Canada will allow a handful of health care professionals to possess and consume psilocybin mushrooms in order to better treat the growing number of patients now permitted to use the psychedelic drug, the country’s top health official revealed in a recent interview.
The statements by Minister of Health Patty Hajdu appear to be the first public announcement of the health ministry’s response to pending applications by therapists to use psilocybin. Hajdu’s office over the summer granted requests by some patients in end-of-life care to use the drug for psychotherapy, but officials left unanswered whether they would approve similar requests by the therapists themselves.
Speaking at a virtual town hall meeting hosted by Hedy Fry, a member of the House of Commons, last week, Hajdu said that national health regulators had granted therapists’ request just a day earlier.
“I also am happy to say that yesterday Health Canada granted exemptions to a number of health care professionals who wanted to possess and consume mushrooms containing psilocybin,” the health minister said. She described the move as “controversial for some and not for others, but the doctors that prescribe this therapy wanted to understand what it would feel like and how to best use it to help their patients that are struggling.”
At my Virtual Townhall Health Min @PattyHajdu answers question from Spencer on the use of psilocybin mushrooms in palliative care.
Watch here ⬇️https://t.co/O9iFJgziH6
— Dr. Hedy Fry (@HedyFry) December 6, 2020
Hajdu’s office has the ability to grant exemptions that effectively give individuals immunity from the country’s laws against controlled substances. That power has made the health minister a focal point in a concerted push by advocates of psychedelic therapy to grant wider approval to legally use entheogenic substances for therapeutic and religious purposes.
In a landmark decision in August, Health Canada approved four cancer patients’ request to legally use the drug for end-of-life care. In the months since, regulators have granted more than a dozen other exemptions, including to at least one patient not in palliative care. In October, Health Canada approved the application of a non-terminal patient to use psilocybin to treat unresolved trauma.
In last week’s interview, Hajdu called that development “an exciting moment…for many people who are looking at this as a potential therapy.”
Behind many of the successful exemptions is Victoria, B.C.-based nonprofit TheraPsil, which advocates for legal access to psilocybin therapy. The group has supported more than a dozen psilocybin applications by patients in end-of-life care, it says, and helped secure approval for the non-palliative patient with trauma.
Earlier this year, TheraPsil also applied for exemptions for some of its therapists. The group told Marijuana Moment that those applications were the ones recently approved by Health Canada.
“We’re grateful to Health Minister Patty Hajdu,” Spencer Hawkswell, the group’s CEO, said. “Training will be absolutely necessary to meet patient demand and to begin exploring the many challenges of patient access, primarily a lack of doctors and therapists trained in psilocybin-assisted psychotherapy.”
TheraPsil noted in a press release sent after the initial publication of this article that 17 health care providers have been granted exemptions so far, and that the group is seeking to raise $250,000 to fund a training program for them.
Asked during an earlier July interview with Marijuana Moment about the group’s request to allow therapists use to psilocybin, Hawkswell said it was a common-sense step to make sure therapists are familiar with the drug’s effects and how it can best be put to use in treatment.
“Part of ensuring a very high-quality psychedelic treatment for patients is to ensure high-quality training for therapists,” he said. “It’s greatly beneficial if therapists have had psychedelic therapy themselves.”
Few people, he offered by analogy, “would advise going to a sex therapist who’s never had sex before.”
Dr. Sean O’Sullivan, an emergency room physician and psychotherapist who serves on TheraPsil’s board of directors, told Marijuana Moment that “the point is to allow therapists to understand the field they’re plowing in.”
“The fundamental reason to expose therapists to their own experiences with psychedelics is that, unless you have visited these realms, you are unlikely to understand their importance,” he said.
M.P. Fry, a doctor who spent more than two decades working in hospitals, acknowledged during the town hall with Hajdu that there still exist “all kinds of moral judgments” about the therapeutic use of psychedelics, but said that “in fact, most of these products have some medical benefit.”
“I think it’s interesting that some professionals are going to be able to try it,” Fry said, “because especially when you’re looking at psychotherapy…being able to understand how the patient is impacted by the drugs—what is going on in the psyche, what they’re feeling, what it does to the perception—is going to be very important if you’re going to treat patients with psilocybin and with psychotherapy at the same time.”
Hajdu indicated that while she’s willing to grant exemptions in certain cases, she would also like to see more formal research into psilocybin.
“I think we need more evidence in this area,” Hajdu said, “and I would encourage Spencer and TheraPsil to partner with our office, because what we’re trying to do is collect that research. It’s so important not just to understand the potential value of the treatment with psilocybin, but also to help pave the pathway for others that maybe don’t understand this.”
“The more research that we can get, and the more understanding that we get through clinical trials and research, the better it is,” she continued, “so we’re on standby to support any organization or academic or healthcare professional that’s interested in applying for clinical trial authorization. I think that would really help move forward this conversation and take it kind of out of the shadows and into more of a mainstream conversation.”
As the conversation has changed in recent years, officials and advocates have disagreed over how quickly and widely to allow access to psychedelics. Last month, in response to a petition signed by thousands of residents demanding the government decriminalize the personal possession of psychedelics, three separate government officials replied that no immediate changes to the nation’s drug laws were necessary.
A statement from Hajdu’s office, signed by M.P. Darren Fisher, said psychedelic drugs would need to pass the country’s drug review process and receive authorization from Health Canada before sweeping changes could be made.
Given that existing laws and regulations “already provide a mechanism to access such organisms for medical or scientific purposes, or for reasons that are otherwise in the public interest (such as religious uses),” the statement said, “no amendments to the current legislation or regulations are required.”
Image courtesy of Kristie Gianopulos.
Congressional Bill Filed To Protect Marijuana Consumers From Losing Public Housing
A congresswoman on Thursday reintroduced a bill that would allow people living in federally assisted housing to use marijuana in compliance with state law without fear of losing their homes.
As it stands, people living in public housing are prohibited from using controlled substances in those facilities regardless of state law, and landlords are able to evict such individuals. But the bill from Rep. Eleanor Holmes Norton (D-DC) would change that.
It would provide protections for people living in public housing or Section 8 housing from being displaced simply for using cannabis in states that have legalized it for medical or recreational purposes.
“Individuals living in federally assisted housing should not be denied admission, or fear eviction, for using a legal product,” Norton said on Thursday. “Adult use and/or medical marijuana is currently legal in 36 states and the District of Columbia, and over 90 percent of Americans support legalized medical marijuana.”
The legislation would also require the head of the Department of Housing and Urban Development (HUD) to enact regulations that restrict smoking marijuana at these properties in the same way that tobacco is handled.
“HUD, like DOJ, should not be allowed to enforce federal marijuana laws where states have taken action to legalize marijuana,” the congresswoman said, referring to a congressionally approved rider that prevents the Department of Justice from interfering with state medical cannabis laws.
Norton filed earlier versions of the Marijuana in Federally Assisted Housing Parity Act in 2018 and 2019, but they did not receive hearings or votes.
In 2018, a Trump administration official said that she was working to resolve conflicting federal and state marijuana laws as it applies to residency in federally-subsidized housing, but it’s not clear what came of that effort.
Rep. Alexandria Ocasio-Cortez (D-NY) also raised the issue during a committee hearing in 2019, pressing former HUD Secretary Ben Carson on policies that cause public housing residents and their families to be evicted for committing low-level offenses such as marijuana possession.
She pointed to two specific HUD policies: the “one strike” rule, which allows property managers to evict people living in federally assisted housing if they engage in illicit drug use or other crimes, and the “no fault” rule, which stipulates that public housing residents can be evicted due to illicit drug use by other members of their household or guests—even if the resident was unaware of the activity.
Ocasio-Cortez and then-Sen. Kamala Harris (D-CA) also filed legislation that year that would protect people with low-level drug convictions from being denied access to or being evicted from public housing.
Sen. Jeff Merkley (D-OR) also introduced an affordable housing bill last year that included a provision to prevent landlords from evicting people over manufacturing marijuana extracts if they have a license to do so.
Read the text of the marijuana housing legislation below:
Photo courtesy of Martin Alonso.
FDA Clears Researchers To Study MDMA Use By Therapists Being Trained In Psychedelic Medicine
The Food and Drug Administration (FDA) has already authorized clinical trials into the therapeutic potential of MDMA for patients with post-traumatic stress disorders—but now it’s given the green light to a psychedelics research institute to expand its studies by administering the substance to certain therapists.
Volunteer therapists who are being trained to treat people with PTSD will be able to participate in the Phase 1 trials to gain personal experience with the treatment option. This is a complementary research project that comes as the Multidisciplinary Association for Psychedelic Studies (MAPS) is in the process of conducting Phase 3 trials involving people with the disorder.
The development comes months after Canadian regulators announced that certain therapists would be allowed to take psilocybin in order to gain a better understanding of the psychedelic when treating patients.
MAPS sought permission to proceed with the therapist-specific trials in 2019, but FDA placed them on a 20-month hold because of concerns about the merits, risks and credentials of investigators. MAPS appealed that hold, providing evidence about the study’s scientific value and ability of its staff, and FDA cleared them on Tuesday.
— MAPS (@MAPS) May 13, 2021
The organization “chose to dispute” FDA’s hold not just because of the impact it had on the planned studies, “but in an attempt to resolve an ongoing issue with the FDA regarding investigator qualifications across studies,” it said in a press release on Wednesday.
“While the term ‘dispute’ may seem adversarial, this process can actually strengthen the relationship and trust between us and our review Division and ensures the Division has support on this project from the [FDA] Office of Neuroscience,” MAPS Public Benefit Corporation (PBC) CEO Amy Emerson said. “This decision demonstrates how our strategic, data-driven strategy in challenging the FDA rulings can be successful.”
Now MAPS is able to launch the Phase 1 clinical trials into MDMA-assisted therapy for therapists.
It will be designed to “measure development of self-compassion, professional quality of life, and professional burnout among clinicians delivering the treatment to patients,” the association said.
Getting personal experience with the substance “is widely considered to be an important element in preparation and training to deliver psychedelic-assisted therapies.”
This will “support the goals of the MDMA Therapy Training Program to provide comprehensive training to future providers,” and it “builds capacity to deliver quality, accessible care to patients, pending approval of MDMA-assisted therapy as a legal prescription treatment,” MAPS PBC Director and Head of Training and Supervision Shannon Carlin said.
FDA first granted MAPS’s request for an emergency use authorization for MDMA in PTSD in 2017. The organization expects to complete its Phase 3 trails in 2022.
The scientific expansion move also comes as the psychedelics decriminalization movement continues to build in the U.S.
Missouri Regulators Derail Medical Marijuana Business Ownership Disclosure Effort With Veto Threat
Missouri regulators say they feel requiring medical marijuana business license ownership disclosures under a House-approved amendment could be unconstitutional, and they may urge the governor to veto the legislation.
By Jason Hancock, Missouri Independent
An effort by lawmakers to require disclosure of ownership information for businesses granted medical marijuana licenses was derailed on Thursday, when state regulators suggested a possible gubernatorial veto.
On Tuesday, the Missouri House voted to require the Department of Health and Senior Services provide legislative oversight committees with records regarding who owns the businesses licensed to grow, transport and sell medical marijuana.
The provision was added as an amendment to another bill pertaining to nonprofit organizations.
Its sponsor, Rep. Peter Merideth, D-St. Louis, said DHSS’s decision to deem ownership records confidential has caused problems in providing oversight of the program. He pointed to recent analysis by The Independent and The Missourian of the 192 dispensary licenses issued by the state that found several instances where a single entity was connected to more than five dispensary licenses.
The state constitution prohibits the state from issuing more than five dispensary licenses to any entity under substantially common control, ownership or management.
On Thursday, a conference committee met to work out differences in the underlying bill between the House and Senate.
Sen. Eric Burlison, a Republican from Battlefield and the bill’s sponsor, called the medical marijuana amendment an “awesome idea. I think it’s awesome.”
However, he said opposition from the department puts the entire bill in jeopardy.
“The department came to me,” he said, “and said they felt that this was unconstitutional.”
DHSS has justified withholding information from public disclosure by pointing to a portion of the medical marijuana constitutional amendment adopted by voters in 2018 that says the department shall “maintain the confidentiality of reports or other information obtained from an applicant or licensee containing any individualized data, information, or records related to the licensee or its operation… .”
Alex Tuttle, a lobbyist for DHSS, said if the bill were to pass with the medical marijuana amendment still attached, the department may recommend Gov. Mike Parson veto it.
The threat of a veto proved persuasive, as several members of the conference committee expressed apprehension about the idea of the amendment sinking the entire bill.
Merideth said the department’s conclusion is incorrect. And besides, he said, the amendment is narrowly tailored so that the information wouldn’t be made public. It would only be turned over to legislative oversight committees.
Rep. Jered Taylor, R-Republic, chairman of the special committee on government oversight, said the amendment is essential to ensure state regulators “are following the constitution, that they’re doing what they’re supposed to be doing.”
The medical marijuana program has faced intense scrutiny in the two years since it was created by voters.
A House committee spent months looking into widespread reports of irregularities in how license applications were scored and allegations of conflicts of interest within DHSS and a private company hired to score applications.
In November 2019, DHSS received a grand jury subpoena, which was issued by the United States District Court for the Western District. It demanded the agency turn over all records pertaining to four medical marijuana license applications.
The copy of the subpoena that was made public redacted the identity of the four applicants at the request of the FBI. Lyndall Fraker, director of medical marijuana regulation, later said during a deposition that the subpoena wasn’t directed at the department but rather was connected to an FBI investigation center in Independence.
More recently, Parson faced criticism for a fundraiser with medical marijuana business owners for his political action committee, Uniting Missouri.
The group reported raising $45,000 in large donations from the fundraiser. More than half of that money came from a PAC connected to Steve Tilley, a lobbyist with numerous medical marijuana clients who has been under FBI scrutiny for more than a year.