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DEA Schedule 1 Psychedelic Hearings Coming to Your TV?

What: DEA Hearing to Ban DiPT, 4-OH-DiPT, 5-MeO-AMT 5-MeO-MiPT and 5-MeO-DET
When: 9 AM EST, August 22 to September 2
Where: DEA Hearing Facility, 1550 Crystal Drive, Suite 901, Arlington, Virginia 22202 – *open to the public

If you’ve ever wondered how the government banishes a drug to Schedule 1, you’re in luck. The Drug Enforcement Administration (DEA) is trying to place a series of currently unscheduled psychedelic drugs into the most restrictive category reserved for drugs with no medical benefit. In January, the DEA filed a notice in the Federal Register which announced their intent to place 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) in Schedule 1. Dozens of people submitted comments against the DEA plan, and a few requested a hearing to challenge it.

The DEA announced that it had granted Panacea Plant Sciences (full disclosure: I am the CEO and founder of Panacea Plant Sciences/PPS and am acting pro se as my own counsel for the DEA legal fight) and a collection of other researchers, activists, and lawyers a hearing in February. Now, the hearings between the DEA and the opposition are officially scheduled from August 22 until September 2. These hearings will decide the fate of public access to DiPT, 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, and 5-MeO-DET.

The hearings will be held at the DEA Hearing Facility in Arlington, Virginia, are open to the public, and are expected to be broadcast on TV and the internet as well.


The Wave

As a wave of decriminalization and scientific research on psychedelics sweeps across the United States, the DEA is swimming against the tide. Psychedelics are being shown to be effective to help treat a host of conditions such as: depression, anxiety, post-traumatic stress disorder, addiction, migraines, and more.

The primary mechanism of action for psychedelics from mescaline to psilocin to lysergic acid diethylamide (LSD) is the 5-HT2A receptor. While many other systems are also involved in the actions of psychedelics, this receptor is key to the psychedelic experience and to the medical benefits these compounds hold. This can be equated to the CB1 receptor being involved in the high and anti-inflammatory action of tetrahydrocannabinol (THC).

The DEA is using the activity of the five tryptamines on the 5-HT2A receptor as a reason to move these compounds to Schedule 1. This argument is oxymoronic as it is precisely this 5-HT2A activity which gives these molecules their medical benefits and, thus, should also make them immune from being placed into Schedule 1. In fact, it turns out that these compounds are being studied for medical use, by companies such as Panacea Plant Sciences and Field Trip. Field Trip is holding meetings with the FDA and US government regarding trials for their 4-OH-DiPT related formulations.


The Risk

In the entirety of the records that the DEA has provided to support its case, there have been only a handful of deaths attributed to the five tryptamines. Additionally, deaths have only occurred with comorbid use of psychiatric medications (bupropion and others) along with alcohol and the identified tryptamines. As such, it is likely that these deaths have very little to do with the tryptamines alone and are either directly due to the use of alcohol and psychiatric medications which present a known danger, or from the combination of those items with the drugs.

Additionally, the doses and purity of the drugs used by the affected individuals is unknown. These factors which led to unknown drug dosing and the polydrug use are due to lack of education and transparency associated with the drugs’ prohibition for human use under the Federal Analogue Act of 1986. As such, the public cannot share information directly and openly about their drug use, which exacerbates unsafe drug use. These compounds have only been encountered a few hundred times by law enforcement versus thousands of daily encounters for other compounds. The attributed risks and dangers are overblown by the DEA analysis.


Bad Incentives

The DEA, in its analysis for scheduling, claims that these compounds have not been approved for a medical use. It seems to be curious timing for the DEA to be moving to place items into Schedule 1 which are on the precipice of being proven and/or approved for medical uses. However, if one were to look at how the DEA generates revenues which are used to fund agency actions, you can see some correlations.

Under the Controlled Substances Act, the DEA is in charge of running the process in which drugs are moved into Schedule 1. If a drug is placed into Schedule 1, then only researchers and companies which have a Schedule 1 license (obtainable from the DEA) are able to possess and utilize these compounds. A DEA manufacturer license costs $3,699 just in application fees to the DEA. There are additional fees and inspection costs that go to the DEA. This isn’t considering the massive security costs and legal fees, often upward of $250,000, which don’t go to the DEA.

These fees and costs are also barriers to science as they reduce the pool of researchers which can afford the licenses. Scientists who are studying the 5-HT2A receptors will now have to switch to other compounds (likely to also be eventually moved to Schedule 1) which will lead to an additional barrier to the reproducibility of scientific research.

The fees are also an incentive for an agency to increase the number of items which are controlled to increase the number of licenses. There is also incentive for companies working in the space to encourage the DEA to schedule items which they work with to reduce competition by creating artificial barriers. These incentives are especially strong if a company were to be located in a jurisdiction or country such as Canada where these items continue to remain unscheduled.

In a bizarre case of catch-22, once a drug is moved to Schedule 1, even if FDA trials prove its efficacy for medical use, then only the formula which is studied will then be moved out of Schedule 1. The compound in question would for the rest of the public remain illegal to manufacture or possess. A good example of this precedent is Epidiolex which the FDA approved and DEA rescheduled six months before cannabidiol was made legal in hemp via the Farm Bill. The DEA is taking legal-to-manufacture compounds just prior to FDA trials and making it illegal for anyone except their licensees.

Due to civil forfeiture laws allowing law enforcement to sell property of offenders, there is an additional perverse potential incentive to criminalize compounds. This does not mean that any individual in the DEA is necessarily acting in any particularly corrupt way, but rather that the system which has been created is inherently designed to expand criminalization and benefits from it rather than serving a public good.


What Can You Do?

If you want to lend your support to fighting the DEA effort to criminalize psychedelics, you can attend the hearings and write or call your federal representatives to ask them to decriminalize drugs and tell the DEA they don’t support this process.


About the Author

David Heldreth

David Heldreth is a patented inventor as well as the founder and CEO of Panacea Plant Sciences, a biotechnology company developing a portfolio of cultivation and related IP and patents around the cannabis plant, psychedelic life forms, and formulations. He has testified at the FDA, White House, USDA, DEA, and World Health Organization along with several state legislatures and agencies. He is a leading scientist, educator, and activist in the cannabis and psychedelics communities.

About the author

David A. Heldreth Jr.

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