It came as a surprise to many when, on Feb. 3, Australian regulators announced that medicines containing the psychedelic substances MDMA and psilocybin can soon be used there to treat post-traumatic stress disorder (PTSD) and treatment-resistant depression, respectively. That decision makes Australia the first country in the world to formally recognize the therapeutic use of psychedelics.
Other countries, including the U.S., may be headed toward a similar outcome, some experts say.
Research increasingly suggests that psychedelics can be powerful tools for treating a variety of mental-health conditions, from PTSD and depression to addiction and eating disorders. “I’ve been doing this for 11 years,” says Albert Perez Garcia-Romeu, an assistant professor of psychiatry and behavioral sciences at the Johns Hopkins University School of Medicine who studies psychedelics. “The overwhelming majority of people that I’ve worked with in this process have been helped by their experiences, and the data are remarkably consistent.”
In Nov. 2022, the U.S. nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS) announced that it had completed a second phase-three trial on MDMA as a treatment for PTSD—a step widely seen as the last hurdle to clear before applying for approval from the U.S. Food and Drug Administration (FDA). While the data from that study have yet to be published in a peer-reviewed journal, MAPS says its findings echo the positive results from its first phase-three MDMA trial, published in the journal Nature Medicine in 2021, which found that PTSD patients who took MDMA while also undergoing therapy reported significant improvements in their symptoms 18 weeks after their first dose, compared to those who received a placebo. Rick Doblin, MAPS’ founder and executive director, says his group is preparing to apply for FDA approval based on those data. If all goes well, he says, the drug could be approved as soon as 2024.
Research on psilocybin, the psychoactive component in “magic” mushrooms, may take a little longer to progress to that stage, Garcia-Romeu says, but he expects psilocybin to be considered for FDA approval within the next few years. In Nov. 2022, results from a phase-two psilocybin trial were published in the New England Journal of Medicine. They found that a single 25-milligram dose of psilocybin eased symptoms among people with treatment-resistant depression over a period of three weeks, though it did come with side effects including headaches, nausea, and dizziness.
Australia’s approval of these drugs, Doblin says, may only expedite the approval process in the U.S. “It’s going to help regulators in the U.S. and elsewhere feel more comfortable,” he says. “Regulators don’t like to be the first or the only ones.”
A representative for the FDA did not respond to TIME’s request for comment before press time. But in a May 2022 letter first published by the Intercept, a U.S. Department of Health and Human Services official wrote that FDA approval of MDMA and psilocybin was “anticipated” within “approximately 24 months.”
The FDA has also previously granted “breakthrough therapy” status to MDMA and psilocybin. That designation recognizes a drug’s therapeutic potential and is meant to streamline the road from research to approval. The agency has also allowed a limited number of people to use MDMA under what’s known as “expanded access,” a program meant to help seriously ill patients who have not responded to other treatments try drugs that are still being studied.
Regulators in other countries have made similar decisions. Switzerland, Canada, and Israel allow clinicians to use certain psychedelics under specific circumstances for patients with severe conditions. Jamaica and Costa Rica, among other countries, also already operate legal psilocybin clinics.
Some U.S. states have embraced the use of psychedelics, too. Psilocybin use became legal in Oregon on Jan. 1 when used by adults under the supervision of a licensed facilitator, and Colorado residents recently voted to do the same. Legislation to legalize psilocybin has also been introduced in states including Connecticut, New Jersey, and California.
Australia, however, will be the first country in the world to make psychedelics available for medicinal use at a national level, starting July 1. But access to the drugs won’t be as straightforward as it is for other prescription medications. Despite their decision to make MDMA and psilocybin available to patients, Australian regulators have not approved any medications that contain these substances. To prescribe drugs that are technically still unapproved, psychiatrists must apply to become authorized prescribers—a process that involves securing approval from both Australia’s Therapeutic Goods Administration (TGA) and a human research ethics committee, and obtaining a permit to import the drugs from Australia’s Office of Drug Control.
That’s a “deviation” from standard process, says Dr. Michael Bogenschutz, director of the NYU Langone Center for Psychedelic Medicine. “Allowing [a drug] to be used as though it already had been approved is what I would be concerned about.”
While Bogenschutz is excited by the advances in psychedelics research, and says it’s “looking more and more like these drugs may find their place in medicine,” he’s concerned about enthusiasm outpacing science. “We hope [psychedelics] will represent a major breakthrough, but we really can’t say that is true until we’ve accumulated and analyzed the evidence that is needed to make that determination,” he says.
Australia’s TGA acknowledged in its Feb. 3 announcement that “there is only limited evidence that the substances are of benefit in treating mental illnesses,” but maintained that “there is a need for access to new therapies for treatment-resistant conditions.”
Doblin says his concern with Australia’s plan is whether authorized psychiatrists will receive adequate training. “The drug is not the treatment,” he says. “The drug makes the therapy more effective, but it’s about the therapy.” MAPS’ leadership has recommended to U.S. regulators that therapists complete a 100-hour training program before they can use MDMA to treat patients.
That caution is primarily to ensure that patients are getting the best care, but also to help the drugs’ rollout goes as smoothly as possible.
“Things that happen in one country are really broadcast around the world,” Doblin says. That means whatever happens in Australia, for better or for worse, could have ripple effects for countries all around the globe. (Full Story)