The Drug Enforcement Agency listens to psychedelic experts

By Professor David Nutt and James Bunn

The Drug Enforcement Agency (DEA) recently withdrew a proposal to ban five psychedelic substances:

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).

Earlier this year, the DEA proposed that these substances ought to be moved to schedule 1 (the most restrictive schedule in the Controlled Substances Act). However, the DEA has since rescinded that decision based on the expert testimony of Professor David Nutt and other academics and advocates.

Matthew Zorn of Yetter Colemann LLP and Graham Pechenik of Calyx Law LLP co-led the litigation proceedings against the DEA’s decision, and they had the following to say:

Matthew Zorn

“We are Immensely grateful for the support of Drug Science and Dr. David Nutt, the world’s leading psychopharmacologist, in this endeavor and achieving an unprecedented victory for drug science. The mental health crisis continues to grow, but it is a silent killer. It is imperative that industry, scientists, and academics who want to do the work be able to do the work and not be impeded by overly restrictive drug regulations.”

Graham Pechenik

“DEA’s abrupt withdrawal of their scheduling proposal came after an extraordinary effort by companies and scientists such as Prof. David Nutt to demonstrate why psychedelics are inappropriate for Schedule I. But it’s a travesty that so much work is needed to sway the DEA—since research from Prof. Nutt, Drug Science, and others has demonstrated for decades that psychedelics are safe and lack abuse potential. It is long past due for DEA to recognize their regulatory approach to drugs is based neither on reason nor science, but on an unjust and shameful war on drugs that must be ended.”

Professor David Nutt’s argument against the scheduling of these substances

Our understanding of psychedelic drugs has come a long way since the first wave of clinical experimentation. While their potential range of psychological and psychiatric risk remains to be fully understood, the physiological safety of psychedelics is by now relatively well established and they are one of the safest known classes of Central Nervous System drugs.

Drug control has obstructed our ability to understand the psychological and psychiatric risks of these substances. Initial classification decisions according to laws made in the 1960s and 70s were made in view of misunderstandings of the science and without the benefit of more modern science that allows a proper understanding of their pharmacologies and toxicologies. These classifications, including those under the Controlled Substances Act, appear to be unclear, inconsistent, and made for political rather than health-related reasons.

At a first glance, this does not seem to be particularly problematic. However, obtaining permissions to study Schedule I substances takes a significant amount of time and subjects the license holder to regular administrative reviews. As a result, many researchers and small businesses that would like to work on these substances and develop new medicines lack the resources to do so. Even researchers who use only sub-hallucinogenic doses must comply with these regulations.

Moreover, if an investigator can obtain all the necessary approvals and licenses to study a Schedule I drug, the problem then becomes obtaining the pharmaceutical substance, because these substances are not available from most chemical manufacturers because they are Schedule I substances. Those that do supply these substances can charge exorbitant prices, for example, $12,000 per gram for psilocybin. Until recently, no company was committed to manufacturing medical-grade psychedelics.

For at least the reasons I just explained, there has been a de facto severe censorship on research into many psychoactive drugs over the past 50 years. The one exception has been government-sponsored studies focused on identifying the negatives (for example, brain-impairing) properties of psychoactive drugs. This close-minded approach only goes to further stigmatise these substances as the tenuous link between ‘risk/harm’ and legal status has unravelled over the past 50 years. Recently, we have expanded our knowledge regarding the potential medical benefit of psychedelic substances to individuals and society. If the initial classification of a substance was a mistake based on incomplete or grossly misunderstood science, then a subsequent classification predicated on the initial classification is no less a mistake.

Drug Science is grateful that the DEA were willing to overturn their decision regarding the scheduling of these five substances. In fact, we welcome regulators to question whether a substance ought to be scheduled, so long as they are willing to listen and engage with evidence-based science. Repentant leadership ought to be commended and we hope that decision-making such as this is duplicated in the UK and the EU.

What about UK and EU regulations? 

Tadeusz Hawrot – Founder and Policy Lead at the Psychedelic Access and Research European Alliance (PAREA) had this to say about the recent decision:

Tadeusz Hawrot

“I’ve had a pleasure to work with PAREA Chair Prof. David Nutt for more than a decade. He is one of the most prominent advocates for reducing drug-related harm and for advancing the psychedelic renaissance by grounding it firmly in scientific evidence. As David once said, “the War on Drugs wasn’t so obviously the wrong thing to try in the 1970s, but today it is clearly doing more harm than good”. Today, it is difficult to understand why it took the DEA several decades to realize that a moral crusade against drugs is anything but fit for purpose. Likely, they are one of the last bastions of those who still need to “change their minds”. I very much hope that the next fortress that follows the science will be the European Union.”