Australia’s medical regulator on Wednesday rejected a bid to approve psychedelics for therapeutic use, saying the risks of the drugs outweigh the potential mental health benefits. In a final decision from the Therapeutic Goods Administration (TGA), the agency declined to approve an application to amend Australia’s poison standards by reclassifying psilocybin and MDMA as Schedule 8 controlled substances instead of their current status as prohibited substances under Schedule 9.

The decision will prohibit the use of psychedelic drug as a therapeutic treatment for serious mental disorders. This is an acceptance that many therapists are beginning to accept. The drugs can be used to treat anxiety, depression and addiction according to studies. 

The TGA pointed out that most of the current research has been done in controlled settings, which could limit the therapeutic potential of psychedelics. TGA also expressed concern that the legalization of psychedelics for therapeutic purposes could lead to drug abuse in other non-clinical settings.

“The benefit is very limited because psilocybin studies indicate only potential therapeutic value in circumstances where the treatment was provided to subjects within the setting of a clinical trial,” the TGA wrote in its December 15 final decision. 

“In relation to the risks, I am satisfied that psilocybin poses a high danger for both acute and long-term effects if abused or misused by way of access outside of strictly controlled medical and scientific research settings,” the author of the agency’s decision wrote. “Given this increased risk to individuals of acute and long-term effects, a high level of control across the supply chain commensurate with Schedule 9 is warranted.”

The Royal Australian and New Zealand College of Psychiatrists did not support the application to reclassify psilocybin and MDMA, according to the TGA’s statement. Australian Medical Association also voiced support, calling for additional research that uses larger and more high-quality studies in order to assess the therapeutic efficacy of the drug.

Decision a ‘Step Backward’ for Australia

Dr. John Huber, the founder and CEO of psychedelic therapy consultation platform Tripsitter Clinic, says that “Australia’s decision to reject the use of MDMA and psilocybin mushrooms for clinical use is a step backward.” 

“The declaration that there is not enough research limits Australia’s ability to conduct any research on the benefits of psychedelic therapy,” Huber wrote in an email to Chronic News. “This form of thinking suppresses progress and portrays 1960s ideologies. The pandemic greatly impacted people’s mental health, and political leaders need to get up to speed and expand access to mental health services in this time of need.”

David Nikzad (CEO of Ei.Ventures, a Hawaii-based startup that makes psychedelic medicine), said the TGA’s decision was inconsistent with the recent efforts to reform psychedelic medicine. Canada has made psilocybin legal for clinicians and has seen a rise in psychedelic retreats within the Caribbean.

Oregon also legalized psilocybin as a supervised treatment for mental disorders. Several U.S. cities, including Seattle, Oakland, and Portland, have adopted measures to make it illegal to possess psychedelic drugs or entheogenic plants.

“We find this very disappointing and counter to the larger trend of psychedelics being decriminalized or approved for medical use in numerous jurisdictions globally,” Nikzad said. “We hope that Australia comes around once the studies underway give further credence to earlier work that shows the effectiveness of psilocybin use for positive mental health outcomes in clinical settings.”

“It’s really a shame that this outdated thinking is stifling advancement in the important arena of psychedelics and mental health when these natural products could help so many people with depression, anxiety and other mental health issues,” he added.