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:
Bipartisan Lawmakers Push VA To Allow Medical Marijuana Access For Veterans ‘As Soon As Possible’
The U.S. Department of Veterans Affairs (VA) must urgently institute a policy change to ensure that military veterans can access cannabis for therapeutic use, a bipartisan coalition of congressional lawmakers said in a new letter.
Writing to VA Secretary Denis McDonough on Wednesday, the co-chairs of the Congressional Cannabis Caucus urged the official to consider “a change in policy to allow access to medical cannabis fro VA patients” and to “act swiftly and implement this change as soon as possible.”
The lawmakers pointed to surveys showing high rates of opioid addiction and post-traumatic stress disorder (PTSD) among the veteran community.
“Research has shown that cannabis can be safe and effective in targeted pain-management. Additionally, cannabis has proven benefits in managing PTSD and other health issues, including multiple sclerosis (MS) and seizure disorders,” the letter states. “Despite its efficacy, antiquated bureaucratic red-tape continues to deny veterans these life-altering treatments.”
“Congress and several administrations have enacted various well-intentioned intervention attempts, however, over twenty veterans continue to die by suicide each day—it is past time we stop barring access from these innovative therapies. We therefore respectfully urge you to ensure no veteran can be denied medically prescribed cannabis treatments.”
The letter comes weeks after McDonough participated in a Veterans Day Q&A where he said that VA officials are “looking at” the possibility of an internal policy change and have discussed it with the White House and Department of Justice. The secretary also talked about being personally moved by stories from veterans who’ve found relief using medical marijuana.
“We’re trying to explore what more we can do,” he said at the time. “And I’ve talked to our friends in the rest of the federal government, including the Department of Justice, on what we can do on this, and with the White House.”
The Congressional Cannabis Caucus co-chairs—Reps. Earl Blumenauer (D-OR), David Joyce (R-OH), Barbara Lee (D-CA) and Don Young (R-AK)—want McDonough to speed up the policy change process.
“America’s veterans have risked life and limb to preserve our freedoms, so we must not allow the unnecessary politicization of medical cannabis to hinder their lifesaving therapies,” they wrote. “We stand ready to work with you and your administration in advancing these necessary treatments.”
While congressional lawmakers are working to advance legislation to end marijuana prohibition, McDonough’s department has resisted even modest proposals meant to promote veteran access and clinical research into the medical value of cannabis.
One such research bill was approved by the House Veterans Affairs Committee earlier this month, despite testimony from the department opposing the reform. VA’s David Carroll told lawmakers that the legislation was overly prescriptive and argued that the department is already conducting robust research into marijuana.
Some had held out hope that VA would back the reform this session after the sponsor, Rep. Lou Correa (D-CA), said that he’d had a conversation with McDonough about the issue of marijuana and veterans.
On the Senate side, a coalition of lawmakers recently filed an amendment to the National Defense Authorization Act (NDAA) that would federally legalize medical cannabis for military veterans who comply with a state program where they live. VA doctors would also be explicitly allowed to issue marijuana recommendations.
Read the letter to the VA secretary on marijuana access below:
Photo courtesy of Chris Wallis // Side Pocket Images.
Biden Treasury Secretary Says ‘Of Course’ Marijuana Banking Would Make IRS’s Job Easier
The secretary of the U.S. Treasury Department said on Wednesday that freeing up banks to work with state-legal marijuana businesses would “of course” make the Internal Revenue Service’s (IRS) job of collecting taxes easier.
At a hearing before the House Financial Services Committee, Rep. Ed Perlmutter (D-CO) referenced recent comments from an IRS official about the “special type of collection challenge the IRS undertakes regarding tax collection from cannabis-related businesses forced to operate in cash only.”
“Do you agree if these business were simply allowed to access the banking system and didn’t have to transact business only in cash it would make the IRS job easier?” Perlmutter asked Secretary Janet Yellen.
“Yes, of course it would,” she replied matter-of-factly.
HAPPENING NOW: @SecYellen agrees allowing cannabis businesses to access the banking system would help the IRS do their job and enable them to better collect taxes from the industry. #SAFEBanking https://t.co/w23GdFPQFy
— Rep. Ed Perlmutter (@RepPerlmutter) December 1, 2021
The congressman also talked about his bill—the Secure and Fair Enforcement (SAFE) Banking Act—which has passed the House in some form five times now and would resolve the issue by protecting financial institutions that service state-legal cannabis businesses.
Numerous financial, labor and insurance associations, as well as key lawmakers, are pushing the Senate to attach the measure to must-pass defense spending legislation, as the House already has. Bipartisan members of the Senate Armed Services Committee, as well as senators representing Colorado, made the same request in recent letters.
While Yellen’s response was quick, it’s yet another example of a federal official recognizing the untenability of the status quo.
Steven Mnuchin, the Treasury secretary under the Trump administration, repeatedly addressed the issue, saying the current policy conflict creates “significant problems” for IRS and financial regulators. It “creates significant risk in the communities for collecting this amount of cash. It’s problematic,” he said last year.
IRS, for its part, said in September that it expects the cannabis market to continue to grow, and it offered some tips to businesses on staying compliant with taxes while the plant remains federally prohibited.
With respect to the SAFE Banking Act, a bipartisan coalition of two dozen governors recently implored congressional leaders to finally enact marijuana banking reform through the large-scale defense legislation.
A group of small marijuana business owners also recently made the case that the incremental banking policy change could actually help support social equity efforts.
Rodney Hood, a board member of the National Credit Union Administration, wrote in a recent Marijuana Moment op-ed that legalization is an inevitability—and it makes the most sense for government agencies to get ahead of the policy change to resolve banking complications now.
Federal data shows that many financial institutions remain hesitant to take on cannabis companies as clients, however, which is likely due to the fact that the plant is a strictly controlled substance under federal law.
Texas Activists Turn In Signatures To Put Marijuana Decriminalization On Austin’s 2022 Ballot
Texas activists on Wednesday turned in signatures to place a marijuana decriminalization initiative on Austin’s 2022 ballot.
Ground Game Texas, a progressive organization that was established earlier this year, submitted more than 30,000 signatures to qualify the local measure to go before voters in the May 7 election next year.
While Austin, as well as other Texas cities like Dallas, have already independently enacted law enforcement policy changes aimed at reducing arrests for cannabis-related offenses by issuing citations and summons, the Austin Freedom Act of 2021 would take the reform a step further.
The initiative seeks to end arrests and citations for misdemeanor marijuana possession within Texas’s capital city. Also, it says police cannot issue citations for residue or paraphernalia in lieu of a possession charge.
The City Clerk will now verify that we submitted at least 20,000 valid signatures.
After that, the City Council will have the opportunity to adopt the new law directly, or place it on the May 7, 2022 “uniform election.”
— GroundGameTX (@GroundGameTX) December 1, 2021
“Thanks to the tireless efforts of on-the-ground organizers from Ground Game Texas and partner organizations, Austin residents will soon have the ability to make lasting change to our antiquated and racist criminal justice laws,” Mike Siegel, political director of Ground Game Texas, said in a press release. “With successful campaigns like these, Ground Game Texas will continue to empower and excite communities around progressive change—and deliver for the marginalized communities that too often get left behind.”
The measure would further prohibit the use of city funds to request or test cannabis to determine whether it meets the state’s definition of a lawful product. Hemp is legal in the state, creating complications for law enforcement, as they are now tasked with determining if seized cannabis products are in compliance with state statute.
Under the initiative, the execution of no-knock warrants would also be prohibited in the city—a policy that generated significant national attention last year after it led to Kentucky officers entering Breonna Taylor’s apartment and fatally shooting her in a botched drug raid.
Activists were joined by Austin City Council members Greg Casar and Vanessa Fuentes for Wednesday’s signature turn in.
Game Ground Texas previously attempted to place the measure on this year’s ballot, but they did not meet the signature turn-in deadline and shifted their attention to 2022.
This is huge news, a significant milestone for us in building long-term progressive organizing infrastructure to last beyond electoral cycles in TX.
Tremendously grateful to the organizers, volunteers, and staff who made this possible.
From the bottom of my heart, thank you! https://t.co/0rAG3ibq1M
— Julie Oliver (@JulieOliverTX) November 30, 2021
While the measure is now set to appear on the May ballot, it’s also possible that the Austin City Council could independently move to adopt the ordinance prior to the election.
“Austinites continue to work towards reducing the decades of negative impacts prohibition has caused by any means available,” Jax Finkel, executive director of Texas NORML, told Marijuana Moment. “During the interim, local actions like this create pressure for more action during the next legislative session. With a majority of Texans supporting the creation of a regulated cannabis market, it is important to continue pushing this conversation forward.”
Elsewhere in the state, activists in San Marcos launched a campaign in September to put marijuana decriminalization on the November ballot next year.
Ground Game Texas told Marijuana Moment on Wednesday that it is also planning to place a cannabis decriminalization measure before voters in Killeen next fall.
There is no statewide, citizen-led initiative process that would enable advocates to put an issue like decriminalization or legalization on the Texas ballot. But at the local level, there are limited cases where activists can leverage home rule laws that allow for policy changes.
A recent poll found that a strong majority of Texans—including most Republicans—support even broader reform to legalize marijuana for adult use.
The survey from the University of Houston and Texas Southern University found that 67 percent of Texas residents back the broad reform. Fifty-one percent of participants who identified as Republican said they back legalization.
In Texas, drug policy reform did advance in the legislature in the latest session, but not necessarily at the pace that advocates had hoped to see.
Advocates remain disappointed, however, that lawmakers were unable to pass more expansive cannabis bills—including a decriminalization proposal that cleared the House but saw no action in the Senate.
The Texas Republican Party adopted a platform plank endorsing decriminalization of marijuana possession in 2018.
Another Texas poll that was released over the summer found that 60 percent of voters in the state support making cannabis legal “for any use.”
Photo courtesy of Brian Shamblen.