A federal health agency kicked off a speaker series on Thursday that’s dedicated to recapping science on the therapeutic potential of psilocybin mushrooms. And the experts who spoke at the first event said in response to Marijuana Moment’s questions that federal drug laws are out of step with voters and undermine the research objectives of the scientific community.
The National Cancer Institute (NCI), under the National Institutes of Health (NIH), which is hosting the events, says that while federal law classifies the psychedelic as a Schedule I substance with no currently accepted medical value, clinical trials “are researching psilocybin to treat cancer related depression, for example, and moreover for its potential medicinal application in treating a range of severe psychiatric disorders.”
To that end, the agency is organizing a first-of-its-kind Psilocybin Research Speaker Series that’s taking place over the next several weeks.
— NCI Cancer Training (@NCI_Training) April 22, 2021
Thursday’s initial event featured professors from UCLA and Johns Hopkins University, who led presentations on the use of psilocybin in end-of-life care and the “neuropsychopharmacology and implications for therapeutics” of the entheogen.
Dr. Charles Grob of UCLA talked about the need for increased diversity among participants in psychedelics studies and also noted the “thorny issue” of funding.
“I’ll say that the National Institutes of Health really have not funded this area,” he said. “As far as I’m aware, since the late 60s, they funded mechanistic questions but not actual treatment—whether psychedelics may have some role as a treatment model that I think that needs to be relooked at.”
He also said in response to a question from Marijuana Moment that he views the scientific and decriminalization policy movements around psychedelics as a “parallel process.” He added that “the decriminalization phenomena is actually quite fascinating and, honestly, it took me by surprise.”
Decriminalization measures “seem to be passing by large majority, so it seems like the public, to a significant degree, is done with the drug war—and I certainly would applaud that,” he said. However, he noted the importance of “public education programs” about the safe use of psychedelics in jurisdictions that opt to enact decriminalization or loosen criminal penalties.
Asked by Marijuana Moment about whether the scheduling status of psilocybin under federal law inhibits research into the compound’s risk and benefits, Dr. Roland Griffiths of Johns Hopkins University said that the “Schedule I status is anathema to research because it makes research much more difficult—and that’s both clinical research and even preclinical research.”
“Even a preclinical neurological researcher, if they want to work with a Schedule I compound, they still have to jump through all the hurdles and create a [Drug Enforcement Administration] license and track their substance in a way that’s really quite discouraging of research,” he said. “I wish there were an easier workaround for Schedule I compounds and research generally, but as the laws are currently written, there isn’t a workaround.”
The next event in the federally hosted series on the psychedelic, scheduled for May 27, will give a scientific perspective on advancing public health initiatives through “dynamic regulatory frameworks. Another panel is titled “Transcendent, Spiritual, and Humane: Psychedelic Medicine Ends the Epoch of Psychiatric Reductionism and Rouses the Dawn of a New Mental Health Universe.”
Psilocybin, a natural active compound found in 200+ fungi species, is being studied for possible use in the treatment of severe psychiatric disorders. @theNCI’s Psilocybin Speaker Series starts TODAY at 3 pm ET & will look at current psilocybin research. https://t.co/WTXMKVqFDA https://t.co/S5WT0oBFem
— NIH NCCIH (@NIH_NCCIH) April 22, 2021
Microdosing psilocybin will be a focus of the June 7 event, as well as the use of the psychedelic in treating depression. A representative from the National Institute on Drug Abuse will discuss the “synthesis, characterization, and preclinical pharmacology of psilocybin analogs and related tryptamines.”
Finally, on June 10, participants will learn about psilocybin-assisted psychotherapy for advanced cancer-related psychiatric and existential distress, led by an NYU professor.
As a reminder: all these presentations on psychedelics research are being organized and promoted by a federal agency. Despite strict restrictions on psilocybin at the federal level, the speakers series is highlighting science that runs counter that notion that the entheogen has no medical utility—undermining its ongoing Schedule I status.
NCI said the series has two purposes:
- Education: provide time-sensitive and evidence-based scientific information, utilizing expert speakers from academia, government, and the community.
- Research: assess the current state of the science, identify research gaps and opportunities, regarding future research needs for investigation among diverse research communities.
But while it may seem counterintuitive that the federal government is sanctioning this research series, it’s not without precedent.
NCI hosted a symposium this month on research into marijuana as a therapeutic in the treatment of cancer and other related issues in December 2020, for example.
The Food and Drug Administration also held a public conference that year that looked at the use and effects of CBD differ based on sex and gender.
The National Center for Complementary and Integrative Health in 2018 sponsored a working that touched on various aspects of marijuana research, particularly under the current federal framework of prohibition.
But the psilocybin-focused event series from a federal agency serves as a unique reminder that psychedelics are gaining attention amid a national movement to end criminalization over the substances that show significant therapeutic potential.
In California, for example, two Senate committees have recently approved a bill to legalize possession of a wide range of psychedelics and create a working group to study broader reform.
The Northampton, Massachusetts City Council passed a resolution earlier this month to deprioritize enforcement of laws against the possession, use and distribution of a wide range of psychedelics such as psilocybin and ayahuasca. It’s the third city in the state to advance the policy change, following Somerville and Cambridge.
These are some of the latest iterations of a national psychedelics reform movement that’s spread rapidly since Denver became the first city to decriminalize psilocybin mushrooms in 2019.
In Oregon, November’s election saw the passage of a historic initiatives to legalize psilocybin mushrooms for therapeutic purposes and more broadly decriminalize possession of all drugs.
In Oakland, the first city where a city council voted to broadly deprioritize criminalization of entheogenic substances, lawmakers approved a follow-up resolution in December that calls for the policy change to be adopted statewide and for local jurisdictions to be allowed to permit healing ceremonies where people could use psychedelics.
After Ann Arbor legislators passed a decriminalization resolution last year, a county prosecutor recently announced that his office will not be pursuing charges over possessing entheogenic plants and fungi—“regardless of the amount at issue.”
Photo courtesy of Wikimedia/Mushroom Observer.
Virginia Has Sealed 64,000 Marijuana Distribution Charges Since Legalization Took Effect This Summer
“These aren’t just numbers and there are families attached.”
By Ned Oliver, Virginia Mercury
Virginia has sealed records documenting more than 64,000 misdemeanor marijuana distribution charges since the state legalized the drug in July.
The figure came out Thursday during a meeting of the legislature’s Cannabis Oversight Commission.
Officials said the records were scrubbed from the state’s criminal record database, which is used by employers like school boards, state agencies and local governments to screen employees.
The state had already sealed 333,000 records detailing charges of simple possession last year after the state reduced the offense to a civil infraction on par with a traffic offense, said Shawn G. Talmadge, the Deputy Secretary of Public Safety and Homeland Security.
Lawmakers directed the state to expand that effort when they voted to broadly legalize recreational use of marijuana earlier this year.
The legislature also agreed to a broader expungement reform that will automatically seal other misdemeanor charges, including underage possession of alcohol, use of a fake ID, petit larceny, trespassing and disorderly conduct. Talmadge said those charges will remain in the system until the state finishes updating the software it uses to track criminal records.
“As of right now, the process is proceeding,” he said.
The Virginia Joint Commission on Cannabis Oversight is meeting now. You can find the agenda and links to livestream and to provide public comment at https://t.co/f1wsPn7SV7
— Jennifer McClellan (@JennMcClellanVA) October 14, 2021
Members of the oversight commission also heard from two advocates who urged them to move fast to address people currently imprisoned for marijuana offenses—a category of people the legalization legislation passed this year did not address.
Chelsea Higgs Wise, the leader of the advocacy group Marijuana Justice, and Gracie Burger, with the Last Prisoner Project, said Department of Corrections data suggests there are currently 10 people being held solely on serious marijuana charges.
They said it remains unknown how many more are being held because of marijuana related probation violations.
“These aren’t just numbers and there are families attached,” Burger said.
DEA Proposes Dramatic Increase In Marijuana And Psychedelic Production In 2022, Calling For 6,300 Percent More MDMA Alone
The Drug Enforcement Administration (DEA) is proposing a dramatic increase in the legal production of marijuana and psychedelics like psilocybin, LSD, MDMA and DMT to be used in research next year.
In a notice scheduled to be published in the Federal Register on Monday, the agency said there’s been a “significant increase in the use of schedule I hallucinogenic controlled substances for research and clinical trial purposes,” and it wants authorized manufacturers to meet that growing demand.
DEA had already massively upped its proposed 2021 quota for cannabis and psilocybin last month, but now it’s calling for significantly larger quantities of research-grade marijuana and a broader array of psychedelics to be manufactured in 2022.
It wants to double the amount of marijuana extracts, psilocybin and psilocyn, quadruple mescaline and quintuple DMT. What especially stands out in the notice is MDMA. The agency is proposing an enormous 6,300 percent boost in the production of that drug—from just 50 grams in 2021 to 3,200 grams in the coming year—as research into its therapeutic potential continues to expand.
LSD would see a 1,150 percent increase, up to 500 grams of the potent psychedelic.
Marijuana itself would get a 60 percent boost under DEA’s proposal, up to 3.2 million grams in 2022 from the 2 million grams last year.
Here’s a visualization of the proposed quota increase from 2021 to 2022 for marijuana and cannabis extracts:
For all other THC, psilocybin, psilocyn and MDMA:
And for other psychedelic substances like LSD, mescaline and DMT:
DEA said in the Federal Register notice that it has been receiving and approving additional applications to “grow, synthesize, extract, and manufacture dosage forms containing specific schedule I hallucinogenic substances for clinical trial purposes” to achieve these ambitious quotas.
“DEA supports regulated research with schedule I controlled substances, as evidenced by increases proposed for 2022 as compared with aggregate production quotas for these substances in 2021,” the agency said, adding that it working “diligently” to process and approve marijuana manufacturers applications in particular, as there’s currently only one farm at the University of Mississippi that’s permitted to cultivate the plant for research.
“Based on the increase in research and clinical trial applications, DEA has proposed increases in 3,4- Methylenedioxyamphetamine (MDA), 3,4-Methylenedioxymethamphetamine (MDMA), 5-Methoxy-N,N-dimethyltryptamine, Dimethyltryptamine, Lysergic acid diethylamide (LSD), Marihuana, Marihuana Extract, Mescaline, Psilocybin, Psilocyn, and All Other Tetrahydrocannabinols to support manufacturing activities related to the increased level of research and clinical trials with these schedule I controlled substances.”
Here are the exact numbers for the proposed 2021 and 2022 quotas:
|All other tetrahydrocannabinol||1,000||2,000|
A 30-day public comment period will be open after the notice is formally published on Monday.
It’s difficult to overstate just how significant the proposed 2022 increases are, but it’s certainly true that scientific and public interest in marijuana and psychedelics has rapidly increased, with early clinical trials signaling that such substances show significant therapeutic potential.
National Institute on Drug Abuse (NIDA) Director Nora Volkow told Marijuana Moment in a recent interview that she was encouraged by DEA’s previous proposed increase in drug production quota. She also said that studies demonstrating the therapeutic benefits of psychedelics could be leading more people to experiment with substances like psilocybin.
Advocates and experts remain frustrated that these plants and fungi remain in the strictest federal drug category in the first place, especially considering the existing research that shows their medical value for certain conditions.
A federal appeals court in August dismissed a petition to require the DEA to reevaluate cannabis’s scheduling under the Controlled Substances Act. However, one judge did say in a concurring opinion that the agency may soon be forced to consider a policy change anyway based on a misinterpretation of the therapeutic value of marijuana.
Separately, the Washington State attorney general’s office and lawyers representing cancer patients recently urged a federal appeals panel to push for a DEA policy change to allow people in end-of-life care to access psilocybin under state and federal right-to-try laws.
Image element courtesy of Kristie Gianopulos.
Supreme Court Won’t Hear Case On Legalizing Safe Drug Consumption Sites, But Activists Are Undeterred
The U.S. Supreme Court (SCOTUS) has rejected a request to hear a case on the legality of establishing safe injection sites where people can use illicit drugs in a medically supervised environment.
The justices announced on Tuesday that they decided against taking up the case raised by the nonprofit Safehouse, despite the pleas of attorneys general from 10 states and D.C. who recently filed amici briefs urging the court’s involvement.
Representatives from 14 cities and counties, as well as the mayor of Philadelphia, which is at the center of the current case, also filed briefs in support of the case in recent days.
Safehouse was set to launch a safe consumption site in Philadelphia before being blocked by a legal challenge from the Trump administration. It filed a petition with the nation’s highest court in August to hear the case.
But while the Supreme Court declined to take action—and the Biden administration passed up its voluntary opportunity to weigh in at this stage, which may well have influenced the justices’ decision—activists say the battle will continue at a lower federal court level, where the administration will have to file briefs revealing its position on the issue.
Disappointed but not surprised U.S. Supreme Court declined to hear our case. We’re pursuing our claims in federal court. As that litigation proceeds, Biden administration will have to take a position, which it avoided by waiving its right to respond to our Supreme Court petition.
— Safehouse (@SafehousePhilly) October 13, 2021
“We were disappointed that the government chose not to respond to our petition,” Safehouse Vice President Ronda Goldfein told Filter. “They said, ‘We’re going to waive our right to respond,’ [and] the Supreme Court declined to review our case. Ordinarily that sounds like the end of the road—but in our case we are still pursuing our claims in a different venue.”
That venue will be the the federal district court in Philadelphia, where activists plan to submit multiple arguments related to religious freedom and interstate commerce protections. The Biden administration will be compelled to file a response in that court by November 5.
“If they don’t respond, they lose,” Goldfein said.
A coalition of 80 current and former prosecutors and law enforcement officials—including one who is President Joe Biden’s pick for U.S. attorney of Massachusetts—previously filed a brief urging the Supreme Court to take up Safehouse’s safe injection case.
Fair and Justice Prosecution, the group that coordinated the amicus brief, also organized a tour of Portugal for 20 top prosecutors in 2019 so they could learn about the successful implementation of the country’s drug decriminalization law.
If the Supreme Court were to have taken the case and rule in favor of Safehouse, it could have emboldened advocates and lawmakers across the country to pursue the harm reduction policy.
The governor of Rhode Island signed a bill in July to establish a safe consumption site pilot program where people could test and use currently illicit drugs in a medically supervised environment. It became the first state in the country to legalize the harm reduction centers. It’s not clear whether the Department of Justice will seek to intervene to prevent the opening of such facilities in that state.
Massachusetts lawmakers advanced similar legislation last year, but it was not ultimately enacted.
A similar harm reduction bill in California, sponsored by Sen. Scott Wiener (D), was approved in the state Senate in April, but further action has been delayed until 2022.