Good morning and welcome back! You might have missed the news on Friday that the Food and Drug Administration has chosen not to approve MDMA — better known as the recreational drug ecstasy — for treatment of PTSD. Though not entirely unexpected, the move scuttled what some had hoped would be a breakthrough in the use of psychedelics as medicine. Senior producer Haleema Shah spent months reporting on the drug and its long history for a new series, and is here to share how the effort to destigmatize and medicalize psychedelics got here, and where it goes now.
—Lavanya Ramanathan, senior editor |
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MDMA's 40-year fight for medical approval continues |
Alexander "Sasha" Shulgin, developer of MDMA, in 2002. Anthony Pidgeon/Redferns |
2024 was supposed to be the year MDMA, better known by its street variations, "ecstasy" or "molly," shed its reputation as a mere party drug. Advocates touted its potential to treat mental illness, but MDMA research was long stymied by its status as an illicit drug with no medical use. This year, the FDA reviewed Lykos Therapeutics's late-stage clinical trials, which paired MDMA with psychotherapy to treat post-traumatic stress disorder. But on Friday, what was expected to be a landmark moment for the use of psychedelics in medicine ended in a rejection from the agency. It was a far cry from what most observers expected when I began reporting on MDMA-assisted therapy at the beginning of the year. Clinicians and patients were (and remain) overwhelmingly supportive of researching psychedelics for psychiatric use. In the absence of novel treatments for PTSD, MDMA received surprising bipartisan support in Congress and the Department of Veterans Affairs was instructed to prepare a rollout of the treatment. But even before the FDA's rejection, its advisers were concerned about research bias, trial misconduct, and data integrity. While the rejection does not fully quash hopes of the drug's future in medicine, it will delay it. Lykos Therapeutics announced that the FDA requested an additional phase 3 trial to further study safety and efficacy of the treatment, something that the company CEO said would take several years to complete. The delay is a critical blow to psychedelic advocates who expected that MDMA would finally find therapeutic use after four decades of advocacy. Here's how they got MDMA this far — and what they're planning next. |
The roots of therapeutic MDMA |
I began reporting on MDMA's roots in therapy this spring for Vox's podcast Today, Explained. I visited Shulgin Farm, the Bay Area home of the late chemist Alexander "Sasha" Shulgin, who synthesized the drug in 1976. Though his lab — a converted tool shed — looked more like a Hollywood rendition of a meth lab than the sterile laboratories of my college chemistry class, it was historically significant, because Shulgin is said to have synthesized hundreds of psychoactive substances, some of which he tested on himself, including MDMA. Shulgin would admit he found MDMA enjoyable, calling it a "low-calorie martini." But he didn't set out to design recreational drugs. "I'm looking for tools that can be used for studying the mind," and he believed his peers could then use those tools in neuroscience or psychology, he said in a 1996 interview. His wife, Ann Shulgin, who died in 2022 and is sometimes referred to as "a lay therapist," was even more ardent about her view of psychedelics as "spiritual tools." In the early 1980s, she and countercultural psychotherapists believed that MDMA, with its ability to flood people with feelings of love and empathy, could relieve clients of shame and allow them to process trauma or face challenging emotions. "This chemical has already accomplished enough so that many psychiatrists who have used it, and are using it, have spoken of a possible need to substantially restructure the classical psychotherapeutic 50-minute hour concept," Ann wrote in a letter to President Ronald Reagan, arguing for the drug's legal use. That description bears striking resemblance to what some trial participants say today: An 18-week treatment regimen with MDMA and psychotherapy can relieve PTSD symptoms that years of therapy and SSRI prescriptions couldn't. But MDMA's development as a therapeutic drug was hindered by its reputation as a medically useless street drug. |
MDMA's descent deeper into the underground |
Despite underground therapists' belief in MDMA's therapeutic potential in the early 1980s, the euphoric experiences the drug induced could not be contained for long. MDMA escaped the therapeutic space, was produced in clandestine labs, and found a home in nightclubs as "ecstasy" or "X." And it happened during a drug war that already banned psychedelics like LSD. By 1985, MDMA was quickly placed under emergency ban after the DEA said it posed a public health risk. "There was a lot of lurid press about MDMA," Paul Daley, a friend of the Shulgins and chief science officer at the Alexander Shulgin Research Institute, told me. "Brain scans were showing 'Oh, there are holes in people's brains who are taking MDMA.' Of course, it's all hogwash." The most damning study of MDMA was in the early aughts, and suggested it caused Parkinson's-like brain damage, but the study was retracted after a major experimental error was discovered. Evidence, however, supports that MDMA can cause rapid heart rate, cardiovascular events, and bad trips. As DARE programs and news reports warned of the dangers of ecstasy, a community of evangelists remained committed to bringing MDMA into respectability through medicine. |
MDMA's makeover and foray into medicine |
Shortly after MDMA was banned, a friend of the Shulgins, Rick Doblin, sprung into action. With the goals of "mass mental health" and "spiritualized humanity," Doblin founded the Multidisciplinary Association for Psychedelic Studies (MAPS), an organization he still leads, and is regarded as one of the most successful psychedelic advocates. "To bring psychedelics back from the underground, it was necessary to, first off, have a patient population that the general public is sympathetic with and for which Big Pharma's drugs are not really working," Doblin said in a 2021 interview with self-help author (and former presidential candidate) Marianne Williamson. The sympathetic population he described are military veterans, who face high rates of PTSD and for whom first-line treatments are decades-old SSRIs that are partially effective. Doblin's organization and pharmaceutical spinoff, Lykos Therapeutics, are responsible for the clinical trials that the FDA reviewed this month. But months before the agency announced its decision, the trial design was criticized for not meeting the gold standard of clinical trials, which is to be double-blinded. Participants were usually able to determine whether they received the drug or placebo because of MDMA's obvious psychedelic effects. Moreover, some who received the drug said they felt pressured to report positive results because their participation was framed as "making history" and "part of a movement" to end psychedelic prohibition. Friday's FDA decision is a blow to the decades-long efforts to medicalize MDMA, but psychedelics are now more mainstream than ever — they're a subject of discussion at the VA, on wellness podcasts, and studied in academic institutions around the world. And in a statement, Doblin showed no signs of quitting after a 40-year odyssey to mainstream psychedelics: "Our collective commitment to MDMA-assisted therapy remains unwavering."
— Haleema Shah, senior producer and reporter, Today, Explained |
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| Students are returning to college campuses this month armed with generative AI tools. One professor who has banned them and one who has embraced them explain why. |
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- The ugly fight over Jordan Chiles's gymnastics bronze medal: The Paris Olympics closed on Sunday, with Team USA gymnasts bringing home 10 medals for their show-stopping performances at the Games. But now, gymnast Jordan Chiles may have to return her bronze medal — not due to doping or another scandal, but a timing technicality.
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WHAT VOX WRITERS ARE READING
Animal lovers, this story is trolling you. The decorated writer Mary Gaitskill (notably the author of Lost Cat: A Memoir) penned a controversial essay (for The Cut, where controversial essays are wont to live) analyzing her desire to euthanize her cat, Suki, for being too annoying. The piece is making the rounds because, well, that line of thought is pretty chilling. "As predator or prey, animals are always closer to the reality of killing than we are, and on a very subliminal level, their proximity brings us closer too," she writes. Pull up a chair and park in the comments after you read. [The Cut] Aging well: This list ranking the 100 best movies of the 2000s is a good way to pad out your watch list (and a great way to start an argument with your friends.) Click to see the top pick that came as a hilarious shock to a few of our writers, who remember the sci-fi film being panned during its 2001 release. [IndieWire] |
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You should be watching Industry |
Fall TV is on the way. Till then, our staffers are delving into season 3 of Industry on HBO, which isn't exactly Succession, but is a fun, soapy way to spend your Sunday nights through the end of September. The show, which follows a group of young coworkers at a fictional, British investment bank is a delicious watch (especially because of Kit Harington's addition to the cast this season). Writing on the latest in Sunday night TV, staff reporter Kyndall Cunningham says: "While supposedly high-brow shows have become predictable, with their focus on trauma and grief as main qualities of the human experience, Industry seems to be one of the few shows interested in offering viewers naughtiness and pleasure." |
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Today's edition was produced and edited by senior editor Lavanya Ramanathan, with contributions from staff editor Melinda Fakuade. We'll see you tomorrow! |
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