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Australia has become the first nation in the world to OK the use of psychedelic medicines for treating PTSD and depression. The June 2023 online issue of Nature reports that Australia’s drug authority will OK MDMA and psilocybin for treatment of PTSD and depression. The Therapeutic Goods Administration (TGA) based their decision on years of research and after a three-year review by the agency. The psychedelic medicines will be available for approved psychiatrists.

Why Did Australia Approve Psychedelic Medicines?

The Australian Therapeutic Goods Administration reviewed years of psychedelic medicine research in coming to their decision to make MDMA and psilocybin legal for treatment by approved psychiatric professionals. MDMA and psilocybin have been illegal drugs in Australia as well as the US and many nations. However, research studies have demonstrated remarkable treatment results for both MDMA and psilocybin in the treatment of PTSD and depression. These medicines require only a dose or two to improve these conditions. This is unlike standard antidepressants used for the same purpose. Antidepressants require constant use for weeks, months, and even years. The agency noted that recent studies showed much greater effectiveness of higher doses of psilocybin as well as significant side effects. Taking all available information into consideration, Australia has now OK’d use for these medicines for non-research therapy.

The USA, Israel, and Canada all allow compassionate use of these medicines in research studies but no one else has OK’d these medicines for general use even in controlled circumstances.

Why Did Australia Approve Psychedelic Medicines?

Risks Related to MDMA and Psilocybin Use

The response among professionals in Australia is mixed in regard to legalizing MDMA and psilocybin for standard use even limited to approved psychiatrists. The first argument put forward against the decision is that it not yet clear which patients are the best choices for these treatments as opposed to standard approaches. The second concern is how to know which patients will have negative experiences instead of therapeutic ones. One Australian researcher working in this area says that in her experience anywhere from one in ten to one in five people who take MDMA or psilocybin have very negative experiences. Her concern is that some people, if not properly screened, will have lasting negative effects.

Who Requested Approval of Psychedelic Medicines in Australia?

Mind Medicines Australia, a Melbourne non-profit group, asked for approval of these meds in 2020. This was after a previous request was denied. What has happened in the intervening three years is that more research has been done and more evidence has accumulated showing that MDMA and psilocybin are more effective than current standard treatments as adjunctive therapy for depression and PTSD as well as substance abuse disorders and anxiety.

Who Requested Approval of Psychedelic Medicines in Australia?

How Will Psychedelics Be Used in Treatment in Australia?

The Nature article quoted a University of Queensland psychiatrist, Steve Kisely regarding how the medicines will be used. He noted that current research shows that MDMA and psilocybin have produced positive results when used as adjunctive treatment along with coaching or psychotherapy. He notes that researchers are still trying to decide which patients are best suited for treatment with these medicines and which specific treatment plans will be most effective.

Dr. Kisely’s concern is that the ruling by the Australian drug authority does not include any guidance about how the medicines should be administered, stipulated clinical settings, or length of treatment. According to the previous head of the drug authority, their responsibility is regulating medical devices and medicines and not dictating treatment protocols. They do not tell clinicians how to practice. This will be left to the professional associations affected by their rulings.

A valid concern is that the Australian drug authority did not consult researchers doing work on psychedelic medicines in Australia in coming to their decision. Psychedelic medicine researchers in Australia and US experts like Alan Davis, director of the Center for Psychedelic Drug Research and Education at Ohio State University in Columbus, both note that safety and clinical effectiveness have not been nailed down sufficiently to make these medicines generally available.

FDA Position on Psychedelic Medicine Use

The FDA has recently issued a first draft of proposed guidance for clinical trials with psychedelics. Concerns include long term and repeat dosing, effectiveness, and optimal protocols for psychotherapy. The position of the FDA is that psychedelics are still in the investigational phase and not ready for general use.

Individual treatment professionals in Australia who will be allowed to use psychedelic medicines in treatment will need to pass reviews of their medical and professional conduct via the appropriate medical and psychiatric boards.

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