For Americans for whom ayahuasca is “The Medicine,” there is only one legal option. An individual may join the Santo Daime or Uniao do Vegetal church, which have legal authority to administer ayahuasca tea to people as a sacrament.

Among this world’s known psychedelic medicines, ayahuasca is uniquely honored for its ability to help transform the mind and body. The Amazonian brew can introduce us to new realms of consciousness with astounding breadth and depth. It is a full mind-body medicine that affects the entire body—including the brain, the gastrointestinal system, and the immune system.  Ayahuasca is also what could be called an ordeal medicine. We are shaken to our core and sometimes brought to our knees.

The purgative effects of ayahuasca are an important aspect of its healing effects because it affects the entire intestinal system from mouth to rectum and everything in between. In this sense, it is a strong whole-body, whole-psyche medicine. We can experience realms of consciousness previously unexplored and, in the end, heal each time in a new and often unexpected way.

Ayahuasca therapy is not for the faint of heart and not for everyone. It is remarkably different from typical Western medicines and in ways that challenge dominant ideas about illness, suffering, healing, and health. Given its radical nature, can ayahuasca be integrated into modern healthcare systems? Below, I explore some of the core challenges of this complex encounter between ayahuasca and modern medicine.

Is it possible to make a safe, reliable, and potent ayahuasca tea for US clinical research without patents and investors? I believe the answer is yes, we can.

Currently in the US, ayahuasca tea is illegal because it contains dimethyltryptamine (DMT).  DMT is designated by the US government as a controlled illegal substance with “abuse potential and no medical benefit.”  

For those Americans for whom ayahuasca is “The Medicine,” there is only one legal option. An individual may join the Santo Daime or Uniao do Vegetal church, which have legal authority from the US Drug Enforcement Agency (DEA) to make and administer ayahuasca tea to people as a sacrament. There are other options to receive ayahuasca healing; however, currently, all are illegal in the US.

Option 1: An individual may travel to another country to participate, at his or her own risk, in legal ceremonies with an unknown healer, administering an unknown botanical medicine in an unknown setting.

Option 2: An individual may participate, by personal invitation, in group ceremonies that are conducted underground in the US, led by self-proclaimed healers and medicine men and women.

Option 3:  An individual may obtain, usually by purchase, an illegal psychedelic agent from another person on the black market and take this agent alone or in a group. An individual may also purchase plant material that is sold on the internet and then can attempt to brew these agents into a tea.

Providing Ayahuasca Healing to Those in Countries Where Ayahuasca Is Illegal

There are several barriers and challenges to ayahuasca therapy in North America. First, psychedelic plant and fungal medicine research is technically difficult—especially ayahuasca, which is the combination of two plants, each contributing hundreds of active constituents.  Thus far we know about only two of the molecules in ayahuasca, dimethyltryptamine and harmine alkaloids. It is likely that the unusual taste of ayahuasca is related in part to immune-stimulating molecules called polysaccharides present in the tea. While plant medicines, like ayahuasca and psilocybin mushrooms, contain many interesting molecules beside the ones known to be responsible for the psychedelic effects, we understand little about this. 

A second challenge to making ayahuasca safely and legally available in the US is meeting Food and Drug Administration (FDA) and DEA regulations that ensure safety of human drug research. A third challenge, and responsibility, is to ensure that the sacred plants used to make ayahuasca are harvested in a sustainable way, are protected, and are grown using organic farming methods.

Progress To Date

My first step in my 20-year journey towards legal ayahuasca research was to protect and grow the two plant species that, together, make ayahuasca tea (Psychotria viridis and Banisteriopsis caapi). Shortly after the untimely death of Terence McKenna in 1999 I became steward of the Hawaiian Island ethnobotanical preserve created by Kat Harrison and Terence and Dennis McKenna in the late 1970s. Here in this old growth rain forest I have tended, grown, and studied the ayahuasca vine (B. caapi) and leaves of the “Queen of the Forest” (P. viridis). 

The next step was to obtain a license from the DEA to legally study ayahuasca tea and the plants used to make the tea. With my DEA researcher’s license, I learned how to make ayahuasca by studying with traditional healers. I then gathered, with permission, many ayahuasca samples from traditional ayahuasceros in Brazil and Peru to find out, using modern chemistry methods, how much DMT and the beta carboline harmala alkaloids were present in each tea. Then, using these data, my students and I developed a simple formula to make a potent and clean tea suitable for administering to human study volunteers.

The third step was to apply to the FDA to do legal human ayahuasca research. In 2016 the FDA granted me permission to conduct the first legal US study of ayahuasca in humans—a Phase I trial to determine if ayahuasca tea at several doses is safe. This clinical trial will be conducted in Seattle, Washington at the Advanced Integrative Medical Science (AIMS) Institute under institutional review board ethical oversight.

The fourth step is where we are today in 2019. We are ready to make 100 liters of standardized ayahuasca tea that meet FDA standards for safety and DEA standards for security. We have applied for a DEA license to “manufacture and distribute” ayahuasca tea for clinical research purposes. US regulations require us to show that the ayahuasca tea we make for this research is the same from batch to batch, that it is stable across time and free of microorganisms and toxic chemicals. These standards are not unreasonable, but the cost of meeting them is expensive. 

Is Ayahuasca Research Ethical?

The desire and capacity of a Western mind to study a complex natural medicine that was developed and used for thousands of years by Indigenous peoples raises ethical concerns. First, we must ask whether the clinical research and medical use of ayahuasca amounts to little more than another instance of Western cultural hegemony and appropriation—selfishly stealing a traditional medicine. Some worry that ayahuasca will become a commodity for sale and used as a tool for self-aggrandizement.

As the interest in the healing use of ayahuasca has grown among Westerners, a brisk ayahuasca tourism economy (that may benefit local communities) has expanded in several South American countries. However, this industry may contribute to the decimation of the Amazonian forests where B. caapi and P. viridis thrive. It is of considerable concern whether the commercialization of these plants may benefit Western bodies and minds but only at the expense of the forests and communities whence they come.

We must also ask whether Western scientific research on ayahuasca is a type of biopiracy. In capitalist countries, drugs are developed, manufactured, and sold by for-profit pharmaceutical companies. In the US, pharmaceutical drug development creates important advancements in Western medicine, but it is based on a capitalist model. Pharmaceutical companies fund drug development by attracting investors and rewarding shareholders who seek to make profits on their investment. Drug formulas are patented to assure investors that the company’s new drug will not have competitors that will reduce profit. 

Can one, should one, patent ayahuasca tea? The very idea seems ridiculous. Is it possible to make a safe, reliable, and potent ayahuasca tea for US clinical research without patents and investors? I believe the answer is yes, we can.

We are following in the pioneering footsteps of the Multicultural Association for Psychedelic Studies (MAPS). MAPS has successfully used a wise, responsible, sustainable, and respectful way to bring MDMA, a psychedelic medicine, to people in the US who suffer from PTSD. MAPS has conducted FDA-approved Phase I and Phase II trials and is now completing Phase III human clinical trials. The FDA has designated MDMA as breakthrough therapy in the treatment of PTSD. This took 35 years and millions of dollars of donations from people like us who believe that psychedelic medicines should be studied and, when proven safe and effective, be used in Western healthcare.

In 2014, MAPS formed a public benefit corporation, the purpose of which is to serve the public good rather than to generate profits for shareholders. MAPS uses its public benefit corporation as the vehicle for managing distribution of MDMA and clinical research. When the FDA approves the sale of MDMA as a prescription drug, the MAPS public benefit corporation will manufacture and distribute MDMA to qualified prescribers, therapists, and researchers.  The profits will be used for mission-related purposes. MAPS has led the way in devising a strategy to synergize the “awakened consciousness and the evolution of business” in order to develop psychedelic medicines for the people who need them in the US. Psychedelic medical research is expensive and depends on all of us who see the need for safe and legal ayahuasca healing to contribute to this enterprise.

Vision for the Future

We envision a time when trained healers of all kinds—even in America—will have available to them the sacred plant medicines discovered by our ancient ancestors. Someday, we will have trained healers in every community who know the value of, and the time and place for ayahuasca.

Please help us to protect ayahuasca and make ayahuasca healing safely and effectively available to all those need it. We ask for your help. Please donate to MAPS to support ayahuasca research in the US by clicking here.

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Leanna J. Standish, PhD
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