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.
Illinois Will ‘Blow Past’ $1 Billion In Legal Marijuana Sales In 2021, Chamber Of Commerce President Says
“Are we going to get to a billion dollars? I think we’re going to blow past the billion dollars based on the experience in smaller states,” the Chamber leader said.
By Elyse Kelly, The Center Square
Illinois’s cannabis industry is growing up fast, with adult-use recreational cannabis sales expected to hit $1 billion by year-end.
In March alone, Illinoisans spent $110 million on recreational marijuana.
Todd Maisch, president and CEO of the Illinois Chamber of Commerce, said one factor contributing to Illinois’ explosive growth is that most neighboring states haven’t legalized marijuana yet.
“What we saw early on in states like Washington and Colorado is they did have demand come in from surrounding states, which frankly benefits our industry and benefits the taxes collected,” Maisch said.
Cannabis sales have already surpassed alcohol’s tax revenues for the state, and Maisch said he thinks $1 billion estimates are conservative.
“Are we going to get to a billion dollars? I think we’re going to blow past the billion dollars based on the experience in smaller states,” Maisch said.
There are only a couple of things that could stop Illinois’ explosive cannabis market growth, Maisch said. He said that policymakers could ruin things by pushing taxes too high as evidenced by the tobacco market.
“As taxes have gone up and up and up, they’ve pushed people all the way into the black market or they’ve created this grey market in which people are ostensibly paying some of the taxes, but they’re still getting sources of tobacco products that avoid much of the tax,” Maisch said.
The other thing that could head off continued growth is other states opening up recreational-use markets.
“So if you start to see surrounding states go to recreational, that’s definitely going to flatten the curve because we’re not going to be pulling in demand from other states,” Maisch said.
Maisch points out some concerns that accompany the explosion of Illinois’s recreational cannabis market including workforce preparedness.
“All of those individuals who are deciding to go ahead and consume this product are really taking themselves out of a lot of job opportunities that they would otherwise be qualified, so there’s a real upside and a downside,” Maisch said.
While it’s easy to track the revenues this industry brings into state coffers, he points out, it will be harder to track the lack of productivity and qualified individuals to operate heavy machinery and other jobs that require employees to pass a drug test.
DEA Finally Ready To End Federal Marijuana Research Monopoly, Agency Notifies Grower Applicants
The Drug Enforcement Administration (DEA) on Friday notified several companies that it is moving toward approving their applications to become federally authorized marijuana manufacturers for research purposes.
This is a significant development—and one of the first cannabis-related moves to come out of the Biden administration. There is currently a monopoly on federal cannabis cultivation, with the University of Mississippi having operated the only approved facility for the past half-century.
It was almost five years ago that DEA under President Barack Obama first announced that it was accepting applications for additional manufacturers. No approvals were made during the Trump administration. And the delay in getting acceptances has led to frustration—and in some cases, lawsuits—among applicants.
But on Friday, organizations including the Biopharmaceutical Research Company (BRC), Scottsdale Research Institute (SRI) and Groff NA Hemplex LLC were notified by the agency that their requests were conditionally accepted.
“DEA is nearing the end of its review of certain marijuana grower applications, thereby allowing it to soon register additional entities authorized to produce marijuana for research purposes,” DEA said. “Pending final approval, DEA has determined, based on currently available information, that a number of manufacturers’ applications to cultivate marijuana for research needs in the United States appears to be consistent with applicable legal standards and relevant laws. DEA has, therefore, provided a Memorandum of Agreement (MOA) to these manufacturers as the next step in the approval process.”
The Wall Street Journal first reported on the move, and it’s unclear just how many organizations have received a DEA communication so far.
Matt Zorn, who has represented SRI in a suit against DEA over the processing delays, told Marijuana Moment that the agency explained that it is “moving forward” with the facility’s application and that it appears to be “consistent with public interest” to give the institute the ability to grow marijuana for study purposes.
SRI’s Dr. Sue Sisley is in a process of completing a memorandum of agreement that DEA requested “so that it can be executed and official,” according to a press release.
BRC CEO George Hodgin said in another press release that after being finalized, “this federal license will forever change the trajectory of our business and the medicinal cannabis industry.”
“The DEA’s leadership will set off a nationwide wave of innovative cannabis-derived treatments, unlock valuable intellectual property and create high quality American jobs,” he said. “The BRC team is already familiar with DEA compliance procedures based on our extensive history of controlled substances activity, and our world class staff is ready to hit the ground running on this new business arm that the DEA has authorized.”
DEA said it has presented applicants that appear to meet legal requirements “with an MOA outlining the means by which the applicant and DEA will work together to facilitate the production, storage, packaging, and distribution of marijuana under the new regulations as well as other applicable legal standards and relevant laws.”
“To the extent these MOAs are finalized, DEA anticipates issuing DEA registrations to these manufacturers,” the agency said. “Each applicant will then be authorized to cultivate marijuana—up to its allotted quota—in support of the more than 575 DEA-licensed researchers across the nation.”
DEA said it “will continue to prioritize efforts to evaluate the remaining applications for registration and expects additional approvals in the future” and will publicly post information about approvals as they are finalized.
Following a 2019 suit against DEA by SRI, a court mandated that the agency take steps to process the cultivation license applications, and that legal challenge was dropped after DEA provided a status update.
That suit argued that the marijuana grown at the University of Mississippi is of poor quality, does not reflect the diversity of products available on the commercial market and is therefore inadequate for clinical studies.
That’s also a point that several policymakers have made, and it’s bolstered by research demonstrating that the federal government’s cannabis is genetically closer to hemp than marijuana that consumers can obtain in state-legal markets.
Last year, DEA finally unveiled a revised rule change proposal that it said was necessary to move forward with licensing approvals due to the high volume of applicants and to address potential complications related to international treaties to which the U.S. is a party.
SRI filed another suit against DEA in March, claiming that the agency used a “secret” document to justify its delay of approving manufacturer applications. And that was born out when the Justice Department Office of Legal Counsel document was released last year as part of a settlement in the case, revealing, among other things, that the agency feels that its current licensing structure for cannabis cultivation has been in violation of international treaties for decades.
Photo by Aphiwat chuangchoem.
Mississippi Supreme Court Overturns Medical Marijuana Legalization Ballot That Voters Approved
A voter-approved initiative to legalize medical marijuana in Mississippi has been overturned by the state Supreme Court.
On Friday, the court ruled in favor of a Mississippi mayor who filed a legal challenge against the 2020 measure, nullifying its certification by the Secretary of State. The lawsuit was unrelated to the merits of the reform proposal itself, but plaintiffs argued that the constitutional amendment violated procedural rules for placing measures on the ballot.
While the court acknowledged that a “strong, if not overwhelming, majority of voters of Mississippi approved Initiative 65” to legalize medical cannabis in the state, Madison Mayor Mary Hawkins Butler’s (R) petition was valid for statutory reasons.
Madison’s challenge cites a state law stipulating that “signatures of the qualified electors from any congressional district shall not exceed one-fifth (1/5) of the total number of signatures required to qualify an initiative petition for placement upon the ballot.” But that policy went into effect when Mississippi had five congressional districts, and that’s since been reduced to four, making it mathematically impossible to adhere to.
The secretary of state and other officials pushed back against the lawsuit and argued that a plain reading of the state Constitution makes it clear that the intention of the district-based requirement was to ensure that signatures were collected in a geographically dispersed manner—and the result of the campaign met that standard.
But in the court’s 6-3 ruling released on Friday, the justices said that their hands were tied. The legislature or administration might be able to fix the procedural ballot issue, but it had to follow the letter of the law.
“We find ourselves presented with the question squarely before us and nowhere to turn but to its answer,” the decision states. “Remaining mindful of both the November 3, 2020 election results and the clear language in section 273 seeking to preserve the right of the people to enact changes to their Constitution, we nonetheless must hold that the text of section 273 fails to account for the possibility that has become reality in Mississippi.”
In sum, a Census-driven change in the number of congressional districts in Mississippi “did, indeed, break section 273 so that, absent amendment, it no longer functions,” meaning there’s no legal way to pass a constitutional ballot initiative in the state.
“Whether with intent, by oversight, or for some other reason, the drafters of section 273(3) wrote a ballot-initiative process that cannot work in a world where Mississippi has fewer than five representatives in Congress. To work in today’s reality, it will need amending—something that lies beyond the power of the Supreme Court.”
“We grant the petition, reverse the Secretary of State’s certification of Initiative 65, and hold that any subsequent proceedings on it are void,” the court ruled.
One justice who dissented said that the district-based requirement is arbitrary as it concerns Mississippi elections. While the federal government defines the state as having four congressional districts, the state Constitution “lays out the five districts,” and “there have been zero changes to the five districts” as far as the state’s laws are concerned.
In any case, this marks a major defeat for cannabis reform activists in the state who collected more than 214,000 signatures for their initiative. Sixty-eight percent of voters approved a general ballot question on whether to allow medical cannabis, and 74 percent signed off on advocates’ specific measure in a separate question.
“The Mississippi Supreme Court just overturned the will of the people of Mississippi,” Ken Newburger, executive director for the Mississippi Medical Marijuana Association, said in a press release. “Patients will now continue the suffering that so many Mississippians voted to end. The Court ignored existing case law and prior decisions. Their reasoning ignores the intent of the constitution and takes away people’s constitutional right.”
“It’s a sad day for Mississippi when the Supreme Court communicates to a vast majority of the voters that their vote doesn’t matter,” he said.
Today the MS Supreme Court ruled against the state’s ballot initiative process, killing the medical marijuana program 74% of Mississippians voted to pass. This is devastating for not only patients, but voters as a whole. Below is our statement: https://t.co/jrDoJM3K16 pic.twitter.com/AR3xuId3xR
— Mississippi Medical Marijuana Association (@medmarijuanams) May 14, 2021
Under the voter-approved initiative, patients with debilitating medical issues would have been allowed to legally obtain marijuana after getting a doctor’s recommendation. The proposal included 22 qualifying conditions such as cancer, chronic pain and post-traumatic stress disorder, and patients would have been able to possess up to 2.5 ounces of marijuana per 14-day period.
There was an attempt in the legislature to pass a bill to legalize medical marijuana in the event that the court overruled the voter-approved initiative, but it failed to be enacted by the session’s end.
The Mississippi State Department of Health told WJTV that it will cease work on developing medical cannabis regulations in light of the court ruling.
“However, the agency has certainly learned a lot in the process of putting together a successful medical marijuana program, and we stand ready to help the legislature if it creates a statutory program,” Liz Sharlot, director of the Office of Communications for the department, said.
This is the latest state Supreme Court setback to affect cannabis reform efforts.
Last month, the Florida Supreme Court dealt a critical blow to marijuana activists working to legalize marijuana in the state—killing an initiative that hundreds of thousands of voters have already signed and forcing them to start all over again if they want to make the 2022 ballot.
While a Nebraska campaign collected enough signatures to qualify a reform initiative in 2020, the state Supreme Court shut it down following a legal challenge. It determined that the measure violated the state’s single-subject rule, much to the disappointment of advocates.
In South Dakota, the fate of an adult-use legalization initiative that voters approved last November is also in the hands of the state’s Supreme Court, where a sheriff is challenging its constitutionality based on a single subject rule as well.
Opponents to a Montana marijuana legalization measure that was approved by voters have also filed lawsuits contesting the voter-approved initiative for procedural reasons, arguing that its allocation of revenue violates the state Constitution. While the state Supreme Court declined to hear the case last year, it did not rule on the merits and left the door open to pursuing the case in district and appeals court, which plaintiffs then pursued.
Read the Mississippi Supreme Court ruling on the medical cannabis initiative below: