The Bureaucratic Burden on Psychedelic Science

“Even though there are snakes in the world, it’s good to go barefoot so you can feel the grass between your toes.”

—Ted Roberts

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The War on Drugs, the near-uniform drug policy of global governments, has increased violence, crime, death, disease, and incarceration. A less obvious result of the prohibitive and punitive approach to drug policy is stunted scientific progress resulting from bureaucratic friction.

Something’s Rotten in the State of Drug Policy

As a parent of an energetic three-year-old boy, I deeply understand the parental impulse to prohibit certain behaviors to keep him safe. For example, not far from our house is a beach with a barrier built with enormous boulders between the sand and the road that my son loves to climb, and I would be justified if I didn’t allow it for his safety. He could fall and hurt himself, and of course, my job is to protect him. However, he loves to climb, and the body awareness, movement dexterity, balance, and confidence that comes from climbing will serve him well in many areas of his development.

So I let him climb.

I keep an eye on him and don’t let him get into a truly dangerous position, but I let him explore and test his capacities.

I believe that if I prohibited him from climbing, insisting it was for his own good, he would resent me for it, the trust between us would erode, and I would be robbing him of an opportunity to build confidence and self-belief.

Along similar lines, I also understand the impulse to punish undesirable behavior. But, in my experience, when I find myself prohibiting or punishing my son, it is mostly based on managing my own fear, anxiety, or anger rather than a consideration of what is best at the moment for him.

In pausing and considering the options available, a more nuanced approach to these situations is most beneficial for my son’s development, even though a reflexive scolding or stern “no” is easier in the moment. (Actually acting on this insight is another matter, sorry kid.)

Like parenting, the impulse for a government to adopt prohibition and punishment as an approach to managing the cultivation, sale, and use of certain classes of substances is understandable but far from optimal.

In fact, this approach has been one of the most destructive policies in history.

However, the extent to which current drug policy, predicated on prohibiting and punishing drug use and drug commerce, is not the point of this post, there are ample resources to understand better this phenomenon including a CATO Institute Report:

“We conclude that prohibition is not only ineffective but counterproductive, at achieving the goals of policymakers both domestically and abroad. Given the insights from economics and the available data, we find that the domestic War on Drugs has contributed to an increase in drug overdoses and fostered and sustained the creation of powerful drug cartels. Internationally, we find that prohibition not only fails in its own right, but also actively undermines the goals of the Global War on Terror.”

While such reports focus on the economic and geopolitical burden, crime, deaths, and disease burden, here I am interested in the effects of prohibition and the controlled substances act on the scientific study of psychedelics.

The prohibitionist and punitive stance on drugs taken by global governments have thwarted scientific understanding to the detriment of society and personal wellbeing.

While the initial halt to research in the ’60s and ’70s has been well documented, and the excitement around current clinical trials is top of mind, I am interested in understanding the result of bureaucratic friction that drug policy has created for scientists and researchers interested in psychedelics.

Counter to the prohibitionist position on research, there are two essential reasons for doing science with controlled substances:

1. Many, many, many people use drugs regardless of their legality, and it would be helpful to better understand the effects, risks, and benefits.

2. Many controlled substances, including naturally occurring substances and those created out of human ingenuity, the so-called novel psychoactive substances (NPS) likely have utility for human flourishing and medicine—we should know these benefits and how to use these substances.

However, the collateral damage to scientific progress resulting from the government’s approach is best captured by the below image:

From: An ethical exploration of barriers to research on controlled drugs

The Catch 22 of Controlled Substances on science and the Public good

“An important and unfortunate outcome of the controls placed on these and other psychoactive drugs is that they make research into their mechanisms of action and potential therapeutic uses — for example, in depression and post-traumatic stress disorder — difficult and in many cases almost impossible” —Prof. David Nutt

The Catch-22 stems from the fact that it was arbitrarily and without proper scientific understanding determined in that these substances have no medical utility and high abuse potential. Even Bobby Kennedy questioned the rationale for categorizing LSD as such:

“Why if [clinical LSD projects] were worthwhile six months ago, why aren’t they worthwhile now? I think we have given too much emphasis and so much attention to the fact that it can be dangerous and that it can hurt an individual who uses it that perhaps to some extent we have lost sight of the fact that it can be very, very helpful in our society if used properly.”

As a result, the laws and regulations governing scientific research are incredibly strict, which has effectively stunted work that could establish the effects and risks of these substances.

Let’s say you’re a scientist and you want to research Schedule 1 controlled substances—here’s a primer on the challenges ahead:

IRB

You need approval from a credentialed authority known as an Institutional Review Board (IRB), which is tasked with gauging the ethics and risks of a research project. MAPS has had issues of IRBs being spooked in the past, but I sense that IRBs, like the FDA, are capable of taking a science-first approach, and IRB approval is a less significant hurdle.

Funding

Funding for science comes from governments, philanthropies, and commercial investment. We see a flurry of commercial investment into psychedelic projects. Still, funding agencies like the NIH, National Science Foundation, and the Veterans Affairs are beholden to current drug policy, and grants for controlled substances are still viewed as dangerous and less prestigious.

Organizations like MAPS and Usona and researchers like Rolland Griffiths have had to rely on large donations from individuals and philanthropic organizations, which by comparison have been minimal.

State and Federal DEA Licenses

Then, you need to get permission from the state and federal government—this varies country to country but is somewhat uniform based on the adoption of the United Nations’ Single Convention on Narcotic Drugs and subsequent Psychotropic Substances and the broad acceptance of the Comprehensive Drug Abuse Prevention and Control Act of 1970—in the US you’re going to first apply for a state DEA license. Then you’ll be eligible for a federal DEA license.

The application process can take months or years. Dr. Nutt, in his 2013 paper, notes the burden for researchers in England:

“Applying for a licence takes about 1 year, costs many thousands of pounds and, once granted, is subject to regular police reviews. As a consequence, many researchers who would like to work on these pharmacologically fascinating substances cannot afford to do so.”

Psychedelic Scientist James Rucker in a 2015 opinion piece in the British Journal of Medicine:

“These restrictions, and the accompanying bureaucracy, mean that the cost of clinical research using psychedelicsis 5-10 times that of research into less restricted (but more harmful) drugs such as heroin—with no prospect that the benefits can be translated into wider medical practice. The self reinforcing cycle of stigma generated by schedule I classification means that almost all grant funders are uncomfortable funding research into psychedelics, and similar problems are encountered with ethics committees.”

Getting and Storing Study Drug

Obtaining study drugs is not as simple as logging onto an encrypted browser and ordering from a reliable source on the latest iteration of Silk Road. Manufacturers, too, are beholden to licensing requirements, strict audit procedures, and compliance that adds costs and complexity. James Rucker again:

“However, larger clinical studies are almost impossible throughout the Western world because of the practical, financial, and bureaucratic obstacles imposed by schedule 1 classification or its equivalent. For example, because of the burden of compliance with the UN’s schedule I, only one manufacturer in the world produces psilocybin at sufficient quality, quoting our group a prohibitive £100 000 for 1 g (50 doses).”

Another example of this process comes from MAPS Canada, as highlighted by David Nutt in a 2013 paper:

“it took a research group in Canada sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS) more than 4 years to obtain approvals to import MDMA from Switzerland for a trial of its therapeutic use in post-traumatic stress disorder (PTSD) in Canada, even after Health Canada (the department of the Canadian government that is responsible for national public health) and a Canadian Institutional Review Board had approved the protocol design”

Adding further complexity, time, and resources, the DEA and equivalent federal agencies require meticulous and paranoid-like storage and recording keeping of Schedule 1 substances. Again from Prof. Nutt:

“In addition, if researchers do obtain approval to use the drugs, the rules regarding the storage of the drug in the laboratory are stringent. For example, in a trial of psilocybin for patients with cancer in the United States, the researchers were required to ensure that the few milligrams of substance was weighed daily by two people to protect against theft”

Another burden is the possibility of an unannounced DEA audit, which could shut down a research program if any of the requirements are not met.

Second-Order Effects: Hindering Non-commercial Research

We’ve established the difficulty that scientists have in getting approval, funding, permission, and drug supply. The ultimate effect of this burden is that interesting and useful research doesn’t get done, our understanding lags, and potential solutions to severe illnesses go unfounded.

There are many categories of medical research, and the type that’s getting the most attention at the moment in psychedelics is clinical research, which involves giving a study drug (or placebo) to human subjects to understand if it works.

MAPS, Usona, and COMPASS pathways are furthest along in their clinical research programs, and many others (MindMed, Perception, DemeRx, etc.) are in the earlier phases.

Typically, clinical trials are funded by pharmaceutical and biotech companies that hope to create a marketable drug.

However, clinical trials are built on the foundation of basic and translational research, which aims to understand the underlying molecular biology, chemistry, genetics, and safety by conducting experiments with cellular cultures, animals, and other means.

This foundational work in most areas is done at universities or other non-commercial research laboratories. It is funded in the traditional way, namely through grants from government and philanthropic agencies.

However, as we noted, psychedelics because of their Schedule 1 classification are not readily funded by these traditional avenues, and the pipeline of new projects entering clinical trials is stunted.

The problem we now face is that even with increasing interest in psychedelic science, the challenge posed by Schedule 1 restrictions is still the primary barrier to the wide-ranging translational and pragmatic research needed for new treatment modalities and to better understand the use of psychedelics as therapeutic tools.

My suspicion is that as the field of psychedelic science moves further down this pipeline, non-commercial translational and pragmatic research will be stunted.

The role of such research is to lay the groundwork for future commercial clinical trials, but also to understand broader questions about the effects of drugs in specific populations, identify additional uses, clarify risks in larger studies, and others.

This breed of non-commercial translational, pragmatic, and clinical research and the insights it offers to providers and patients to make informed decisions will be lacking as psychedelic medicine enters the market and as a result, we’ll have an inconclusive understanding of how best to use these tools.

Climb Rocks My Son

There is no doubt that medical research comes with its risks.

There is no doubt that there are risks to using drugs currently listed as schedule 1 controlled substances.

But the approach of essentially blocking scientific inquiry stunts the growth and development of human society.

For many, it may seem paradoxical, but by unburdening society and science through easing laws and regulations around consumption and study of controlled substances we can move towards a world of less suffering and greater human flourishing.