A Seattle doctor hoping to expand access to psilocybin mushrooms for terminally ill cancer patients is taking the U.S. Drug Enforcement Administration (DEA) to court over the agency’s recent denial of an application to legally use the psychedelic in end-of-life treatment.
Attorneys filed a lawsuit Monday in the U.S. Circuit Court of Appeals for the Ninth Circuit, arguing that DEA’s denial of the application was unfounded. They’re asking judges to throw out the decision and force the agency to “expeditiously reconsider and accommodate valid requests made from qualified health providers for the therapeutic use of the eligible investigation drug psilocybin.”
“It is a first-of-its-kind lawsuit,” lead attorney Kathyn Tucker said on a press call on Tuesday. “The case is about seeking to ensure that patients with serious, life-threatening illness are able to realize the promise of state and federal right-to-try laws and access psilocybin for therapeutic.”
The push to expand patient access began last year, when Dr. Sunil Aggarwal, who specializes in end-of-life care, began searching for a legal way to obtain psilocybin for treating patients. In November, he began applying to state and federal regulators for approval to cultivate psilocybin mushrooms and use them in treatment.
“We know that it’s a naturally occurring substance that we can cultivate safely, we know how to dose it and there’s really good reason to believe it can help,” Aggarwal told Marijuana Moment at the time.
Aggarwal’s team argues that psilocybin should be made available under state and federal right-to-try laws, relatively new policies that give patients with terminal conditions the opportunity to try investigational medications that have not been approved for general use. Washington state adopted a right-to-try law in 2017. President Donald Trump signed the federal Right to Try Act the following year. Dozens of other states have also passed right-to-try laws.
Aggarwal and the clinic where he works, the Advanced Integrative Medical Science (AIMS) Institute, wrote to DEA in January asking for guidance on how to move forward on psilocybin, which remains a Schedule I controlled substance, under right-to-try laws.
“What we hoped the DEA would be doing under right-to-try is creating a user-friendly approach to how clinicians like Dr. Aggarwal can navigate the system to obtain an eligible investigational drug for an eligible patient,” Tucker said on the press call.
Instead DEA rejected the application, replying in a February 12 letter that the agency lacks the authority to waive the federal Controlled Substances Act, despite what the federal Right to Try Act says. The only way to dispense psilocybin legally, the agency added, would be to apply for a federal research permit, which “would not be applicable to Dr. Aggarwal at this time.”
In response, Aggarwal and the AIMS Institute filed their petition for review this week. At Tuesday’s press conference, he criticized DEA’s decision as an obstacle for terminally ill patients who simply want to improve their quality of life.
“This is absolutely unacceptable for their care, because they have this right under the law, and the law states that that medicines like this should be made available expeditiously for patients,” Aggarwal said. “I’m hoping that the judges who look at that will take into consideration the great potential [of psilocybin], the suffering of my patients, and the law and what their rights are.”
Tucker, the lead attorney in the suit, explained that psilocybin seems to fit the criteria listed in state and federal right-to-try laws, having completed a Phase I research trial and remaining under active investigation. “Psilocybin, hence, is what the right-to-try laws designate as an eligible investigational drug,” she said.
The team noted noted that health regulators in Canada have already extended legal exemptions to certain patients seeking to use psilocybin in end-of-life care. Officials there granted the first such exemption in August of last year, and in December the country’s health minister said some therapists and health care professionals could also legally use the drug.
One of the patients represented in the new lawsuit is Erinn Baldeschweiler, a mother of two who has been diagnosed with stage four metastatic breast cancer. Psilocybin, she believes, could help ease the emotional trauma of a terminal diagnosis.
“Whatever remaining time I have left,” Baldeschwiler said, “I want to have the highest quality of life.”
This isn’t the first time DEA has found itself battling lawsuits over the criminalization of controlled substances that hold therapeutic value.
Scientists and veterans sued the federal agency last year, arguing that the legal basis DEA has used to justify keeping marijuana in Schedule I of the Controlled Substances Act is unconstitutional. They asked for a review of its decisions to reject rescheduling petitions in 2020, 2016 and 1992. DEA subsequently requested that the court dismiss that suit.
The agency has also been taken to court over delays in approving additional cannabis manufacturers for research purposes.
The Scottsdale Research Institute alleged that DEA has been deliberately using delay tactics to avoid approving cultivation applications. A court mandated that the agency take steps to make good on its promise, and that suit was dropped after DEA provided a status update.
In March 2020, DEA finally unveiled a revised rule change proposal that it said was necessary due to the high volume of applicants and to address potential complications related to international treaties to which the U.S. is a party.
But the new psychedelics-related litigation is unique and reflects the growing public interest in loosening laws governing plant- and fungi-based materials, particularly for medical use.
A New York lawmaker filed a bill on Monday to decriminalize psychedelic mushrooms in the state, for example.
Six cities—Oakland, Santa Cruz, Ann Arbor, Washington, D.C., Somerville and Cambridge—have decriminalized possession of a broader collection psychedelics since Denver became the first to deprioritize enforcement against psilocybin in 2019. Activists in Spokane, Washington have also recently submitted a similar reform proposal to local lawmakers.
A Republican lawmaker in Iowa introduced a bill to remove psilocybin from the list of controlled substances, which received a subcommittee hearing last week but did not advance. He also filed another piece of legislation to let seriously ill patients use psychedelic mushrooms, LSD, DMT and other drugs.
Read the full psilocybin lawsuit against DEA and related correspondence below:
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.