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The FDA’s Decision on MDMA-Assisted Psychotherapy: A Call for Pragmatism and Scientific Rigor

September 13, 2024 / MDMA, Policy, Law & Economics / 1 Comment / By

On behalf of the OPEN Foundation.

10 min reading time

The recent decision by the US Food and Drug Administration (FDA) to withhold approval for MDMA-assisted psychotherapy (MDMA-AT) has sent ripples of disappointment and frustration throughout the scientific, psychedelic and therapeutic communities. This decision, issued via a Complete Response Letter to Lykos Therapeutics, effectively delays access to a promising treatment for millions of patients suffering from Post-Traumatic Stress Disorder (PTSD) by years. At OPEN, we feel compelled to express our concerns, while also proposing a path forward: one that emphasizes both rigorous scientific validation and compassionate pragmatism.

Disappointment in the FDA’s Decision to Restrict Access to Mdma-at

The FDA’s decision represents a significant setback for those advocating innovative approaches in mental healthcare. MDMA-AT has shown remarkable potential in treating PTSD, a condition that remains notoriously difficult to treat with existing therapies. The evidence presented by MAPS (Multidisciplinary Association for Psychedelic Studies) and Lykos Therapeutics (formerly MAPS PBC) demonstrates substantial improvements in PTSD symptoms among patients treated with MDMA-AT. These findings are not only statistically significant but also clinically meaningful, offering hope to those for whom traditional therapies have failed.

The FDA’s decision, while ostensibly rooted in a commitment to safety and efficacy, ultimately restricts access to a treatment that could transform and even save lives. For patients who have exhausted all other options, this decision feels like a denial of hope. 

Surprise at the Divergence from the Dutch State Committee Report “Beyond Ecstasy”

What is particularly surprising is the stark contrast between the FDA’s decision and the conclusions reached by the Dutch State Committee on MDMA. Based on the same body of evidence, the Dutch committee (consisting of scientists, psychiatrists, legal experts, drug prevention and harm reduction specialists) arrived at a radically different conclusion: MDMA-AT is promising, effective, relatively safe and warrants more scientific research to further explore its therapeutic potential.

The committee even concluded that based on the relatively low potential for harm, MDMA could be down-scheduled: moving the compound from List 1 to List 2 of the Opium Act. Finally, the Committee advised the Dutch government to start a naturalistic study to allow patients access to this new therapy form, while also allowing scientists to collect more data on an ongoing basis, all the while gaining important clinical experience in delivering this novel treatment form. These diverging perspectives raise important questions about the interpretation of scientific data and the role of cultural and institutional factors in regulating novel therapeutic approaches. 

The Dutch committee’s recommendation reflects a nuanced understanding of both the risks and benefits associated with MDMA-AT. They recognize that while methodological and ethical concerns remain, the potential therapeutic benefits of MDMA-AT cannot be ignored. This discrepancy between the FDA and the Dutch committee highlights the need for international dialogue and collaboration in the evaluation of novel therapies.

Want to learn more about the Dutch State Committee Report? Click here.

Acknowledging Methodological Concerns In MDMA Assisted Psychotherapy

At the moment, the specific reasons why the FDA rejected the approval of MDMA-AT are not yet publicly available, but we presume these concerns are likely based on the report from the FDA’s scientific advisory panel. These concerns are not without merit. The methodological issues raised, particularly those related to expectancy and placebo effects, are valid and warrant careful consideration. In randomized controlled trials (RCTs), both the MDMA and control groups have shown dramatic improvements, raising the possibility that nonspecific factors may be contributing to the observed outcomes. The contribution of these nonspecific factors to treatment outcomes is not unique to MDMA-AT, but is of concern in the evaluation of any psychoactive medicine. It is also crucial to note that the magnitude of improvement in the MDMA group far exceeds that of the control group, suggesting that the effects of MDMA-AT are not merely due to placebo or breaking blind. Placebo effects, while powerful, tend to diminish over time, whereas the benefits of MDMA-AT have been sustained in many cases. This durability is a critical factor in assessing the therapeutic potential of MDMA and underscores the need for further research to refine our understanding of its mechanisms of action.

Questions that need to be addressed

In our view, specific open questions that need to be addressed in future research include:

  1. Role of Expectations: What is the role of patient expectations in the therapeutic benefits associated with MDMA-AT?
  2. Blinding Integrity: How many participants are able to accurately guess their treatment assignment, and how does this impact the study outcomes?
  3. Prior Experience with MDMA: Does the therapy work equally well for patients with and without prior experience with MDMA?
  4. Control Conditions: Could alternative control conditions with experiential components, such as breathwork, be equally effective as MDMA in improving PTSD symptoms?
  5. Non-Responders: What are the characteristics of patients who do not respond well to MDMA-AT, and how can their outcomes be improved?
  6. Therapist-Client Interactions: What checks and balances are necessary to ensure the standardization and careful conduct of therapist-client interactions in MDMA-AT? 
  7. Proper aftercare: How can we ensure appropriate, sensitive, and durable aftercare for patients who may struggle for a substantial period after having undergone MDMA-AT (or placebo-assisted therapy)? 

These questions highlight the need for further evaluating the efficacy of MDMA-AT and underscore the need for open science practices, including transparent reporting and rigorous study designs, to address these issues.

Addressing Ethical Concerns

Ethical concerns surrounding MDMA-AT are significant and need to be taken very seriously,  particularly regarding the risks related to boundary violations. We are acutely aware of the need for rigorous training, careful monitoring and adequate supervision of both therapists and patients involved in MDMA-AT. This is particularly true when these therapies do become approved, and will be rolled out at a large scale, to more diverse groups of patients. The therapy should only be conducted in controlled environments by qualified professionals who adhere to the highest standards of care. This includes official oversight of relevant professional associations, ideally with a thorough understanding of the nature of – and specific risk factors related to – psychedelic-assisted therapies.

A more difficult issue revolves around the standardization of the psychotherapeutic component of MDMA-AT. While some argue that standardized psychotherapy is essential to ensure consistent and safe treatment across different settings, others propose getting rid of psychotherapy altogether, while a third group suggests that common factors – like therapeutic alliance – are the defining feature, and that the specific form of psychotherapy is less important. 

What we can be sure of, is that as the demand for MDMA-AT grows, there will be an increasing need for well-trained therapists who can deliver this therapy responsibly. The establishment of clear guidelines and protocols is imperative to mitigate risks and protect patient safety.

The Impact of the FDA’s Decision on the Legal Landscape & Future Research on MDMA-aT

The FDA’s likely requirement for a third phase-3 trial presents a serious hurdle to the timely approval of MDMA-AT. The time and costs involved in conducting such a study are substantial, and will require additional fundraising. It is likely that this will postpone the availability of MDMA-AT in the USA by years. This delay is particularly concerning given the urgent need for effective treatments for PTSD, a condition that affects millions of people worldwide.

The implications for Europe are uncertain. It remains unclear whether the results of a future phase-3 trial in the USA will be leveraged to apply for marketing authorisation from the European Medicines Agency (EMA) as well. Theoretically, another phase 3 trial could also partially take place in Europe (there are trained and experienced MDMA-AT therapists sites in multiple European countries), thereby overcoming the EMA’s wish to have studies conducted in Europe. If Europe is not included, and the EMA does require additional data, this will further delay the availability of MDMA-AT in Europe, leaving many patients without access to this potentially life-changing treatment.

A Pragmatic Approach: Naturalistic Studies and Early Access

In light of these challenges, we propose a pragmatic approach that balances the need for rigorous science with the urgent need for patient access to MDMA-AT. Specifically, we support the recommendation of the Dutch State Committee on MDMA to initiate a naturalistic study in which patients are given MDMA-AT by qualified therapists in specialized treatment settings.

Such a study would provide valuable data on the real-world effects and risks associated with MDMA-AT, while also offering patients access to a therapy that they might otherwise seek in the so-called ‘underground’ or ‘grey’ circuit. A naturalistic study has the dual benefit of providing potential relief to suffering patients while advancing our understanding of the roll out of MDMA-AT in a controlled and ethical manner.

Furthermore, implementing this approach in the Netherlands could position the country as a leader in psychedelic science and innovative mental healthcare. It would enable us to gather valuable real world data, understand the complexities of offering such a therapeutic innovation in the real world, and, importantly, ensure that an increasing  number of qualified therapists can gain experience conducting MDMA-AT, putting in place structures, protocols, and guidelines to enable a smooth rollout when MDMA-AT eventually becomes a mainstream therapy.

Conclusion: Balancing Rigor with Compassion In Psychedelic Science

In sum, the OPEN Foundation believes that the FDA’s decision overlooks the immediate needs of patients who stand to benefit from MDMA-AT. We recognize the importance of rigorous science in establishing the safety and efficacy of this therapy, but we also advocate a pragmatic approach that allows for early access through naturalistic studies. Only by adopting this dual strategy can we ensure that MDMA-AT is administered safely and responsibly, while also collecting the data necessary to satisfy regulatory requirements. Ultimately, the goal of such an approach would be to minimize harm, maximize patient benefit, and pave the way for MDMA-AT to become a valuable tool in the treatment of PTSD.

We call on regulatory agencies, researchers, and clinicians to work together in the spirit of collaboration and innovation, to bring this promising therapy to those who need it most.

Looking back on ICPR 2024 – the leading interdisciplinary conference on psychedelic research

September 13, 2024 / Anthropology & Sociology, Biology & Ethnobotany, Ethics, Humanities & Art, Neuroscience, Pharmacology & Chemistry, Philosophy & Religious Studies, Policy, Law & Economics, Psychiatry & Medicine, Psychology, Technology / By

It’s been 2 months since the leading conference on psychedelic research in Europe, ICPR 2024, took place in Haarlem, the Netherlands. Despite having taken steps to integrate it all, the OPEN foundation team has accepted that we still lack the words to convey what the whole event felt like and meant to us.

Pia Dijkstra – Minister of Healthcare, The Netherlands – Opening ICPR 2024

From combating prejudice and stigma back in 2007 to having not one but two subsequent Ministers of Healthcare lining up to inaugurate ICPR, our mission to advance psychedelic research to benefit science, healthcare and society has come a long way.

At ICPR 2024, we had it all, from Minister from the Netherlands, Pia Dijkstra’s moving opening speech to the heartfelt realities shared by trial participants Maryam Zahra Jabir and Patty B., the Wet Blanket Award for presentations representing rigor and critical thinking’ awarded to Dr. Jamila Hokanson, M.D, MBA, the kind of deep thinking showcased by Leor Roseman, Erik Davis’ magnificent storytelling and accompanying visuals, the important discussions around decolonization curated by Yogi H., and so so so much more.

Access ICPR 2024 talk recordings & more

Become a member

You might imagine why the OPEN Foundation & ICPR team was unable to attend most talks on-site. Yet, via the high-quality recordings (more on this will follow), we didn’t miss out. What we saw was consistently great.

Immense effort went into crafting ICPR’s mind-blowing programme. And no doubt those efforts have been worth it. ICPR embodied the true spirit of interdisciplinarity: from clinical trial design, neuroscience, archaeology, integration, psychotherapy, adverse events, spirituality, literary analysis—it was all there.

The programme and ICPR 2024 fulfilled their purpose: to gather and facilitate conversation and connection between open-minded, committed, curious, and caring individuals whose collective perspective creates a critical and constructive narrative for what psychedelics mean moving forward in 21st-century Europe.

Vibrant lunch breaks @ICPR

We are honored and humbled by the ICPR 2024, the progress in the field of psychedelic research and therapy, and what lies ahead. Lastly, gratitude. Gratitude, for our co-creation, persists. Fortunately so, as it’s our fuel to do our part in this ongoing process of integrating psychedelics safely and responsibly into healthcare and society.

Thank you,
The OPEN & ICPR team

And please, a big applause for….. the rockstar volunteers who made ICPR 2024 possible!

Access ICPR 2024 talk recordings & more

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Key Insights from the Dutch state commission MDMA Report: Beyond Ecstasy

September 13, 2024 / MDMA, Policy, Law & Economics / 1 Comment / By

In a landmark moment for drug policy, the Dutch State Commission on MDMA has released its highly anticipated report, “Beyond Ecstasy“. Spanning over 200 pages, this document explores the multifaceted dimensions of MDMA, including its recreational use, potential therapeutic benefits, and broader implications for public health and policy. We aim to provide you with the key highlights of this thorough examination aimed at guiding the Dutch government in its future decisions regarding MDMA.

Context of the Dutch State Commission on mdma

The formation of the State Commission on MDMA was a response to a coalition government promise to re-evaluate the drug’s status within the Dutch Opium Act. The commission, which included experts from various fields such as addiction psychiatry, criminology, emergency medicine, and drug prevention, worked from April 2023 to May 2024. This multidisciplinary approach ensured a holistic understanding of MDMA’s impact.

report presentation by wim van den brink, md, phd

Wim van den Brink, professor of Addiction Psychiatry at the Amsterdam University Medical Centers presented the report 2 days after its release at the ICPR conference in Haarlem, June 2024.

Discover more talks from ICPR 2024 talks, symposia, lectures & Q&A!

the Potential of MDMA assisted therapy

A central aspect of the report is its exploration of MDMA’s potential therapeutic benefits, particularly in the treatment of PTSD. The commission reviewed existing research and concluded that MDMA-assisted therapy shows promise for patients with treatment-resistant PTSD. 

efficacy and Safety in Treating PTSD

The report discussed current research and clinical trials, highlighting the effectiveness of MDMA-assisted therapy in treating PTSD. To ensure safety and efficacy of MDMA-assisted therapy, the report highlights the importance of context.

“MDMA-assisted therapy has shown significant promise in the treatment of PTSD, particularly for patients who have not responded to traditional therapies. This could represent a major advancement in psychiatric treatment”  — MDMA /// Beyond Ecstasy Report

“The therapeutic use of MDMA must be conducted under strict medical supervision to ensure safety and efficacy.” — MDMA /// Beyond Ecstasy Report

Need for Further Research: state commission Proposing a Naturalistic Study in the Netherlands

“Further research is needed to explore the long-term effects and potential applications of MDMA in various psychiatric and neurological conditions.” — MDMA /// Beyond Ecstasy Report

To facilitate the use of MDMA in therapy to treat PTSD, the commission proposes a large naturalistic study in the Netherlands. This study would help gather more data and refine treatment protocols. Wim van den Brink highlighted, “A large naturalistic study will provide the necessary data to support the safe and effective use of MDMA in clinical settings”

education and training to meet the need

“Investing in training programs and specialized centers is essential for the successful implementation of MDMA-assisted therapy.” — MDMA /// Beyond Ecstasy Report

Establishing specialized centers and training therapists are critical steps for implementing MDMA-assisted therapy. While some qualified therapists are already available, more are needed to meet the potential demand. 

Prevalence and Risks of Recreational MDMA Use

“The prevalence of MDMA use in the Netherlands is among the highest in the world, yet the number of MDMA-related deaths remains relatively low, highlighting a unique consumption pattern and harm reduction practices in place” — MDMA /// Beyond Ecstasy Report

The second central theme of the report is the prevalence and associated risks of recreational MDMA use in the Netherlands. Despite the high prevalence, the report highlights that the frequency of use and the number of pills consumed per session are relatively low compared to other countries. This pattern may contribute to the lower number of MDMA-related deaths observed in the Netherlands.

The Dutch approach to drug policy heavily emphasizes harm reduction, which is reflected in the safety measures implemented at events where MDMA use is common. As noted in Wim van den Brink’s presentation at ICPR 2024, who emphasized the importance of “set and setting” in minimizing harm during MDMA use, factors such as the availability of care facilities, water, and first aid services at events significantly reduce the risks associated with MDMA use. 

The report calls for improved postmortem evaluations to better understand the exact causes of MDMA-related risks. Currently, the lack of comprehensive postmortem studies makes it difficult to determine the precise role of MDMA in fatalities, especially when other substances or external factors might be involved.

Public Health and Drug Policy

The report emphasizes a public health-focused approach to drug policy, advocating harm reduction overcriminalization. It criticizes the current lack of a cohesive national drug policy and calls for an integrated prevention program. The importance of targeted drug education and continuous monitoring of drug trends is also highlighted.

“The Dutch drug policy should remain primarily aimed at public health, avoiding the criminalization of users. Prevention strategies must be evidence-based, focusing on harm reduction rather than punitive measures.”  — MDMA /// Beyond Ecstasy Report

to conclude

The Dutch State Commission on MDMA’s report “Beyond Ecstasy” is a pivotal document that could shape the future of drug policy and medical treatment in the Netherlands. By addressing the risks and potential benefits of MDMA and MDMA-assisted therapy, the report aims to provide a framework for policymakers.

As the Dutch government considers these recommendations, patients in need, therapists, researchers and the general public will be paying attention. At OPEN Foundation, we are hopeful that this may be a step toward responsible, safe, and beneficial integration of psychedelics into society and healthcare.

Dutch Minister Pia Dijkstra to Open Interdisciplinary Conference on Psychedelic Research

November 6, 2024 / Policy, Law & Economics / By
pia dijkstra dutch minister of healthcare

Dutch Minister Pia Dijkstra to Open Interdisciplinary Conference on Psychedelic Research

The Dutch minister of Medical Care, Pia Dijkstra (D66), will inaugurate the sixth edition of the Interdisciplinary Conference on Psychedelic Research (ICPR) on June 6th. We are excited about the growing support by the Dutch government for psychedelic-assisted therapy, a field gaining significant momentum across Europe.

pia dijkstra dutch minister of healthcare

Previously held by Ernst Kuipers, the role of Minister of Medical Care has passed to Dijkstra, who continues the support for research into the therapeutic potential of psychedelics.

Under Kuipers, the Dutch government had already shown a commitment to leading in this innovative area. Kuipers stated that the Netherlands should be at the forefront of psychedelic research. He also contributed to a report commissioned by the Dutch research funding organisation ZonMw that offered a first glimpse of the potential psychedelic research landscape in the Netherlands. Lastly, he allocated 1.6 million euros of funding to psychedelic research.

The shift in leadership, while maintaining support for psychedelic research, underscores a broader acceptance and interest in psychedelic research among politicians, thanks to increasing evidence of its effectiveness. The upcoming ICPR and Pathways to Access Summit promises to further explore these possibilities, continuing the Netherlands’ influential role in this important field of medicine.

For more insights into psychedelic-assisted therapy and the critical perspective of OPEN’s director Joost Breeksema & Ernst Kuipers, check out the video below. (in DUTCH)

EUROPEAN SUPPORT

You might wonder whether this support for psychedelic-assisted therapy is only reserved to the small and progressive country of the Netherlands. But this is certainly not the case. In the past year, support has been gaining momentum and is expanding towards the scale of European support. 

Recently, Joost Breeksema, the executive director of the OPEN Foundation chaired the meeting at the European Parliament to launch PsyPal – a 6.5 million EU-funded multi-site research consortium with over 19 different partners, including OPEN Foundation, that seeks to alleviate suffering from existential distress in patients with a incurable illness through the use of psilocybin.

Only a few days later, Breeksema participated in a two-day workshop at the European Medicines Agency to explore the views of stakeholders and experts on the therapeutic potential of psychedelics, providing further clarity on defining the safe and effective use of psychedelics, informing on regulatory challenges associated with the development and evaluation of psychedelic medicines, and defining areas for which further regulatory guidance is required.

towards safe and responsible integration of psychedelic-assisted therapy

As thrilling as it is to witness the rapidly increasing support for psychedelic-assisted therapy, a critical perspective and patience are the keys to shaping a future where psychedelic therapy can be integrated safely and responsibly for the benefit of science, healthcare and society.

For the moment, we look forward to welcoming you to the sixth edition of ICPR, which will be held from June 6 to June 8 at the PHIL in Haarlem, the Netherlands.

co-create the future pathways to access in Europe

The full-day Pathways to Access Summit (Paths) convenes key stakeholders from Europe and beyond to explore the opportunities and challenges around the development, approval, and eventual integration of psychedelic medicines into mainstream European health care. Join us in co-creating the future of psychedelic medicine.

Dutch Government establishes MDMA state commission

October 22, 2024 / MDMA, Policy, Law & Economics, Scienitific Discipline, Substance, Uncategorized / By

The Dutch Government establishes a state commission to investigate the risks and benefits of MDMA, including its potential medical use. The commission will study the impact of MDMA on individuals, society, and public health. Additionally, the commission will examine the advantages and disadvantages of potential medical applications of MDMA. 

According to Dutch Minister of Health, Ernst Kuipers, there are good indications that the use of MDMA can help patients in specific situations where conventional forms of therapy cannot. Recently, the minister received a report from ZonMW (the Dutch organisation that subsidises scientific research to develop and innovate healthcare) about the therapeutic applications of psychedelics in the Netherlands.

The state commission will also assess the European legal context and relevant treaties related to MDMA use. This comprehensive review of MDMA’s status and potential therapeutic applications will provide valuable insights that should inform future drug policies and decisions related to psychedelic assisted psychotherapy in the Netherlands.

It’s worth noting that the state commission is an independent, ad hoc advisory body that functions autonomously from any Ministry. This means that the commission will operate with impartiality and objectivity, providing unbiased insights and recommendations to the Council of Ministers. State commissions in the Netherlands usually investigate a wide range of topics, including the functioning of the parliamentary system and democracy, euthanasia and institutional discrimination.

The commission, which includes experts in various fields such as the treatment of psychotraumas, criminology, and addiction care, aims to provide the cabinet with its conclusions and advice by January 2024.

We eagerly await the commission’s findings and recommendations. Stay tuned for updates on this important development as we continue to follow this issue closely.

Ketamine in the Dutch mental healthcare system

October 22, 2024 / Ketamine, Policy, Law & Economics, Scienitific Discipline, Substance / By

This report (only available in Dutch) describes the current state of (es)ketamine treatments within mental healthcare in the Netherlands. The report aims to contribute to an effective and safe implementation of ketamine in the Dutch mental healthcare system. The first chapter discusses the history of ketamine, its mode of action, administration forms, and its use in mental healthcare. The second chapter discusses ketamine in the Dutch healthcare system. The third chapter focuses on ketamine as an antidepressant. Chapter four discusses the risks associated with its implementation. The last chapter addresses unresolved issues and steps that can be taken in the future. In addition to studying relevant information from previous studies and reports, information was also obtained from a large number of Dutch professionals and experts in the field. Six psychiatrists, five therapists, and three scientific researchers contributed their perspectives on current ketamine treatments, identified existing challenges, and shared their visions for the future of ketamine treatment in the Netherlands. The unanswered questions are included in chapter five and serve as a starting point for further collaborations and study of outstanding issues. The report aims to provide a clear overview of registration, implementation, unresolved issues, and guidance so that the implementation of ketamine as a treatment for TRD can be realized efficiently and safely.

Click here to read the full PDF report, written by two of our interns!

The Netherlands should be ‘at forefront’ of psychedelic research, says Dutch government

October 22, 2024 / Anxiety Disorders / PTSD, MDMA, Policy, Law & Economics, Scienitific Discipline, Substance, Therapeutic Application / By /

‘The Netherlands can play a pioneering role in developing the right frameworks, limiting potential risks, and designing training programs,’ the Dutch health minister said.

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Ernst Kuipers, the new Dutch Minister of Health, Welfare, and Sports, has given his green light to more research in psychedelic therapy, citing “promising results” for typically difficult-to-treat mental illnesses through psychedelics-assisted therapy. His endorsement came in response to questions from three members of parliament from the Dutch political party D66. Kuipers summed up his stance on psychedelic research in a letter directed to the Speaker of the Dutch House of Representatives, and its content is factual and amenable to recent scientific results.

This is a departure for the Dutch government, which in recent years produced more prohibition-focused or avoidant language when it came to issues surrounding psychedelics. The new government has also announced that a state committee will look into the medical use of MDMA – a political compromise arising from the ongoing discussion in the Netherlands about the possible legalisation of MDMA for recreational use.

The new government’s health minister demonstrated conviction about the prominence psychedelic therapy will gain in global healthcare in the coming years, and envisions how the Netherlands could become a leader at the forefront of psychedelic research: “It is paramount that these and other potentially innovative treatments are safely accessible to the target population,” the minister writes. “The Netherlands is one of the leading countries in research into psychedelics in mental health care. In addition, the Netherlands can play a pioneering role in developing the right frameworks, limiting potential risks, and designing training programs for therapists. I am in favour of sharing earned knowledge with parties in the field across different countries.”

Get €100 off on all tickets by using the code OPENBLOG100

The Netherlands at the forefront of psychedelic research

Apart from MDMA, other psychedelic substances – such as psilocybin1 and ketamine2 – have also demonstrated promise. Kuipers strikes a more cautious tone when speaking about these compounds, affirming the need for more research due to the preliminary nature of current results: “Most of these substances are still in the investigative phase of research. […] It is up to the relevant field parties to follow up on these results. This concerns conducting the necessary research, completing the step-by-step registration process for approval of the substance, and the development of guidelines and protocols necessary for treatment.”

Kuipers further stresses the need for extensive education, the training of psychedelic therapists, and the need to better understand individuals engaged in self-experimentation. He adds that he is “willing to play a facilitating and advising role” in implementing psychedelic research and that his ministry has recently conducted exploratory meetings with researchers and mental healthcare institutions.

He envisions the Netherlands as playing a major role internationally in the coordination and promulgation of psychedelic research, writing that “[t]he Netherlands can stimulate cooperation in a European and international context. In addition, the Netherlands can draw attention to removing barriers in conducting research. In the framework of the United Nations Commission on Narcotic Drugs, I continue to advocate for the removal of barriers to therapeutic use and research into substances on United Nations drug convention lists.”

New Research

According to Kuipers, an estimated 1.2 million Dutch citizens currently seek curative mental healthcare each year. Another 215,000 citizens suffer from severe psychiatric illness, a segment of the patient population that is very difficult to treat with current therapies. Kuipers has announced he will allocate 35 million euros to mental healthcare research over the next four years, made available through the Dutch grant organisation ZonMw. Grants will support multidisciplinary studies focused primarily on clinical applied research.

The availability of these funds presents psychedelic researchers with a rare opportunity. Results from these new studies could further elucidate the therapeutic mechanisms by which psychedelics function, thereby putting their clinical application on firmer scientific footing.  Ultimately, Kuiper’s initiative offers the promise of advancing the field beyond its “investigative phase” and imagines a not-too-distant future in which psychedelics are used as legitimate therapeutic agents in clinical contexts, offering hope to the millions who suffer from severe psychiatric illness around the globe.

Barriers to breakthrough therapy status

The three representatives of D66 asked further questions surrounding the current “breakthrough therapy status” of certain psychedelics in the United States. A breakthrough therapy designation is granted to a drug that treats a serious or life-threatening condition, where preliminary clinical evidence indicates that the drug might demonstrate substantial improvement on clinically significant endpoints over available therapies.

Recently, the American Food and Drug Administration (FDA) granted ‘breakthrough therapy status’ to psilocybin for treatment-resistant depression and to MDMA for PTSD. Kuipers explains that a similar status within the Netherlands and other countries in Europe can be attained through organisations such as the European Medicines Agency (EMA).

The minister acknowledges the barriers that still exist for psychedelic research, like “a lack of financial resources for doing the necessary clinical research and developing an approved product for the patient. In addition, psychedelics are substances that are generally non patentable and thus do not fit the ordinary development and revenue model. The potential high costs for the therapeutic treatment with these substances (due to the large amount of hours therapists dedicate to patients during treatment) might also impede incorporating psychedelics as a standard treatment.” 

The issue of the relative expense of psychedelic therapy bears further scrutiny. How, for instance, would the cost of psychedelic therapy compare to that of treatment as usual (TUA) if we take into account factors such as the economic burden of different psychiatric illnesses and/or disability-adjusted life years (i.e,. the number of years lost due to an illness)? To resolve the issue of financial expenditure, cost-effectiveness analyses of psychedelic therapy should be conducted, such as that performed in 20203. This study found that MDMA-assisted psychotherapy versus TUA per 1,000 patients produced savings of up to $103.2 million over 30 years including costs, and surmised that “third-party payers are likely to save money within three years by covering this form of therapy [MDMA].” This, however, is just the conclusion of one study, and the issue of financing deserves further investigation.

Central management and the Netherlands

Kuipers acknowledges the risks involved in the lack of central management of psychedelics. Possible risks include personal experimental use of psychedelics and the development of  commercially exploitative practices that fail to the interests of patients first. Kuipers emphasises the urgency with which these questions need to be answered, and references the Dutch researchers and clinicians who authored Therapeutic use of psychedelics4: “[…] they can develop a framework for this new form of treatment by means of high quality guidelines, standards, and protocols.”

Finally, the new government of the Netherlands has called for more research into MDMA and the possible legalisation of it in the near future. Kuipers mentions that there will be a state committee specifically for MDMA. The state committee will “investigate the status of MDMA in the context of public health and provide advice surrounding the pros and cons of medicinal use by adhering to a multidisciplinary analysis, which takes into account potential risks for health, prevention, and the European context and its relevant treaties.” Kuipers expects to inform the House of Representatives of the committee’s findings in the second quarter of this year.

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References:

1. Davis, A. K., Barrett, F. S., May, D. G., Cosimano, M. P., Sepeda, N. D., Johnson, M. W., … & Griffiths, R. R. (2021). Effects of psilocybin-assisted therapy on major depressive disorder: a randomized clinical trial. JAMA psychiatry, 78(5), 481-489.

2. Nieuwsuur (2022). Keta kan ‘revolutionair’ middel zijn tegen depressie, maar er zijn ook zorgen.  Consulted on 27 March 2022.

3. Marseille, E., Kahn, J. G., Yazar-Klosinski, B., & Doblin, R. (2020). The cost-effectiveness of MDMA-assisted psychotherapy for the treatment of chronic, treatment-resistant PTSD. PloS one, 15(10), e0239997.

4. Universitair Medisch Centrum Groningen. Manifest therapeutische gebruik van psychedelica. Retreived March 20, 2022.

Truffle therapy in the Netherlands is running ahead of the science

October 22, 2024 / Mushrooms / Psilocybin, Policy, Law & Economics, Scienitific Discipline, Substance / By

The promising results of psychedelic treatments in small scale clinical trials are feeding an emergent health and wellness industry around these substances. The Netherlands, where psilocybin truffles remain unregulated, has become fertile ground for entrepreneurs aiming to position themselves at the cutting-edge of the psychedelic medicine market. Even though most of these psychedelic retreats cater to healthy participants, an increasing number of companies are planning to offer truffle sessions as psychedelic therapy to psychiatric patients. At the current stage, when scientific evidence proves promising but not yet conclusive, researchers are worried about the risks of commercial providers running ahead of the ongoing research. Should companies tread more carefully and let clinical researchers take the lead in the development of psychedelic therapy?

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In the upcoming ICPR 2024, leading experts and cutting-edge research around the use of psilocybin for therapy will be presented.

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Psilocybin in the Netherlands

Psilocybin is a controlled substance in the Netherlands and the possession and sale of any species of psilocybin containing mushrooms is forbidden. However, this regulation does not apply to truffles, given that these are not strictly mushrooms but a different part of the fungus. This legal loophole has allowed the spread of psychedelic retreat centers offering truffle ceremonies for self-development or spiritual purposes.

Even though truffles qualify as a legal food in the Netherlands, they cannot be advertised as a medical treatment. The Dutch Health and Youth Care Inspectorate (IGJ) states that truffles may fall under the regulatory scope of the Medicines Act if medical claims are made. “In that case, we qualify the truffles as a medicine, for which no trade permit has been granted in the Netherlands”, an IGJ spokesperson declared.

Most entrepreneurs, aware of the existing regulation, avoid making explicit medical claims when advertising their services and try to use terms like “inner healing” and “personal development” instead. Many also warn that their ceremonies are not meant to substitute medical or psychotherapeutic care and make an effort to exclude clients with mental diagnoses and possible physical risks from participating through careful health screening.

This is, however, not always the case. The clinical director of a new truffle clinic recently declared to Dutch media: “We administer truffles to people in order to make them feel better and to overcome psychological disorders such as depression, anxiety and stress”. Others openly claim to provide “psychedelic-assisted therapy” on their websites and display the available scientific evidence to illustrate its efficacy in the treatment of depression, addiction or PTSD. We asked Nick (whose real name is not disclosed) about the apparent targeting of mental health patients on his retreat center’s website. “We are not pretending to treat or cure PTSD”, he assured, “we are acknowledging that there are people who have PTSD and that those clients that we have received (and not targeted) had very beneficial experiences”.

The hype around psychedelics is sparking a race among startups to become pioneers of a new therapeutic or wellness market, the boundaries are not always clear. But the emergence of truffle therapy is not just about opportunistic entrepreneurship. The mainstreaming of psychedelics is also bringing some of the underground therapists to the surface and from their perspective, there might not be meaningful reasons to wait for approval and regulation. Peter (whose real name is not disclosed) has conducted truffle therapy for the last eight years and more recently decided to start advertising their services online. “Back then we also thought we were moving too fast but people were really searching for this. We just couldn’t wait. Regulation can be helpful, but for a lot of us who already walked that path it’s not that great, especially for the ones who believe more in alternative therapies”.

The lack of formal regulation governing the profession has led some psychedelic guides in the Netherlands to found the Guild of Guides. This professional association is developing its own ethical codes in order to ensure best practices during psychedelic sessions. Peter also acknowledges the importance of the guild in the self-regulation of psychedelic facilitators. When it comes to offering therapy, however, their guidelines are unequivocal: “Guides do not claim to be psychedelic therapists nor offer ‘therapeutic’ services when they lack the appropriate accreditation.”

Scientists’ call for caution

A number of Dutch researchers and therapists are currently working on trials investigating the safety and efficacy of psilocybin for patients with treatment-resistant depression. They are concerned about commercial providers rushing to open up the market even before the scientific evidence is established. Clinical psychologist Jan Mars, therapist at the University Medical Centre Groningen (UMCG), says: “I am not a supporter of this practice because we are still doing research right now and you don’t want to run ahead of the science”. Joost Breeksema, researcher at the UMCG and director of the OPEN Foundation, echoed similar concerns: “The main problem is that we don’t know yet if this can be done safely and if so, which patients might benefit and which may be more at risk. And we’re only talking about the treatment of depression, where clinical research with psilocybin is relatively advanced. Offering psilocybin truffles to treat PTSD is even more problematic, not just because of the nature of this disorder, but also because we lack solid research. I understand the need for better treatments, and the impatience of patients who’ve sometimes suffered for decades, but it’s unethical, unwise and irresponsible to experiment blindly with these powerful treatments.”

It is important to remark that most scientists and therapists see no harm in conducting truffle ceremonies with experienced guides outside the medical realm. Renske Blom, psychiatrist at GGZ Centraal and therapist at UMC Utrecht, noted: “Truffles are legally available in the Netherlands so they can be and are being offered for spiritual care, wellbeing and self-improvement”.

While there are signs to be hopeful about the potential of psychedelics for the future of mental health treatments, research has not yet offered conclusive evidence that would warrant safe and efficacious provision of psilocybin therapy. Two psilocybin trials so far have shown significant and long-term improvements for depression. However, these trials lacked placebo controls and the samples were pretty small. Several ongoing multisite trials with hundreds of participants will be able to give more reliable evidence about the therapeutic value of psilocybin. Nonetheless, these studies have not yet been completed and experts warn that it is precisely at this stage of drug development where most new pharmaceuticals fail. In the case of PTSD, larger studies are proving that MDMA-assisted psychotherapy may be useful, but not a single clinical trial has investigated psilocybin for this indication yet. In general, there are still a number of incognitas around safety, short- and long-term efficacy, relapse rates and the optimal amount of integration sessions.

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The mainstreaming of psychedelics causes challenges for the psychedelic field.

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One of the main concerns of researchers relates to the qualifications and therapeutic experience of these truffle providers. This is a complicated issue given that clinicians and researchers are still debating the adequate standards and training requirements for the certification of future psychedelic therapists. Some companies currently offering truffle therapy have a team of professionals with a background in mental health. In other cases, the psychotherapeutic and medical credentials of guides and their experience with disorders such as PTSD or depression are dubious.

The exposure of these sensitive populations to the intensity of the psychedelic experience can be risky if guides are not able to respond to the particular needs of psychiatric patients. In working with depression and psychedelics, Jan Mars emphasizes that “supporting a psychedelic journey is a humbling experience. You don’t know what is going to happen during the session. You can expect anything to happen,” and therefore, he adds, “It’s important that therapists know how to provide a safe environment. We still need much more experience and knowledge about how to work with patients who suffer from chronic psychological conditions. Trauma often lies beneath the surface and pops up during a session with psychedelics”. In regard to trauma therapy with these substances, Joost Breeksema adds: “Patients may relive traumatic moments, completely dissociate or become overwhelmed with fear and anxiety. This can be hard to handle even for an experienced therapist. Now imagine what happens with well-intended, but under-qualified and unprepared guides”.

Although these treatments are known to be generally safe in terms of toxicology and no serious adverse events are commonly reported in trials, their safety profile resides precisely in the close psychotherapeutic support and monitoring performed before, during and after psilocybin administration. Jan Mars hopes that in future clinical practice, “psychedelic journeys will be embedded in a safe and trusting therapeutic environment. These journeys are no magic bullets.”

In general, truffle providers understand the concerns of scientists, but they feel that the benefits of psilocybin treatment outweigh its risks. According to the clinical director of a truffle clinic, clients with depression may be thinking: “Damned! Science says that this can help me. It is not yet approved but there are places where it can be done safely so I am going to try”. From his own experience guiding sessions, Peter concluded that: “It all comes down to a balance between safety and effectiveness. We are all trying to find out, but at the moment psychedelic sessions do more to help people than to harm them”.

For psychiatric patients for whom other treatments have failed, this call for patience and caution may be difficult to accept. At the same time, they should be able to make informed decisions. Given the current exclusion criteria in psychedelic trials, researchers discourage patients with a history of personality or psychotic disorders from seeking these treatments at all. Jan Mars sends a piece of advice to those other patients without complex comorbidities who, despite potential risks, decide to seek truffle therapy: “Involve a loved one in the journey that you are about to embark on, for support before and after. Do some research on who is guiding it, what the setting will be like and whether there is enough time dedicated to the preparation of the session. Make sure that you feel you can trust the guide. If you have doubts, then there is probably a good reason for it, and it might not be a good idea.”

The relation between retreat and research

Truffle therapists in the Netherlands definitely have clinical research on psilocybin as their reference of best practice. Nick explained: “We frame it in a therapeutic setting to optimize positive outcomes and keep clients safe”. Nonetheless, researchers remain sceptical about the degree to which truffle providers actually manage to screen out participants with mental diagnoses or maintain high standards of care. To be fair, even some research protocols could be criticized for including the minimal amount of preparation and integration sessions.

Besides the potential harm to patients, researchers also seem to be worried about the future of research itself. The controversial history of the field has made psychedelic scientists generally cautious about avoiding any kind of social backlash. An unfortunate incident with a patient could set back the progress made in the last years. Renske Blom added: “If a major incident happens in the context of these therapy sessions, inside or outside clinical trials, it could influence upcoming research as well”.

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Check out the speaker list to discover which experts might be speaking about the latest advancements in the use of psilocybin in therapy!

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While acknowledging the importance of further research, Nick also stressed that “truffles were never researched. They cannot say that psilocybin session guides are too early. Actually, the research is late because more people trip on naturals than on lab-grade psilocybin”. Bearing in mind the likely pharmacological difference between the synthetic compound and whole truffles, the current research agenda may not represent the interests of truffle therapists. In other words, it is unclear whether research with pure psilocybin would ever be considered valid evidence to justify their practice. Joost Breeksema said: “We don’t really know what truffles contain because they haven’t been standardized or analyzed in the laboratory, but I do think that if psilocybin goes through the approval process, it is likely that people and investors will get interested in the whole product as well.”

Despite the rather marginal position of truffles in current research, some investigators have realized the potential role that the retreat ecosystem can play in psychedelic science. In collaboration with retreat centers, several research projects have administered questionnaires to participants to learn more about the effects of these substances and their ritual use on healthy people. These centers could also become a place where all kinds of alternative models of psychedelic care can develop. The rigid regulatory and scientific frameworks within which researchers operate may limit the possible treatment conditions. In contrast, retreats offer the chance to explore new experimental protocols such as group sessions or natural settings. Joost Breeksema said: “The retreats may offer an infrastructure that is better suited to the psychedelic experience than clinical hospital settings”.

Nick is enthusiastic about future collaborations: “We want to set up research at our centers and we would love to count on scientific organizations, so we can actually build up the science needed and move beyond this internal dialogue about truffle therapy.” Joost Breeksema adds: “If they do proper data collection and analysis, they can contribute to the body of knowledge about the potential effects and risks of psychedelics. There are definitely options for collaboration but it has to be done judiciously and cautiously.”

The medicalization of psilocybin appears to raise tensions among different stakeholders in the psychedelic field. In the eyes of researchers, the underground therapy scene and the booming industry around psychedelic medicine may entail risks for patients and for the public image of ongoing research. Hopefully, future collaborations between retreat centers and research teams may offer a way forward to generate the evidence needed for an eventual regulation of the medical, as well as the non-medical uses of psilocybin truffles. However, at this stage, the open commercialization of psychedelic therapy to potentially vulnerable patients may be an unwise step ahead.

Written by Alberto Cantizani López
Art by Anna Temczuk
*The names of all informants involved in the commercial provision of truffles as therapy have been omitted or replaced by pseudonyms

Stichting OPEN in Vrij Nederland

October 22, 2024 / Policy, Law & Economics, Scienitific Discipline / By

Vrij NederlandIn het laatste nummer van Vrij Nederland (12 december 2015) komt Stichting OPEN uitgebreid aan bod in een artikel over de gestage opkomst van psychedelisch onderzoek. In haar artikel “Trippen op recept” spreekt journaliste Freke Vuijst eerst met Dinah Bazer, een kankerpatiënte die dankzij haar psilocybinebehandeling haar doodsangst voorgoed wist te verjagen. Bazer was een van de proefpersonen van de studie aan de New York University over psilocybine voor de behandeling van doodsangst bij kankerpatiënten. Stephen Ross, een van de hoofdonderzoekers van de NYU-studie, noemt het succes van de psilocybinebehandelingen in zijn studie zonder meer indrukwekkend. Neal Goldsmith, co-organisator van het Horizons-symposium, dat in oktober plaatsvond in New York, en waar Vuijst Stephen Ross en zijn patiënte sprak, is het volmondig eens met deze laatste. “De data uit de studies zijn soms haast niet te geloven, zo overtuigend zijn ze,” legt hij uit. Terwijl de medische wereld volgens hem geen antwoord heeft op bijvoorbeeld post-traumatische stressstoornis (PTSS), en de psychiatrie zelden iets kan genezen, maakt hij zich sterk dat MDMA wel werkt. De onderzoeken naar de behandeling van doodsangst met psilocybine et die van PTSS met MDMA zijn momenteel de verst gevorderde.

Het artikel schetst vervolgens een kort historisch overzicht van de ‘eerste golf’ van het psychedelisch onderzoek tussen 1950 en 1970, waar president Nixon een einde aan stelde. Dat had niets te maken met de resultaten ervan: “Het was de counterculture revolution van de jaren zestig die de autoriteiten tot een algeheel verbod aanzette.” Ook in Nederland kende psychedelische therapie in die tijd een bloeiperiode, voornamelijk met het werk van psychiater Jan Bastiaans met overlevenden van de concentratiekampen uit WOII. Er kwam echter forse kritiek op de wetenschappelijkheid van de werkmethoden van Bastiaans. Joost Breeksema, voorzitter van Stichting OPEN, beaamt dat Bastiaans het imago van psychedelisch onderzoek in Nederland geen goed heeft gedaan, maar wijt het huidige gebrek aan onderzoek in Nederland vooral aan onbekendheid met moderne research over het onderwerp en blijvende associaties met hippies en muziek.

Ondertussen vordert het MDMA-onderzoek vrij snel. Volgens Rick Doblin, oprichter van MAPS, komt de goedkeuring van de Amerikaanse Food and Drug Administration er in 2021, en kan vanaf dan een netwerk van psychedelische therapieklinieken worden opgericht. Als voordelen van MDMA noemt hij het feit dat de ervaring minder ingrijpend en vreemd is dan bij de meer klassieke psychedelica, en dat er minder stigma aan vastkleeft.

Eerst moeten MDMA en psilocybine nog door het fase 3-onderzoek dat nu op til staat, waarbij de stoffen op een veel groter aantal patiënten worden getest. Dergelijke studies kosten hopen geld, en worden noch door de overheid noch door de farmasector gefinancierd. Die laatste is immers niet geïnteresseerd in stoffen waarop het patent vervallen is. In de VS bestaat er een traditie van grote non-profitorganisaties zoals MAPS, die privéfinanciering kunnen bieden, en zijn er belangrijke researchuniversiteiten die onderzoek voeren. In Nederland valt men traditioneel eerder terug op overheidsgeld. Bijgevolg gaat het onderzoek naar bijvoorbeeld MDMA eerder over de schadelijkheid ervan dan over mogelijke therapeutische toepassingen. Een toenemende interesse hiervoor bestaat wel: de lezingen en symposia van Stichting OPEN trekken volle zalen. Maar voorlopig komt het onderzoek naar psychedelische therapie in Nederland slechts moeizaam van de grond.

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