Psychedelics

5 Takeaways from Colorado’s Proposition 122 – The Natural Medicine Health Act

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2 years ago

February 2, 2023

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Article by: Partner Jeff Zuber , Counsel Raza Lawrence, and Associate Lizzie Fanckboner.

In November 2022, Colorado voters passed Proposition 122, the Natural Medicine Health Act (NMHA), which establishes a regulated natural medicine access program and provisions for personal use of natural medicines. Under this new law, Colorado will become the second US state – following Oregon – to issue licenses allowing the commercial production and administration of federally-illegal psychedelic substances. The state-licensed psychedelic programs follow in the footsteps of cannabis state legalization initiatives adopted by states across the country that, like the psychedelic measures, license and regulate conduct under state law that constitutes a crime under the federal Controlled Substances Act.

Regulated Psilocybin Program in Colorado

Just like Oregon’s psilocybin licensing program, Colorado’s state-regulated program will provide participants with access to natural psychedelic substances under the supervision of a licensed facilitator. The NMHA tasks Colorado’s Department of Regulatory Agencies (DORA) with overseeing and adopting rules to govern the natural medicine access program, taking guidance from the Natural Medicine Advisory Board’s recommendations. There are two initial license types contemplated by the statute – Licensed Healing Centers and Licensed Facilitators – but additional licenses and registrations may be created by DORA.

Although Colorado’s NMHA uses words typically associated with the medical and pharmaceutical industries – “medicine,” “health,” “treatment,” “recovery,” and “healing” – it does not contemplate any involvement of medical doctors. Instead, Colorado’s law – like Oregon’s– will allow all people 21 years of age or older to purchase and use psychedelics, without the recommendation or approval of any doctor or other health care professional.

Colorado’s program will start with psilocybin and psilocin, but may be expanded after June 1, 2026 to include one or more of the other substances identified in the definition of “natural medicine”: DMT, ibogaine, and mescaline (but not mescaline extracted from peyote).

The definition of a “healing center”is broad and purposefully flexible.

(d) “HEALING CENTER” MEANS AN ENTITY LICENSED BY THE DEPARTMENT THAT IS ORGANIZED AND OPERATED AS A PERMITTED ORGANIZATION:

(I) THAT ACQUIRES, POSSESSES, CULTIVATES, MANUFACTURES, DELIVERS, TRANSFERS, TRANSPORTS, SUPPLIES, SELLS, OR DISPENSES NATURAL MEDICINE AND RELATED SUPPLIES; OR PROVIDES NATURAL MEDICINE FOR NATURAL MEDICINE SERVICES AT LOCATIONS PERMITTED BY THE DEPARTMENT; OR ENGAGES IN TWO OR MORE OF THESE ACTIVITIES;

(II) WHERE ADMINISTRATION SESSIONS ARE HELD; OR

(III) WHERE NATURAL MEDICINE SERVICES ARE PROVIDED BY A FACILITATOR.

There is a lot to unpack here, but suffice it to say, psychedelics can potentially be cultivated, sold, and consumed at any of a wide variety of locations under this definition. The NMHA also directs DORA to establish rules that will allow for psychedelics to be administered in “another location” that is not a designated healing center, “as permitted by rules adopted by the Department.” Such locations could potentially include private residences, other types of health-care facilities, and outdoor natural settings. With that said, we will see how the framework and boundaries take shape with the creation of the rules, which are scheduled to be adopted in 2024.

There will be training programs for facilitators and certain education and qualification requirements. Licensing for facilitators will be tiered, so as to provide for varying levels of education and training depending on the participants the facilitator will be working with and the services.

Personal Use Now

Part of the NMHA removed criminal penalties for the personal use of natural medicine for persons 21 years of age or older. The personal use section is separate from the regulated natural medicine access program in the NMHA. Think of the NMHA as having two parts – one is the regulated natural medicine program and the provision of natural medicine services; and the other is personal use. The personal use provisions allow for the cultivation, processing, storing, using, transporting, obtaining and ingesting of natural medicines, including dimethyltryptamine (DMT), ibogaine, mescaline (not from peyote), psilocybin and psilocyn, for personal use. There are some boundaries to this personal-use decriminalization written into the NMHA, which are summarized below.

– Retail sales are prohibited. There is no retail market provided for, or intended by the NHMA, outside of what is allowed in the context of licensed healing centers. Outside of the licensed healing centers, a person may still charge for bona fide therapy or harm reduction services, or other support services with a connection to natural medicine, but there can be no remuneration for the natural medicine.

– Personal use is not allowed for those under the age of 21. A person who is under 21 year of age will be subject to a drug petty offense for possession, use, transporting, sharing, natural medicine or natural medicine paraphernalia, subject only to a penalty of more than four hours of drug education or counseling provided at no cost to the person.

– There is no cultivation or consumption permitted in schools, detention centers, public spaces or federal lands. Keep in mind that the natural medicines under NMHA are still schedule I substances, and are still federally illegal.

– People are not allowed to give away any amount of natural medicine as part of a business promotion or other commercial activity,

– People are not allowed “to permit paid advertising related to natural medicine, sharing of natural medicine, or services intended to be used concurrently with a person’s consumption of natural medicine.” It is unclear how, or whether, this provision would apply to any advertising done in connection with licensed psilocybin healing centers.

The takeaway here is that the intent for personal use under the NMHA is to provide individuals with additional options for their mental health and spiritual growth, and to remove penalties associated with indigenous and traditional uses.

In practice, most people who use psychedelic substances acquire them from other people, whether or not any compensation exchanges hands. Outside the context of licensed healing centers, any such transactions will continue to be prohibited, although the decriminalization of personal possession and use will likely result in fewer overall prosecutions, and a de-emphasis on prosecution of lower-level transactions.

Colorado’s NMHA differs in notable respects from Oregon’s Psilocybin Services Act

There are several differences between Colorado’s NMHA and Oregon’s Psilocybin Services Act. A few salient points of comparison are outlined below.

Under Oregon’s Psilocybin Services Act, psilocybin may only be administered in licensed service centers. The effect is that the number of service centers will be limited and that limitation in turn reduces options and may increase costs. On the other hand, Colorado’s NHMA allows for the provision of psilocybin services outside of licensed healing centers and specifically contemplates natural medicine services being provided in places such a residential homes, community mental health centers, long-term care facilities, or other types of facilities where health care is provided. There is purposeful flexibility worked into the NMHA with regard to where natural medicine services may be provided. As the regulations are being developed, we will see exactly how this will look, but the hope is to create opportunities for equitable access to natural medicines.

Another difference is that Colorado does not have a residency requirement written into the NMHA. We previously wrote about Oregon’s requirement that psilocybin businesses be majority-owned by Oregon residents here.

Oregon’s psychedelics program is limited to the licensing and regulation of psilocybin activities. Colorado’s program, however, expressly contemplates extending the licensing program to cover the distribution and administration of three other psychedelic substances: DMT, ibogaine, and certain forms of mescaline.

Colorado’s NMHA contemplates that licensed healing centers will be allowed to cultivate and manufacture psychedelic substances in addition to administering them to adults. Oregon, by contrast, has separate license types for psilocybin manufacturers and psilocybin service centers, contemplating that many businesses may focus on either manufacturing or administration, and will not be a single vertically-integrated organization.

Colorado’s NMHA decriminalizes the personal possession and use of various psychedelic substances, while Oregon’s psilocybin licensing program did not address personal use of psilocybin outside the context of licensed service centers. Oregon, however, passed a law in November 2020 (Measure 110) decriminalizing the possession for personal use of small amounts of all controlled substances, making such conduct civil infractions punishable only by citation and a $100 fine (which can be waived by calling a hotline to screen for substance use disorder).

Finally, the Oregon Psilocybin Services Act provided an out for local jurisdictions whose residents did not want to participate in the program. As such, many cities and counties opted out of the program in this past November’s election. Conversely, under Colorado’s NMHA, a local jurisdiction may not completely prohibit the establishment or operation of a healing center. Localities can, however, enact reasonable ordinances and regulations so long as they do not conflict with NMHA, and thus will have the practical ability to make it difficult for psychedelic businesses to operate.These are just a few points and only skim the surface in the comparison of the two programs. As Colorado gets moving on discussing the regulations, we will see start to see the program take shape.

Will it be like the cannabis industry?

Yes and no.

While both industries contemplate a state-regulated program or industry that is illegal under federal law, one major difference is that the NMHA is not intended to create an open retail market like we are all familiar with in the cannabis industry. The intention of the NMHA is to create a program for the supervised use of natural medicines, starting with psilocybin or psilocin, but the NMHA does not contemplate a dispensary model, or retail sales outside the context of supervised use.

On the similarity side, interested parties hoping to enter this new ecosystem of natural medicine and natural medicine services will face barriers similar to those that the cannabis industry confronted. The common denominator between the two industries is the fact that cannabis and psilocybin are both listed on schedule I of the federal Controlled Substances Act. Therefore, psilocybin businesses will face issues with taxes (280E), access to banking (or lack thereof), buying or leasing property for the business (cost, lease agreements, etc.), obtaining insurance, and securing federal trademark protection. As with cannabis businesses, absent a change in federal law, everyone participating in Colorado’s licensed psychedelic industry will also face the continuous threat of federal criminal prosecution and asset forfeiture, even if operating in full compliance with state laws.

What is coming up?

The first date to keep in mind is January 31^st. By then, the Governor of Colorado will have hopefully appointed the members of the Natural Medicine Advisory Board, who will be drafting recommendations for the regulations, to provide to DORA.

Next, by September 2023, we will hopefully see recommendations from the Natural Medicine Advisory Board for DORA’s eventual rules, as well as recommendations related to research, training, product safety, harm reduction, cultural responsibility, and requirements to ensure that the regulated natural medicine access program is equitable and inclusive, just to name a few.

Then, by a year from now, DORA is expected to adopt rules that establish the qualifications, education, and training requirements that facilitators must meet before providing natural medicine services and to approve any required training programs.

Finally, by September 30, 2024, the rules governing the program should be adopted and DORA will open its doors to accepting applications, which by law are to be processed and approved or rejected within 60 days of submission.

In the meantime, interested parties can participate in the rulemaking process, work on developing a corporate structure and business plan, engage with local officials and community groups regarding zoning and other local considerations that may impact psychedelic businesses, and start discussions with their CPA or accountant on a tax strategy.

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Dutch police find gnome made of MDMA during drug bust

Published

6 hours ago

November 23, 2024

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BBC

Officers in the southern Netherlands have found a garden gnome weighing nearly 2kg (4lb) and made of the drug MDMA.

“Drugs appear in many shapes and sizes, but every now and then we come across special things,” Dongemond Police said in a translated social media post.

The gnome was found among suspected narcotics during a large drug search.

“In itself a strange place to keep your garden gnome,” the force said. “That’s why we decided to test [it] for narcotics”.

“The gnome himself was visibly startled,” police said, referring to the gnome having its hands covering its mouth.

It is not known which area the gnome was recovered in, but the Dongemond Police covers the municipalities of Oosterhout, Geertruidenberg, Drimmelen and Altena.

MDMA – which is an illegal substance in the Netherlands – is a synthetic party drug also known as ecstasy.

As of 2019, the Netherlands was among the world’s leading producers of MDMA.

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Paper 24 October 2024: Expert recommendations for Germany’s integration of psychedelic-assisted therapy

Published

3 weeks ago

November 1, 2024

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Psychedelic-assisted therapy (PAT) is a modality of mental health treatment that merges psychotherapeutic interventions with psychedelic states, often facilitated by substances such as lysergic acid diethylamide (LSD), psilocybin, and 3,4-Methylenedioxy-methamphetamine (MDMA). The latter two being in phase III trials. Whereas MDMA is considered an entactogen that enhances self-awareness and emotional connectivity, psilocybin is a naturally occurring psychedelic compound found in certain mushrooms. Recent research suggests that these and other psychedelics, all small molecules, most with benzene or phenyl rings, uniquely work by reopening a “critical period” in the brain, allowing for new learning within social contexts in a process involving changes in brain plasticity and oxytocin signaling [1]. Despite their classification as a Schedule I drugs under the Controlled Substances Act by the Drug Enforcement Agency (DEA) in the United States, their therapeutic potential has been increasingly recognized, with demands from the public to make them available for those with treatment resistant conditions. These among other developments resulted in MDMA being granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the treatment of treatment-resistant PTSD (TR-PTSD) in phase II, (phase III studies were for ‘moderate to severe’ PTSD). Psilocybin (COMP360) and a deuterated psilocybin analogue (CYB003) were granted FDA Breakthrough Therapy designation for treatment resistant depression (TRD) [2,3,4].

Methodologically rigorous clinical research suggests that PAT may offer substantial long-term alleviation of symptoms in patients suffering from psychopathologies such as PTSD, TRD, major depressive disorder (MDD), end of life anxiety, obsessive–compulsive disorder (OCD), substance use disorders (SUD), psychotic conditions, and more [5, 6]. Notably, a single session of substance-assisted therapy has been reported to lead to significant symptom reduction, with some patients achieving remission that can persist for at least twelve months [7]. This enduring effect underscores the potential of psychedelic-assisted therapy in providing therapeutic outcomes that are significantly superior to antidepressant medications such as SSRIs, which often have poor efficacy rates and unwanted side-effects such as agitation, weight gain, sexual performance difficulties, gastrointestinal issues, and other symptoms [1, 8].

In February 2024, Lykos (formerly MAPS PBC) submitted a new drug application (NDA) to the FDA for MDMA (Midomafetamine) capsules in combination with psychotherapy for the treatment of PTSD [9]. Following the submission, a citizen petition was filed, raising concerns about the integrity of the clinical trials. This prompted the FDA to convene an advisory board meeting in June 2024 to review the claims. The petition raised several issues, including alleged bias in the trial design, inadequate sample diversity, insufficient double-blinding, underreporting of adverse events such as sexual misconduct, and confusion regarding the integration of psychotherapy within the study design [10]. Despite the principal view that MDMA trials are sound, and even the FDA’s participation in the creation and oversight of the studies these concerns influenced the FDA’s review process. Subsequently, in August 2024, the FDA issued a final decision rejecting the NDA under the Prescription Drug User Fee Act (PDUFA). It is important to note however that the FDA encouraged ongoing MDMA research and asked for another Phase III trial.

This decision led to additional actions, including the Journal of Psychopharmacology retracting three articles related to the MDMA clinical trials conducted by the MAPS research team and the initiation of an FDA investigation. Lykos has since filed for a reevaluation of their NDA. If approved, MDMA would become the first psychedelic-assisted therapy officially recognized in the United States.

As unexpected as the August 2024 rejection of the application by Lykos for approval of MDMA was for some, the hope based on the phase II studies, remains that either MDMA or psilocybin will within the next two to three years receive a positive evaluation from the FDA although the exact timing remains unknown. Unlike the MDMA trials, where the FDA was initially satisfied with the blinding process prior to the advisory board meeting, Compass’ psilocybin trials were designed to minimize the unblinding caused by psychotropic effects, following the FDA’s advice to their satisfaction until this day.

Lykos and Compass have been the two major companies driving development, and although Lykos has yet to submit a new phase III proposal, Compass continues with their phase III clinical trial. In general enthusiasm in the field for further research continues as there remains a need for novel treatments, and despite the uncertainty, the FDA seems generally favorable toward psychedelic medicine [10].

This paper outlines the current and required infrastructure for the successful integration of PAT, including rescheduling of psychedelic drugs beyond ketamine, accessibility, reimbursement strategies, accreditation of practitioners, ethical considerations and educational requirements. The role of the German government and affiliated agencies is pivotal in shaping this framework, ensuring that the setup not only complies with regulatory standards but also supports the ethical deployment of these therapies.

Moreover, with the European Medicines Agency (EMA) currently deliberating on the integration of psychedelics within the European framework, Germany has a unique opportunity to lead by example, showcasing a meticulous approach to the adoption of psychedelic-assisted therapies and must therefore also prepare to accommodate these innovative treatments [11]. This could serve as a model for other European nations, promoting a harmonized approach to these promising treatments across the continent.

The first half of this paper covers the regulatory environment in Germany, as it is impossible to understand the steps required to make PAT a reality without some in-depth understanding of the country’s unique health care system. The second half of this paper covers the German provision of outpatient mental healthcare and how and where PAT would fit and critically, proposes a training scheme for the education of PAT facilitators.

Historical roots of psychedelics in Germany

Psychedelic research in Germany harkens back to the 1910s and 1920s when the atypical psychedelic MDMA was first synthesized, and pioneering research was being conducted on the properties of mescaline. During this early period, Beringer and colleagues [12] saw in mescaline and similar substances, an opportunity to explore the phenomenology of psychopathology, creating what they described as ‘model psychoses.’ Although problematic in many ways, this stream of research opened up a new dimension of empathy and understanding into the experience of individuals with chronic psychosis [13]. In fact, the research carried out at the University of Heidelberg, culminating in Beringer’s habilitation thesis “Der Meskalinrausch” from 1927, can be considered the first major work in the field of psychedelic psychopharmacology in the West [12]. Another noteworthy event in the history of psychedelic drugs in German-speaking Europe is Albert Hoffman’s accidental discovery of the properties of lysergic acid diethylamide (LSD) on April 19, 1943, which accelerated interest in psychedelic compounds throughout the Western world [14]. In particular, this landmark event led to the widespread experimental use of psychedelics for a diverse range of psychiatric conditions across Europe and North America.

This period of research during the 1950s and 1960s, though short-lived, would later become known as the first wave of psychedelic research [14, 15]. During this brief moment in history, Betty Eisner, a German-educated American, first described the implementation of low-dose LSD in combination with psychotherapy, making a major contribution in the field which still today remains underrecognized [16]. Margot Cutner, a German psychoanalyst who was leading psychedelic research in England after fleeing from the Nazis, provided some of the first insights on the relevance of the role of the facilitator in psychedelic-assisted therapy (PAT) and the now well-known notion of ‘set and setting’ [16]. Following this, Hanscarl Leuner coined the term “psycholytic therapy” at the University of Göttingen underscoring the drug’s therapeutic potential in a sub-threshold dose range [17]. Despite Leuner and colleagues’ extensive research on LSD being among the most comprehensive bodies of work on the topic to date, it has been largely neglected until recently due to never being published in English [18].

A surprising turn of events occurred when in 1961, the United States passed the seemingly politically motivated US Controlled Substances Act, which resulted in an immediate and indefinite suspension of psychedelic research throughout the U.S. Europe was quick to follow suit, and psychedelics became labeled as potentially dangerous and addictive with no accepted medical use [19]. Subsequently, despite early breakthroughs and extensive research, these restrictions ushered in a prohibition era that would last decades, hampering progress and limiting the exploration of psychedelic compounds throughout the Western world. Germany was no exception, and psychedelic treatments now being championed for their therapeutic potential were outlawed.

Economic burden of treating PTSD and depression in Germany

The economic and human costs of PTSD and depression in Germany highlight an urgent need for more effective interventions [20]. Trauma-related healthcare costs range from 524.5 million to 3.3 billion euros annually [21], while depression adds another 1 to 5.2 billion euros [22, 23]. Current pharmaceutical treatments, such as serotonin-reuptake inhibitors (SSRI), offer limited efficacy and fail to fully address the needs of individuals with PTSD, depression, or their comorbidities [24].

A recent study of German insurance claims highlighted both the direct and indirect costs of PTSD (ICD-10-GM F43.1) [20, 21]. PTSD patients typically suffer for about 6 years, with a 50–100% likelihood of comorbid conditions such as major depressive disorder (MDD), panic disorder, and substance use disorder (SUD). Per-patient costs were 43,000 EUR, three times higher than for those without PTSD, driven by increased healthcare utilization, impaired work capacity and reduced quality of life. PTSD also accounts for approximately 200,000 Disability-Adjusted Life Years (DALYs) annually in Germany, a metric that reflects both premature mortality and years lived with disability, quantifying the overall burden of disease [25].

Similarly, depression carries significant economic burdens with indirect costs from labor absenteeism, social benefits, and prevention measures estimated at 10 to 16 billion euros annually, surpassing direct healthcare costs [26, 27]. Depression accounts for approximately 470,000 DALYs in Germany [28], while globally, PTSD contributes an additional 3 million DALYs, underscoring its substantial public health impact.

In short, PTSD and depression remain conditions with a high unmet need. SSRIs, first introduced in 1988 (fluoxetine), are still the primary pharmaceutical treatment for many psychological disorders, despite their limited efficacy and adverse side effects, including symptom exacerbation and suicidal thoughts [29].

Regulatory landscape

The European Medicines Agency (EMA) grants marketing authorization for new medicines across the EU. The sponsor of the medication submits an application for approval to the EMA following phase III trials, and after EMA approval, marketing authorization is granted, which allows the medication to be sold in all European Union member states. Sponsors then must decide which member states they wish to enter, as, even if the Sponsor has marketing authorization, each EU state has its own rules about how health insurers will be reimbursed for new medications. European member states furthermore have country specific processes and infrastructure around the provision of therapeutic services which are an essential part of PAT.

In Germany, the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) oversees both clinical trial approval (pre- and post-EMA approval) and the documentation as well as considerations related to safety, efficacy, and quality, and specific labeling requirements tailored to the German context (Fig. 1).

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https://bmcmededuc.biomedcentral.com/articles/10.1186/s12909-024-06141-3?utm_medium=email&_hsmi=97789529&utm_content=97789529&utm_source=hs_email

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Jacobin Article: “Nationalize Psychedelics” | Cannabis Law Report

Published

4 weeks ago

October 26, 2024

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Here’s the introduction

here were high hopes that MDMA-assisted therapy would be approved by US regulators in 2024. The data showed that the drug-therapy combo significantly reduces post-traumatic stress disorder (PTSD) symptoms, or even eases them completely — despite a strong placebo effect in the trials, which involved well under a thousand participants. When the study data was published in September 2023, the New York Times reported that MDMA-assisted therapy was “inching closer to approval.” But in an August ruling that came as a wake-up call to figures in the nascent psychedelic industry as well as an underlying psychedelic movement made up of a hodgepodge of campaigners, the Food and Drug Administration (FDA) declined to give the green light, citing a lack of convincing clinical evidence and issues with the studies. The FDA requested further data from a new study, which would take several years, marking a significant setback for the prospect of medical psychedelics.

As early as 2026, however, the FDA will likely have another opportunity to approve another psychedelic drug for Americans with depression — psilocybin, which is derived from magic mushrooms — depending on the results of late-stage research. Even if it does pass, the therapy will likely not be immediately covered by insurance and so will remain beyond the reach of most Americans. This reality, plus the fact that psychedelics are meant to make you feel more interconnected (and thus perhaps less likely to want to squeeze profits from your peers), raises an intriguing possibility: that the psychedelics industry could be nationalized for the public good.

“Psychedelics, like pharmaceutical products, are just going to be inaccessible to many, many people,” says Professor Susi Geiger, a patent expert from University College Dublin. Step one to ensuring equitable access, and giving hospitals some respite from the straightjacket that often forces them to pay well over the odds for drugs, is reforming a patent system that enables Big Pharma to hike prices on existing drugs cartel-style thanks to the monopolies they enjoy over their products. To prevent the far-out possibility of Google founder Sergey Brin controlling the price of certain psychedelic therapy protocols, Geiger suggests a complete moratorium on private patents over psychedelics. “That’s the equivalent of nationalizing it at the source and keeping it as a public good.”

The idea may sound utopian and raise more questions than it immediately solves, even if the US patent office got on board and Congress created a European-style semi-socialized health care system, free at the point of use. “How can we trust exclusive access through a national health service when the state has only previously handled access [to psychedelics] through prohibition and religious censorship?” asks Chris Byrnes, a patent attorney at CalyxLaw. Matt Brockmeier, counsel at Antithesis Law, says less charitably: “I don’t trust the federal government — this or any other administration — to oversee something as monumental as our collective consciousness. Their track record is abysmal; they ruin everything they so much as look at because of the influence of special interests, fraud, waste, abuse, outright corruption, and general incompetence.”

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https://jacobin.com/2024/10/psychedelics-nationalization-psilocybin-mdma-therapy

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