Psychedelic researchers have backed the medical regulator’s decision. Photo by James MacDonald / Bloomberg via Getty Images
Psychedelic drugs will not be legalized for therapeutic purposes in Australia, the country’s medical regulator has said.
The Therapeutic Goods Administration (TGA) on Wednesday rejected a request to change Australia’s poison standard and reduce drugs like psilocybin and MDMA from schedule 9 – banned substances – to schedule 8 – controlled substances.
The ruling means the drugs cannot be used in psychotherapeutic treatment for mental illness, depression and post-traumatic stress disorder, even with permission from an attending psychiatrist or doctor addiction specialist in a medically controlled environment.
In one declaration, the TGA said its decision was based on concerns that legalizing the use of the substances in therapeutic settings could lead to misuse or abuse in non-clinical settings.
“The benefit is very limited because studies with psilocybin only indicate potential therapeutic value in circumstances where the treatment has been provided to subjects in a clinical trial,” said the decision maker. final.
“Regarding the risks, I am convinced that psilocybin presents a high danger for both acute and long-term effects if misused or misused by access outside strictly controlled medical and scientific research parameters. . ”
“In view of this increased risk to individuals of both acute and long-term effects, a high level of control throughout the supply chain in accordance with Annex 9 is warranted.”
The author further noted that most submissions supporting the downscaling of psilocybin and MDMA came from people who were consumers or patients with a personal interest in how the drugs were scheduled, as well as experts who had previously provided comments on the matter.
The Royal Australian and New Zealand College of Psychiatrists (RANZCP) has not supported the proposal to reprogram the drugs, according to the TGA statement, while the Australian Medical Association (AMA) has reportedly suggested that more high-quality research using larger scale studies need to be completed to determine the safety and effectiveness of psilocybin or MDMA use for mental illness.
While the TGA’s ruling is an effective reinforcement of the status quo, it lags a growing number of jurisdictions in other parts of the world. Last November, Oregon became the first state in the United States legalize psilocybin for the treatment of mental health in supervised settings, while Canada has started allowing people with depression to legally use the psychedelic. Researchers in the United States are also currently conducting a second Phase 3 trial of the effectiveness of MDMA-assisted therapy, and if successful, the Food and Drug Administration (FDA) may approve the substance for use. therapies by 2023.
Dr Martin Williams, chief executive of Psychedelic Research in Science and Medicine (PRISM), said he agreed with the TGA’s decision not to reschedule any of the drugs in Australia.
“Although excellent late-phase clinical research is underway worldwide and the results so far have been very promising, we agree that the standards of evidence required for formal approval and implementation have yet to be completed. be respected, “Williams said in a statement. emailed to VICE. “Our strong support for the eventual reprogramming of psilocybin and MDMA…
“Meanwhile, Australian research needs to be done to ensure successful implementation in the local environment, to engage our medical community and to pave the way for proper training and accreditation of Australian mental health professionals in this revolutionary area of mental health practice. “
Dr Stephen Bright, founding member and director of PRISM, also highlighted concerns that rescheduling could “open the door to dangerous and unethical practices”.
“It was no surprise to me,” he told VICE. “Australia was never going to be the first country in the world to manufacture these drugs. [do that]. “
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