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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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    Feud Flares Between U.S. and Global Antidoping Agency

    American officials allowed athletes to compete after testing positive for performance-enhancing drugs so they could work undercover. Their global counterparts call that a breach of the rules.Since the World Anti-Doping Agency first came under scrutiny this spring for its handling of positive tests for banned substances by nearly two dozen Chinese swimmers, the United States has been the agency’s chief critic.Congress has threatened to cut funding for the agency, which is known as WADA. The Justice Department and F.B.I. have opened criminal investigations into how the tests were handled. And the head of the United States Anti-Doping Agency and American swimmers have raised doubts about whether WADA can be trusted to do its job.On Wednesday, WADA launched its latest counterattack on the Americans, accusing the United States Anti-Doping Agency, known as USADA, of doing the same thing it has accused WADA of: failing to strictly follow the rules when an athlete tests positive for a banned drug.In a lengthy statement, WADA said that USADA had gone against the global antidoping code a decade ago by allowing athletes who had been doping to continue competing.WADA acknowledged a wrinkle in the case — that the athletes in question were allowed to keep competing so they could work undercover to help authorities with a criminal investigation — but said it did not matter because the U.S. agency was still bound to follow the rules and had failed to get WADA’s approval.“In one case, an elite level athlete, who competed at Olympic qualifier and international events in the United States, admitted to taking steroids and EPO yet was permitted to continue competing all the way up to retirement,” WADA said, referring to two categories of banned drugs. “Their case was never published, results never disqualified, prize money never returned and no suspension ever served. The athlete was allowed to line up against their unknowing competitors as if they had never cheated.”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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    Mexico’s President Faces Inquiry for Disclosing Phone Number of Times Journalist

    President Andrés Manuel López Obrador of Mexico has repeatedly made attacks on members of the news media in a country that is one of the world’s deadliest for journalists.Mexico’s freedom of information institute, a government agency, said Thursday that it would start an investigation into the president’s disclosure on national television of the personal cellphone number of a journalist for The New York Times.The investigation centers on a decision by President Andrés Manuel López Obrador during a televised news conference on Thursday that left many aghast in Mexico, one of the deadliest countries in the world for journalists. At least 128 journalists have been killed in Mexico since 2006, according to the Committee to Protect Journalists.During the news conference, Mr. López Obrador read aloud from an email from Natalie Kitroeff, The New York Times’s bureau chief for Mexico, Central America and the Caribbean. She had requested comment for an article revealing that U.S. law enforcement officials had for years been looking into claims that allies of Mr. López Obrador met with and took millions of dollars from drug cartels.In addition to railing against Ms. Kitroeff and identifying her by name, Mr. López Obrador publicly recited her phone number.“This is tantamount to doxxing, illegal by Mexican privacy laws and places reporters at risk,” Jan-Albert Hootsen, the Mexico representative for the Committee to Protect Journalists, said on X, the social media platform.Mexico’s National Institute of Transparency, Access to Information and Personal Data Protection, or INAI, said in a statement that its investigation would seek to establish whether Mr. López Obrador had violated Mexican legislation protecting personal data. The institute runs Mexico’s freedom of information system, which was created more than two decades ago to make government operations more transparent and curb abuses of power.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