DEA Failed To Explain Rejection Of Psilocybin Waiver To Treat Cancer Patients, Federal Appeals Court Challenge Says

Lawyers for a doctor in Washington State seeking to legally use psilocybin for end-of-life care argue in a new federal appeals court filing that the Drug Enforcement Administration (DEA) failed to explain a key decision when it denied him access to the psychedelic. They’re asking judges to reverse that move, calling it arbitrary and capricious, and order the government to review the matter anew.

The opening brief filed in the U.S. Court of Appeals for the Ninth Circuit last week is the latest development in what’s become a years-long effort by Dr. Sunil Aggarwal and the Advanced Integrative Medical Science (AIMS) Institute to treat terminally ill cancer patients with psilocybin.

The new action takes aim against DEA’s decision in 2022 to deny Aggarwal’s requests to access psilocybin under state and federal right-to-try (RTT) laws, which 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, and then-President Donald Trump signed the federal Right to Try Act the following year. Dozens of other states have enacted their own right-to-try policies.

Over the years, Aggarwal has presented DEA with multiple proposals in order either to legally cultivate or otherwise obtain psilocybin to treat his patients, arguing that the federal Controlled Substances Act (CSA) must accommodate a path to legally accessing the substance under RTT laws.

“DEA has rejected each request,” the new brief says, “but has never addressed the arguments that Dr. Aggarwal has raised in support of them.”

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Psilocybin, LSD And Other Psychedelics Improve Sexual Satisfaction For Months After Use, New Study Finds

Psychedelic substances, including psilocybin mushrooms, LSD and others, may improve sexual function—even months after a psychedelic experience, according to a new study.

The findings, published on Wednesday in Nature Scientific Reports, are based largely on a survey of 261 participants both before and after taking psychedelics. Researchers from Imperial College London’s Centre for Psychedelic Research then combined those responses with results of a separate clinical trial that compared psilocybin and a commonly prescribed selective serotonin reuptake inhibitor (SSRIs) for treating depression.

Authors say it’s the first scientific study to formally explore the effects of psychedelics on sexual functioning. While anecdotal reports and and qualitative evidence suggest the substances may be beneficial, the study says, “this has never been formally tested.”

“It’s important to stress our work does not focus on what happens to sexual functioning while people are on psychedelics, and we are not talking about perceived ‘sexual performance,’” said Tommaso Barba, a PhD student at the Centre for Psychedelic Research and the lead author of the study, “but it does indicate there may be a lasting positive impact on sexual functioning after their psychedelic experience, which could potentially have impacts on psychological wellbeing.”

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Rhode Island House Panel Weighs Bill That Would Temporarily Legalize Psilocybin

Lawmakers on Rhode Island’s House Judiciary Committee considered a bill on Thursday that would effectively legalize psilocybin mushrooms in the state, temporarily removing penalties around possession, home cultivation and sharing of psilocybin until mid-2026.

The proposal, H. 7047, from Rep. Brandon Potter (D), would not establish a commercial retail system around the psychedelic—at least until after federal reform is enacted. Until then, it would exempt up to an ounce of psilocybin from the state’s law against controlled substances provided that it “has been securely cultivated within a person’s residence for personal use” or is possessed by “one person or shared by one person to another.”

The measure is identical to a bill passed 56–11 by the House last year, though that matter did not move forward in the Senate before the end of the session.

“I don’t think it was that long ago that if you were to put a proposal like this forward, it would be thought of as very controversial,” Potter told the panel on Thursday. “But I think it’s become much more popularized and people are well aware of it, especially when you see just like the abundance and overwhelming amount of clinical research and medical science that is promoting the effects this has had on people.”

“These are not, you know, small, low-budget operations,” he added of emerging scientific research indicating the therapeutic potential of psilocybin. “These are leading medical institutions like Johns Hopkins and Yale and Stanford and so on and so forth—NYU, Columbia.”

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NJ looks to make magic mushrooms legal for recreational use and to treat mental health

It took at least five years of public debate, lobbying and bill amendments for New Jersey to make marijuana legal for recreational use in 2021. Now the state may do the same with psychedelic mushrooms — but much faster.

After it was pulled back for revisions late last year, a bill was reintroduced in the state Senate last week that sets up a legal framework for the manufacture and sale of products containing psilocybin — the chemical in magic mushrooms that produces a hallucinogenic effect.

The bill would decriminalize the use of psilocybin by anyone over 21 and expunge past and pending offenses involving the drug.

Although language in the bill, called the “Psilocybin Behavioral Health Access and Services Act,” is centered around mental health, its provisions would decriminalize recreational use. Anyone 21 or older could “possess, store, use, ingest, inhale, process, transport” 4 grams or less of psilocybin.

Unlike with marijuana, residents would be allowed to grow their own mushrooms for personal use in their homes under the bill.

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Field trip: inside America’s first magic mushroom school

At a forest facility in Oregon, the first US state to allow supervised use of the drug, students work toward becoming licensed trip facilitator.

  • Inside a spacious and light-filled retreat in the forest outside Portland, 30 students sat gazing into each other’s eyes.

A heavy silence filled the room, save for the occasional creaking chair. A soft voice urged the group to envision the pain and joy their fellow students had experienced during their lives, to view them as a friend, a child, a teacher. Some broke into grins, others teared up.

“We never get the opportunity to just look at somebody,” the instructor said.

The intense exercise was a fitting start to the day for students preparing for unconventional careers as facilitators in Oregon’s groundbreaking new psilocybin program.

The state is the first in the US to allow supervised use of the psychedelic for adults 21 and older. In a few months, the students, who include midwives, educators and retirees, could support people through a magic mushroom experience at one of Oregon’s 19 service centers.

But first, they’ll need to complete a program like the one taking place at InnerTrek – the first government-recognized licensed and operating training program in the world, according to staff. After they complete the training, they can go on to apply for their licenses with the state.

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I spent over £100,000 on therapy… but it was taking magic mushrooms that helped me conquer my OCD

On the surface, Pandora Morris, 35, has everything. She’s pretty, blonde, well-connected and has a posh London address – the type of woman you might see on the pages of society magazine Tatler.

But there is a sadness about her cornflower blue eyes which reflect a less golden story. Pandora, a lawyer by profession and scion of a large London banking dynasty, has spent decades battling obsessive compulsive disorder (OCD), which developed into a severe exercise addiction and eating disorder in her early teens.

It has been more than three years since her last ‘relapse’, and though wary of describing herself as ‘cured’, Pandora is now in a very different place to her condition before lockdown, when her heart rate fell to 31 and doctors told her that if she didn’t stop exercising eight hours a day and eat more than 700 calories, she would probably die.

When we meet, Pandora has just come from the studio where she is recording the second series of Hurt To Healing, the podcast she launched in October 2022, in which she interviews experts and those who have struggled with mental health issues.

Pandora certainly knows her subject. Her desperate parents spent the price of a small house on treatments — none of which, including seven months in an eating disorder clinic in South Africa, seemed to work long term.

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DEA Confirms That Psychedelic Mushroom Spores Are Federally Legal Prior To Germination

A top Drug Enforcement Administration (DEA) has affirmed that spores that produce so-called magic mushrooms are not, on their own, federally prohibited.

DEA’s Drug & Chemical Evaluation Section Chief Terrence Boos was asked about the legal status of the spores in a letter from attorney Michael McGuire in November, and he sent a response on Tuesday that clarified the agency’s position.

“If the mushroom spores (or any other material) do not contain psilocybin or psilocin (or any other controlled substance or listed chemical), the material is considered not controlled” under the Controlled Substances Act (CSA), Boos wrote.

“However, if at any time the material contains a controlled substance such as psilocybin or psilocin (for example, upon germination), the material would be considered a controlled substance under the CSA,” he said, as Kight On Cannabis first reported.

This isn’t especially revelatory, as its long been understood that the CSA doesn’t explicitly ban spores that can be used to produce so-called “magic mushrooms.” Rather, it lists the key psychoactive ingredients in psychedelic mushrooms, psilocybin and psilocyn, as Schedule I controlled substances.

Because the spores themselves don’t contain those specific compounds, they are uncontrolled under the CSA.

However, it should be noted that while the spores are technically considered federally legal—as long as someone doesn’t use them to produce mushrooms that contain psilocybin or psilocin—states such as California, Georgia and Idaho do prohibit the spores themselves.

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DEA Calls For Even More THC, Psilocybin And DMT To Be Produced For Research In 2024

The Drug Enforcement Administration (DEA) is now calling for the production of even more THC, psilocybin and DMT for research purposes than it initially proposed for 2024—raising its quotas for those drugs while maintaining already high production goals for marijuana and other psychedelics.

In a notice set to be published in the Federal Register on Wednesday, DEA said it received comments from registered manufacturers requesting increases to previously proposed 2024 quotas for the Schedule I substances in order to “meet medical and scientific needs,” and it agreed to do so in the new final order.

Accordingly, the agency nearly doubled the quotas for delta-9 THC and all other tetrahydrocannabinol, increasing them to 1,523,040 grams and 1,166,130 grams, respectively.

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Could magic mushrooms replace oxycodone?  Ingredient found in psychedelic helps treat chronic pain by reshaping the brain, study suggests

An injection of psilocybin, the key ingredient in so-called ‘magic mushrooms,’ could offer lasting relief from chronic pain, according to new research.

A team of scientists at the University of Michigan found that rats given the psychedelic drug were significantly less sensitive to pain for weeks compared to animals who did not receive it. 

These results suggest that the drug is altering pathways in the brain, the study authors wrote.

Scientists suspect many chronic pain conditions are the result of changes to the brain and spinal cord, not just the body part that’s in pain. 

Psilocybin may modify these pathways rather than just treating the symptoms of pain.

In the new study, rats were given a small injection of formaldehyde in their foot to simulate chronic pain. 

Injections like this can lead to a month or more of hypersensitivity, even in the feet that haven’t been injected.

So, while this pain isn’t the same as a person with a back injury or other chronic pain experiences, it is one way for scientists to study long-lasting pain.

The lab animals were then given either a low-dose injection of psilocybin, a high-dose injection, or an injection of harmless salt water – a placebo to ensure the drug was responsible for the observed effects. 

The low-dose group received 1mg per kilogram of body weight, the equivalent of a microdose, while the high-dose group received 10mg per kilogram, a hallucinogenic dose. 

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New York Bill Would Create Psilocybin Therapy Pilot Program For 10,000 Military Veterans And First Responders

A New York lawmaker has introduced a bill that would create a pilot program to provide psilocybin therapy to 10,000 people, focusing on military veterans and first responders, while the legislature also considers broader psychedelics reform.

Assemblymember Pat Burke (D), who has championed various psychedelics measures over recent sessions, filed the therapeutic psilocybin pilot program legislation on Wednesday.

It would create the program under the state Department of Health, which would be required to provide funding to cover the therapy and develop training guidelines for professional facilitators. It would need to issue a report on findings and policy recommendations to the governor and legislature every two years after enactment.

A total of 10,000 patients could participate, including veterans and their families, first responders and people who suffer from cluster headaches. They would need to reside in the western region of New York.

The pilot program would end if psilocybin is approved for medical use by the federal Food and Drug Administration (FDA).

“Psilocybin therapy offers serious potential benefits to assist with mental health, but it suffers from a lack of substantial medical testing,” a memo attached to the measure says. “This bill would alleviate that problem by establishing a pilot program to test psilocybin therapy’s effectiveness on mental health.”

“This pilot program would help record the effects of this treatment on their conditions in order to better understand the effects of this new therapy which promises substantial benefits,” it says.

Under the legislation, the health department would be able to enter into agreements with experts, non-profit organizations, universities or other institutions “for the performance of an evaluation of the implementation and effectiveness” of the program.

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