ”, Julia Pollak, ZipRecruiter’s, ” David Mafe, Mafe, it’s, “ We’ve, ” Mafe, “ We’re, Sebastien Girard, Girard, ” Girard, “, Pollak, ” Pollak, “ She’s, She’s Organizations: Washington CNN, Employers, Labor Department, CNN, “, Novant Health Locations: UCHealth, Denver, North Carolina, “, California

If approved, it would have been the first new treatment for PTSD in more than two decades. Lykos Therapeutics had asked the FDA to approve the drug as part of a treatment regimen, given alongside talk therapy. Lykos Therapeutics had asked the FDA to approve the drug as part of a treatment regimen, given alongside talk therapy. Lykos added that the agency expressed concerns similar to those raised during the advisory committee meeting in June. Davis Institute for Psychedelics and Neurotherapeutics, said he doesn’t think the FDA decision will hinder the development of psychedelics for mental health disorders, including PTSD.

Persons: “, ”, Holly Fernandez Lynch, Lykos, Amy Emerson, Sarah Silbiger, David Olson, Olson, ” Olson, Brian Barnett, ” Barnett, Joe Biden, Biden, Robert Califf, ” Lynch, psychedelics, David Rind Organizations: Drug Administration, Therapeutics, FDA, Lykos Therapeutics, University of Pennsylvania, Davis Institute for Psychedelics, Cleveland Clinic, Clinical Locations: U.S, White Oak, Md, Ohio

☆ Why Are Silicon Valley Therapists Becoming Tech Coaches?
▼ + stars: | 2024-08-06 | by ( Daniel Duane | ) www.nytimes.com time to read: +1 min

Carnochan has been my therapist for over a decade, a privilege for which I am grateful on two accounts. First, the surging national demand for therapy has so outstripped supply that it can be hard to find a good therapist anywhere, but especially in San Francisco. Second, working with Carnochan has been so healing that I have come to see psychotherapy as a beautiful profession and Carnochan as its beau idéal — deeply learned, emotionally present and capable of moving in a single conversation from D. W. Winnicott’s theory of the false self to Otis Redding’s “(Sittin’ on) the Dock of the Bay,” from infinity in the Lotus Sutra to the ecstasies of backcountry skiing. I knew Carnochan did some other form of talking to people one on one — coaching, that is — because I once told him that I worried about money and career. Carnochan responded by mentioning that he sometimes helped company executives on professional matters and could work with me in the same spirit.

Persons: Carnochan, —, Otis Redding’s “ Locations: San Francisco .

They spent six years behind bars until they were freed in 2022 in another prisoner exchange engineered by the Biden administration. And like the newly sprung Americans, Pereira’s first stop back in the U.S. was the Brooke Army Medical Center in San Antonio, Texas. “When you come back from something like this, you are like a bottle of Coca-Cola. And sometimes we were treated better and sometimes it was worse.”“The questions they kept asking us were, ‘How did you do it? “I didn’t realize there were so many people supporting my family and working to free me.

Persons: Evan Gershkovich, José Pereira, ”, Biden, Pereira’s, Pereira, he’d, readjust, Jorge Arreaza, Jose Angel Pereira, Gustavo Cardenas, Jorge Toledo, Jose Luis Zambrano, Tomeu, Alirio Jose Zambrano, Paul Whelan, Alsu, Vladimir Kara, Murza, “ Everybody, ” Pereira, Jason Rezaian, ” Rezaian, “, ’ ” Pereira, you’re, it’s, Gershkovich, Whelan, Kurmasheva, Rezaian, Sam Goodwin, Goodwin, Sam, I’m Organizations: Wall Street, Brooke Army Medical Center, Twitter, Venezuela's, Bolivarian National Intelligence Service, Ministry, NBC News, Washington Post, Brooke Army Medical, military’s, Medical Center Locations: American, Venezuela, U.S, San Antonio , Texas, PISA, Caracas, Germany, Washington, North Carolina, Kara

☆ Opinion | Toxic Families: Is Breaking Away the Answer?
▼ + stars: | 2024-07-28 | by ( ) www.nytimes.com time to read: +1 min

The purpose of therapy is to understand and resolve the many ways the parent relationship affected someone — and to understand the complicated person the parent is and why they may have acted in a way that created such pain. Part of healthy maturity and resilience is to be able to manage complicated relationships and not see people as either good or bad, but some mix. So much is embedded in the unconscious that without looking at oneself, rather than just blaming the other person, the child is more likely to repeat unhealthy patterns going forward. To the Editor:Encouraging family cutoffs, as described in this article, has been practiced by some therapists for a long time, even though it’s getting more attention now. It reflects a growing culture of hyper-individualism in which family bonds become disposable when they involve personal pain.

Persons: Ellen Barry, Patrick Teahan’s, Laurie Levi Merion, it’s Organizations: Science Times Locations: Pa

☆ Mental health and the Olympics: How the USOPC is preparing for the toll on athletes
▼ + stars: | 2024-07-25 | by ( Nicole Auerbach | ) www.nytimes.com time to read: +10 min

AdvertisementThere are no surgeries or physical rehabilitation plans to address mental health challenges. Phelps has made mental health a huge focus in retirement, trying to help others avoid the feelings he endured. Bartley, who has worked with the USOPC since it created a mental health task force in 2020, said that her main goal over the past four years has been building out the organization’s infrastructure for therapy for mental health needs. Now, there are 15 psychological service providers — meaning those qualified to work on mental health, mental performance or even sleep. What does it mean to make the Olympic Games or not make the Olympic Games?

Persons: Simone Biles, ” Biles, “, ”, Jess Bartley, Michael Phelps, Cameron Spencer, Phelps, Caeleb Dressel, couldn’t, Bartley, ” Bartley, Dressel, Gretchen Walsh, raved, Lydia Jacoby, Tom Pennington, ” Jacoby, He’d, ” Dressel, I’m, it’s, Biles, “ She’s, Cecile Landi, ” “ She’s, ” Simone Biles ’, Jamie Squire, Dana O’Neil, Dan Goldfarb, Tim Clayton, Corbis, Francois Nel Organizations: Paris Games, Tokyo Games, U.S, Olympic, Paralympic Committee’s, Games, Olympic Games, Paris, Tokyo, Athletic, Tokyo Summer, Beijing Winter Games Locations: Tokyo, Alaska, it’s, France

☆ Psychedelic therapy with ketamine aims to ease PTSD for Ukrainian soldiers coming back scarred from front-line fighting
▼ + stars: | 2024-07-21 | by ( Ella Sherman | ) www.businessinsider.com time to read: +6 min

Read previewAdministered ketamine is being used in concert with therapy to treat Ukrainian veterans who experience post-traumatic stress disorder from fighting on the battlefield. AdvertisementA study published earlier this year focused on the treatment of depression among veterans using ketamine taken through an IV. The doses provided at least partial relief to many of the test subjects and after six weeks of ketamine infusions, depression scores dropped significantly. "Soldiers, for them, it's natural to consider themselves like a strong man," Matrenitsky said, explaining that the effects of the ketamine therapy allow individuals to overcome defensive barriers over their emotions. In partnership with Heal Ukraine Trauma, Matrenitsky along with other healthcare professionals have teamed up to form the Ketamine-Assisted Psychotherapy initiative in hopes of educating Ukrainian therapists on Ketamine-Assisted Therapy.

Persons: —, Elaine Klein, Julia Rendleman, Dr, Vladislav Matrenitsky, Yulia Brockdorf, Wolfgang Schwan, Matrenitsky, Bandura, Paula Reynal, Klein Organizations: Service, Business, Heal, Washington, Center, Psychotherapy, 24th Brigade, Getty, Strategic, International Studies Locations: American, Ukraine, US, Kyiv, Anadolu, That's, Washington

☆ A psychologist explains how to deal with feelings of despair after the assassination attempt on Trump
▼ + stars: | 2024-07-15 | by ( Katie Balevic | Lloyd Lee | ) www.businessinsider.com time to read: +6 min

The assassination attempt on former President Donald Trump may have just kicked things into overdrive. As world leaders and politicians call for peace and unity, a poll found 50% of Americans believe political violence is a "very big problem" following the shooting at a Trump campaign event on Saturday that left two people dead. AdvertisementAn alarming 67% of Americans polled said the current political climate makes such violence "more likely" than normal. It'll allow people to be aware of their three domains, Porterfield said: the biological, the psychological, and the social. ControlIn the past five years, people have lived through a pandemic, several wars, and now, an assassination attempt on a former president.

Persons: —, Donald Trump, Katherine Porterfield, John F, Kennedy, Rev, Martin Luther King Jr, that's, Porterfield Organizations: Service, Dart Center for Journalism, Trauma, Columbia School of Journalism, Business, Trump

☆ Is Cutting Off Your Family Good Therapy?
▼ + stars: | 2024-07-14 | by ( Ellen Barry | ) www.nytimes.com time to read: +1 min

As she struggled through her sophomore year in college, Zhenzhen spent hours in therapy, but it hadn’t addressed the central strain in her life: her parents. When she pushed back, her father screamed, she said, and her mother wept. The pressure made it hard to function, and Zhenzhen fended off thoughts of suicide. Mr. Teahan’s videos introduced her to a new idea — that to heal from childhood trauma, it may be necessary to “go no contact” from abusive parents. Around half of Mr. Teahan’s clients restrict or sever ties with their families, which he describes as “brutally hard” but, when it is appropriate, deeply rewarding.

Persons: Zhenzhen, hadn’t, badgering, “, Patrick Teahan Locations: China, Massachusetts

☆ She tried everything to overcome an eating disorder. Then, she found 'magic' mushrooms.
▼ + stars: | 2024-07-09 | by ( Julia Pugachevsky | ) www.businessinsider.com time to read: +8 min

Meinert started going to food therapists at five years old, but it wasn't until she tried psilocybin — the psychedelic property in "magic" mushrooms — that she felt her symptoms fade. A lifelong struggle with foodDanielle Meinert eating Mexican food with ingredients that she used to find scary. Still, Meinert felt progress was agonizingly slow and involved "force-feeding" herself foods that scared her. An eating disorder treatment in 'magic' mushrooms? Unlocking motivation to do hard thingsDanielle Meinert happily eating a range of foods after her psilocybin session.

Persons: —, Danielle Meinert, Meinert, ARFID, Michael Pollan's, Johns Hopkins, Natalie Gukasyan, Gukasyan, nervosa, I'd, you've Organizations: Service, Business, Columbia University Irving Medical Center

☆ 5 counterintuitive pieces of relationship advice, from therapists: Don't 'hyper-fixate' on your own needs
▼ + stars: | 2024-07-05 | by ( Aditi Shrikant | ) www.cnbc.com time to read: +2 min

I've interviewed dozens of therapists about how to navigate relationship turbulence and found that they generally offer up pretty predictable advice: communicate, compromise, express appreciation. Here are five surprising pieces of advice, from relationship and family therapists. This is especially important during times of friction, says Vienna Pharaon, a marriage and family therapist and author of "The Origins of You." People often dismiss or forget the value of community once they enter a partnership, says Dené Logan, a marriage and family therapist and author of "Sovereign Love." Dené Logan marriage and family therapist3.

Persons: I've, Lisa Marie Bobby, Vienna Pharaon, Dené Logan, Bobby, Logan Locations: Denver, Vienna

☆ These retail traders lost big in the first meme stock episode. Here's why they won't stop betting on GameStop.
▼ + stars: | 2024-06-29 | by ( Jennifer Sor | ) www.businessinsider.com time to read: +5 min

GameStop stock is still the fascination of day traders, even after many saw big losses in 2021. The allure of striking it rich on the meme stock is too great to ignore, traders told BI. Business Insider spoke with retail traders, who asked to use only their first name for privacy, about how past losses are impacting their decision to go long GameStop again. Still, he couldn't help himself from scooping up more GameStop shares when the stock rocketed higher this year. Advertisement"I dabbled a little bit with this current uptrend, certainly nowhere near the levels I was putting in before.

Persons: they're, —, Keith Gill —, Dan, couldn't, Brian, I've Organizations: GameStop, Service, Business, lotto Locations: Reddit, Gill's, California

☆ Why Some People Don’t Talk About Money With Their Partner
▼ + stars: | 2024-06-28 | by ( Ann Carrns | ) www.nytimes.com time to read: +1 min

People worried about bills, feeling overwhelmed about overspending or concerned about money management may expect a “money talk” to lead to an argument, so they avoid bringing up the topic, according to a report from researchers at Cornell University and Yale University, published this month in The Journal of Consumer Psychology. Yet prior research has found that communicating about money helps couples spend more responsibly and better manage their debt. Why is it so difficult for some people to talk about money with their partners in the first place? Aja Evans, a financial therapist in New York, said people may feel ashamed that they are having money troubles. (Financial therapists aim to help clients understand how their emotions and beliefs about money can affect their financial behavior.)

Persons: ”, Emily Garbinsky, Aja Evans Organizations: Cornell University, Yale University, Consumer Psychology Locations: New York

☆ Chronic loneliness puts older adults at risk for stroke, study suggests
▼ + stars: | 2024-06-26 | by ( Madeline Holcombe | ) edition.cnn.com time to read: +6 min

And it may impact your stroke risk, according to a new study. This suggests that the biggest impact on stroke risk occurs over the long term. People who scored high on the loneliness scale both times they were surveyed had a much higher risk of stroke, the study said. And that feeling of loneliness is what the study found to be correlated to the increased risk of stroke, Soh said. “Make it be known that you are experiencing feelings of loneliness, and also identify what would be helpful for you specifically to address the feelings of loneliness,” Soh said.

Persons: ”, Yenee, Harvard T.H, Soh, Matt Pantell, Pantell, Edwin Tan, “, Vivek Murthy, ” Soh, Olivia Remes, Remes, Louise Hawkley Organizations: Lifeline, CNN, Department of Social, Behavioral Sciences, Harvard, of Public Health, Health, Center for Health, Community, University of California, University of Cambridge, Interact, Research Centers, University of Chicago Locations: Chan, San Francisco, United States, United Kingdom

Morsa Images | Digitalvision | Getty ImagesIt's no secret that many college graduates are struggling with student loan debt. Nearly 1 in 5 student loan borrowers in the U.S. — or 19% — say they are hiding their loan balance from their partner, according to a new report from NerdWallet . Shame, guilt, depression and anxiety swirling the topic of student debt can lead borrowers to keep the details of their loans secret, therapists say. If your significant other doesn't also have outstanding student debt, the topic can feel especially taboo, he added. Student debt can make it harder to buy a house, start a family and save for the future, research shows.

Persons: Traci Williams, Clay Cockrell, Cockrell, Kate Wood, Wood, you've Organizations: Getty, Harris Poll, Finance Locations: U.S, NerdWallet, East Point , Georgia, New York

☆ The unregulated multibillion-dollar life coaching industry can be a haven for discredited therapists
▼ + stars: | 2024-06-23 | by ( Lakshmi Varanasi | ) www.businessinsider.com time to read: +1 min

Some therapists who have lost their licenses have rebranded themselves as "life coaches." The life coaching industry generated $4.5 billion in revenue in 2022. Life coaching is an unregulated industry, so prospective patients should tread carefully. They can try "life coaching" instead. This loosely defined group of professionals generated $4.5 billion in revenue in 2022, according to The International Coaching Federation.

Persons: —, they're Organizations: Service, International Coaching Federation, Business

☆ I'm a therapist who's been hospitalized for a manic episode. I worried about the stigma at work — then, another patient recognized me.
▼ + stars: | 2024-06-19 | by ( Marcia Naomi Berger | ) www.businessinsider.com time to read: +7 min

download the appSign up to get the inside scoop on today’s biggest stories in markets, tech, and business — delivered daily. A year later, in 1975, I had a second manic episode, which landed me in Langley Porter Hospital. I first met Henry when I was a patient myselfI played ping-pong with Henry, a stocky, lively patient around my age. Then I saw his name on my list of patients on the large whiteboard that paired patients with their primary therapists. AdvertisementExcerpted from The Bipolar Therapist: A Journey from Madness to Love and Meaning by Marcia Naomi Berger.

Persons: —, Henry, Langley Porter's, I've, Marcia, Doreen, I'd, Langley Porter, Henry —, Barbara, Marcia Naomi Berger Organizations: Service, Langley Porter Hospital, Business, Elmhurst, Bitachon Press Locations: Queens , New York, San Francisco, Langley Porter, earshot

☆ Apple Is the First Giant Tech Company to Make Useful AI Products
▼ + stars: | 2024-06-16 | by ( Linette Lopez | ) www.businessinsider.com time to read: +9 min

Apple's scale and specificity of vision also make it the first Big Tech company to get AI integration right. The fact that people are disappointed in Apple says more about the hype around AI's capabilities than it does about Apple. In that way, Apple's cautious approach may be a service for the rest of the tech industry. By slowly acclimatizing its constellation of users to AI that makes their lives better instead of frustrating them, Apple makes the tech feel like a natural upgrade instead of an unreliable, scary intrusion. AdvertisementSure, Apple's AI may not be sexy or scary, but at least it doesn't seem stupid.

Persons: Katie Collins, Mark Gurman, Jordan Hart, Elon Musk, OpenAI's, Marc Andreessen's, confidants, Musk, Tesla, AI's, that's, Yann LeCun, Siri Organizations: Worldwide Developers, Apple, Apple Intelligence, Big Tech, Nvidia Locations: Silicon Valley, Silicon, Albany, New York City, New York

☆ Germany sets aside unease over its military to celebrate first Veteran’s Day
▼ + stars: | 2024-06-15 | by ( Sophie Tanno | Nadine Schmidt | ) edition.cnn.com time to read: +6 min

CNN —Germany is marking its first Veterans’ Day since World War Two on Saturday, a once unthinkable move that sets aside long-standing unease over the honoring of its soldiers. “We on the left reject this Veterans’ Day,” he told CNN in a statement. The commemorations, modeled on Armed Forces Day in the UK and Veterans Day in the US, will honor all Germans who have worn military uniform – not only those wounded or killed in combat. But the biggest spur to creating a Veterans’ Day has been Ukraine. He played a prominent role in forming the new Veterans’ Day bill.

Persons: Ates Gürpinar, ”, “, Boris Pistorius, ” Johannes Kiess, Johannes Arlt, Arlt, ” Arlt, Andreas Eggert, ” Eggert, Andreas Eggert “, Pistorius, Stefan Huss Organizations: CNN, Veterans ’, Veterans, Linke, Armed Forces Day, UK, Defense, National People’s Army, Bundeswehr, University of Leipzig, Social Democrats Locations: Germany, ”, Ukraine, Soviet, East Germany, Kosovo, Afghanistan, Mali, Berlin, Europe

☆ How therapy can boost happiness
▼ + stars: | 2024-06-09 | by ( Andrea Kane | ) edition.cnn.com time to read: +8 min

“(One) is that you’re going to go in, you’re going to download the problem of the week, and you’re going to leave, and you’re basically just complaining and getting validated for your complaints. Therapy helps to connect with othersModern times have created an epidemic of loneliness; the pandemic only made it worse. Therapy helps us see the big pictureTherapy helps people see that they are part of larger forces, and not simply individuals who formed with no external influences. “(Therapy) helps you to process that unfinished business.”She pointed out that our parents were human and often did what they learned from their parents. Therapy helps us control our storyOur life is a narrative, and therapy can help us make sense of it.

Persons: it’s, don’t, Lori Gottlieb, Sanjay Gupta, Gottlieb, I’m, ”, they’d, ” Gottlieb, you’re, you’ve, who’s, —, “, ’ ”, … they’re Organizations: CNN, Pew Research Center

☆ F.D.A. Panel Weighs MDMA Therapy and Its Risks
▼ + stars: | 2024-06-04 | by ( Andrew Jacobs | ) www.nytimes.com time to read: +1 min

The Food and Drug Administration is weighing whether to approve the use of MDMA, also known as Ecstasy, for treatment of post-traumatic stress disorder. An independent advisory panel of experts will review studies on Tuesday and is expected to vote on whether the treatment would be effective and whether its benefits outweigh the risks. The panel will hear from Lykos Therapeutics, which has submitted evidence from clinical trials in an effort to obtain agency approval to sell the drug legally to treat people with a combination of MDMA and talk therapy. Methylenedioxymethamphetamine (MDMA) is a synthetic psychoactive drug first developed by Merck in 1912. After being resynthesized in the mid-1970s by Alexander Shulgin, a psychedelic chemist in the Bay Area, MDMA gained popularity among therapists.

Persons: Alexander Shulgin Organizations: Drug Administration, Lykos Therapeutics, Merck Locations: Bay

☆ F.D.A. Panel Rejects MDMA-Aided Therapy for PTSD
▼ + stars: | 2024-06-04 | by ( Andrew Jacobs | ) www.nytimes.com time to read: +1 min

An independent advisory panel of the Food and Drug Administration rejected the use of MDMA-assisted therapy for post-traumatic stress disorder on Tuesday, highlighting the unparalleled regulatory challenges of a novel therapy using the drug commonly known as Ecstasy. Before the vote, members of the panel raised concerns about the designs of the two studies submitted by the drug’s sponsor, Lykos Therapeutics. The panel voted 9-2 on whether the MDMA-assisted therapy was effective, and voted 10-1 on whether the proposed treatment’s benefits outweighed its risks. Other panelists expressed concerns over the drug’s potential cardiovascular effects, and possible bias among the therapists and facilitators who guided the sessions and may have positively influenced patient outcomes. A case of misconduct involving a patient and therapist in the study also weighed on some panelists’ minds.

Organizations: Food and Drug Administration, Lykos Therapeutics

☆ F.D.A.’s Review of MDMA Cites Health Risks and Study Flaws
▼ + stars: | 2024-05-31 | by ( Andrew Jacobs | Christina Jewett | ) www.nytimes.com time to read: +1 min

The Food and Drug Administration on Friday raised concerns about the health effects of MDMA as a treatment for post-traumatic stress disorder, citing flaws in a company’s studies that could pose major obstacles to approval of a treatment anticipated to help people struggling with the condition. The agency said that bias had seeped into the studies because participants and therapists were readily able to figure out who got MDMA versus a placebo. It also flagged “significant increases” in blood pressure and pulse rates that could “trigger cardiovascular events.”The staff analysis was conducted for an independent advisory panel that will meet Tuesday to consider an application by Lykos Therapeutics for the use of MDMA-assisted therapy. The agency’s concerns highlight the unique and complex issues facing regulators as they weigh the therapeutic value of an illegal drug commonly known as Ecstasy that has long been associated with all-night raves and cuddle puddles. Approval would mark a seismic change in the nation’s tortuous relationship with psychedelic compounds, most of which the Drug Enforcement Administration classifies as illegal substances that have “no currently accepted medical use and a high potential for abuse.”

Persons: ” Organizations: Drug Administration, Lykos Therapeutics, Drug

Search resuls for: "Therapists"

25 mentions found