Australia will be the first country to prescribe MDMA and psilocybin for disorders like post-traumatic stress and depression
The Story of a Man Who Dropped a Dog in the Water: The Psychedelic First Responder (Jackiw Greenberg)
The understanding, preparation, and support structures that help make a brain exploding experience positive were mastered by Indigenous communities for thousands of years. Although Western culture has gotten its hands on these substances, it did not show any interest in that wisdom until recently.
By chance, Greenberg found himself in one of those rare moments when the cultural plates begin to shift. In response to the growth of psychedelics, a new figure has emerged on the psychic landscape. Call them psychedelic first responders, versed in the science of existential first aid and operating, at times, apart from the traditional sphere of psychiatrists and therapists. Where once you might take a free CPR class on a Saturday, you now can learn to escort the addled through the thickets of their own heads.
Greenberg was moving. Passing thoughts became black holes clawing him to untold depths, playing and replaying in a mad, warping whirlpool. Tricks that would have typically changed the channel—classical music, a splash of water to the face, waiting it out, crying it out—had no effect. He had no one to help him. This wasn’t a guided journey, after all, just a man alone in his house, losing his mind. Who do you call in such a state? Who could possibly understand this otherworldly misery with its indescribable new dimensions, its billowing revelations, its slithering dream logic?
And now it wouldn’t stop slamming. How could a fellow human slam a door on him because of what he’d done? A dam burst. Greenberg’s life began to explode in dark technicolor. What had happened? Who was that person? He felt mushrooms on his head in front of a big screen showing his life story. His heart rate went from the 90’s to the 150’s.
Greenberg thought about his puppy. He and his wife had a shared recollection of when they were married, but he couldn’t forget about the day he dropped the dog off with the father-in-law. The two had always enjoyed a great relationship, but after the handover, the older man slammed the door in his face.
The FDA’s first draft guidance on designing psychedelic clinical trials: ‘Here’s the clinical protocol’ — John Skerritt at the TGA
Last week, in contrast to Australia’s regulatory shift, the FDA published its first draft guidance for designing psychedelic clinical trials. The guidance suggests that clinical trials are yet to answer several questions regarding efficacy; the safety of long-term repeat dosing; and optimal psychotherapy protocols.
Everything was fine. The walls were starting to bend and the grain in the floorboards was running. Greenberg had blown his body apart into particles. When he closed his eyes, chrysanthemums blossomed.
The Authorised Prescriber scheme allows registered psychiatrists to prescribe drugs that have yet to be formally included on Australia’s register of therapeutic goods. To apply for the scheme, a Psychiatrist will need to get approval from the human research ethics committee (HREC) in Australia. Once approved by an HREC and the TGA, a clinician needs to provide the TGA with six-monthly reports on patient numbers and serious adverse effects.
The Clinical Setting for the prescription was not under the jurisdiction of the TGA, as John Skerritt, who was head at the time, explained in an email that month. The US Food and Drug Administration and the European Medicines Agency are the main regulatory agencies for medicines and medical devices. It doesn’t play any part in the evolution of broader clinical protocols.
We wanted to avoid saying, ‘Here’s the clinical protocol.’ We’re not the regulators of clinical practice,” Skerritt told the webinar. It is likely that other groups will give guidance around it.
Australia’s first regulatory decision to regulate psychedelic-aided therapy (MDMA): “We are so disappointed by the opportunity to lose track of what we have done”
Some drugs that are often used recreationally are effective when used in conjunction with psychotherapy to treat some mental-health disorders. MDMA is widely known as the party drug ecstasy, and psilocybin is the active ingredient in hallucinogenic mushrooms. A phase II trial published late last year2, showed that a 25 gram dose of the drug was twice as effective as a one gram dose in treating treatment resistant depression, although some side effects were noted. The phase III trial of MDMA was described as a potential breakthrough treatment for post-traumatic stress disorder. The drugs have the ability to treat anxiety, anorexia and substance dependency.
Alan Davis, director of the Center for Psychedelic Drug Research and Education at Ohio State University in Columbus, agrees: “It was too soon to make these changes before the research could fully determine clinical efficacy and safety.”
Richard Harvey, who chairs the RANZCP’s Psychedelic-Assisted Therapy Steering Group has confidence in the protocols that the group has developed. He believes that Australian state and territory governments will regulate licences for premises that offer drug treatments or require a permit for each patient.
The RANZCP has strongly recommended data-collection protocols, but there are no mandated requirements and no centralized patient-data registry will exist. This missed opportunity to learn more about the drugs is why Liknaitzky says it is a missed opportunity. It’s a shame for accountability and a shame for us being able to learn from the ground.
On 1 July Australia will be the first country to regulate the drugs as prescriptions after they were granted on compassionate grounds or in clinical trials.
Australia’s drug regulator, the Therapeutic Goods Administration (TGA), which approved the move, says that the decision followed a nearly three-year process and included extensive consultation with experts.
