Home » Side event: Science in Context: Freedom of Research and Treatment of Controlled Substances

Side event: Science in Context: Freedom of Research and Treatment of Controlled Substances

Organised by the International Center for Ethnobotanical Education, Research & Service (ICEERS), the Multidisciplinary Association for Psychedelic Studies (MAPS), Associazione Luca Coscioni and Science for Democracy.

INTRODUCTION: Marco Perduca (Associazione Luca Coscioni, Science for Democracy)

UN bodies have repeatedly stated that the “world drug problem” needs to be addressed in an “evidence-based” and “human rights-based” way. Regarding human rights, much has been said about the prohibition on the death penalty for drug related offences, non-discrimination policies, and the rights of women, indigenous peoples and other vulnerable groups.

In the meantime, the UN bodies that are based in Geneva are currently discussing the content of Article 15 of the International Covenant on Economic, Social and Cultural Rights (“ICESCR”) (one of the most ratified instruments at the international level) which contains, inter alia, the right to science and the right of science. Article 15 recognizes the right of everyone to “enjoy the benefits of scientific progress and its applications” (the right to science) and demands that States “respect the freedom indispensable for scientific research and creative activity” (the right of science). It continues that “the steps to be taken by [States] to achieve the full realization of this rights shall include those necessary for the conservation, the development and the diffusion of science and culture.”

Although the existence of the rights is clear, the meaning of research, science and evidence within the rights context is not. Science comes from the Latin word “ciencia,” which means “knowledge.” However, over the last sixty years, the three UN Conventions on Drug Control have restricted this notion of knowledge, which now needs a resurrection, due in part to the constant contradiction of principles between the ICESCR and the drug conventions. It is expected that the General Comment on Article 15 of the Covenant will reach consensus within committee by September, so the content of the right to science will be finally available by the next CND session in 2020.

Different panelists from many countries and experiences were invited to this Side Event. The intention is to explain the application of the right to science and the right of science in particular contexts.

CASE STUDY: Researcher experience on MDMA-assisted psychotherapy for Post-Traumatic Stress Disorder (“PTSD”) research & clinical trials – presented by Keren Tzarfaty, PhD therapist & researcher (Israel)

Firstly, it is important to understand the complexity of the Post-Traumatic Stress Disorder (PTSD) which occurs when there is a traumatic event and a subjective experience of a life threat. At the time, the response to the experience is a healthy psychological response of the whole body-mind system that comes with fear, anger, terror, depression, anxiety, feelings of isolation, and disconnection, amongst others. It is estimated that 8% of the general population suffers from PTSD.

However, this intelligent force that occurs inside of us when we encounter trauma sometimes continues, even after the event is over, crystallizing the inner response and preventing it from adapting to a new, non-traumatic environment. This means that the psychological response, which was originally healthy, becomes chronic and the mind-body system is stuck in the emotion of trauma with a continuation of extreme symptoms. Those who suffer from PTSD often develop a tolerance or resistance to treatment, like medication and therapy.

Although MDMA is currently under the most restrictive category of the Conventions (Schedule I), MDMA-assisted psychotherapy is intended to be a safe and efficient treatment with a long term effect, and is being developed into a medication by the US non-profit  The study design for MDMA-assisted PTSD, currently in Phase III of the United States Food and Drug Administration (FDA) includes three preparatory sessions, one session with MDMA (which takes place in a hospital and lasts eight hours), multiple integrative sessions, and holistic, human-oriented therapy that pays exceptional attention to feelings, emotions, and body sensations. Integrative psychotherapy has already been proven to be safe, and is connected to experiences relevant to psyco-pharmalogical complexities like mindfulness, loving sensations, and well-being. It is crucial to reconnect patients experiencing PTSD or with histories of trauma to their inner experience and self-directed healing process. MDMA opens a gateway that allows to process and transform trauma, which provides therapists another avenue to treat the symptoms. In a 12-month follow up to the MDMA-assisted psychotherapy, 68% of the participants no longer qualified as having PTSD in MAPS Phase II studies. Phase III and other studies are also happening in Israel 

The challenges in Israel with MDMA-assisted psychotherapy ware long standing. Ten years ago, during Phase II, finding hospitals was quite complicated – there is a bad reputation for psychedelic therapy, and participants were scared of being treated.

Today during Phase III, the Ministry of Health has recently approved Compassionate Use for fifty more participants in two major hospitals, as the government has now realized how useful this treatment may be. Currently, there are 700 people in our waiting list that want to be treated.

CASE STUDY: Participant experience on MDMA-assisted psychotherapy for PTSD clinical trial – presented by Jonathan Lubecky, former military, study participant (USA)

Jonathan Lubecky was deployed to Iraq as a member of the US Army and returned to the United States with PTSD. Although he tried every available treatment, including regular medication and different kinds of therapy, no solution was found and he attempted suicide numerous times. He eventually found cannabis, which helped manage his suicidal ideation, extreme depression, and PTSD symptoms; however, he was later put into jail for three days for possession of cannabis in the state of North Carolina.

After years of unsuccessful attempts at treatment, Jon was put in touch with MAPS, which was conducting clinical trials on MDMA-assisted psychotherapy to treat PTSD. This treatment significantly reduced Jon’s PTSD (by 50% according to the CAPS-4 measurement scale) and he was finally able to interact in social and professional environments, eventually securing positions on political campaigns and now as a veteran and government affairs liaison with MAPS.

The lack of research for compounds like MDMA means that there are people who are not able to access essential medicines which have the potential to treat mental injuries, as they did with Jon. MAPS has spent over thirty years researching MDMA, especially for veterans, and survivors of sexual assault or childhood abuse. Seeing trauma as “mental injuries” instead of incurable mental illness might finally bring a public health dimension to the conversation about mental health and psychedelic healing, and challenge stigma that surrounds PTSD and other mental issues.

SCIENCE IN CONTEXT: A transdisciplinary approach to evidence and knowledge generation – presented by José Carlos Bouso, medical researcher (Spain)

Dr. José Carlos Bouso, as the Scientific Director at the International Center for Ethnobotanic Education, Research, and Service (ICEERS), is in charge of ensuring that the public policies that ICEERS supports are evidence- and rights-based, that they promote bottom-up social changes, and that they are guaranteed by evidence-based science. The three drug conventions mostly recognize biomedical-based evidence, which is expensive and also extremely limited in usefulness when it comes to making political decisions. ICEERS non-exclusive biomedical models includes studies on substances including cannabis, ibogaine, and ayahuasca.

Regarding cannabis, longitudinal observational studies have been implemented as an alternative to clinical trials to prove the safety of cannabis. Retrospective observational studies consist of studying natural laboratories like the Cannabis Social Clubs, and comparing their engagement with risk reduction, comparing strains higher in THC and/or CBD, and cannabis’ effect on pro-social behavior.

In addition, there is a longstanding history of the effectiveness of ibogaine used to treat opioid dependence such as: ongoing clinical trials for the use of ibogaine to treat methadone, heroin and alcohol dependence in Spain, Brazil, and Afghanistan (pending approval).

Several non-medical studies about the use of ayahuasca – including longitudinal studies, pharmacological studies and cohort studies – have been conducted in Brazil, Peru and Spain, many of which have been inclusive of anthropological evidence.

Biomedicine, the main source of evidence that is taken into consideration, must necessarily coexist with other disciplines, epistemologies, and knowledge systems.  The actual challenge to the principles of Article 15 is the establishment of a hierarchy of evidences and disciplines, and the fact that we overly rely on biomedicine when making political decisions, which does not always cover the root causes of social problems.

CASE STUDY: Social/anthropological research for harm reduction services – presented by Aura Roig, harm reduction researcher (Spain)

The war on women who use drugs started a long time ago, during the inquisition when the stigma and demonization of women began. Women survive multiple forms of violence and the harm reduction services available tend not to be safe. Metzineres is the first harm reduction and research program for women in Spain which has a holistic approach. This community-oriented program is inclusive of human rights and gender mainstreaming perspectives, and generates data from numerous disciplines.

After one year and a half of operating, the collection of data includes around 150 women who use substances, many of whom are injectors of heroin and cocaine. Due to the lack of data on women and the masculinized methodologies that are commonly used, Metzineres – in partnership with the women they are studying – designed data collection models which are respectful of the right to privacy and intimacy and which take into consideration the multiple forms of violence that women suffer. This violence comes from various sources including childhood, partners, or social and sanitary services, and often derives from criminalization and stigma.

Metzineres attempts to use transdisciplinary new metrics and indicators beyond biomedicine to collect data. These research principles are collective, are based on harm reduction, human rights, and intersectional feminism, and aim to approach this “invisible” population from a wider perspective of evidence.

See more about ICEERS, Associazione Luca Coscioni, MAPS and Metzineres. Watch the complete Side Event here.

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