Christopher Koddermann is the Co-founder and Chair of Board of the International Therapeutic Psilocybin Rescheduling Initiative (ITPRI), a global coalition launched to pursue and secure a rescheduling of psilocybin under the 1971 Convention on Psychotropic Substances. ITPRI’s partners include MAPS, the Beckley Foundation, Drug Science, the Open Foundation, the Osmond Foundation, the Heroic Hearts Project UK and Mind Medicine Australia.
In addition to his work with ITPRI, Christopher runs a Swiss-based public affairs consultancy serving clients operating in complex, highly regulated, multi-stakeholder industries, including for-profit and not-for-profit clients active in psychedelics. Prior to launching Koddermann Public Affairs, Christopher held senior communications and government affairs leadership roles in the corporate sector. In addition to his other activities, Christopher is a member of Drug Science's Medical Psychedelics Working Group.
What is the International Therapeutic Psilocybin Rescheduling Initiative and why did you create this initiative?
The International Therapeutic Psilocybin Rescheduling Initiative (ITPRI) is a global coalition that was launched to promote and secure a rescheduling of psilocybin under the 1971 Convention on Psychotropic Substances.
In most jurisdictions, legal control of psilocybin and other psychedelics results from the 1971 Convention. Negotiated in response to the growing popularity of psychedelics and amphetamines in the 1960s, the 1971 Convention contains four Schedules of controlled substances, ranging from Schedule I, the most restrictive, to Schedule IV, the least restrictive. Schedule I includes psychedelics drugs such as psilocybin, MDMA, mescaline and LSD, whereas Schedules II through IV are mainly composed of licitly manufactured pharmaceuticals. The evidentiary basis for including various psychedelics compounds in Schedule I is unclear but appear to have been based largely on political considerations and a presumption that these drugs offered no medical benefit and posed a high risk of abuse and dependence.
These scheduling decisions and implementing legislation such as the U.S. Psychotropic Substances Act, the UK Misuse of Drugs Act 1971 and the Canadian Controlled Drugs and Substances Act make conducting research on these drugs, either basic or clinical, both costly and difficult. State Parties to the 1971 Convention are obligated to implement the Convention’s special provisions regarding substances in Schedule I. These provisions provide for a level of regulatory control and supervision that is drastically more onerous than for those drugs in Schedules II through IV. As a result, researchers wishing to study psilocybin face numerous regulatory hurdles which create significant barriers in terms of the cost, complexity and length of time required to carry out research and advance the development of treatments.
Given that Schedule I is meant to be reserved for drugs that are an especially serious risk to public health in terms of their abuse liability and offer very little, if any, therapeutic benefit, our aim is to get psilocybin moved out of Schedule I. Such a change will allow parties to the treaty to remove many of the regulatory controls that are presently hindering research and the development of treatments for patients.
Your experience lies in government affairs, public policy and communications, advising clients operating in complex, highly regulated, multi-stakeholder industries. How did you become interested in psychedelics and their medical potential?
I was first introduced to the topic of psychedelics at the age of about 14 or 15 when I read Tom Wolfe’s The Electric Cool-Aid Acid Test, which details the writer Ken Kesey’s participation in a government psychedelic research program at Menlo Park Veterans Hospital. That program involved the testing a variety of psychoactive drugs such as LSD and was later revealed to be part of the CIA’s MK-Ultra Project. This led me to discover the extensive research that had taken place during the 1950s and 1960s on the use of various psychedelics to treat mental illness and addiction.
As a result of this, I was fascinated to discover a number of years ago that Johns Hopkins, Imperial College London and others were undertaking research on the potential therapeutic applications of these drugs. Given how woefully underserved those suffering from mental health issues have been it was immediately obvious to me that the public health benefits of these drugs were potentially massive in scale. After following developments for a couple of years I decided to launch this initiative. I now spend a considerable amount of my time working on psychedelics issues, both through ITPRI and my public affairs business, which includes several clients operating in the space.
What impact would having psilocybin rescheduled under the United Nations 1971 Convention on Psychotropic Substances have on the psychedelics medicinal therapies space?
Rescheduling procedures under the 1971 Convention offer a significant opportunity to advance further research and accelerate the development and approval of treatments for patients by providing State Parties to the treaty with the legal flexibility and evidentiary basis adopt changes in regulatory controls for scientific and medical use. With such changes, governments can either remove or lower many of the barriers that currently make conducting research on psilocybin so complex, costly and time consuming.
I believe there are a number of governments that may be minded to make changes to their domestic regulatory regimes were it not for their obligations under the 1971 Convention and the often very complicated and risky politics around changes in drug policy. Rescheduling would address both these barriers in a way that would allow these governments to act. In the case of other governments, I believe that rescheduling would provide a strong signal that their domestic regimes need to be re-examined. And of course, there is also the very important symbolic impact that would result from a rescheduling recommendation from the World Health Organizations Expert Committee on Drug Dependence, which would be based on a recognition that psilocybin offers medical benefits and is not an especially serious risk to public health in terms of its abuse liability.
Can you explain the rescheduling process and how you hope to work towards rescheduling?
Scheduling decisions in terms of adding substances or changing the scope of control are governed by scheduling procedures detailed in the Convention and fall under the purview of the UN Commission on Narcotic Drugs (CND). Broadly speaking there are essentially three steps to the process of getting a drug rescheduled.
First, is to get a review initiated. Formal scheduling or ‘critical reviews’ as they are called, may be initiated either by the World Health Organization or by any State Party to the treaty. In other words, any one of the 184 governments that are a party to the treaty may call for a review of psilocybin’s current scheduling status. In addition to a “critical review” there is also something called a “pre-review” which can be undetaken to assess whether a critical review is justified based on current evidence. Pre-reviews may be initiated by the WHO Secretariat, any member of the WHO’s Expert Committee on Drug Dependence (ECDD) or any one of the various organizations invited to participate in ECDD meetings such as the UN Office on Drugs and Crime or the International Narcotics Control Board.
Second, once a review is initiated the ECDD, which is composed of independent experts in the field of drugs and medicines, is tasked with making a scheduling recommendation based on a medical and scientific assessement of the drug in question. This involves them examining such things as a drug’s pharmacology, toxicology, pharmacokinetics, pharmacodynamics and the degree to which there exists an illicit market for it. In making scheduling recommendations, the ECDD must weigh two considerations; 1) a drug’s therapeutic usefulness and 2) the risk, if any, its presents to public health in terms of its abuse liability. According to guidance adopted by the WHO Executive Board in 2010, drugs should only be included in Schedule I if they are an especially serious risk to public health and have very little, if any, medical benefit.
Third, where a critical review is undertaken and a WHO scheduling recommendation provided, the CND will vote on the WHO’s recommendation, which it may accept or reject. While the Commission may consider legal, administrative, economic, social and other factors in reaching its decision, the 1971 Convention specifies that assessments by the ECDD are determinative as to medical and scientific matters. In other words, the CND must accept the findings of the ECDD and cannot base its decision on other medical or scientific views. CND decisions are subject to review by the UN Economic and Social Council if any party to the Convention objects to the CND’s decision within 180 days.
To succeed in our efforts to secure a rescheduling of psilocybin we will need to be active during all three stages of this process but obviously our initial focus is to get a review initiated. For that first critical step we are engaging a number of governments we believe are candidates for a State Party initiated review but will also be engaging with the WHO, ECDD and other organizations that can initiate either a critical review or pre-review.
Who else has joined you in this coalition?
We are fortunate to have put together a truly international coalition which includes many of the leading organizations in the world of psychedelics. Currently, our partners include the Beckley Foundation, Drug Science, MAPS, Nierika AC, the Open Foundation, the Osmond Foundation, the Heroic Hearts Project UK and Mind Medicine Australia. We’ll soon be announcing the addition of another partner and will be looking to add others who can add value to our efforts.
We are also privileged to be supported by an advisory board, which is composed of an exceptional group of individuals representing a diverse set of backgrounds from the fields of research, advocacy, business, international law, human rights, and public and international administration, including several individuals with direct experience in the field of international drug control.
What do you believe is the most common misconception about psychedelics?
Despite the progress that has been made over the last few years in terms of public awareness when it comes to the therapeutic value of psychedelics, I think there remains a lot of misinformation and misunderstanding regarding the potential dangers of these drugs. There are many people who still view psychedelics as highly addictive and dangerous substances. While these are obviously very powerful drugs that need to be approached with a great deal of care and respect, I think the evidence is overwhelmingly clear that these drugs are not addictive nor a threat to public health in the way other drugs may be viewed. At the same time, I think it’s important that we recognize that these drugs are not without some risks and that they need to be made available in a manner that prioritises patient safety.
What do you see the future of psychedelic medicines being and what will their impact be on healthcare as a whole?
That’s really the million-dollar question. Obviously so much depends on the success of different research and drug development efforts in advancing various compounds through pre-clinical and clinical studies in order to establish safety and efficacy for treating an ever-lengthening list of mental health, neurological and neurodevelopmental conditions. In many cases, the research on the use of particular compounds for specific indications is at such an early stage of the drug development process that we are a long way from knowing which drugs will be eventually used to treat which conditions. As the same time, there are drugs like psilocybin that clearly appear to be of substantial benefit for a significant percentage of patients suffering from conditions that affect very large patient populations. On that basis, I think it’s safe to conclude that even if many of the early-stage research efforts fail the overall public health impact of psychedelics is likely to be massive, particularly considering the ineffectiveness of the current standard of care available for many conditions.
If you succeed with this initiative, what will your next steps be?
At the moment we are very much focused on our efforts to get psilocybin rescheduled. However, if we succeed, and I am confident we will, there are a number of other psychedelic compounds that are showing great promise in terms of their therapeutic value. Undoubtedly research efforts on these drugs would benefit from a move out of Schedule I of the 1971 Convention. We’ll take this one step at a time, but I suspect there is plenty of work to keep us busy over the coming years.