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    Three MDMA Studies Are Retracted by Scientific Journal

    The journal Psychopharmacology has retracted three papers about MDMA-assisted therapy based on what the publication said was unethical conduct at one of the study sites where the research took place.Several of the papers’ authors are affiliated with Lykos Therapeutics, the drug company whose application for MDMA-assisted therapy to treat post-traumatic stress disorder was rejected last week by the Food and Drug Administration. The company said the research in the retracted papers was not part of its application to the F.D.A. In declining to approve Lykos’s application, the agency cited concerns about missing data and problems with the way the company’s study was designed, according to a statement released by Lykos on Friday.The F.D.A. has asked Lykos to conduct an additional clinical trial of its MDMA-assisted therapy, which would have been the first psychedelic medicine to win approval by federal regulators. Lykos has said it would appeal the decision.The journal retraction was first reported by Stat, the health and medical news website.On Sunday, Lykos said that it disagreed with Psychopharmacology’s decision and that it would file an official complaint with the Committee on Publication Ethics, a nonprofit that sets guidelines for academic publications.“The articles remain scientifically sound and present important contributions to the study of potential treatments for PTSD,” the company said in the statement.The incident cited by Psychopharmacology has been well documented. In 2015, an unlicensed Canadian therapist who took part in the trial engaged in a sexual relationship with a participant after the conclusion of the trial’s dosing sessionsIn civil court documents, the patient, Meaghan Buisson, said she was sexually assaulted by the therapist, Richard Yensen, who at the time was working alongside his wife, a licensed therapist. Mr. Yensen has said the relationship was consensual and initiated by Ms. Buisson. Six months after the final session, she moved from Vancouver to Cortes Island, in British Columbia, where the couple lived, according to court documents. The relationship between patient and practitioner continued for more than a year, the documents said. Professional associations in both Canada and the United States prohibit sexual relationships between psychologists and patients for at least two years after their final session. The incident helped highlight some of the challenges associated with psychedelic medicine, which can render patients especially vulnerable during dosing sessions. For that reason, most clinical trials involving psychedelic compounds require the presence of two mental health professionals. (Lykos’s trials with MDMA require only one of the practitioners to be licensed.)The Multidisciplinary Association for Psychedelic Studies, or MAPS, is the nonprofit that carried out the research and later created Lykos to market its proprietary MDMA-assisted therapy. The association publicly acknowledged the incident in 2019, adding that it had been reported to the F.D.A. and to Canadian health authorities.The company acknowledged on Sunday that it had failed to notify Psychopharmacology about the violations, but it said that the oversight should have been addressed through a correction, not a retraction. More

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    FDA Declines to Approve MDMA Therapy, and Seeks Further Study

    The agency said there was insufficient data to allow the use of a treatment for PTSD that involves the drug known as Ecstasy.The Food and Drug Administration on Friday declined to approve MDMA-assisted therapy for the treatment of post-traumatic stress disorder, dealing a serious blow to the nascent field of psychedelic medicine and dashing the hopes of many Americans who are desperate for new treatments.The F.D.A. said there was insufficient data to allow its use, and it asked the company seeking approval for the treatment, Lykos Therapeutics, to conduct an additional clinical trial to assess whether the drug, commonly known as Ecstasy or molly, would be safe and effective.An additional clinical trial could add years, and millions of dollars, to the approval process.If approved, MDMA would have become the first psychedelic compound to be regulated by federal health authorities. Supporters of psychedelic medicine were deeply disappointed, and some said they were stunned, having assumed the therapy’s promising data would overcome flaws in the company’s clinical trials, which had been designed in consultation with F.D.A. scientists.“This is an earthquake for those in the field who thought F.D.A. approval would be a cinch,” said Michael Pollan, the best-selling author and co-founder of the UC Berkeley Center for the Science of Psychedelics. His book, “How to Change Your Mind,” helped catalyze public interest in the therapeutic potential of psychoactive compounds, demonized during the nation’s long war on drugs.But the agency’s decision had not been entirely unexpected, after a group of independent experts convened by the F.D.A. to evaluate Lykos’s data met in June and did not recommend the treatment. On two central questions, the experts voted overwhelmingly that the company had not proven the treatment was effective, and that the drug therapy’s benefits did not outweigh the risks.The agency generally follows the recommendations of its outside panels. Critics, however, have questioned the panel’s expertise, noting that only one of its 11 members had experience in psychedelic medicine.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More

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    This Is Literally Your Brain on Drugs

    A small new study shows reactions in the brain in people who were given psilocybin in a controlled setting.If you had to come up with a groovy visualization of the human brain on psychedelic drugs, it might look something like this.Sara Moser/Washington University School of MedicineThe image, as it happens, comes from dozens of brain scans produced by researchers at Washington University School of Medicine in St. Louis who gave psilocybin, the compound in “magic mushrooms,” to participants in a study before sending them into a functional M.R.I. scanner.The kaleidoscopic whirl of colors they recorded is essentially a heat map of brain changes, with the red, orange and yellow hues reflecting a significant departure from normal activity patterns. The blues and greens reflect normal brain activity that occurs in the so-called functional networks, the neural communication pathways that connect different regions of the brain.The scans, published Wednesday in the journal Nature, offer a rare glimpse into the wild neural storm associated with mind-altering drugs. Researchers say they could provide a potential road map for understanding how psychedelic compounds like psilocybin, LSD and MDMA can lead to lasting relief from depression, anxiety and other mental health disorders.“Psilocybin, in contrast to any other drug we’ve tested, has this massive effect on the whole brain that was pretty unexpected,” said Dr. Nico Dosenbach, a professor of neurology at Washington University and a senior author of the study. “It was quite shocking when we saw the effect size.”We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More

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    FDA Panel Weights MDMA Therapy for PTSD

    An independent group of experts is meeting Tuesday to consider whether to allow use of this illegal drug, also known as Ecstasy, to treat PTSD. 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.Millions of Americans suffer from PTSD, including military veterans who are at high risk of suicide. No new treatment for PTSD has been approved in more than 20 years.What is MDMA?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. Early research suggested significant therapeutic potential for a number of mental health conditions.MDMA is an entactogen, or empathogen, that fosters self-awareness, feelings of empathy and social connectedness. It is not a classic psychedelic like LSD or psilocybin, drugs that can cause altered realities and hallucinations. Among recreational users, MDMA is commonly known as molly or Ecstasy.In 1985, as the drug became a staple at dance clubs and raves, the Drug Enforcement Administration classified MDMA as a Schedule I substance, a drug defined as having no accepted medical use and a high potential for abuse.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More

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    The Psychedelic Evangelist

    Before he died last year, Roland Griffiths was arguably the world’s most famous psychedelics researcher. Since 2006, his work has suggested that psilocybin, found in magic mushrooms, can induce mystical experiences, and that those experiences, in turn, can help treat anxiety, depression, addiction and the terror of death.Dr. Griffiths and his colleagues at Johns Hopkins University received widespread recognition among scientists and the popular press, helping to pull the psychedelic field from the deep backwater of the 1960s hippie movement. This second wave of research on the hallucinogenic compounds bolstered political campaigns to decriminalize them and spurred biotech investment.Dr. Griffiths was known to friends and colleagues as an analytical thinker and a religious agnostic, and he warned fellow researchers against hype. But he also saw psychedelics as more than mere medicines: Understanding them could be “critical to the survival of the human species,” he said in one talk. Late in life, he admitted to taking psychedelics himself, and said he wanted science to help unlock their transformative power for humanity.Perhaps unsurprisingly, he held a vaunted, even prophetic role among psychonauts, the growing community of psychedelic believers who want to bring the drugs into mainstream society. For years, critics have denounced the outsize financial and philosophical influence of these advocates on the insular research field. And some researchers have quietly questioned whether Dr. Griffiths, in his focus on the mystical realm, made some of the same mistakes that doomed the previous era of psychedelic science.Now, one of his longtime collaborators is airing a more forceful critique. “Dr. Griffiths has run his psychedelic studies more like a ‘new-age’ retreat center, for lack of a better term, than a clinical research laboratory,” reads an ethics complaint filed to Johns Hopkins last fall by Matthew Johnson, who worked with Dr. Griffiths for nearly 20 years but resigned after a charged dispute with colleagues.Roland Griffiths, director of the Center for Psychedelic and Consciousness Research at Johns Hopkins, in 2021.Matt Roth for The New York TimesWe are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More