Psychedelics
Drew Kriete -Paper: FROM COUNTER-CULTURE TOWARDS OVER THE COUNTER THE LEGALIZATION OF PSILOCYBIN MUSHROOMS: WHAT A LONG, STRANGE TRIP IT’S BEEN……
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2 years agoon
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Author
Drew Kriete is a third-year J.D. Candidate at California Western School of Law. Drew is he co-chair of the Psychedelic Committee and the class representative for the Cannabis Law Student Society.
He writes…..I am very passionate about promoting the history and proven therapeutic benefits of cannabis, psilocybin, and other natural medicines. I am eager to deepen my ties with the psychedelic legal community so that I may become more involved in policy discussions and help plant-based businesses navigate through cumbersome legal processes.
Drew Kriete
J.D. Candidate 2023
CALIFORNIA WESTERN
SCHOOL of LAW | SAN DIEGO
FROM COUNTER-CULTURE TOWARDS OVER THE COUNTER
THE LEGALIZATION OF PSILOCYBIN MUSHROOMS: WHAT A LONG, STRANGE TRIP IT’S BEEN
- INTRODUCTION
- PART I: BACKGROUND
- WHAT PSILOCYBIN DOES TO PEOPLE
- WHAT PSILOCYBIN MEANS TO CULTURE AND HISTORY
- PART II: THE LEGAL STATUS OF PSILOCYBIN AND CONFLICTS BETWEEN LEVELS OF GOVERNMENTS
- PART III: RECENT STATE DEVELOPMENTS
- WHAT MAY CHANGE THROUGH LEGALIZATION AND DECRIMINALIZATION
- CRITICISMS AND POSSIBLE SOLUTIONS
- CONCLUSION
INTRODUCTION
“‘Magic mushrooms’ for PTSD therapy? Vets help sway conservatives.”1 “‘Magic mushroom’ psychedelic may help heavy drinkers quit.”2 “Psychedelic Treatment with Psilocybin Relieves Major Depression, Study Shows.”3 Recent headlines such as these have brought psilocybin mushrooms and the use of other entheogens as a therapeutic tool to the forefront of scientific research and popular culture. Entheogens are “psychoactive, hallucinogenic substance[s] or preparation[s] especially when derived from plants or fungi and used in religious, spiritual, or ritualistic contexts.”4 One entheogen receiving the most attention is psychedelic mushrooms, commonly known as ‘magic mushrooms,’ ‘mushrooms,’ or ‘shrooms.’5 Over 200 species of hallucinogenic fungi have been recorded.6 The most common come from the genus Psilocybe.7 Psilocybe cubensis (“Gold Caps”) and psilocybe semilanceata (“Liberty Caps”) have become the most distributed and recognizable species.8
These mushrooms have been featured in movies and television,9 as well as scientific studies.10 Yet many people, even those who consider themselves experienced “psychonauts” (a person who uses altered states induced by substances to “explore human experience and existence”),11 may not know or understand the history and legal background behind psilocybin mushrooms.
While psilocybin remains illegal federally, some states and large cities have begun to relax their laws concerning mushrooms and other plant-based entheogens.12 Psilocybin mushrooms have been legalized in Oregon and Colorado with service centers opening in the near future.13 Bills to decriminalize, investigate, or ease restrictions are active in Florida, Georgia, Hawaii, Iowa, Kansas, Maryland, Massachusetts, Missouri, New Jersey, New York, Oklahoma, Rhode Island, Vermont, Virginia, and Washington.14 Notable cities that have decriminalized psilocybin include Denver, Oakland, San Francisco, Seattle, Detroit, Ann Arbor, Cambridge, and a growing list of others.15
This article will examine psilocybin mushrooms: what they have come to mean to our culture, their evolving history, an argument in support of change in their legal status, and a description of what may change through decriminalization or legalization. Part I will examine psilocybin mushrooms, their cultural background, the effects of psilocybin, and what the developing history has come to mean to our culture. Part II examines the legal status of psilocybin and conflicts between various levels of United States government, using developments in cannabis as a comparison. This includes a discussion of Constitutional law and preemption. Part III examines recent state level developments, primarily in Oregon and Colorado, but also briefly examines a few countries besides the United States, as well as criticisms to legalization and possible solutions.
PART I: BACKGROUND
WHAT PSILOCYBIN DOES TO PEOPLE
Psilocybin is a naturally occurring hallucinogenic compound found in a variety of mushroom species.16 Psilocybin mushrooms have “slender stems topped by caps with dark gills on the underside.”17 Psilocybin is typically consumed through ingestion, as a brewed tea or paired with other food products, and is later broken down into psilocin through dephosphorylation in the digestive system.18 Psilocin is a pharmacologically active compound, structurally similar to the neurotransmitter serotonin, that alters mood, perception, and cognition.19 Serotonin has a causal association with mental and physical health.20 This is why the “first-line pharmaceutical treatment” for depression is typically a Selective Serotonin Reuptake Inhibitor (SSRI).21 SSRIs alter behavior and mood by influencing the amount of serotonin in the brain.22 However, it has been hypothesized and demonstrated that “in line with SSRIs and ketamine . . . psychedelics enhance molecular and cellular neuroplasticity.”23 Neuroplasticity is defined as “the brain’s ability to change throughout life” and it “consists of changes in cell structure, structural plasticity, and changes in the efficacy of synaptic transmission.”24
Examples of typical effects of psilocybin (or psilocin) include distorted thinking, visual alteration, and distortion, as well as a feeling of spiritual awakening.25 Stanislav Grof, a psychedelic research psychiatrist, has described psychedelics as “non-specific catalysts and amplifiers of the psyche.”26 While most psilocybin users experience euphoric alterations in mood, some may experience panic or dysphoria.27 It has been stated that “[t]he nature of the [psychedelic] experience depends almost entirely on set and setting.”28 Set refers to the personal mindset and expectations before and during the experience, while setting refers to environmental factors.29 However, “survey data on challenging experiences from recreational psilocybin users suggest even highly challenging experiences can be associated with increased well-being and perceived benefits in retrospect.”30 Despite a public perception that psychedelic substances are dangerous, they are physiologically one of the safest.31
The effects and duration of psilocybin can vary based on the size of the dose and potency of the mushroom.32 For usual varieties (P. cubensis and P. semilanceata) of dry mushrooms: a microdose is less than 0.25 g; a low dose is between 0.25 and 1 g; an average dose is between 1 and 2.5 g; a high dose is between 2.5 and 5 g; and a very high dose would be more than 5 g. For pure psilocybin: a microdose is less than 4 mg; a low dose is between 4 and 8 mg; an average dose is between 6 and 20 mg; a high dose is between 20 and 35 mg; and a very high dose is over 35 mg. 33 The duration of the experience depends on the dose, but the effects generally last 4 to 6 hours.34
Microdosing has become a popular way to consume psilocybin mushrooms.35 Microdosing involves taking a sub-hallucinogenic amount.36 It is seen as a relatively safe method of use that can relieve the potential for psychological risks.37 However, as one article notes, microdosing has many associated benefits and challenges.38 Some benefits of microdosing include improved mood, creativity, and decreased social anxiety; conversely, challenges of microdosing include illegality, discomfort, impaired mood, and increased anxiety.39 The illegal status leads to negative social stigma, the consumption of too much or too little (due to potency or dosage), substance availability, and cost.40 Overall, the positive or negative effects of microdosing are similar to taking larger doses and largely depend on the individual.41
WHAT PSILOCYBIN MEANS TO CULTURE AND HISTORY
Human consumption of hallucinogenic mushrooms has been well documented, particularly in pre-Columbian Mesoamerican societies.42 Its ritual use there is thought to be at least 3,500 years old.43 The religious ceremonies were further documented in the 16th century by Spanish historians as they explored the new world.44 Similar shamanistic rituals have also been documented in indigenous Siberian and East Indian cultures.45 This is also comparable to the ritual use of peyote in religious ceremonies by indigenous Native Americans.
This ritual and cultural history of entheogens appear to lend some credence to what has become known as the “Stoned Ape theory.” As argued by ethnobotanist Terrance McKenna, the theory hypothesizes that psilocybin “was involved in the emergence of human self-reflection on the African grasslands some tens of millennia ago.”46 The theory suggests that early humans following herds of cattle foraged mushrooms out of cattle dung.47 Through incorporation of psychoactive chemical compounds into the early human diet, mutations were caused that “directly influenced the rapid reorganization of the brain’s information-processing capacities.”48 This hypothesis never achieved much academic acclaim due to a lack of scientific evidence. Although it developed popularity within psychedelic culture and with well-known mycologists,49(one who studies mycology, the biological study of fungi) such as Paul Stamets.50 Whatever the case, psychedelic mushrooms certainly played a role in the development of human culture.51
Psilocybin mushrooms were popularized in the United States through the combination of shamanistic rituals and academic interest, which helped develop the American psychedelic counterculture in the 1960s.52 This occurred through R. Gordon Wasson, a banker with J.P. Morgan, and his wife Dr. Valentina P. Wasson.53 During their marriage, Gordon and Valentina Wasson explored the various roles mushrooms have in cultures across the world.54 They are considered to be “the founders of the science of ethnomycology, the study of human uses of and lore concerning mushrooms and other fungi.”55
In 1953, the Wassons discovered and pursued “the existence of still active shamanic mushroom cults in the mountains of the Sierra Mazateca of Oaxacan Mexico.”56 They made several unsuccessful trips, but their luck changed in 1955.57 Then, in the Oaxacan village of Huautla de Jiménez they met María Sabina, a curandera (a native healer or shaman), who performed sacred mushroom rituals called velada.58 Sabina has become colloquially known as the “Saint Mother of the Mushrooms.”59 The Wassons continued to study and participate in the rituals, even on expeditions that were unwittingly financed by the CIA and its infamous psychedelic mind control project MKULTRA.60 The Wassons later published their research in their first book Mushrooms, Russia, and History in 1957.61 The book was accompanied by a Life Magazine photo article, Seeking the Magic Mushroom.62 Between these two works, a massive public interest in psilocybin and psilocybin mushrooms developed. Gordon Wasson also delivered samples of the mushrooms to Swiss pharmaceutical chemist and LSD discoverer Albert Hofmann who isolated and synthesized psilocybin in 1957.63 Thereafter, Hofmann’s pharmaceutical company Sandoz distributed psilocybin to research institutions.64
The widespread interest in psilocybin reached academic circles, and over a thousand clinical papers discussing 40,000 psychedelic patients occurred from 1950 through the mid 1960s.65 In 1960, Doctors Timothy Leary and Richard Alpert began the Harvard Psilocybin Project.66 The project’s aim was to record and document the effect of psilocybin on human consciousness by using volunteer graduate students.67 However, by 1962, a number of Harvard faculty claimed the project’s methodology was unconventional, dangerous, and lacked scientific objectivity.68 These concerns stemmed from poorly controlled conditions, including the use of psilocybin by the researchers during volunteer studies.69 In 1963, Alpert was fired “after he administered psilocybin to an undergraduate student off-campus”70 and the project ended that same year when Leary was also fired.71 Nonetheless, the two went on to become prominent figures in the psychedelic counterculture of the 1960s.72 Alpert as a modern spiritual leader under the name Baba Ram Dass and Leary later became famous for his slogan of, “Tune in, Turn On, Drop Out.”73 Psychedelic use continued to be prevalent during the 1960s, which strongly influenced youth culture, science, and politics.74 However in 1965, Sandoz ceased to provide psychedelic drugs for clinical research and access became more difficult.75
In 1965, Leary was arrested for possession of marijuana in Texas. Through his conviction and subsequent appeal, he continued to influence national drug laws. In Leary v. United States, Leary challenged the constitutionality of the Marihuana Tax Act. The act required him to obtain an order form, “identify himself not only as a transferee of marihuana but as a transferee who had not registered and paid the occupational tax”, then directed that this information be conveyed to state and local law enforcement officials on request.76 Leary argued successfully that the act violated his privilege against self-incrimination.77 On October 27, 1970, Congress responded by repealing the Marihuana Tax Act and passing the Controlled Substance Act (“CSA”). 78
Psilocybin mushrooms remained legal until the passage of the CSA.79 The legislation was championed by President Richard M. Nixon who famously stated in a press conference on June 17, 1971 that drug abuse was “public enemy number one.”80 The CSA provides a framework for scheduling or categorizing substances based on their medical use and potential for abuse, with Schedule I being the most dangerous and Schedule V being the least.81 Psilocybin was listed as Schedule I, where it still remains with heroin, quaaludes, and bath salts.82 Therefore, nearly all psilocybin consumption and research in the U.S. since has been facilitated by illicit means.
This changed in 2000, when researchers from Johns Hopkins University gained regulatory approval to resume psychedelic research, albeit with much more scientific scrutiny than Leary’s Harvard Psilocybin Project.83 Since then, researchers at Johns Hopkins Center for Psychedelic and Consciousness Research have continued to lead the way in psilocybin research
as a therapeutic treatment and have published numerous studies on the topic.84 As a therapeutic tool, psilocybin has been shown to have positive long-term associations with depression and anxiety, alcohol and cigarette dependence, as well as an “enduring sense of personal meaning and increased well-being.”85 Further research is being done exploring psilocybin assisted psychotherapy as a potential treatment for other conditions such as chronic pain, inflammation, epilepsy, and a variety of serious personality disorders.86 Psilocybin as a therapeutic tool seems to bridge the gap between shamanistic natural medicine and western medicine. The positive therapeutic benefits have become primary reasons why support for the legalization of psilocybin has grown.
PART II: THE LEGAL STATUS OF PSILOCYBIN AND CONFLICTS BETWEEN LEVELS OF GOVERNMENTS
As noted above, psilocybin and psilocybin mushrooms remain a Schedule I drug under the CSA.87 Schedule I means there is no currently accepted medical use in treatment in the United States, a lack of accepted safety for use under medical supervision, and a high potential for abuse.88 “The regulatory scheme is designed to foster the beneficial use of [Schedule II-IV] medications, to prevent their misuse, and to prohibit entirely the possession or use of substances listed in Schedule I.”89
Some researchers have argued for psilocybin rescheduling if it is approved as a medicine.90 They argue that psilocybin provides therapeutic benefits and the adverse effects are manageable “when administered according to risk management approaches.”91 Researchers have concluded that placement in Schedule IV would be a more appropriate scheduling.92 Schedule IV substances have current medical uses and a much lower potential for abuse.93 Psilocybin has demonstrated both medical uses and a lower potential for abuse,94 as repeated administration leads to a rapid tolerance development.95
Under the CSA, scheduling decisions are given to the Attorney General, working with the U.S. Department of Health and Human Services (“HHS”). 96 The Attorney General has delegated its authority to the Drug Enforcement Agency (“DEA”) and the HHS has delegated its authority to the Food and Drug Administration (“FDA”) and the National Institute on Drug Abuse (“NIDA”).97 Ultimately the DEA is responsible for scheduling decisions and can reject a rescheduling request after a hearing with an administrative law judge so long as their decision is not “arbitrary or capricious.”98 They are further responsible for regulating scheduled substances and those performing medical or scientific research with scheduled substances.99
In their recent article, authors Karen Luong, Esq. and Kimberly Chew, Esq. describe many of the legal developments that have occurred in psychedelic therapeutics.100 The FDA designated psilocybin breakthrough therapy status in 2018 and again in 2019.101 The status allows the FDA to expedite the review and approval process.102
One suggested path to psilocybin legalization would be to sue the DEA, though this would only be successful after the DEA denies a rescheduling petition.103 As seen in Washington v. Barr, a similar strategy with cannabis was not successful as the Plaintiffs did not exhaust administrative remedies with the DEA prior to filing their lawsuit.104 While not explicitly stated in the CSA, the court found exhaustion of administrative remedies was consistent with the intent of Congress.105 However the Second Circuit Court of Appeals also noted and critiqued the DEA’s “dilatory proceedings.”106
Currently, the federal penalty for simple possession of a controlled substance, like psilocybin mushrooms, is up to 1 year in prison and a minimum fine of $1,000, or both.107 A second conviction is punishable by a minimum of 15 days but not more than 2 years in prison and a minimum fine of $2,500.108 Subsequent convictions beyond that are punishable by a minimum of 90 days but not more than 3 years in prison and a minimum fine of $5,000.109 Meanwhile, manufacturing or possession with intent to distribute faces a minimum penalty of 10 years’ imprisonment.110
Through decriminalization, cities impose a “lowest law enforcement priority” (“LLEP”) and signal their support for both state and federal decriminalization. 111 Although psilocybin has been decriminalized in a few states and several cities, it is not equivalent to legalization, as psilocybin and psilocybin mushrooms remain illegal on a federal level, “but prosecuting people for their possession or use is deprioritized or discouraged.”112 Decriminalization occurs when the governing authority decides “to not enforce criminal laws relating to the use and possession of drugs such as psychedelics.” Meanwhile, legalization allows for psilocybin regulation and taxation, as well as “permission for personal use within parameters set by the government.”113
Psilocybin services, like cannabis, could create significant tax revenue and business opportunities when legalized. Since 2018, tax revenue from the legalization of cannabis in California alone has produced over $4.3 billion.114
By examining the similar structure inherent in marijuana cases, we can gain great insight into how the laws legalizing psilocybin will likely unfold. Marijuana or cannabis, like psilocybin, is also considered a Schedule I drug under the CSA.115 Yet states have legalized both medical and recreational cannabis use.116 However, these substances create different physiological responses.117 While cannabis is seen as safer, survey data suggests that psilocybin mushroom use creates fewer emergency medical responses.118 However, this statistic could be because fewer people use psilocybin than cannabis.
Like marijuana, a dichotomy between local and state governments and state and federal government may emerge. As seen in Ruggles v. Yagong, decriminalization through lowest law enforcement priority does not necessarily mean complete freedom from criminal charges for those who use, produce, or distribute.119 In that case, plaintiffs alleged prosecutors and police continued to use funds to prosecute cannabis offenses in violation of a county code section.120 The county code section prohibited “expending ‘public funds for the investigation, arrest, or prosecution of any person, [or] the search or seizure of any property’ in a manner inconsistent with the LLEP.”121 However, the state argued successfully that the county code section was preempted by state law.122 The Hawaii Supreme Court held that the state attorney general retains the duty to enforce the penal code, and this duty is “further delegated to county prosecuting attorneys.”123 Ultimately, LLEP does not guarantee freedom from prosecution. The state attorney general still has a duty to prosecute violations of the statewide Penal Code.124
There is another conflict that can emerge between city and state laws. In City of Riverside v. Inland Empire Patients Health & Wellness Ctr., Inc., the California Supreme Court held that a city zoning ordinance that labeled medical marijuana facilities as a nuisance was not preempted by California’s medical marijuana act. 125 Following this precedent, cities could likely prohibit psilocybin service centers within their borders, despite broader state legalization.
Besides the potential for conflicts within the state level, there is also potential conflict between the state and federal government over psilocybin that is like the conflict regarding marijuana. This conflict concerns preemption and the competing principles of the Supremacy Clause and the Anti-Commandeering doctrine in the 10th Amendment. The Supremacy Clause establishes that federal law is “the supreme Law of the Land . . . any Thing in the Constitution or Laws of any State to the Contrary notwithstanding.”126 Meanwhile, the 10th Amendment gives the powers, such as the power to police, that the Constitution does not expressly award to the federal government to the states.127 Preemption occurs “where it is impossible for a private party to comply with both state and federal law” and where the challenged state law is “an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.”128 It is an obstacle if “the purpose of the act cannot otherwise be accomplished.”129 Here, it is not impossible to comply with both state legalization and the federal CSA, as a person would not have to consume psilocybin under the state law.
Next, psilocybin legalization must be analyzed as an obstacle to the purposes of the CSA. Due to a clause in the CSA, its preemptive effect is extremely limited.130 “The CSA explicitly contemplates a role for the States in regulating controlled substances, as evidenced by its pre emption provision.”131 The provision requires a “positive conflict” between federal and state law so that the two cannot consistently stand together.132 The Supreme Court has interpreted this as meaning a state’s decision to simply permit what the federal government prohibits does not create a “positive conflict” with federal law.133 Therefore, state psilocybin legalization is not technically preempted under the CSA.
However, there remains another issue between state and federal governments. According to the Commerce Clause within the Constitution, Congress has the authority to “make all Laws which shall be necessary and proper” to “regulate Commerce . . . among the several States.”134 This has been defined by the Supreme Court to include an “economic ‘class of activities’ that have a substantial effect on interstate commerce.”135 In Gonzales v Raich, Plaintiffs were legally growing marijuana for their personal use according to California’s medical marijuana laws.136 The Court determined that Congress could, under its commerce power, prohibit marijuana cultivation and use, even when done in compliance with California law.137 The Court relied on Wickard v Filburn, a case regarding a farmer’s production of wheat for his personal consumption.138 The Court stated, “regulation is squarely within Congress’ commerce power because production of the commodity meant for home consumption, be it wheat or marijuana, has a substantial effect on supply and demand in the national market for that commodity.”139 The private cultivation of psilocybin mushrooms will also run into a similar conflict with the Commerce Clause.
Yet state laws do not prevent the federal government from enforcing federal laws against psilocybin users if the federal government chooses to do so.140 In Printz v United States, the Supreme Court examined the anti-commandeering rule.141 “The Federal Government may neither issue directives requiring the States to address particular problems, nor command the States’ officers, or those of their political subdivisions, to administer or enforce a federal regulatory program.”142 This means that the federal government can create regulations, but the federal government must also enforce them through their own agents.143
However as Robert Mikos notes in his article, On the Limits of Supremacy: Medical Marijuana and the States’ Overlooked Power to Legalize Federal Crime, “Raich did not stop (or even slow) state legalization campaigns.”144 Mikos further explains that “state laws and most related regulations have not been – and, more interestingly, cannot be – preempted by Congress, given constraints imposed on Congress’s preemption power by the anti-commandeering rule, properly understood.”145 Therefore, in his view, states can effectively legalize federal crimes.146 The Supreme Court has interpreted the Constitution to give “power to Congress to regulate individuals, not States.”147 The Constitution allows Congress to regulate interstate commerce directly but does not authorize Congress to regulate state governments’ regulation of interstate commerce.148 Congress may still use a variety of incentivizing methods to urge a state to adopt a program that conforms with federal law.149 One way Congress incentivizes states is to place conditions on the receipt of federal funds, however the conditions must be related to the purpose of the funds, among other limitations.150 Another way Congress can incentivize federal standards is to “offer States the choice of regulating that activity according to federal standards or having state law pre-empted by federal regulation.”151
Scott Bloomberg defined this relationship as “Frenemy Federalism.”152 As Bloomberg explains, “States must implement robust legal and regulatory regimes to, inter alia, keep marijuana activity from spilling-over into other states. This condition furthers the federal objective of reducing interstate marijuana activity and functions as a command for states to keep their markets insular and intrastate.”153 This sort of tense relationship will presumably develop similarly towards other federally prohibited entheogens, such as psilocybin.154 All of this to say, the states have the freedom to regulate and allow legal psilocybin therapy or services within their borders.
Freedom of religion is another argument that has been used to justify illicit entheogen use, although with mixed results. The Native American ceremonial use of peyote, another federally illegal entheogen, has been protected. In Employment Div. v. Smith, the Supreme Court held that the First Amendment does not protect Native American practitioners who use peyote in connection with religious ceremonies.155 This raised the important question whether this religious practice would be protected.156 To protect this important practice, Congress amended the American Indian Religious Freedom Act, 42 U.S.C. §1996, to include the traditional ceremonial use of peyote.157 Native American use of psilocybin is not protected, despite Native sovereignty. While the Native American ritual use of psilocybin was not as common as peyote, a similar argument for its protection can be made. Mexico already recognizes an exception for indigenous people regarding the prohibition against psilocybin mushrooms.158
In United States v. Meyers, Meyers argued under the First Amendment and Religious Freedom Restoration Act (“RFRA”) that he was the founder and Reverend of the Church of Marijuana.159 Under the RFRA, there are five factors to determine if a belief is a religious belief, which is protected by the First Amendment, or simply a way of life which does not receive the same constitutional protections.160 These factors are: (1) Ultimate Ideas, (2) Metaphysical beliefs, (3) Moral or Ethical System, (4) Comprehensiveness of Beliefs, and (5) Accoutrements of Religion, such as a prophet, important writings, holidays, gathering places, and other symbols of a religion.161 After examining these factors, the 10th Circuit Court of Appeals affirmed that “[m]arijuana’s medical, therapeutic, and social effects are secular, not religious.”162 When applying this outcome to the religious use of psilocybin, a church of psilocybin would be highly unlikely to be considered a religion. However, this argument would seem to be much stronger for Native American ritual use of psilocybin and other entheogens.
PART III: RECENT STATE DEVELOPMENTS
With the passage of voter approved Measure 109 in 2021, Oregon became the first state to legalize psilocybin and psilocybin mushroom services.163 Measure 109 “allow[s] the manufacture, delivery, and administration of psilocybin at supervised, licensed facilities . . . under the supervision of a licensed psilocybin service facilitator.”164 These psilocybin services will use the most common species, Psilocybe cubensis.165 Further, the services will require a preparation session at least 24 hours before the administration session.166 The maximum dosage is 50 mg of psilocybin,167 and the amount consumed determines the duration of the administration session.168 The services will be available for individuals or groups and can be held indoors or outdoors.169 The amount consumed also determines the facilitator to group size ratio, and a maximum dose requires a one-on-one session.170 Finally, the services must offer an integration session after psilocybin administration to help with a client’s potential need for support or community resources.171
By using the term “service providers,” the law effectively allows for both quasi-medical and recreational facilitated use. These facilitators will have to undergo extensive education and training on adverse behavioral reactions and adverse medical reactions.172 Multiple companies have been given approval to train facilitators for therapeutic psychedelic trips.173 The two-year period to develop the policies, procedures, and infrastructure ends December 30, 2022.174 The administrative rules also permit licenses to manufacturers to extract psilocybin and create edible psilocybin products.175 This will certainly attract additional investments and businesses into this expanding market.
Service providers open doors in Oregon on January 1, 2023, and psilocybin proponents see this as the first step in a larger legalization movement. However, feelings within Oregon remain mixed towards psilocybin, as several rural counties in November 2022 voted against having psilocybin manufacturing and service centers within their borders.176
As the next step in the legalization movement, Colorado voters also passed a psilocybin legalization ballot measure in November 2022.177 The measure was similar to Oregon’s but more expansive. It both defines psilocybin as a “natural medicine” and decriminalizes adult (21+) personal use, possession, growth, and transport of natural medicines.178 Colorado Proposition 122 entitled “Access to Natural Medicine” mirrors Oregon’s measure closely, but describes its facilities as “licensed healing centers to administer natural medicine services.” This will also allow for the expansion into other natural medicines, such as dimethyltryptamine (“DMT”), Ibogaine, and mescaline (excluding peyote, lophophora williamsii) after June 1, 2026, if recommended by the Natural Medicine advisory board. The Colorado Department of Regulatory Agencies will adopt rules and begin accepting applications for facilitators by September 30, 2024.179
WHAT MAY CHANGE THROUGH LEGALIZATION AND DECRIMINALIZATION
Currently, there is already a large community that has formed underneath the prohibition of entheogens or natural medicines. These communities already offer and engage in facilitated trips. Some facilitators are oriented towards life coaching and personal growth while others aim to treat veterans with severe post-traumatic stress disorder. Either way, these groups aim to use psilocybin and other natural medicines as a tool to guide others through their various traumas and mental health issues. The strategies developed by underground facilitators have been incorporated into the current legalization models as facilitators have been made a part of the Oregon Psilocybin Advisory Board.
One area that has already been impacted by psilocybin research is the financial markets.180 There is a growing and expanded market interest in the investment potential for clinical drugs and businesses.181 This can be clearly seen in the fact that companies actively engaging in psychedelic research are being traded on the New York Stock Exchange.182 The psychedelic substance market is projected to grow from $4.75 billion in 2020 to $10.75 billion by 2027.183
While this is not a complete list of the countries addressing psilocybin decriminalization or legalization, the economic growth of psilocybin is largely due to the status of psilocybin in western countries. Countries such as Canada, Jamaica, Brazil, Spain, Portugal and the Netherlands, where psilocybin or psilocybin mushroom research and recreational use have fewer barriers, continue to help propel psilocybin into mainstream culture.
In Canada, psilocybin is currently available medically through a special access program and healthcare provider.184 In Brazil, according to the Brazilian Controlled Drugs and Substances Act, psilocybin mushrooms are not named as controlled substances185 and can be ordered online or in retail shops.186 Further both Portugal and Spain have decriminalized drugs for personal use.187
In Jamaica, psilocybin is not listed on the Jamaica’s Dangerous Drugs Act as a controlled substance and, in fact, the nation has never prohibited psilocybin mushrooms.188 Various retreats have already commodified the psilocybin experience and provide a possible model to follow.189 Psilocybin research centers are also active in Jamaica.190
Finally, while psychedelic mushrooms have been illegal in the Netherlands since 2008,191 psilocybin containing sclerotia, or truffles, are legal. While truffles are not botanically mushrooms, they are a part of the same organism.192 In response, several retreats and research organizations have emerged there as well.193 The most well-known, Synthesis, plans to open a retreat in Oregon that boasts 124 acres of property.194
CRITICISMS AND POSSIBLE SOLUTIONS
However, not all psychedelic enthusiasts are excited about the current plans to legalize psilocybin and a list of criticisms have developed. One criticism is that the current formulation will primarily benefit corporations and those with previous capital.195 This has been an issue seen in the cannabis market. There are a limited number of licenses available, and alcohol and tobacco companies are buying large interests in cannabis businesses.196 Logically, it seems pharmaceutical companies will do the same, and a battle over patent rights has already begun.197 Those who are currently facilitating illegally may also be unable to compete with larger operations and will be pushed out of the market. This criticism can seemingly be addressed by distributing psilocybin service center and manufacturing licenses in a more equitable way than that in which cannabis licenses were distributed. Service operators in Oregon are even required to have a social equity plan.198 It also seems important to recognize, protect, and support the activists who have risked criminal charges to start this movement.
Another criticism is that people with “treatment resistant depression” and other mental health disorders will seek psilocybin treatment and potentially exacerbate their conditions.199 With proper training and education for facilitators, they will be able to recognize potential mental health issues and refuse service to those who may be unstable. Further, the training facilitators receive will focus on handling adverse medical behaviors and reactions. In Oregon, this also comes with a duty to contact emergency services if necessary.200
An obvious criticism is that legalizing psilocybin could influence children and the perception of substance use.201 To address this issue, it would be best to use some of the tax revenue from psilocybin service centers for substance abuse and education programs. For example, in Colorado, marijuana tax revenue goes toward healthcare, education, monitoring health effects of marijuana use, law enforcement, and substance abuse prevention and treatment.202 A potential rise in crime rates may also seem like a valid criticism. However, in contrast to what may be popular opinion, an additional benefit to psilocybin use throughout life is an association with lower odds of criminal arrest.203
Another criticism is that ketamine treatments may be similarly effective, yet ketamine has lower risk of adverse effects and is already federally legal. Both substances effect the brain in similar ways, however ketamine has a more negative effect on body-movement while psilocybin has a more positive effect.204 Though more testing needs to be done to determine the comparative efficacy of the two treatments,205 both treatments have scientific merit and should be made available to the public. Some consumers may view psilocybin as a natural medicine, while ketamine remains a traditionally western medicine.
An additional important criticism is that this may take away from the cultural and spiritual significance of the indigenous ritual use of psilocybin and other plant medicines.206 In a recent article, critics Alnoor Ladha & Rene Suša suggest that decriminalization is superior to legalization in the sense that decriminalization “allow[s] those who work in support and cultivation of these plants to do so without legal recourse and without the machinery of the corporate-state nexus underwriting the extraction and expansion of psychedelics.”207 They suggest less profit driven business models could be accomplished through worker-owned cooperatives and gifting circles.208 They also suggest a form of reparations could be appropriate.209 Western forms of psilocybin therapy and a more indigenous or shamanistic approaches do not have to be mutually exclusive. Under future legalization, psilocybin services will naturally adapt and cater to their customers or markets. Although various standards will be established, legalization will not mean uniform services across different providers. Native American tribes should be encouraged to join this process and share their culture in this way if they so desire. However, in line with this criticism, the commercialization of psilocybin will inevitably affect and alter the cultural spirituality behind mushroom use.
CONCLUSION
While there are valid criticisms, the benefits of psilocybin legalization appear to outweigh the potential costs. However, there remains much to be determined in this burgeoning and controversial field. As demonstrated above, there are a variety of reasons psilocybin should be legalized. Psilocybin has proven therapeutic benefits and market appeal that could influence the overall direction of our culture.
From ancient cultures to the modern era, psilocybin mushrooms and other entheogens have greatly impacted human culture and creativity. While it is impossible to say for certain where the future of psilocybin is headed, the renewed and continued interest will impact many parts of our culture and society. Nonetheless, it will impact financial markets and the way natural-plant medicines are socially viewed. It will also introduce new therapeutics, challenging 209 Id. legal issues, and potentially even recreational use. Although, as with cannabis, more scientific research is clearly warranted in this mushrooming field.
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34 Id.
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37 Id.
38 Id.
39 Id.
40 Id.
41 Id.
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47 Id. at 17.
48 Id. at 19.
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67 Id.
68 Id.
69 Id.
70 Id.
71 Id.
72 Id.
73 Id.
74 David E. Nichols, Psychedelics, 68 PARMACOL. REV. 2, 264-355 (Apr. 2016),
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75 Wayne Hall, Why was early therapeutic research on psychedelic drugs abandoned?, CAMB. UNIV. PRESS (October 21, 2021), https://www.cambridge.org/core/journals/psychological-medicine/article/abs/why-was-early therapeutic-research-on-psychedelic-drugs-abandoned/59F93D11DE21F420465559BBEB99CC14. 76 Leary v. United States, 395 U.S. 6, 16 (1969).
77 Id.
78 21 U.S.C. § 801 et seq.
79 Id.
80 Public Enemy Number One: A Pragmatic Approach to America’s Drug Problem, RICHARD NIXON FOUNDATION (Jun 29, 2016),
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81 21 U.S.C. § 801 et seq.
82 Id.
83 JOHNS HOPKINS MED., supra note 10.
84 Id.
85 Garcia-Romeu, supra note 30.
86 Lowe, supra note 64.
87 21 U.S.C. § 812.
88 21 U.S.C. § 801 et seq.
89 Gonzales v. Raich, 545 U.S. 1, 24 (2005).
90 Matthew W. Johnson et al., The abuse potential of medical psilocybin according to the 8 factors of the Controlled Substances Act, 142 NEUROPHARMACOLOGY 143-166 (Nov. 2018),
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91 Id.
92 Id.
93 21 U.S.C. § 812.
94 Johnson, supra note 90.
95 Nichols, supra note 31.
96 21 U.S.C. § 811.
97 28 C.F.R § 0.100(b).
98 Americans for Safe Access v Drug Enforcement Admin., 703 F.3d 438, 440 (D.C. Cir. 2013). 99 Kimberly Chew & Karen Luong, Legal Developments in Psychedelic Therapeutics, 34 HEALTH LAWYER 4, 5 (2022).
100 Id. at 8.
101Id.; see also Mason Marks, A Strategy for Rescheduling Psilocybin, SCI. AM. (Oct. 11, 2021), https://www.scientificamerican.com/article/a-strategy-for-rescheduling-psilocybin/.
102 Chew, supra note 99.
103 Marks, supra note 101.
104 Washington v. Barr, 925 F.3d 109 (2d Cir. 2019).
105 Id. at 116.
106 Id. at 113.
107 21 U.S.C. § 844.
108 Id.
109 Id.
110 21 U.S.C. § 841.
111 Zoe Sottile, San Francisco takes one step closer to decriminalizing plant-based psychedelics, CENT. NEWS NETWORK (Sept. 10, 2022, 12:21 AM EDT), https://www.cnn.com/2022/09/10/us/san-francisco-decriminalization psychedelics
trnd/index.html#:~:text=It%20was%20probably%20only%20a,CNN%20affiliate%20KPIX%2DTV%20reported. 112 Makin, supra note 15.
113 Chew, supra note 99 at 8.
114 Cannabis Tax Revenues, CAL. DEP’T. OF TAX AND FEE ADMIN.,
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115 21 U.S.C. § 812.
116 Robert L. Page II et al., Medical Marijuana, Recreational Cannabis, and Cardiovascular Health: A Scientific Statement From the American Heart Association, 142 CIRCULATION 10 (Aug. 5, 2020),
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119Ruggles v Yagong, 135 Haw. 411 (Haw. 2015).
120 Id. at 415.
121 Id. at 415.
122 Id. at 422.
123 Id.
124 Id.
125 City of Riverside v. Inland Empire Patients Health & Wellness Ctr., Inc., 56 Cal. 4th 729 (2013). 126 U.S. CONST., art. 6, cl. 2.
127 U.S. CONST., art. 1, § 10.
128 Crosby v. Nat’l Foreign Trade Council, 530 U.S. 363, 372 (2000).
129 Savage v. Jones, 225 U.S. 501, 533 (1912).
130 Scott Bloomberg, Frenemy Federalism, 56 U. RICH. L. REV. 367, 385 (2022).
131 Gonzales v. Oregon, 546 U.S. 243, 251 (2006).
132 21 U.S.C. § 903.
133 Barnett Bank v. Nelson, 517 U.S. 25 (1996).
134 U.S. CONST., art. 1, § 8.
135 Gonzales v. Raich, 545 U.S. 1, 17 (2005).
136 Id.
137 Id.
138 Wickard v. Filburn, 317 U.S. 111 (1942).
139 Gonzales, 545 U.S. at 125.
140Emerald Steel Fabricators, Inc. v. Bureau of Labor & Indus., 230 P.3d 518, 529 (2010). 141 Printz v. United States, 521 U.S. 898 (1997).
142 Id. at 935.
143 Id. at 935.
144Robert Mikos, On the Limits of Supremacy: Medical Marijuana and the States’ Overlooked Power to Legalize Federal Crime, 62 VAND. L. REV. 1421, 1423 (2009).
145 Id. at 1481-82.
146 Id. at 1421.
147 New York v. United States, 505 U.S. 144, 166 (1992).
148 Id.
149 Id.
150 Id. at 167.
151 Id.
152 Bloomberg, supra note 130 at 368.
153 Id.
154 Id. at 402.
155 Emp’t Div. v. Smith, 494 U.S. 872, 888 (1990).
156 42 U.S.C § 1996.
157 Id.
158 Código Penal Federal [CPF], art. 195 bis, Diario Oficial de la Federación [DOF] 10-1-1994, últimas reformas DOF 20-08-2009 (Mex.).
159 United States v. Meyers, 95 F.3d 1475, 1482 (10th Cir. 1996).
160 Id.
161 Id. at 1483.
162 Id. at 1484.
163 Peipert, supra note 12.
164 Or. Admin. R. 333-333 et seq.
165 Id.
166 Id. at 5000.
167 Id. at 5240.
168 Id. at 5250.
169 Id. at 4450.
170 Id. at 5230.
171 Id. at 5260.
172 Id. at 1010.
173 Anthony Effinger, Second Company Says It Has Been Approved to Train Facilitators for Therapeutic Psilocybin Trips, WILLAMETTE WEEK (October 20, 2022 11:10 AM PDT),
https://www.wweek.com/news/state/2022/10/20/second-psilocybin-company-says-it-has-been-approved-to facilitate-therapeutic-trips-under-measure-109/.
174 Or. Admin. R. 333-333 et seq.
175 Id. at 2110.
176 Jane Vaughan, Several rural Oregon counties vote against therapeutic use of psilocybin, OPB (Nov. 9, 2022 11:06 AM PST), https://www.opb.org/article/2022/11/09/several-rural-oregon-counties-vote-against therapeutic-use-of-psilocybin/.
177 Peipert, supra note 12.
178 Col. Rev. Stats. 12 art. 170, § 101 et.al.
179 Id.
180 Psychedelic Drugs Market, By Drugs (LSD, Ecstasy, Phencyclidine, GHB, Ketamine, Ayahuasca, Psilocybin), Route of Administration (Oral, Injectable, Inhalation), Distribution Channel, End-Users, Application and Geography – Global Forecast to 2026, (December
See https://www.researchandmarkets.com/reports/5240207/psychedelic-drugs-market-by-drugs lsdecstasy?utm_source=GNOM&utm_medium=PressRelease&utm_code=894w6r&utm_campaign=1513085+- +Global+Psychedelic+Drugs+Market+Report+2020%3a+Market+Size+is+Projected+to+Reach+%2410.75+Billion +by+2027&utm_exec=chdo54prd.
181 Id.
182 NYSE Stock Quote, CYBIN, https://ir.cybin.com/investors/stock-info/default.aspx#stock-quote. 183 Psychedelic Drugs Markert, supra note 180.
184 Psilocybin and psilocin (Magic mushrooms), GOV’T. OF CANADA, https://www.canada.ca/en/health canada/services/substance-use/controlled-illegal-drugs/magic-mushrooms.html#a33.
185 Lei No. 11.343, de 23 de Augusto de 2006 (Braz.).
186 Psychedelic Drug Laws in Brazil, TRIPSITTER (May, 23, 2022), https://tripsitter.com/legal/brazil/. 187 Psilocybin Laws: A Country-by-Country Magic Mushrooms Legal Guide, PSILOCYBIN.NET, https://psilocybin.net/laws/.
188 Fred Rocafort, Jamaica: Psilocybin Leader, HARRIS BRICKEN (Aug. 19, 2022),
https://harrisbricken.com/psychlawblog/jamaica-psilocybin-leader/.
189 ATMAN RETREAT, https://atmanretreat.com/.
190 UWI FST/Field Trip Opens ‘World-First’ Mushroom Research Lab, THE UNIVERSITY OF THE WEST INDIES (Feb 11, 2021), https://www.mona.uwi.edu/fpas/uwi-fstfield-trip-opens-%E2%80%98world-first%E2%80%99- mushroom-research-lab.
191 Catherine Hornby, Dutch ban on “magic” mushrooms to take effect, REUTERS (Nov. 28, 2008), https://www.reuters.com/article/us-dutch-mushroom/dutch-ban-on-magic-mushrooms-to-take-effect idUSTRE4AR32R20081128.
192 Peter de Boer, How Do Sclerotia Magic Truffles Differ from Magic Mushrooms?, TRUFFLE MAGIC (Jun. 27, 2017), https://www.trufflemagic.com/how-do-sclerotia-magic-truffles-differ-from-magic-mushrooms/. 193SYNTHESIS, https://www.synthesisretreat.com/; see also OPEN FOUNDATION, https://open-foundation.org/. 194 Olivia Goldhill, ‘It’s not medical’: Oregon wrestles with how to offer psychedelics outside the health care system, STAT (Mar. 10, 2022), https://www.statnews.com/2022/03/10/oregon-wrestles-with-offering-psychedelic therapy-outside-health-care-system/.
195 https://www.denverpost.com/2022/09/08/colorado-initiative-58-psychedelics-natural-medicine-health-act mushrooms/.
196 Ryan Malkin, Why the Alcohol Industry Is Betting Big on Cannabis, SEVENFIFTY DAILY (Mar. 15, 2021), https://daily.sevenfifty.com/why-the-alcohol-industry-is-betting-big-on-cannabis/; see also David Sabaghi, Why Cannabis Is Part Of The Future Of Big Tobacco, FORBES (Aug 2, 2021, 07:00 AM EDT), https://www.forbes.com/sites/dariosabaghi/2021/08/02/cannabis-is-part-of-the-future-of-big tobacco/?sh=5d1e82971ed5.
197 I. Glenn Cohen & Mason Marks, Patents on Psychedelics: The Next Legal Battlefront of Drug Development, HARV. L. REV. (Feb. 20, 2022), https://harvardlawreview.org/2022/02/patents-on-psychedelics-the-next-legal battlefront-of-drug-development/.
198 Or. Admin. R. 333-333-4020.
199 Makin, supra note 15.
200 Or. Admin. R. 333-333-4700.
201 Peipert, supra note 12.
202 Marijuana Tax Revenue and Education, COL. DEP’T OF EDUC.,
https://www.cde.state.co.us/communications/2021marijuanarevenue.
203 Grant M. Jones & Matthew K. Nock, Psilocybin use is associated with lowered odds of crime arrests in US adults: A replication and extension, 36 J. OF PSYCHOPHARMACOLOGY 1, 66-73 (2022),
https://nocklab.fas.harvard.edu/files/nocklab/files/02698811211058933.pdf.
204Adam Wojtas et al., Effect of Psilocybin and Ketamine on Brain Neurotransmitters, Glutamate Receptors, DNA and Rat Behavior, 23 INT. J. MOLECULAR SCI. 12, 6713 (Jun. 16, 2022),
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9224489/.
205 Id.
206 Max Lubbers, Therapists who already incorporate psychedelics in their practice are mixed on Prop 122, COL. PUB. RADIO (Nov. 2, 2022), https://www.cpr.org/2022/11/02/psychedelic-therapy-colorado-prop-122-ballot measure/.
207 Alnoor Ladha & Rene Suša, Why the “Psychedelic Renaissance” is just Colonialism by Another Name, DOUBLE BLIND MAGAZINE (Nov. 9, 2022), https://doubleblindmag.com/colonialism-by-another-name/. 208 Id.
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What happened to Marcela Alcázar Rodríguez?
Soon after beginning the ritual, Rodríguez reportedly started throwing up and eventually suffered from severe diarrhoea – these symptoms are often considered the body’s “healing” reactions during the cleansing process. Initially, she refused help but gave in when her friend visited her.
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November 1, 2024By
admin
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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