An ayahuasca vine in Peru, one of the places where it is authorized for religious use. (Apollo/Flickr)

The future of psychedelic-assisted therapy is accelerating

Researchers who study psychedelics such as psilocybin and ayahuasca are hopeful a new treatment for post-traumatic stress disorder (PTSD) might gain U.S. approval later this summer despite the odds against it. Regardless of the decision, the fresh consideration given to the mind-altering drug MDMA reflects an acceleration in the field just as the 2023 GESDA Science Breakthrough Radar® anticipated. “Now the psychedelic revolution is starting up again,” Radar contributors Eduardo Schenberg and David Nutt wrote. Schenberg also learned new ways of impacting policy during Geneva Science Diplomacy Week in June.

By John Heilprin

July 5, 2024

The U.S. Food and Drug Administration is expected to make its final decision in August on whether to approve the use of MDMA as a treatment, and it is not obliged to follow an advisory committee’s recommendation in June to reject the use of MDMA, also known as Ecstasy or Molly. MDMA, first synthesized by Merck in 1912 and legal in the U.S. until 1985, is the first in a series of psychedelics, including LSD and psilocybin, that are expected to come before the FDA for review over the next few years.

The field of psychedelics has expanded in recent years, Schenberg and Nutt observed, from a few labs that have been examining it as an exotic topic in neuroscience into an extensive network of academic laboratories and dedicated university centers in prestigious institutions, mainly concentrated within the United Kingdom, United States, Switzerland, Spain and Brazil.

“It’s accelerating a lot and it does demand a high level of anticipation. From now until August 11 the whole field is in a state of anticipation and lots of diplomacy is going on,” Schenberg tells GESDA News. “I think the FDA is more aware of these issues than this advisory committee. If it actually rejects this application, the coming of these treatments to the general population could be delayed by some years.”

In June, an FDA advisory committee recommended against using MDMA as part of therapy treatments for PTSD, saying the data do not show it is effective and the benefits do not outweigh the risks. The Dutch government, reflecting the strong demand from psychiatrists seeking new treatments for their patients, jumped into the debate and said it “must act expeditiously to enable the therapeutic use of MDMA.”

As the country where LSD was first discovered, Switzerland also is a leader of innovation and research into the use of psychedelics in psychiatry but sets high regulatory hurdles for researchers and patients. During the 1970s, psychedelics fell from academic and scientific grace. A general societal crackdown on their use, starting in the United States, resulted from stigmatization and uncontrolled consumption. That didn’t subside until the late 1990s when broader research and interest resumed, particularly in Switzerland.

Schenberg, a neuroscientist who is founder and president of Phaneros Institute, was among 21 authors led by Amy McGuire, a Baylor College of Medicine biomedical ethics professor, who published an important new paper on the subject in JAMA Network Open in June. The paper offers a consensus ethics and policy framework for intregrating psychedelic-assisted therapy into clinical practice. It stems from a June 2023 gathering in Banbury Center at Cold Spring Harbor Laboratory for clinicians, researchers, Indigenous groups, industry, philanthropy, veterans, retreat facilitators, training programs, and bioethicists.

“These are not simply drugs, these are complex psychotherapy-plus-drug interventions. Most of the health care professionals nowadays were not educated or trained to use these adequately,” Schenberg says in explaining why a new framework is needed. “We also discussed Indigenous rights and the Indigenous approach to these compounds, which is mostly done in spiritual and ritualistic settings that are very different from a medical approach, and how to make these treatments really affordable.”

McGuire tells GESDA News that FDA regulates drugs, biological products and medical devices, but not therapy, so there have been a lot of questions about the therapeutic component. “The prevailing model of psychedelic-assisted therapy is probably what’s going to move forward,” she says, noting that other countries are starting to approve psychedelic-assisted therapy. “Whether it takes FDA a little bit longer or not, we’re going to be seeing this integrated into medical practice.”

The group at Cold Spring Harbor Laboratory identified areas where more research and deliberation are needed and concluded “this is an incredibly exciting and hopeful moment, but it is critical that policymakers take seriously the challenges ahead.” McGuire explains that “there are a lot of people who have been suffering tremendously from particularly intractable and treatment-resistant mental health disorders that research seems to suggest some of these compounds may be able to alleviate.”

The nomenclature: psychedelic-assisted therapy versus drug use

Netflix’s 2022 adaptation of a Michael Pollan bestselling book about psychedelic-assisted therapy into a four-part docuseries called How to Change Your Mind has lent momentum to a change in public perception about the potential benefits of psychedelics in the healing of mental health conditions.
The Radar contribution by Schenberg and Nutt emphasizes the importance of mental health and notes that “most countries invest less than they should in the field.” The World Health Organization says at least one of every 10 people on the planet suffers from mental health issues, mainly anxiety and depression.

Schenberg and Nutt also stressed the view, based on Indigenous practices, that the proper use of psychedelics cannot be separated from guided human interactions. “Indigenous people always highlighted these as essential,” Schenberg explained. “It’s as important as the plant or the mushroom itself.” Schenberg, who took part in the third annual Geneva Science Diplomacy Week in June, said he also learned the importance of other types of interactions: those based on science diplomacy.

GESDA’s Head of Science Capacity Building Marga Gual Solar says “when it comes to rapidly accelerating fields such as psychedelic medicine, it is essential for scientists not only to understand the policy and societal implications and applications of their research, but to work closely with the multilateral system to ensure these breakthroughs benefit all of humanity and leave no one behind. GESDA supports the next generation of leaders to play the roles of translators and bridge-builders between the different worlds.”

The week’s cohort had a continuing debate about whether science is neutral. Schenberg said that, in his experience, it has not been neutral because during the time since drugs were prohibited, the result has been that “most of the scientific research has been on dangers and risks, and that’s not neutrality.”

Asked by Schenberg about psychedelics, an expert participant speaking under Chatham House rules said it would be a “tragedy” if scientists can show that psychedelics are safe and effective for hard-to-treat conditions but regulators still ban them due to their “reputation on the street” for addiction and abuse.

Ayahuasca churches in Brazil

At the 2023 GESDA Summit, Schenberg held an anticipatory briefing on psychedelic medicine. The Summit coincided with the 80th anniversary of Swiss chemist Albert Hoffman’s first LSD trip, the first time a human ingested it. In 1938, he was working at Sandoz, now part of Novartis in Basel, where he wanted to synthesize a chemical compound to stimulate the respiratory and circulatory systems.

Analyzing compounds found in ergot, a parasitic fungus that grows on rye, he first synthesized lysergic acid diethylamide. But it didn’t show much potential, so he set it aside. Then in 1943, he inadvertently absorbed a trace of the substance – and began learning first-hand about its psychoactive effects.

Most nations still view psychedelic substances as drugs with a high potential for abuse and no recognized medical value, but the widespread isolation and suffering caused by the COVID-19 pandemic fueled some resurgent interest in doing more clinical research into the potential medical uses of these substances.

Schenberg, who launched the Phaneros Institute in 2011 as a Brazilian nonprofit for pioneering clinical research on psychedelic-assisted psychotherapy and training for health professionals, first became interested in the use of psychedelics at a Brazilian church ritual he experienced a quarter century ago.

The church formed out of the colonization of the Amazon, where there is a mix of Indigenous plant rituals, Christianity, African spirituality, and military social hierarchy, he recalled. Most of the rituals have legal authorization for religious use of ayahuasca, which signifies “vine of the soul” in the Quechua language, and the plants and the rituals are both essential to the experience.

“That’s why we would like to call all of these treatment modalities psychedelic-assisted therapy,” says Schenberg. “It’s an indissociable, highly complex, therapeutic intervention, where drug and therapy interact in a variety of ways.”

Eduardo Schenberg explains the potential uses of psychedelic-assisted therapy at the 2023 GESDA Summit (©GESDA/von Loebell)

Where the science and diplomacy can take us

The 2023 GESDA Science Breakthrough Radar®, distilling the insights of 1,500 scientists from more than 70 countries, tells us that research with psychedelics has mostly focused on their psychiatric applications. Although such research has been ignored by funding agencies for a long time, it has continued to evolve for decades through the visionary actions of philanthropic donors.

The findings in the 2023 Science Breakthrough Radar®

Based on the Radar, here’s where we stand in several important areas:

2.4 Consciousness Augmentation

There is no agreed theory of consciousness, and it is unlikely there will be one for a quarter century.

Radar, page 104

2.4.3 Consciousness-augmenting interventions

10-year horizon: The first human-machine interfaces begin to see rollout
25-year horizon: Neural interface for consciousness sharing

Radar, page 108

Invited Contribution: The Future of Psychedelic Medicine

Psychedelics remain associated in the public eye with illicit drug use and are widely perceived as risky and harmful, but that is a policy misclassification with little basis in the scientific evidence to date, which spans a wide range of study designs and approaches.

Radar, page 122

5.53 Synthetic biology

Synthetic biology is a set of technologies that enable the modification and creation of living cells and organisms, and of their building blocks. These include genome editing, artificially evolving biomolecules, tissue engineering and potentially even the creation of synthetic organisms.

Radar, page 236