PsychedeLinks – July 7, 2023

As of last Saturday, July 1, Australian physicians will now be allowed to prescribe MDMA for the treatment of PTSD, and psilocybin for cases of treatment-resistant depression. Enactment of the new legislation makes Australia the first country in the world to legalize the clinical prescription of MDMA and psilocybin to patients. Since Australia’s Therapeutic Goods Administration (TGA) publicized the pending shift in February of this year, the announcement has sparked an ongoing debate within the medical community. Many providers express concern that the move may be rushed, citing the fact that both drugs in question are still undergoing clinical trial and lack formal approval for treatment from organizations such as the US Food and Drug Administration. Additionally, some providers have voiced concerns about ambiguities in the regulation of how patients will be screened for treatment and how treatment will be monitored, as well as management of patient expectations around efficacy of the treatments. At the same time, many providers also acknowledge that patients who have not responded to traditional treatments are in dire need of something new, and that with the proper support, psychedelics may potentially offer a great deal of benefit in such cases. “This shift marks a pivotal moment in early legislation,” says Emerge attorney Kaci Hohmann. “With so many clinical trials underway in the US, we have a real opportunity to learn from Australia as they navigate what has previously been uncharted territory in Western medicine and to gain a clearer understanding of how to successfully incorporate these drugs into mainstream therapies.”

“On June 23rd of this year, the U.S. Food and Drug Administration published a new draft guidance intended to advise researchers on study design when investigating the potential of psychedelics for treating medical conditions, including psychiatric or substance use disorders. The outlined principles are meant to support the ethical conduct and integrity of psychedelic clinical studies and ensure the reliability of the study results. Although psychedelic drug developers and researchers must abide by the same evidentiary standards and regulations in order to obtain FDA approval, the Agency noted that psychedelics have some ‘unusual characteristics’ that necessitate special considerations when discussing their clinical trials design. ‘Psychedelic drugs show initial promise as potential treatments for mood, anxiety and substance use disorders. However, these are still investigational products…’ said Tiffany Farchione, M.D., director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research. ‘The goal is to help researchers design studies that will yield interpretable results that will be capable of supporting future drug applications.’ The guidance highlights some basic considerations throughout the drug-development process, such as data collection, patient safety, and new-drug-development requirements. People wishing to comment on the provided FDA guidance draft can do so for the next 60 days.”

“Jared Polis, the Democrat who was elected to his second term as the state’s governor last year, said Wednesday that he wants Colorado lawmakers to empower him with the ability to issue pardons to individuals who have been busted for crimes related to psychedelics such as psilocybin mushrooms. ‘So anybody who has something on their criminal record that is now legal can have that expunged and doesn’t hold them back from future employment opportunities,’ Polis said at the Psychedelic Science conference, which is being held in Denver this week. ‘It is still ridiculous that in this day and age somebody suffering from anxiety, depression, PTSD can get medical coverage for very costly prescription drugs but cannot get coverage for a treatment in a healing center that will address some of the underlying causes of the issue,’ the governor added. The governor said at the conference that he envisions a significant expansion of the state’s psychedelic laws, including changes that would enable psychedelic therapy to be covered by insurance in Colorado. ‘Once it’s federally scheduled to be a pharmaceutical, it will immediately be rescheduled in Colorado,” the governor added. “We want people to say…Colorado got this right. Look, I’m sure we’ll get a few things wrong, but we can learn from them and build upon them.’”

"A magic mushroom store has opened up on Ouellette Avenue in Windsor, Ont., by a company that says it's setting up psilocybin shops as part of a fight for legalization. ‘We're just providing access to psilocybin in a safe manner, in a clean manner. At the end of the day, if people want to buy magic mushrooms, they will go and find it off the street,’ said the co-owner of Fun Guyz, Edgars Gorbans. Though the production, sale and possession of magic mushrooms are illegal in Canada and police have arrested store operators, similar shops are popping up elsewhere in Ontario and across the country. FunGuyz opened its 11th location on Thursday at 395 Ouellette Avenue, and it's been going ‘great,’ according to Gorbans. Gorbans said most of the people coming into the store are those looking to microdose — taking small amounts of a drug at a time — and treat things like anxiety, post-traumatic stress disorder and depression, though no psilocybin products are currently approved for medical use. Gorbans said customer testimonies have been positive. Health Canada says despite trials having shown ‘promising’ results, there are no approved therapeutic products that include psilocybin. For those who don't approve of the storefront, Gorbans asks they take some time to research. ‘We're not out here selling to kids, you know, we're not bothering anyone, we open up doors open to the public. That's all,’ he said."

“Colorado voters legalized psychedelic mushrooms last November. Rules are being written for licensing their therapeutic use. Meanwhile, therapists are offering treatments in a legal grey area.” Recorded interview. Rob Schmitz reporting.