Connect with us


Mexico could be pioneer for indigenous medicine regulation, says ICEERS

The organisation has said that a new legal precedent has been set in Mexico after indigenous healer Don Jose Campos has been released following imprisonment for traveling with ayahuasca.



Mexico could be pioneer for indigenous medicine regulation, says ICEERS
Photo by Jorge Aguilar on Unsplash

In what has been described as a “historic trial”, ICEERS has suggested that the verdict of an ayahuasca trial in Mexico opens the door for the country to become a pioneer in the regulation of indigenous traditional medicines.

Indigenous healer from the Peruvian Amazon, 64-year-old Don Jose Campos, was arrested and imprisoned on March 9, 2022 for traveling with ayahuasca.

Campos, who was handed an acquittal in Mexico City on Thursday, 7 March, 2023, was facing a potential 10 to 25 years in prison.

The International Center for Ethnobotanical Education, Research, and Service (ICEERS) has said that this is the first trial in a series of similar cases in which the people involved have been put in prison for months due to the country’s official pre-trial detention in the case of alleged “crimes against health.”

See also  EU bodies provide perspective on regulation of psychedelics

The organisation has welcomed the resolution, saying that it sets a legal precedent of respect for the rights of indigenous peoples in Mexico and the world.

Natalia Rebollo, ICEERS lawyer and coordinator of the ICEERS Legal Defense Program (ADF), stated that: “…this first case involved a weighing and prioritisation of the human rights of indigenous peoples against a rigid drug control system that, as has been proven, is based neither on human rights nor on the ample scientific evidence available, and that deserves to be revised.”

In its statement, the organisation notes that Dr José Carlos Bouso, pharmacologist and scientific director of ICEERS, participated as an expert witness in the area of science and pharmacology.

See also  EU bodies provide perspective on regulation of psychedelics

Dr Bouso demonstrated that, based on the available scientific evidence, ayahuasca does not pose a risk to public health, stating: “In this trial we have presented the evidence that exists on the health effects of ayahuasca, coming from both our own research and that of our colleagues, explaining more explicitly the two investigations we have recently published on the effects of ayahuasca on public health in large populations of users.”

ICEERS also confirmed that Ayahuasca Defense Fund (ADF) lawyer Natalia Rebollo testified about the confusions that exist between ayahuasca and DMT, insisting on the human rights of Indigenous people who use ayahuasca ancestrally: “If ayahuasca were regulated in Mexican legislation, the botanical name of the two plants that compose it would be included, as it occurs with other plants that are regulated in the General Health Law, such as peyote (Lophophora williamsii) or mushrooms containing psilocybin.”

See also  Discussing Alberta’s move to regulate psychedelic therapy

“This verdict opens the door for Mexico to become a pioneer country in the regulation of indigenous traditional medicines, as evidenced in the recent Intercultural Forum on Entheogenic Medicine, co-organised by ICEERS and the Senate of the Republic,” ICEERS commented in its statement.

“Although there are still seven more cases of people who remain in preventive detention, awaiting trial, for crossing Mexico’s borders with ayahuasca, this first procedure is decisive in establishing a precedent in the legal defense of ayahuasca in the country.

“ICEERS will continue to provide its expertise to support these cases and ensure that similar sentences can be handed down in various countries.”

Continue Reading
Click to comment

Leave a Reply

Your email address will not be published. Required fields are marked *


Canada recommends launch of Veterans psychedelic research programme



Canada launch Veterans psychedelic research programme

A new report has been released by Canada’s Senate Subcommittee on Veterans Affairs – ‘The Time Is Now: Granting Equitable Access to Psychedelic Assisted Therapies’ – which recommends the launch of a large-scale research programme on psychedelics for Veterans’ mental health.

Emphasising that around 10 to 15% of Canadian veterans are diagnosed with post-traumatic stress disorder (PTSD), the report explores the opportunity presented by psychedelic research as a treatment for alleviating symptoms of the condition.

The Subcommittee suggests the programme should be funded by Veterans Affairs Canada (VAC) and the Department of National Defence (DND) in partnership with Health Canada, the Canadian Institutes of Health Research, and other relevant partners.

The report states: “This approach would ensure, first of all, that those veterans most likely to benefit from it are given access to treatment with the best scientific support available, and second of all, that the initial findings on the effectiveness of this treatment for veterans are either proven or qualified.”

And goes on to say: “It is the Government of Canada’s duty to assure veterans that it is doing everything in its power, immediately, to respect its solemn commitment to support, at any cost, those who chose to defend us with honour.”

Psilocybin and MDMA have already been added to Canada’s Special Access Program (SAP) which enables authorised patients to access psilocybin and MDMA-assisted therapy for conditions such as PTSD and end-of-life anxiety. 

Studies are showing that both psilocybin-assisted therapy and MDMA-assisted therapy could be potentially efficacious treatments for alleviating symptoms of PTSD in Veterans.

However, the report notes that most clinical studies involve the general population and that Veterans often respond differently to treatments, highlighting the need for further research in the Veteran population.

The report and recommendation have been welcomed by the Psychedelic Association of Canada (PAC), which works with lawmakers, healthcare workers, educators and researchers, psychedelic practitioners, businesses and the public to gain access to psychedelic medicines for Canadians.

Jay Katz, Executive Director of the Psychedelic Association of Canada, stated: “The PAC is encouraged by the contents of the Senate Subcommittee’s report. Their acknowledgement of the potential inherent in reshaping our approach to treating mental illness is an auspicious first step. It paves the way for significantly improved outcomes.”

The organisation has highlighted that, in light of growing research, Canadian citizens have demonstrated strong support for increased access to psychedelic medicines.

To read the full report please visit:

Continue Reading


PAREA’s psychedelic push: improving policy for mental health innovation in Europe



Medical psychedelics policy paper launched in Europe

The Psychedelic Access and Research European Alliance (PAREA) has launched a policy paper in line with a recent meeting on medical psychedelics in the European Parliament. 

In a significant step for Europe, the MEP Action Group for the Medical Use of Psychedelics meeting took place to dicuss medical psychedelics within the EU pharmaceutical legislation framework.

PAREA launched its policy paper “Unmet Medical Needs: Aligning Medical Innovation with Societal Health Needs” in line with the event, and as a follow up to the orgainsation’s recent position statement, “Leveraging the EU Pharmaceutical Package: A Life Cycle Approach to Address High Unmet Needs and Foster Mental Health Innovation by Incentivizing Psychedelic Novel Medicines”.

See also  PAREA launches psychedelics manifesto for mental health in Europe

Challenging the current paradigm that narrowly defines unmet and high unmet medical needs, PAREA argues in the policy paper that “the existing focus on life-threatening or severely debilitating conditions fails to consider the broader health and societal context.”

The paper outlines the burden created by prevalent mental health conditions including on the individual as well as healthcare systems, society and the economy, arguing that “the current criteria for unmet medical needs do not adequately account for the potential to significantly improve quality of life, especially for chronic conditions.”

As this criteria dictates what receives funding, the paper argues, “a recalibration is essential for ensuring that medicine development aligns more closely with public health priorities and needs.”

The policy paper also calls for:

  • The urgent expansion of criteria used to define high unmet medical needs to include the prevalence of conditions and their societal impact.
  • The establishment of a European Hub for Mental Health Research and Development that would unite EU institutions, member states, healthcare funders, and philanthropic organizations. 
  • For mental health to be addressed as a central pillar of sustainable development.

On the European Parliament meeting, PAREA stated: “The event, which coincided with the ongoing discussions on the revision of the EU pharma package, focused on creating a supportive regulatory environment to foster innovation in novel mental health treatments, particularly psychedelic therapies.

“The gathering underscored the urgency of addressing unmet medical needs in the EU and the potential of psychedelic therapies to offer rapid, durable improvements for conditions such as depression and PTSD.”

The organisation continued: “As the EU revises its pharmaceutical legislation, PAREA’s policy paper serves as a critical voice, advocating for a recalibrated approach that aligns medicine development with public health priorities and societal needs. It is a call to action for policymakers, healthcare professionals, and stakeholders across Europe to recognise and address the unmet needs in mental health care.”

To read the full policy paper please click here.

Continue Reading


Study to investigate psilocybin therapy for cancer-related depression



Study investigate psilocybin therapy for cancer-related depression

Psychedelic therapy company Sunstone Therapies has announced the start of its first study investigating multiple doses of psilocybin in the treatment of major depression disorder (MDD) in patients with cancer. 

The Phase 2 two-part study, taking place at the Bill Richards Center for Healing at the Aquilino Cancer Center, will examine the safety and efficacy of up to two 25mg doses of psilocybin in 56 patients administered at an interval of 9 to 10 weeks.

The first part of the study will administer a first dose of psilocybin in a double-blind, randomized, placebo-controlled portion, while the second part of the study will take the form of an open-label portion for patients who do not achieve MDD symptom remission after the first dose.

All study participants will be supported through the first dosing sessions by a study therapist in addition to a second therapist monitoring via video feed, and in the second session, all eligible participants will receive psilocybin 25 mg in an open-label fashion using a group session model.

Chief Medical Officer at Sunstone Therapies and Principal Investigator on the study, Paul Thambi MD, commented: “The emotional distress associated with cancer is often as significant as the physical effects, and yet oncologists have few effective treatments to tackle this important aspect of the patient experience. 

“More recently, the use of psychedelic-assisted therapy has seen renewed interest and a number of studies show a positive impact on symptoms of depression in patients with cancer, including our own open label study published in JAMA Oncology. 

“This new study includes a placebo control arm, the use of group administration, and – for the first time – multiple doses. We believe this adds significantly to the understanding of the role psilocybin-assisted therapy could play in improving patients’ lives and how it might best be delivered.”

Chief Executive Officer at Sunstone Therapies, and Clinical Investigator on the study, Manish Agrawal MD, added: “The Sunstone team has a longstanding commitment to advancing clinical research in psychedelic-assisted therapy in cancer patients, and unique depth of experience across psychedelic modalities and indications. 

“This study builds on our pioneering approach to clinical trial design: there is limited data addressing the question of whether multiple administrations of treatment doses of psilocybin in patients with cancer lead to improved efficacy. 

“We look forward to making a further contribution to the clinical development of this potentially vitally important treatment modality.”

The primary efficacy endpoint of the study is the change in the Montgomery-Asberg Depression Rating Scale (MADRS) from baseline to week 8, and secondary endpoints – which include the onset and durability of response, response rate and remission, and the effect on pain – will be used to assess parameters in both the placebo-controlled and open label study conditions.

Continue Reading