The psychedelic researchers that took issue with five tryptamines being classified as schedule 1 controlled substances will have their chance to present their case this spring.
Some good news today for psychedelics advocates: A judge has granted a hearing for opposition of the U.S. Drug Enforcement Agency's proposal to add five more hallucinogenic compounds in schedule I of the Controlled Substances Act.
The regulator announced intent in January to criminalize 4-Hydroxy-N,N-diisopropyltryptamine (4-OH-DiPT), 5-Methoxy-alphamethyltryptamine (5-MeO-AMT), N-Isopropyl-5-Methoxy-N-Methyltryptamine (5-MeO-MiPT), N,N-Diethyl-5-methoxytryptamine (5-MeO-DET), and N,N-Diisopropyltryptamine (DiPT); not just for possession, distribution, import, export or manufacturing, but even research, instructional activities and chemical analysis.
Administrative Law Judge Teresa A. Wallbaum issued an order today declaring a prehearing conference regarding this matter will be conducted by video conference on May 4 at 1 PM ET. In wake of receiving four different requests for a hearing from a mix of psychedelic industry professionals and researchers, Judge Wallbaum ordered that the government file a prehearing statement no later than March 28, and further ordered that each party requesting a hearing file prehearing statements no later than April 27.
A 28-page DEA report — authored in August of 2021, and based on Department of Health and Human Services reviews of these psychedelics from 2012 — states, “These five tryptamines have no known medical use in the United States and are not marketed internationally as approved drug products. They have all been reported as drugs of abuse in the U.S. by law enforcement authorities and identified in seizures.”
The document concludes that these five tryptamines meet requirements for schedule 1 classification because of the following three factors: The drug has a high potential for abuse, the drug has no currently accepted medical use in treatment in the United States, and there is a lack of accepted safety for use of the drug under medical supervision.
As Psychedelic Spotlight previously reported, Washington State biotech company Panacea Plant Sciences was the first to formally request a hearing. CEO David Heldreth argued in a six-page oppositional response that, “The attributed risk and dangers are overblown by DEA analysis. Further, the risks named, science cited and data used for this process started in 2008 and much of the cited info is outdated.”
“At the moment hallucinogens/psychedelics are having a revival for their use as medical treatments,” Heldreth wrote. “This is due to the apparent connection between 5-ht2a agonism and the ability to provide long term relief from and treatment of depression, anxiety, addiction, PTSD and other mental health conditions. 5ht2a receptor agonism has been identified as a primary mechanism of medical benefit.”
“As such it is intriguing to see the DEA document in the docket which is entitled Five Tryptamines Eight-factor Analysis DEA 082021 where one can see the 5ht2a activity and binding levels used as reasons to make these compounds illegal,” the letter continues. “This same activity is precisely why these compounds do, in fact, have medical uses.”
According to today's filing, it appears Heldreth's argument had already convinced Judge Wallbaum to hold a hearing, which she initially set for April 5, and then rescheduled after more three more hearing requests were filed by Kykeon Biotechnologies Inc. and Tactogen Inc., researchers Dr. Jason Wallach and Hamilton Morris, and healthcare advocate Amy Rising.
Dr. Wallach and Morris have conducted extensive laboratory research on DiPT over the last 13 years, and argue their research has “yielded few if any anecdotal reports of its abuse.”
“The paucity of unconfirmed anecdotal reports — published anonymously online and thus utterly unverifiable — does not firmly demonstrate abuse or even use of DiPT,” they argued in their joint request for a hearing. “This substance’s unique auditory effects, which are not what one would readily describe as ‘recreational' or ‘pleasurable,' make it inconceivable that DiPT would be widely abused as a tryptamine hallucinogen.”
“No credible abuse potential for DiPT has been demonstrated; there is no documentation of even modest frequency of use, and it has never been implicated in a human death or hospitalization,” the researchers state. “In the almost ten years since the FDA recommended DiPT be placed in schedule I for concerns of abuse, there is no known seizure, hospitalization, or death discernible from the literature.”
The DEA references “significant availability, trafficking, and abuse of a number of tryptamines including 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT” in the report recommending schedule 1 classification, based on “large numbers of encounters of one or more of these tryptamines by U.S. law enforcement.”
However, the encounters listed in the report add up to a grand total of 487, with just one death associated with one of these psychedelics — 5-MeO-AMT in 2004. Even more contradictory to allegations of a threat to public safety, the DEA admits “it is unclear what role 5-MeO-AMT played in the death,” as “the toxicology report also reported alcohol and the presence of an antidepressant, bupropion.”
For comparison, the National Highway Traffic Safety Administration reported 10,142 deaths from drunk-driving crashes in 2019.
Psychedelic Spotlight will continue to monitor and cover developments relating to this proposal.
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