Australia first in the world to approve MDMA for psychiatric treatment

Starting in July, approved practitioners can treat patients with MDMA and psilocybin

In February, Australia became the first country in the world to approve MDMA for post-traumatic stress disorder (PTSD). It also approved the use of psilocybin for treatment-resistant depression. The new classification for each drug will begin July 1.

Mental health professionals and researchers, however, met the news with mixed responses.

Some welcomed the policy, but cautioned that the field needs more research before psychedelics should be prescribed to the masses.

“These treatments are not well established at all for a sufficient level of broad-scale implementation,” Susan Rossell, who leads Australia’s biggest trial on psilocybin’s impact on depression, told SBS News.

“We’ve got no data on long-term outcomes at all, so that worries me a lot, which is one of the reasons why I’m doing my very large study.”

Vinay Lakra, president of the Royal Australian and New Zealand College of Psychiatrists, told the Guardian that the new policy is a “baby step in the right direction.” Lakra is cautiously optimistic, and believes that there are safeguards in place to allow psychiatrists and the government to figure out a safe, effective system of treatment with the substances.

Some of the safeguards, for example, are the layers of approvals that psychiatrists must obtain before proceeding with treatment. First, they must get approval from a human research ethics committee, which are government-approved bodies across Australia that ensure safe, ethical research with human subjects.

Next, a psychiatrist who would like to prescribe MDMA or psilocybin must obtain approval from the Therapeutic Goods Administration (TGA). The TGA is similar to the U.S.’s Food and Drug Administration (FDA), but in addition to pharmaceuticals also evaluates supplements, medical devices and other health-related goods. Would-be prescribers must show that they have adequate training, evidence-based treatment protocols and patient monitoring, as well as meet reporting criteria. In addition, because Australia doesn’t currently manufacture either substance (legally at least), doctors must apply for a license to import them.

But for others, the success or peril of the new policy is in the details. For Paul Liknaitzky, head of clinical psychedelic research at Monash University, the TGA’s safeguards are still too vague. In an editorial for The Conversation, he writes, “What will constitute adequate psychedelic training is unlikely to be clarified, nor is there a requirement for practitioners to be supervised by psychedelic experts.” Psychedelic therapies, he says, are highly distinct from general psychiatry, and deserve specialized training.

Liknaitzky also questioned who might receive treatment. In most clinical trials, he wrote, more than 90% of patient applicants are denied. Psychedelics can be destabilizing, and who gets treatment is as important as who does the treating, and how. While he applauds the potential to help more people, he also hopes that prescribers exercise caution, too.

Finally, he also points out that while the TGA policy doesn’t include a treatment protocol, there are well-established ways that researchers tend to conduct their trials. Those protocols, while not mandated, are good starting points for practitioners. Typically, researchers work with patients before, during and after treatment, he says. Without agreed-upon protocols, patients may not know what they’re getting—or not getting—from their treatment.

Yet Liknaitzky, like Lakra, is cautiously optimistic.

“There’s so much potential here,” he writes. There’s also, he adds, “plenty at stake, and work to be done.”