What had Greenberg done when he was stuck in his own head? I know what happened, but what had he learned in his life?
Of course, Indigenous communities spent thousands of years mastering that very stuff: the understanding, the preparation, the support structures that help make a brain-exploding experience positive. But Western culture, having gotten its hands on these substances, showed little interest in that wisdom—at least 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. They’re called so because they’re versed in the science of first aid and operating, but not in the traditional sphere of psychiatrists and therapists. You can learn to escort the addled through the thickets of their own heads now that you have taken a free safety class on a Saturday.
Greenberg was looping. Black holes were clawing him to untold depths and he was replaying in a whirlpool. Classical music, a splash of water to the face, and crying it out did not affect the channel. Worst of all, he had no help. The man was alone in his house, lost his mind, and it was not a guided journey. Who are you going to call in such a state? Who could possibly understand this otherworldly misery with its indescribable new dimensions, its billowing revelations, its slithering dream logic?
It wouldn’t stop hitting. How had he done something so awful that a fellow human would slam a door on him after being handed a puppy? A dam burst. The difficult elements of Greenberg’s life—family, career, parenting—began exploding in dark technicolor. What had happened? Who was he? The man felt the mushrooms on his head as he saw the movie of his life. His heart rate went from 90 to 150 in a single day.
Greenberg thought about his puppy. In the aftermath of his divorce, he forgot about the day he dropped off the dog with his father-in-law. The two had enjoyed a friendly relationship but after the handoff, the old man slammed the door in his face.
Jeff Greenberg’s disillusionment: The first FDA guidance for designing a clinical trial of psychedelic effects and optimal psychotherapy protocols
Last week, in contrast to Australia’s regulatory shift, the FDA published its first draft guidance for designing psychedelic clinical trials. Clinical trials have yet to answer several questions about efficacy, the safety of long-term repeat and optimal psychotherapy protocols, according to the guidance.
Everything was fine. The walls were starting to bend and the grain in the floorboards started to run. Jeff Greenberg’s body had blown apart into particles, pleasantly so. He closed his eyes and the plants sprang up.
Why the TGA doesn’t regulate Psilocybin and MDMA for psychiatrists, and how it affects pharmacology in Australia
The Royal Australian and New Zealand College of Psychiatrists (RANZCP) has produced protocols and standards for both psilocybin and MDMA therapy to guide HRECs and psychiatrists. Rossell and Kisely think that these protocols carry no regulatory weight. “There is no standardization in terms of HRECs,” Kisely says. He also wonders how clinical practice will be supervised. How do an HREC monitor if they stick to what they say they are going to do? They just don’t have the resources to do it. So there’s no regulatory oversight.”
John Skerritt, who until April was head of the TGA, said in an webinar that month about the decision that the clinical setting for the prescription was outside the TGA’s purview. Like the US Food and Drug Administration (FDA) or the European Medicines Agency, the TGA is mainly responsible for regulating medicines and medical devices. It plays no part in stipulating broader clinical protocols.
“We were quite deliberate in not saying, ‘Here’s the clinical protocol.’ Skerritt said that we are not the regulators of clinical practice. guidance around it will likely be released by other groups, whether they are clinical professional groups or not.
In a controversial move, Australia will become the world’s first country to allow the drugs psilocybin and MDMA to be prescribed by doctors to treat psychiatric conditions including depression and post-traumatic stress disorder. But many scientists are concerned that research has not yet conclusively shown that these drugs are safe or effective. And some clinicians fear that the regulation that will govern access to the drugs is insufficient.
The prospect of tailoring therapies to the needs of individuals, something that he has not been able to do in formal clinical trials, is something Liknaitzky is excited about. I want to do a better job than I currently do. So the opportunity to get [the drugs] into the real world sooner rather than later is great.”
The change is too fast for Paul Liknaitzky, head of clinical psychedelic research at Monash University. Liknaitzky is joining forces with the Australian heath-care company Incannex, and working furiously to open one of the country’s first psychedelic clinics in Melbourne this year. The suddenness of the TGA decision left him scrambling to set up his clinic before clients begin requesting the therapy.
There are no mandated requirements and there is no centralized patient- data registry, but there are strong recommended data collection protocols. Liknaitzky says this is a missed opportunity for researchers to learn more about these drugs. It is a shame for us to be able to learn from other people on the ground.
Australia will be the first to regulate the drugs as medications after 1 July due to the fact that they are allowed for individual use on compassionate grounds or in clinical trials.
The Therapeutic Goods Administration in Australia approved the move during a nearly three-year process that involved extensive consultation with experts.