For the first time, psilocybin and MDMA have been given medical approval.

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MDMA and psilocybin are the first drugs approved.

Many people are happy that Australia allows the use of these psychedelics, but there are still concerns about access.

Australia has announced that it will officially recognize MDMA and psilocybin as medicines. This is a world first.

A licensed psychiatrist prescribed her MDMA to treat post-traumatic stress disorder (PTSD), according to a statement released by Australia’s Therapeutic Goods Administration (TGA) on February 3. Psilocybin, the active ingredient in mushrooms, can be prescribed. It treats depression that does not respond to other treatments. First, the TGA has not yet approved any real drugs containing these drugs, so patients will be given “unapproved” drugs, including MDMA or psilocybin.

The choice surprised everyone. The same regulatory board has decided not to lower the timeline for using the drug in medical settings at the end of 2021. Simon Raffel, a psychiatrist and senior fellow at the University of Melbourne’s Psychic Institute, said: “This decision shocked me. Before supporters get too excited, experts say there are still many open questions, such as: B. Whether Australia acted too soon without sufficient information about how many people will actually be able to receive these treatments after 1 July and how to provide these treatments safely and effectively. .

“I think it will take time to scale up,” says Daniel Perkins, a senior researcher at the University of Melbourne and an associate professor at Swinburne University’s Center for Mental Health. He says it’s wise to open up slowly so you can figure out what’s working and what’s not.

Before a psychiatrist is allowed to administer drugs, they may have to go through a long and complicated process. Under Australia’s Accredited Prescriber Scheme, a psychiatrist must first be licensed by the Human Research Ethics Committee and then he must be licensed by the TGA. To do this, it is necessary to demonstrate that the treatment plan makes sense from a clinical point of view, that the treatment process is adequately monitored, and that appropriate precautions are taken to protect the patient. need to do it. The TGA has not yet issued a full statement on how these measures will be implemented.

Also, the TGA says nothing about the training required for a psychiatrist to become a licensed prescriber. Evidence for these treatments relies on patients receiving treatment from qualified health professionals in addition to medications, so it is not clear how these treatments are delivered.University of Sydney Rhys Cohen, a member of the non-executive advisory board of the Lambert Initiative for Cannabinoid Therapeutics and an adviser to the medical marijuana industry, said this is the reason, and that the TGA encourages psychiatrists to ensure that their prescribing practices are appropriate. I had the burden of proof to prove it.

Also, not all psychologists or psychiatrists can safely perform these types of treatments. Ruffell says it takes at least five to 10 years of training before people willingly use these types of chemicals in indigenous psychedelic practices around the world. “I think it is a big mistake to think that psychiatric and psychological credentials can be used to prescribe psychedelics without further training.”

Cost can also be another factor that makes access difficult. Since health insurance companies don’t pay for treatment, Perkins believes only the very wealthy who have certain illnesses will get treatment at first.

Some people worry that Australia puts carts over horses when it comes to the safety and long-term effects of these treatments. “We haven’t even looked at long-term data,” says Ruffell. Most of the time we don’t know what will happen in the future.

But Perkins said the benefits “could be huge,” “especially for the treatment-resistant illnesses they’re talking about, like PTSD and depression.”

Most people are surprised that Australia was the first country to be attacked. Psilocybin is an investigational drug that is not yet approved in the United States, but Oregon became the first state to make psilocybin available to adults “under the supervision of a state-approved facilitator” in her early 2023. In 2024, the U.S. Food and Drug Administration could announce that MDMA could be used to treat her PTSD. A small group of doctors in Switzerland can use LSD and MDMA as part of psychotherapy. Whether other countries do the same in the future will likely depend on Australia’s plans. Ruffell says the rest of the world is probably looking at Australia now.

Ruffell’s optimistic side rejoices that psychedelic drugs are getting better. A pessimist asks, “Will this end badly?” But we’ll figure that out later.