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Australia Becomes First Country to Authorize Psilocybin, MDMA Therapy
Doctors can now prescribe psilocybin and MDMA in Australia, a giant leap forward for psychedelic reform.
The Land Down Under made a historic move over the weekend, though some experts are cautious as to how exactly the major change will fully pan out.
Australia became the first country in the world to authorize psilocybin and MDMA use through a doctor’s prescription to treat psychiatric conditions like post-traumatic stress disorder (PTSD) and depression. Beginning Saturday, July 1, both drugs were authorized for therapeutic use after regulators approved the up-and-coming treatment option earlier this year.
Australia Makes Psychedelic History
Australia’s drug regulator, the Therapeutic Goods Administration (TGA), approved the move back in February and indicated that the change wasn’t made lightly. Rather, it came after a nearly three-year decision-making process, including extensive consultation with a number of experts on the topic. MDMA, also known as ecstasy or molly, was approved as a treatment for PTSD, while psilocybin, the psychoactive substance in psychedelic mushrooms, was approved for treatment-resistant depression.
Both drugs will be down-scheduled from Australia’s strictest category, schedule 9 donating “prohibited substances,” to schedule 8, or controlled drugs, but solely for medical use in psychedelic-assisted psychotherapy.
While cities and states in the United States have gradually eased restrictions on psychedelics to similarly usher in a new era of therapeutic care, Australia is the first country in the world to down-schedule psilocybin and MDMA for clinical treatments. The country will now allow these substances to be adopted as part of therapy sessions under the guidance of a qualified and authorized practitioner.
Mounting Evidence on the Potential of Psychedelic Treatments
While psychedelic drugs like psilocybin and MDMA have been long criminalized, research has opened the doors to a potentially game-changing alternative for mental health treatment, especially for conditions that cannot be treated with traditional methods.
Among myriad other studies on the topic, one 2022 study involving the largest randomized, controlled, double-blind study of psilocybin to date showed “significant” improvements to treatment-resistant depression among participants. The study involved two doses, 1 mg and 25 mg of psilocybin, and found that those who received a 25 mg dose with psychological support experienced a “highly statistically significant reduction in symptoms of depression after three weeks.”
Similarly, researchers have heavily examined MDMA as a potential treatment for PTSD as the ongoing psychedelic renaissance unfolds. The results of one clinical trial from earlier this year “support the development of MDMA-assisted therapy as a potentially new breakthrough therapy to treat individuals with PTSD—a patient population that is often left to suffer for years,” according to Amy Emerson, chief executive officer of MAPS Public Benefit Corporation which conducted the study.
These studies are just two of many in the growing psychedelic medicine field, though more research is still needed to fully unravel the potential of drugs like MDMA and psilocybin. And some Australian experts have expressed concern about the recent move.
Concerns and Hopes for the Future of Mental Health
For one, these are psychedelic drugs, so using them carries the risk of having a bad trip. Susan Rossell is a psychiatrist at Swinburne University of Technology in Melbourne and is working on Australia’s only active clinical trial to test psilocybin-assisted psychotherapy for treatment-resistant depression. Rossell indicated that one of the gaps research has yet to close is determining what type of patient is best suited to the treatment.
“It’s not for everybody. We need to work out who these people are that are going to have bad experiences, and not recommend it,” Rossell told Nature, adding that she fears, should the drug be improperly administered, treatment could result in bad trips and leave patients with more psychological issues than they came in with.
In a broader sense, it’s clear that the shift around psychedelic medicine is moving much more quickly than cannabis did prior, as a similarly criminalized drug that is now undergoing major reform. Beyond Australia, some leaders and experts have similarly questioned whether things are moving too quickly.
Others have indicated Australia’s move sets a major milestone for psychedelic-assisted therapies. Payton Nyquest, co-founder and CEO of psychedelic-focused mental healthcare company Numinus, praised regulators for making the bold move.
“The TGA’s approval surrounding MDMA and psilocybin for specific and controlled usage is a welcome step forward for Australia as well as the entire mental health field,” Nyquvest wrote in an email to Forbes. “This decision impacts the millions of people who are enduring treatment-resistant mental health conditions and opens a pathway to profoundly change their lives. I look forward to watching progress being made on a global scale as a result of our industry’s collective mission to help the world heal.”
Source: https://hightimes.com/news/australia-becomes-first-country-to-authorize-psilocybin-mdma-therapy/
New Mexico regulators fined a cannabis operator nearly $300,000 and revoked its license after the company allegedly created fake reports in the state’s traceability software.
The New Mexico Cannabis Control Division (CCD) accused marijuana manufacturer and retailer Golden Roots of 11 violations, according to Albuquerque Business First.
Golden Roots operates the The Cannabis Revolution Dispensary.
The majority of the violations are related to the Albuquerque company’s improper use of BioTrack, which has been New Mexico’s track-and-trace vendor since 2015.
The CCD alleges Golden Roots reported marijuana production only two months after it had received its vertically integrated license, according to Albuquerque Business First.
Because cannabis takes longer than two months to be cultivated, the CCD was suspicious of the report.
After inspecting the company’s premises, the CCD alleged Golden Roots reported cultivation, transportation and sales in BioTrack but wasn’t able to provide officers who inspected the site evidence that the operator was cultivating cannabis.
In April, the CCD revoked Golden Roots’ license and issued a $10,000 fine, according to the news outlet.
The company requested a hearing, which the regulator scheduled for Sept. 1.
At the hearing, the CCD testified that the company’s dried-cannabis weights in BioTrack were suspicious because they didn’t seem to accurately reflect how much weight marijuana loses as it dries.
Company employees also poorly accounted for why they were making adjustments in the system of up to 24 pounds of cannabis, making comments such as “bad” or “mistake” in the software, Albuquerque Business First reported.
Golden Roots was fined $298,972.05 – the amount regulators allege the company made selling products that weren’t properly accounted for in BioTrack.
The CCD has been cracking down on cannabis operators accused of selling products procured from out-of-state or not grown legally:
- Regulators alleged in August that Albuquerque dispensary Sawmill Sweet Leaf sold out-of-state products and didn’t have a license for extraction.
- Paradise Exotics Distro lost its license in July after regulators alleged the company sold products made in California.
Golden Roots was the first alleged rulebreaker in New Mexico to be asked to pay a large fine.
Source: https://mjbizdaily.com/new-mexico-cannabis-operator-fined-loses-license-for-alleged-biotrack-fraud/
Four marijuana companies, including a multistate operator, have filed a lawsuit against U.S. Attorney General Merrick Garland in which they allege the federal MJ prohibition under the Controlled Substances Act is no longer constitutional.
According to the complaint, filed Thursday in U.S. District Court in Massachusetts, retailer Canna Provisions, Treevit delivery service CEO Gyasi Sellers, cultivator Wiseacre Farm and MSO Verano Holdings Corp. are all harmed by “the federal government’s unconstitutional ban on cultivating, manufacturing, distributing, or possessing intrastate marijuana.”
Verano is headquartered in Chicago but has operations in Massachusetts; the other three operators are based in Massachusetts.
The lawsuit seeks a ruling that the “Controlled Substances Act is unconstitutional as applied to the intrastate cultivation, manufacture, possession, and distribution of marijuana pursuant to state law.”
The companies want the case to go before the U.S. Supreme Court.
They hired prominent law firm Boies Schiller Flexner to represent them.
The New York-based firm’s principal is David Boies, whose former clients include Microsoft, former presidential candidate Al Gore and Elizabeth Holmes’ disgraced startup Theranos.
Similar challenges to the federal Controlled Substances Act (CSA) have failed.
One such challenge led to a landmark Supreme Court decision in 2005.
In Gonzalez vs. Raich, the highest court in the United States ruled in a 6-3 decision that the commerce clause of the U.S. Constitution gave Congress the power to outlaw marijuana federally, even though state laws allow the cultivation and sale of cannabis.
In the 18 years since that ruling, 23 states and the District of Columbia have legalized adult-use marijuana and the federal government has allowed a multibillion-dollar cannabis industry to thrive.
Since both Congress and the U.S. Department of Justice, currently headed by Garland, have declined to intervene in state-licensed marijuana markets, the key facts that led to the Supreme Court’s 2005 ruling “no longer apply,” Boies said in a statement Thursday.
“The Supreme Court has since made clear that the federal government lacks the authority to regulate purely intrastate commerce,” Boies said.
“Moreover, the facts on which those precedents are based are no longer true.”
Verano President Darren Weiss said in a statement the company is “prepared to bring this case all the way to the Supreme Court in order to align federal law with how Congress has acted for years.”
While the Biden administration’s push to reschedule marijuana would help solve marijuana operators’ federal tax woes, neither rescheduling nor modest Congressional reforms such as the SAFER Banking Act “solve the fundamental issue,” Weiss added.
“The application of the CSA to lawful state-run cannabis business is an unconstitutional overreach on state sovereignty that has led to decades of harm, failed businesses, lost jobs, and unsafe working conditions.”
Alabama regulators are targeting Dec. 1 to award the first batch of medical cannabis business licenses after the agency’s first two attempts were scrapped because of scoring errors and litigation.
The first licenses will be awarded to individual cultivators, delivery providers, processors, dispensaries and state testing labs, according to the Alabama Medical Cannabis Commission (AMCC).
Then, on Dec. 12, the AMCC will award licenses for vertically integrated operations, a designation set primarily for multistate operators.
Licenses are expected to be handed out 28 days after they have been awarded, so MMJ production could begin in early January, according to the Alabama Daily News.
That means MMJ products could be available for patients around early March, an AMCC spokesperson told the media outlet.
Regulators initially awarded 21 business licenses in June, only to void them after applicants alleged inconsistencies with how the applications were scored.
Then, in August, the state awarded 24 different licenses – 19 went to June recipients – only to reverse themselves again and scratch those licenses after spurned applicants filed lawsuits.
A state judge dismissed a lawsuit filed by Chicago-based MSO Verano Holdings Corp., but another lawsuit is pending.
Source: https://mjbizdaily.com/alabama-plans-to-award-medical-cannabis-licenses-dec-1/
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