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Washington Officials Join Cancer Patients In Federal Court Argument Pushing DEA To Allow Psilocybin Access

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The Washington State attorney general’s office appeared alongside lawyers representing cancer patients on Thursday, telling a federal appeals panel that people in end-of-life care deserve legal access to psilocybin—the main psychoactive compound in psychedelic mushrooms—under state and federal right-to-try laws.

“It is entirely consistent with the purpose and language of the state and federal right-to-try laws to include any controlled substances that have completed Phase 1 trials, including Schedule I controlled substances,” Washington Deputy Solicitor General Peter B. Gonick said in oral argument before a three-judge panel of the U.S. Court of Appeals for the Ninth Circuit, referring to a category of illegal drugs that includes psilocybin. “It’s entirely inconsistent with the right-to-try laws to prevent patient access to these treatments.”

Congress and 41 U.S. states have adopted right-to-try (RTT) laws, which allow patients with terminal conditions to try investigational medications that have not been approved for general use. But in the case before the Ninth Circuit, two patients and a Seattle-based palliative care clinic, the Advanced Integrated Medical Science (AIMS) Institute, say the U.S. Drug Enforcement Administration (DEA) is standing in their way.

The group sued DEA in March, after the agency replied to a request for guidance from the clinic’s co-director, Dr. Sunil Aggarwal. DEA asserted that the only way for the AIMS Institute to dispense psilocybin legally would be to obtain a federal research permit, which “would not be applicable to Dr. Aggarwal at this time.”

Out of the gate at oral argument Thursday, judges initially expressed skepticism over whether they even had jurisdiction to hear the case at this point. DEA maintains its letter to the clinic was simply an informal opinion, not a reviewable decision.

“Isn’t that the beginning and the and of this case?” Judge Ryan D. Nelson, an appointee of President Donald Trump, interjected barely 10 seconds after arguments began. “They wrote, seeking instructions on how to proceed… So if they sought instructions, how can a response for instructions ever be a final order?”

Attorney Matthew Zorn, who represented the patients and clinic suing DEA at Thursday’s oral arguments, replied that the agency’s response effectively gave them no options. “That response was: There is no process,” Zorn said. “If they had identified a process, we would have used that process. Because the agency said, ‘There is nothing for you to use,’ there is nowhere for us to go.”

For several minutes, judges on the panel—which also included Trump appointee Judge Mark J. Bennett and Judge Sandra Segal Ikuta, appointed by President George W. Bush—peppered Zorn with questions about whether DEA’s reply was even reviewable under court precedent.

“You didn’t ask [DEA] for an interpretive rule,” Nelson said.

“You asked for guidance,” agreed Ikuta.

“We didn’t ask for it,” Zorn told Nelson, “but that’s what we got.”

“I agree if that’s what you got the case might be different,” Nelson answered with an audible chuckle.

Though Zorn’s allotted time ended with some questions from judges unanswered, the panel’s mood appeared to change as the attorney dissected a federal court decision out of the Eastern District of Tennessee, which Nelson raised as a challenge. Zorn explained how he thought that decision was made in error, running contrary to a U.S. Supreme Court ruling dealing with the U.S. Environmental Protection Agency.

“This is crystal clear. I do think that court erred,” Zorn argued, as Nelson nodded his head.

Speaking after Zorn, Gonick, the Washington State deputy solicitor general, offered arguments on behalf of that state. Lawmakers there, where the AIMS Institute is located, passed a state right-to-try law unanimously in 2017, allowing terminally ill patients access to treatments that have passed Phase 1 of the U.S. Food and Drug Administration (FDA)’s approval process.

“The average time, Phase 1 to FDA approval, is seven to 10 years,” Gonick told judges, “and Congress and 41 states determined that was just too long for some patients suffering life-threatening illnesses.”

The laws express the recognition that some patients “may not have time to wait for FDA approval to receive treatments,” he added, “treatments that currently have ‘no accepted medical use,’ as the drugs in Schedule I have been designated” under the federal Controlled Substances Act (CSA).

The DEA attorney, Department of Justice (DOJ) appellate lawyer Thomas Pulham, argued the case itself should be dismissed because the court lacks jurisdiction. If the agency had explicitly rejected the clinic’s application for a research permit, he said, only then could that decision be appealed.

“DEA’s action is not subject to judicial review, because it neither reflects the consummation of a decision-making process nor results in any legal consequences,” Pulham said. “It was an informal response to a request for assistance from a member of a regulated community that did nothing more than provide the agency’s view on existing law.”

The agency also argued to the court in a June filing that loosening restrictions on psilocybin could fuel the illegal drug trade.

Judges were skeptical of the government’s stance, however, and repeatedly asked Pulham how the clinic and its patients should have proceeded, in DEA’s view.

“What about under the Right to Try law, though?” asked Judge Ikuta. “Is there a pathway where they could apply under the Right to Try Act?”

No, the lawyer for DEA replied. “As the agency indicated in its letter, there’s no procedure available under the Right to Try Act, because the Right to Try Act does not provide the agency any authority to waive the requirements of the Controlled Substances Act.”

Pulham argued that if the AIMS Institute and its patients were to proceed with psilocybin therapy and face enforcement action by the DEA, they could raise their right-to-try arguments at that point.

“Usually we don’t require a party to go and subject themselves to liability in order to appeal,” interrupted Judge Nelson. “It sounds like there might actually be some legal consequences here. I mean, it is prohibiting them from doing what they want to do, and it’s subjecting them to enforcement action if they were to go forward.”

“The letter does not do that,” Pulham stressed. “The Controlled Substances Act does that.”

“When Congress passed the Controlled Substances Act, it designated psilocybin as a controlled, Schedule I controlled substance based on findings that the drug had a high potential for abuse and no accepted medical use,” he continued. “That determination made psilocybin, in the Supreme Court’s words, contraband for all purposes, except for one exception, which is research.”

In his few remaining minutes of argument for rebuttal, Zorn emphasized that his clients are merely asking DEA to explain how clinicians and patients should move forward under right-to-try laws. “The agency has said it has no authority to give us what we’re asking for, which is a process to apply for a waiver and exemption to vindicate right-to-try use,” he said, “which is very different from research use.” He also noted that DEA has accommodated some ceremonial use of controlled substances under the Religious Freedom Restoration Act (RFRA), which is also not explicitly exempt from the CSA.

Zorn’s colleagues and clients cheered Zorn’s performance and said they hope it helps persuade the three-judge panel to rule in their favor.

“I am so grateful for such a landmark day in a higher court for us, in which our legal team was able to help in the slow chipping away of the DEA–CSA industrial complex status quo that stymies public health, healthcare, religious freedom, and the needs of the seriously ill,” Aggarwal, co-director of the AIMS Institute, told Marijuana Moment. “Now we await a swift and just ruling.”

Attorney Kathryn Tucker, who also represents AIMS and the patients, said that the panel “appeared over the course of the argument to appreciate that the agency had left no avenue open and hence the matter was properly before the court.”

“The sense I had watching the arguments was that the judges wanted to know how DEA would accommodate RTT and enable access for therapeutic use,” she said. “DOJ had no good answer to that.”

As AIMS and its patients challenge DEA’s restrictions on therapeutic psilocybin for end-of-life care, jurisdictions across the country are increasingly removing or reducing penalties around drug possession and consumption, especially when it comes to psychedelics.

A task force in Seattle, where AIMS is located, recently called on the City Council, as well as state lawmakers and other municipalities, to decriminalize all drugs as a way to curb overdose deaths. The group’s report also notes the potential shown by psychedelics in particular for treating various mental health disorders.

At the state level, Washington lawmakers reduced the state’s felony charge for drug possession to a misdemeanor earlier this year and earmarked more money for treatment following a state Supreme Court decision that overturned the states felony law against drug possession completely.

Not far north, in Canada, the country’s Health Ministry has granted case-by-case approval for some patients, as well as health care professionals, to access psilocybin for therapeutic use.

In California, meanwhile, a Senate-passed bill to legalize possession of a wide range of psychedelics advanced through several Assembly committees this session, but it will not move further this year following a decision by the sponsor that more time is needed to build the case for the reform and solidify its chances of being enacted.

California psychedelics activists also recently filed a petition for the 2022 ballot to make the state the first in the nation to legalize psilocybin mushrooms for any use. Oakland and Santa Cruz have already enacted psychedelics decriminalization. The state’s nonpartisan Legislation Analyst’s Office said this week that the statewide ballot measure could save the state tens of millions of dollars in annual enforcement costs.

In Michigan, the Ann ArborCity Council approved the policy change last year—and local lawmakers recently passed a resolution to officially designate September as Entheogenic Plants and Fungi Awareness Month.

In Massachusetts, cities that have enacted the policy change include NorthamptonSomerville and Cambridge.

In Denver the first city to adopt psilocybin reform, activists are now pushing to expand the psilocybin decriminalization policy to cover gifting and communal use of the substance.

The governor of Connecticut recently signed legislation recently that includes language requiring the state to carry out a study into the therapeutic potential of psilocybin mushrooms, meanwhile, and Texas recently enacted a bill to require the state study the medical benefits of psychedelics for military veterans.

A New York lawmaker introduced a bill in June that would require the state to establish an institute to similarly research the medical value of psychedelics.

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.”

The Aspen, Colorado City Council discussed the therapeutic potential of psychedelics like psilocybin and proposals to decriminalize such substances at a meeting in May. But members said, as it stands, enacting a reform would be more better handled at the state level while entheogens remain strictly federally controlled.

Activists in Portland, Oregon, meanwhile, are mounting a push to have local lawmakers pass a resolution decriminalizing the cultivation, gifting and ceremonial use of a wide range of psychedelics.

In a setback for advocates, the U.S. House of Representatives recently voted against a proposal from Rep. Alexandria Ocasio-Cortez (D-NY) that would have removed a spending bill rider that advocates say has restricted federal funds for research into Schedule I drugs, including psychedelics such as psilocybin, MDMA and ibogaine. However, it picked up considerably more votes this round than when the congresswoman first introduced it in 2019.

Report provisions of separate, House-passed spending legislation also touch on the need to expand cannabis and psychedelics research. The panel urged the National Institute On Drug Abuse (NIDA) to support expanded marijuana studies, for example

It further says that federal health agencies should pursue research into the therapeutic potential of psychedelics for military veterans suffering from a host of mental health conditions.

When it comes to broader drug policy reform, Oregon voters also approved an initiative in November to decriminalize possession of all drugs. This year, the Maine House of Representatives passed a drug decriminalization bill, but it later died in the Senate.

In May, lawmakers in Congress filed the first-ever legislation to federally decriminalize possession of illicit substances.

DEA Proposes Massive Increase In Marijuana And Psilocybin Production For Research To Develop FDA-Approved Medicines

Photo courtesy of Wikimedia/Mushroom Observer

Marijuana Moment is made possible with support from readers. If you rely on our cannabis advocacy journalism to stay informed, please consider a monthly Patreon pledge.

Ben Adlin is a Seattle-based writer and editor. He has covered cannabis as a journalist since 2011, most recently as a senior news editor for Leafly.

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Bipartisan Lawmakers Push VA To Allow Medical Marijuana Access For Veterans ‘As Soon As Possible’

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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: 

Click to access caucus-letter-to-va-secretary-december-2021.pdf

Biden Treasury Secretary Says ‘Of Course’ Marijuana Banking Would Make IRS’s Job Easier

Photo courtesy of Chris Wallis // Side Pocket Images.

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Biden Treasury Secretary Says ‘Of Course’ Marijuana Banking Would Make IRS’s Job Easier

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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.

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

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Texas Activists Turn In Signatures To Put Marijuana Decriminalization On Austin’s 2022 Ballot

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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.

“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.

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.

A bill to expand the state’s medical cannabis program and another to require a study into the therapeutic potential of certain psychedelics for military veterans were enacted.

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 House approved a cannabis decriminalization bill in 2019, but it did not advance in the Senate that session.

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.”

Jamaican Government Launches ‘Good Ganja Sense’ Campaign To Debunk Marijuana Myths

Photo courtesy of Brian Shamblen.

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