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European Lobby Says Experienced Trippers Should Advise On Psychedelic Use
Sometimes, first-hand experience matters.
Much like the United States, Europe is currently figuring out how to incorporate psychedelic therapy into its healthcare landscape most effectively. A lobby group representing developers and professionals within the industry advocates for including seasoned practitioners as integral members of a “multidisciplinary advisory body.” They would serve as a guiding authority, offering essential insights to regulators and healthcare practitioners regarding optimal practices as the field expands and changes. This effort comes from the European Psychedelic Access Research and European Alliance (PAREA), as reported by Politico, as per a briefing document slated for submission to the European Medicines Agency (EMA).
It basically says that those with actual experience with psychedelics should have influence. In both legal cannabis and psychedelics space, there is often a feeling that those with an actual relationship with the substance, rather than simply a desire to profit from it, makes for better business.
Europe still needs to legalize any psychedelic treatments. However, as Australia and parts of the United States are already offering psychedelic therapy, many lawmakers in Europe want to be prepared to hit the ground running. Having such an advisory board (with people who have experience with these substances) will make psychedelic treatment easier to implement.
In July, Australia became the first country in the world to authorize psilocybin and MDMA use through a doctor’s prescription to treat mental health conditions like post-traumatic stress disorder (PTSD) and depression. Both were legalized for therapeutic use.
In 2019, Denver, Colorado, became the first U.S. city to decriminalize psilocybin. Cities such as Oakland, Santa Cruz, and Washington D.C. have followed suit. In 2020, Oregon both decriminalized it and legalized supervised therapeutic use, with Colorado passing a similar law in 2022.
Psilocybin remains illegal under federal law.
Ketamine, which is technically a (legal) dissociative anesthetic with hallucinogenic properties, is FDA-approved for treatment-resistant depression in the U.S. under as “esketamine,” the S enantiomer of ketamine, as that’s how Johnson & Johnson could patent and sell it under the brand name Spravato. Often, doctors prescribe an off-label actual ketamine nasal spray that one can have made in a compound pharmacy.
A study by the American Medical Association, published late last month, found growing evidence that psilocybin, the mind-altering ingredient in magic mushrooms, is a potentially effective treatment for those suffering from depression. Psilocybin is also being tested to treat people with anorexia.
MDMA is currently being studied with successful results for its capacity to treat PTSD, among other mental health conditions.
Such substances would be under review of the proposed multidisciplinary advisory body. Before an upcoming EMA workshop on psychedelic treatments, PAREA urged the regulator to provide centralized leadership for the practical and clinical aspects of these therapies, including their delivery methods.
Unlike conventional pills, such as SSRI antidepressants, psychedelics require a comprehensive regimen of pre- and post-care, as well as support during the experience itself. PAREA wants to ensure that this care is uniformly standardized, drawing upon consensus from a diverse group of stakeholders.
In psychedelic spaces, this pre- and post-care is known as integration, or the belief that one needs more than the drug itself. Integration typically involves therapy before the trip and afterwards, helping one take what they learned and “integrate” it into everyday life. One may also need more than one session or return for boosters, as with ketamine IV therapy and other psychedelic therapies. Even within recreational psychedelic spaces, many people use a “trip sitter,” or at least one trusted person to abstain and look after them.
An EU advisory body “would benefit from the collective knowledge of various stakeholders, including the EMA, [the European Monitoring Centre for Drugs and Drug Addiction], national competent authorities, professional organizations, health care professionals and managers, psychedelic organizations, patients’ organizations, drug developers, and the wider community,” the briefing states.
PAREA told POLITICO these professional organizations could include the Open Foundation and the Beckley Academy in the Netherlands and the Mind Foundation in Germany. These groups train therapists in psychedelics using the latest research from institutions like Imperial College London and Johns Hopkins University. Some programs include experiential learning (getting high) on substances like psilocybin or ketamine. The Beckley group teaches people to “navigate non-ordinary states to better serve your clients,” and also runs psilocybin retreats.
“The importance of ensuring that the therapeutic model adopted is evidence-based and in the best interest of the patients cannot be overstated,” the lobby group’s briefing states.
PAREA also advocates for the EMA to ensure consistent delivery strategies throughout Europe. “Centralized coordination would offer an efficient mechanism to propel the field forward, rather than individual EU countries initiating their own work groups,” it states.
Meanwhile, setting the stage for future generations, psychedelic knowledge and industry are now being taken seriously in academia. Last month, the University of California, Berkeley’s Center for the Science of Psychedelics launched a free online course titled “Psychedelics and the Mind.” The new class is another expansion (and win) for the Center, launched three years ago. The course will be available for free.
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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