Australia legalizes medical use of psychedelics

 Scott Cunningham points out that Australia has become the first country to legalize the medical use of certain psychedelics. 

Here's the announcement from the Australian Government's Therapeutic Goods Administration (TGA)

Change to classification of psilocybin and MDMA to enable prescribing by authorised psychiatrists

"From 1 July this year, medicines containing the psychedelic substances psilocybin and MDMA (3,4-methylenedioxy-methamphetamine) can be prescribed by specifically authorised psychiatrists for the treatment of certain mental health conditions.

The Therapeutic Goods Administration (TGA) will permit the prescribing of MDMA for the treatment of post-traumatic stress disorder and psilocybin for treatment-resistant depression. These are the only conditions where there is currently sufficient evidence for potential benefits in certain patients.

Prescribing will be limited to psychiatrists, given their specialised qualifications and expertise to diagnose and treat patients with serious mental health conditions, with therapies that are not yet well established. To prescribe, psychiatrists will need to be approved under the Authorised Prescriber Scheme by the TGA following approval by a human research ethics committee. The Authorised Prescriber Scheme allows prescribing permissions to be granted under strict controls that ensure the safety of patients.

The decision acknowledges the current lack of options for patients with specific treatment-resistant mental illnesses. It means that psilocybin and MDMA can be used therapeutically in a controlled medical setting. However, patients may be vulnerable during psychedelic-assisted psychotherapy, requiring controls to protect these patients.

For these specific uses, psilocybin and MDMA will be listed as Schedule 8 (Controlled Drugs) medicines in the Poisons Standard. For all other uses, they will remain in Schedule 9 (Prohibited Substances) which largely restricts their supply to clinical trials."

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Scott shares a post by Shane Pennington on drugs that contrasts the Australian (medical) decision with the U.S. Drug Enforcement Agency's (legal) decision to maintain the ban on these drugs, despite the growing medical evidence (from U.S. studies, on which the Australian government relied) that psychedelics have some important medical uses.

"To support its decision, the TGA relied heavily on studies conducted in the U.S. and recent U.S. Food and Drug Administration (FDA) decisions recognizing psilocybin and MDMA’s extraordinary therapeutic potential. Around the same time, DEA shot down a petition—based on those same arguments and evidence—that Matt and I submitted on behalf of a palliative-care doctor, requesting rescheduling of psilocybin under U.S. law. The DEA’s four-sentence analysis completely ignored the same studies and FDA decisions that persuaded the Australian regulator to reschedule.  

"The dramatically different fates of these similar petitions reveal a troubling reality about U.S. drug law: Under DEA’s watch, the scientific and medical determinations of the nation’s leading public health agency carry considerable weight around the world but are often ignored at home. That revelation should terrify anyone interested in rational, evidence-driven drug policy. "

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But the States are the laboratory of democracy: here's an earlier related post.

Sunday, November 13, 2022

Colorado legalizes magic mushroom/psilocybin therapies