Drug Policy & Psychedelics
Updated: Aug 29, 2022
Current Events: DEA attempts to schedule several psychedelics
On January 14, 2022 the Drug Enforcement Agency (DEA) proposed the scheduling of five hallucinogenic tryptamine compounds as Schedule I. This proposed rule was withdrawn on Wednesday July 27, 2022. The rule was challenged on many fronts: litigation by Matt Zorn, companies Tactogen Inc. and MindState Labs represented by Graham Pechenik, Panacea Plant Sciences CEO David Heldreth, and researchers Hamilton Morris and Jason Wallach represented by John T. Hunter.
The main argument surrounding this proposed rule was questioning whether the analysis supporting the proposal may be deemed to be, “arbitrary, capricious, contrary to law, or lack[ing] substantial evidence.”
Many others also came forward and requested hearings, logged public comments and provided testimony in the case stating that the compounds in question don’t have abuse liability, and that scheduling them would impede promising research into their potential as therapeutic or tools to understand the brain.
The DEA stated that they have "determined that it is appropriate to submit a new request to HHS for an updated scientific and medical evaluation and scheduling recommendation for these substances." This means that for now, these substances can be researched freely, but the DEA can try to schedule them again at a later date.
On May 2, 2022 the DEA proposed the scheduling of DOC/DOI, two phenethylamine psychedelic compounds, as Schedule I. In a similar fashion, there was an outcry by scientists, advocates and others surrounding this proposed rule.
Several people logged public comments and multiple groups of scientists and activists filed petitions with 30+ signatures, with large efforts by Michael Cunningham co-founder of Gilgamesh Pharmaceuticals, Elijah Ullman and Lindsay Galbo from Students for Sensible Drug Policy, and Harrison Elder, a PhD student from Virginia Commonwealth University. A pre-hearing to present testimonial statements and challenge this proposed rule is set to take place September 30th, 2022 with challengers including a group led by Ullman and Galbo that includes Dr. David Nichols - who has challenged the DEA in regards to scheduling DOI previously. Panacea Plant Sciences CEO David Heldreth will also be at the pre-hearing following a separate request for hearing.
So all of this begs the question, why is the DEA suddenly attacking psychedelics?
What is the Controlled Substances Act?
It goes back to the 1970s, specifically 1971. The controlled substances act is the federal U.S. drug policy under which the manufacture, importation, possession, use and distribution of certain narcotics, stimulants, depressants, hallucinogens, anabolic steroids, and other chemicals is regulated. Basically, it's how the government decides which drugs are "bad" and which drugs are "good" based on a few things.
The scheduling goes from V to I, with Schedule I being the most regulated. Schedule I compounds have no accepted medical use and high potential for abuse. Examples listed on the DEA's website include MDMA, LSD, heroin, and marijuana. The difference between Schedule I and II, is that Schedule II compounds are known to have some medical value, including those drugs considered more dangerous like fentanyl, methamphetamine and cocaine. So what determines which drug goes in what level?
The 8 factors for scheduling drugs:
There are a few issues with these factors, as well as some other policy that goes into keeping drugs scheduled and scheduling new ones.
Paperwork and Obligations
You may have noticed that cannabis is a schedule I compound, despite the Food and Drug Administration (FDA) approving two THC-based medications, dronabinol (Marinol®) and nabilone (Cesamet®). Both of these medications are prescribed in pill form for the treatment of nausea in patients undergoing cancer chemotherapy and to stimulate appetite in patients with wasting syndrome due to AIDS. That sounds like approved medical use to me!
In 2020, there was a petition to reschedule cannabis to a Schedule II standing, but this was dismissed by the DEA. Petitioners asked for a formal process including public comment and hearings similar to proposed rule for scheduling new compounds, but they were denied. The federal appeals court denied this as well, suggesting that "petitioners failed to exhaust their administrative remedies with the DEA." The process for rescheduling is rigorous and involves several steps, including analyses of current scientific literature and evidence, and a whole lot of paperwork. There has been very times where the DEA has rescheduled a compound. For example, in 2014 they rescheduled hydrocodone combination products, the opioid prescription pain medications, from schedule III to schedule II following the increase in opioid addiction following the popularization of these compounds.
As for the case of DOI, one of the main reasons the DEA is attempting to schedule it is "to enable the United States to meet its obligations under the 1971 Convention on Psychotropic Substances." This is a United Nations treaty designed to control psychoactive drugs such as amphetamine-type stimulants, barbiturates, benzodiazepines, and psychedelics. By not scheduling DOI, the United States is technically not in accordance with the Convention. This treaty is one of the major reasons that drugs most likely will never be unscheduled.
Gatekeeping what is and is not beneficial
You may have heard of a term called "The War on Drugs." It's the longest standing war on American soil and it's been threatening the freedom and pursuit of happiness of folks for years.
Before America was ever formed, the use of psychoactive and mind-altering substances occurred for a variety of reasons in cultures around the world. Native American tribes have used these compounds for thousands of years, whether it was peyote as sacred sacrament, tobacco leaves for meditation and clarity, to the use of psilocybin mushrooms for visions. Other cultures in Asia and India also used plants and plant medicines to induce altered states of consciousness, such as opium from poppy plants.
So how did we end up here? In a place where the government is regulating what individual and collective cultures decide is or is not beneficial for them? That answer is extremely complicated, but according the US it was to battle against illegal drug trade and help prevent people from becoming addicted to drugs. They only later realized that they could use the War on Drugs to justify racism and classist ideals, targeting the black and poor during the so-called crack cocaine epidemic and even before with "reefer madness." The War on Drugs has allowed the government and corporations to profit off of cheap labor funneled through the prison industrial complex, and further their power into deciding which drugs are "bad" and which drugs are "good." The good drugs usually consist drugs that are socially acceptable (caffeine, alcohol, nicotine) and the bad drugs usually consist of drugs that have negative connotations brought on by scare tactics, poor education and problematic legislation (heroin, cannabis, methamphetamine).
Back to psychedelics...
Psychedelics were originally scheduled in 1971 following the popularized use in the hippie counterculture and failure of the CIA to use these compounds as weapons. The DEA's continued reasoning to keep psychedelics as schedule I substances and keep scheduling new ones doesn't make any sense given the current climate in research.
Literally the day before the announcement to schedule the tryptamines, the National Institutes of Health (NIH) were hosting a government sponsored titled, “Psychedelics as Therapeutics." At this workshop, research scientists from around the world presented groundbreaking evidence for the use of psychedelics to treat mental health issues, substance use disorders and understand consciousness. But yet, here we are.
The basis of the decision for the ongoing battle with the DEA and psychedelic regulation comes from a long history of misunderstanding scientific evidence surrounding these compounds. The War on Drugs plays a huge role in this, but we're going to end with three points:
Psychedelics have not been properly investigated to assess abuse liability, widely used animal models have not reliably showed any abuse liability of classical psychedelics. Anecdotal reports of use in humans exist, but recreational use of psychedelics should not be classified as "abuse."
The medical use of certain psychedelics has been used for thousands of years and has been recently evidenced by several clinical and preclinical studies, these are just not "acceptable" to the DEA. The FDA has even granted special considerations for some the indications of psychedelics.
Scheduling of compounds, especially has Schedule I, prohibits further investigation into the 8 factors that the DEA uses to schedule substances in the first place. The scheduling of compounds doesn't make them any less used, it just makes them more difficult to understand and learn from.
If you're interested in this topic and want to hear from some of the folks involved in the tryptamine and DOI scheduling battle against the DEA check out this panel and register!
References & Links:
The Drug Enforcement Agency listens to psychedelic experts: https://www.drugscience.org.uk/dea/
Inside the Challenge to DEA’s Proposed Scheduling of 5 Psychedelic Tryptamines: https://psychedelicalpha.com/news/inside-the-challenge-to-deas-proposed-scheduling-of-5-psychedelic-tryptamines
DEA notice for DOI/DOC scheduling: https://ehs.ucla.edu/news/april-dea-updates-placement-doi-and-doc-schedule-i
DEA notice of withdrawal of proposed rule against 5 tryptamines: https://ehs.ucla.edu/news/federal-register-notice-withdrawal-proposed-rule-placement-schedule-i-4-hydroxy-nn
Information on drug scheduling:https://www.dea.gov/drug-information/drug-scheduling
The fight for rescheduling of cannabis: https://www.vox.com/2014/9/25/6842187/drug-schedule-list-marijuana, https://www.marijuanamoment.net/court-dismisses-dea-marijuana-rescheduling-case-but-judge-says-cannabis-reclassification-may-be-coming-anyway/
Spiritual, medicinal and recreational use of plants: https://www.science.org/content/article/did-ancient-mesopotamians-get-high-near-eastern-rituals-may-have-included-opium
The War on Drugs: