Written by Wim van den Brink
Em Prof of Psychiatry and Addiction, Amsterdam University Medical Centers, Amsterdam, The Netherlands
Co-chair of the Dutch State Committee on MDMA
Published
June 20, 2024
On June 6, 2024, the Dutch State Committee MDMA presented its report entitled “MDMA: Beyond ecstasy” to the Dutch Minister of Medical Care.
The committee consisted of six members representing a broad scope of expertise, including international law (Brigit Toebes, chair), addiction (Wim van den Brink, co-chair), psychiatry (Eric Vermetten), criminal law (Emile Kolthoff), emergency medicine (Femke Gresnight, and prevention (Martha de Jonge).
The Committee’s assignment was as follows: “The state commission's task is to examine the status of MDMA in the context of public health and to advise the government on the benefits and disadvantages of the medicinal use of MDMA, including a multidisciplinary analysis of health risks, prevention and the European context and relevant treaties”. This assignment, thus, contains two aspects, i.e. recreational use of MDMA/ecstasy and the use of MDMA in a therapeutic context. The committee addresses these two aspects in a 233 page report, which is based on literature reviews, conversations with stake holders as well as intense internal discussions.
This complex assignment was translated by the committee into the following tasks:
(a) analyse the Dutch public health situation regarding the recreational use of ecstasy and
(b) provide advice to the Dutch government about the medical use of MDMA.
With regard the public health situation of recreational ecstasy use, the committee concluded that:
Although the prevalence of ecstasy use in The Netherlands is among highest in the world (last year prevalence 3.9%: n=550.000), it seems that prevention activities (mainly directed at harm reduction) are successful given the low frequency of ecstasy use sessions per user (mean 2-3 sessions/year), the small number of pills used per session (1-2 pills/session), and the relatively small number of ecstasy-related deaths (5/year).
Drug education and prevention should always focus on specific risks and groups and should never criminalize or stigmatize the user.
Harm due to recreational ecstasy use is limited with no or a very low dependence liability, no clinically relevant persistent cognitive deficits, and a limited number of serious incidents mainly thanks to the presence of freely available water, chill-out rooms, pill-testing, and first aid services at festivals.
For time being, MDMA should remain on List I of the Dutch Opium Act (hard-drug) due to the combination of low harm (not addictive, few serious health consequences, no public nuisance) and severe organised crime related to the illegal mass production of ecstasy in the Netherlands. According to the committee, a future, move of MDMA from List I to List II (soft-drug) should be considered. Meanwhile, the process and criteria to classify substances on different Lists of the Dutch Opium Act should be re-evaluated.
Pictured above - Dutch Minister Pia Dijkstra is Minister for Healthcare
Regarding the clinical use of MDMA, the committee concluded that:
MDMA-Assisted Therapy (MDMA-AT) seems to be an effective and safe treatment for chronic and treatment-resistant patients with PTSD.
There is not sufficient evidence for conclusions about efficacy of MDMA-AT in other psychiatric or neurological disorders, but the committee is aware that with time, a wider application of MDMA-AT might become relevant.
With approximately 400.000 people suffering from PTSD and less than 25% of them receiving evidence-based trauma-treatment, there is a serious unmet need for PTSD treatment. The Dutch government should facilitate the introduction and use of MDMA-AT for these people as soon as possible.
It is unlikely that a registration dossier for MDMA-AT will be submitted (any time soon) to the European Medicines Agency (EMA) or the Netherlands Medicines Evaluation Board (MEB) to obtain marketing authorisation in the EU or the Netherlands.
Potential alternatives such as off-label use, compassionate use, and extended access to MDMA-AT are not possible or not feasible. Therefore, the committee proposes to start a large naturalistic study that prospectively monitors PTSD patients receiving MDMA-AT as soon as possible.
MDMA-AT should only be provided by qualified therapists working in specialized treatment settings.
Initially there will be a shortage of trained therapists and specialized treatment settings. The committee is concerned that this may cause registered therapists to help patients outside the context of these specialized settings and that commercial providers may offer MDMA as a quick solution for mental trauma-related distress. To prevent unnecessary damage, professional organizations of psychiatrists and psychologist should provide clear ethical and judicial guidance to their members and a hotline/helpline should be installed to assisted people with negative experiences outside the regular specialized treatment settings.
The Ministry of Health, professional organizations and treatment providers should be realistic in their communication to the public and the patients about the successes and potential adverse effects of MDMA-AT in PTSD.
With this report, the State Committee provides professional and policy guidance based on scientific data and analyses about the way political parties and future governments should deal with issues related to the recreational use of ecstasy, the development of a new national drug policy and the incorporation of new treatments using MDMA as a supportive medication where it once was “only” a recreational drug.
The report is only available in Dutch and can be found here.
It will be available in English within 4-5 weeks and Drug Science will share this on social media once its available