Australia becomes the first country to recognize psychedelics as a medicine

Australia is the first country to do so psychedelics as a drug after the Therapeutic Goods Administration (TGA) approved the psychedelic compounds in magic mushrooms and MDMA for use by people with certain mental illnesses.

MDMA and psilocybin, the active ingredient in magic mushrooms, will be considered schedule 8 drugs. This means that the substances have been approved for controlled use on prescription from a psychiatrist.

Psychedelics for medical use

The changes allow psychedelics like MDMA to be used to treat post-traumatic stress disorder and psilocybin for treatment-resistant depression. They are still considered banned substances — or schedule 9 drugs — for all other uses.

“Prescribing will be limited to psychiatrists given their specialized qualifications and expertise to diagnose and treat patients with serious mental illness,” a TGA statement published Friday said. Psychiatrists will also need to be approved by the TGA first.

No approved products

However, the TGA has not yet evaluated any approved psychedelic products containing psilocybin or MDMA, which means that psychiatrists must access and legally supply unapproved drugs for the specific permitted uses.

Stephen Bright, the director of the charity Psychedelic Research in Science and Medicine, said the decision made Australia the first country to recognize psychedelics as a medicine, but the industry had not anticipated it. “It was unexpected given that Australia is such a conservative country,” he said. “There are no products available, and no one other than myself and a handful of colleagues has been trained to provide the treatment.”

Little research

MDMA was first developed by a pharmaceutical company in the early 20s and was used by some psychiatrists in the late 1985s and early XNUMXs. However, the drug was banned in the US in XNUMX, after it began to be used recreationally.

"It's terribly sad because the evidence suggests there might be a lot of benefit to using it," Caldicott said. “The conditions for which these drugs can be used (post-traumatic stress disorder and treatment-resistant depression) are currently conditions that require patients to take medicines for life. While MDMA in a number of doses can already help psychotherapy to succeed.”

However, Professor Susan Rossell, a cognitive neuropsychologist – who led Australia's largest trial investigating psilocybin for treatment-resistant depression – said she was very cautious. “These treatments are not well established at all for a sufficient level of large-scale implementation,” she said. “We have no data at all on long-term results, which worries me. It is one of the reasons why I am doing this major research.”

The TGA's decision said it had considered several thousand written public submissions that the benefits to patients combined with tight controls outweighed the risks. “The submissions confirm the need for greater access to alternative treatments for patients with persistent mental illnesses where currently available treatments have been ineffective.”

Source: SMH (EN)