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Dave HodesJuly 7, 2022
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10min1580

There are more and more clinical trials for various psychedelic substances cropping up all the time. Some have completed phase III trials, others are closing in on phase III, the final step before FDA approval leading up to an approved drug that can be brought to market.

But the scientific community is saying “not so fast.” Some of these trials are using very small groups of participants—for example, a Phase II psilocybin clinical trial by Johns Hopkins University used 27 participants, while recommendations for Phase II clinical trials vary from a few dozen to 300 patient volunteers. An MDMA-for-PTSD clinical trial completed Phase III with just 100 participants—Phase III trials usually require 300 to 3,000 participants.

Other researchers are finding that getting qualified participants is particularly challenging due to the time commitment required and other detailed inclusion criteria issues.

And intense media attention could potentially undermine psychedelic clinical trials, resulting in strong pressure from some advocacy groups to fast-track, or even bypass, clinical research and rapidly implement it. “Undue haste in translation to community clinics could compromise essential aspects of efficacy, safety, and equity, ultimately threatening the sustainability of psychedelic-assisted therapies,” authors wrote in an article in “Psychiatry.” 

A study published in “Frontiers in Psychology” about the growing problems with psychedelics clinical trials spells out other issues: “Psychedelics have a checkered past, alternately venerated as sacred medicines and vilified as narcotics with no medicinal or research value. Given psychedelics’ complex history, it is especially important to proceed with care, holding ourselves to a higher scientific rigor and standard of transparency. Universities and researchers face conflicting interests and perverse incentives, but we can avoid missteps by expecting rigorous and transparent methods in the growing science of psychedelics.” 

The study also explained that the resurgence of psychedelic research coupled with profits from cannabis legalization has led to converging clinical, philanthropic, financial, and private industry interest in psychedelics.

The upside of growing public interest is that well-respected (and well-funded organizations) such as the Usona Institute, Multidisciplinary Association for Psychedelic Studies (MAPS), Johns Hopkins University, the Heffter Research Institute, the Beckley Foundation, and others have jumped into helping develop better psychedelics research, along with a handful of psychedelics companies. 

But even with those organizations and companies providing research by renowned scientists, psychedelics research is being done in a field characterized by both pro-and anti-drug agendas, according to the study. “Mainstream narratives are fragile: current excitement favoring psychedelics’ potential could swing swiftly back toward prohibition rhetoric following the emergence of clinically adverse events. Peer-reviewed research provides a more stable foundation for policy recommendations, but only when the research is rigorous and transparent.”

The methodology of psychedelics trials—with one group being given a psychedelic, and another being given a placebo as part of the randomized controlled trial—has been called into question recently. 

One Canadian research team from McGill University in Montreal tested the structure of controlled psychedelics trials with surprising results, as reported in “Psychopharmacology” in March, 2020. Thirty-three students completed a study examining how a psychedelic drug affects creativity. They all took a placebo that was described as a (fictional) drug resembling psilocybin. Other participants working with the research team pretended to act out the effects of the drug, leading the participants to believe that there was no placebo control group. The majority (61%) of participants verbally reported some effect of the fictional non-psychedelic placebo drug. Several stated that they saw the paintings on the walls “move” or “reshape” themselves, others felt “heavy… as if gravity [had] a stronger hold”, and one had a “come down” before another “wave” hit her. 

McGill researchers found a silver lining in this experiment, concluding that understanding how context and expectations promote psychedelic-like effects, even without the drug, may help researchers isolate drug effects to maximize their therapeutic potential.

There is also a belief that clinical research is useless. Useful clinical research should add to what we already know, according to an article by John Ioannidis, professor of medicine in the Department of Health Research and Policy, Stanford University School of Medicine. “This means that, first, we need to be aware of what we already know so that new information can be placed in context,” he wrote. 

Studies should be designed to provide enough evidence to ensure that patients, clinicians, and decision-makers can be confident about the magnitude and specifics of benefits and harms, and these studies should be judged based on clinical impact and their ability to change practice, according to the article. “Reform and improvement are overdue,” Ioannidis wrote.

Solutions for better psychedelics studies that have been proposed include pre-registration, open materials and data, constraints on generality, and replication, which are the best practices for any scientific endeavor and particularly for psychedelics research, as noted in the “Frontiers in Psychology” study. “We recommend working with a university or other recognized institution when studying scheduled substances, obeying the law, and hiring legal counsel to review potential agreements with industry partners,” the study concluded.  “This is an exciting time to study psychedelics, but getting the science right should be our top priority.”


Dave HodesJuly 6, 2022
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13min1860

Today in the psychedelics industry there is a flurry of activity by some of the industry’s biggest donors, business developers, celebrities, and other movers and shakers who are not only upping their involvement in the industry today but also laser-focused on where it is going. 

Many in the industry are calling 2023 a pivotal year based on the activities of the last two years—but even 2022 has become a bigger and better year for the industry than expected.
Here are five examples that prove the psychonaut juggernaut that the psychedelics industry has become:

  1. The most promising product developments are happening this year. Psilocybin therapy developer Compass Pathways (NASDAQ: CMPS) conducted phase IIb clinical trial of their COMP360 psilocybin therapy for treatment-resistant depression (TRD) in December, 2021. This randomized, controlled, multicenter, double-blind phase IIb trial was the largest psilocybin therapy clinical trial ever conducted, with 233 patients from 10 countries in North America and Europe. The company presented their findings at the American Psychiatric Association annual meeting in New Orleans, May, 2022. They plan to go into Phase III trials sometime this year, which is generally considered the last phase before FDA approval. Meanwhile, the results of an MDMA-assisted therapy for severe PTSD, which was a randomized, double-blind, placebo-controlled phase III study by the Multidisciplinary Association for Psychedelic Studies (MAPS), were published in May, 2021. MAPS hopes these results will facilitate FDA approval in 2023. Another psychedelics development company, Awakn Life Sciences, is getting ready to go to phase III with their ketamine for alcohol disorder clinical trial.

 

  1. Research and development donations are piling up. According to the Chronicle of Philanthropy, MAPS got a $5 million donation from Ashawna Hailey, a software entrepreneur. Pine, an anonymous Bitcoin millionaire, donated $1 million to MAPS and pledged another $4 million if that amount could be matched, which it was, by more than 500 new donors. Also supporting psychedelics research are major donors including David Bronner and his family, which owns Dr. Bronner’s, a company that makes organic personal-care products, who began donating $1 million a year in 2017 to MAPS and planned to continue through 2022; Bill Linton, the founder and CEO of life sciences company Promega, who started a nonprofit to secure government approval for psilocybin to alleviate depression; Mercer, the activist, whose concern focuses on veterans with PTSD; and the children of the late Richard Rockefeller, former chair of the Rockefeller Brothers Fund, who was a passionate advocate for the research. Additionally, a collaboration between Yale School of Medicine, Johns Hopkins University School of Medicine, and NYU Grossman School of Medicine to train psychiatrists in psychedelic medicine, announced in March, will be funded by a $1 million grant provided by another group of donors.

Others supporting psychedelics research include the foundation of Facebook co-founder Dustin Moskovitz and his wife, Cari Tuna; the foundation of Nick Pritzker, a venture capitalist and the former president of the Hyatt hotel chain, and his wife, Susan; George Sarlo, a Holocaust survivor and founder of an investment firm; SpaceX founder Elon Musk; and Groupon co-founder Andrew Mason.

 

  1. Psychedelics star on the world media stage. The World Economic Forum featured psychedelics for the first time ever in a program, “Medical Psychedelics House of Davos,” prompting coverage in mainstream publications such as Bloomberg. USA Today often features articles about psychedelics, such as the article on January 7 calling psychedelic therapy “the next big trend in mental health treatments.” The New York Times has also picked up its coverage of psychedelics since 2018—four features so far this year. 

In March, the 2022 SXSW show, which is focused on technology, entertainment and culture, and has presentations by world class celebrities and international thought leaders, featured ten sessions on psychedelics, and has added psychedelics as one of its main conference tracks for 2023. The psychedelics topic is also part of a growing group of discussions at TED talks. And the cannabis industry has begun adding psychedelics tracks to their workshops and seminars: both the annual Marijuana Business Conference and the Cannabis Science Conference feature multiple psychedelics sessions. 

 

  1. Clinical trials are growing and expanding exponentially. According to National Institutes of Health (NIH), there have been 25 MDMA studies started since 2020 in the U.S., including seven in 2022 alone so far, compared to just a handful since 2014. There were 30 psilocybin studies combined that were begun in 2021 and 2022, or almost as many studies as all of the other psilocybin studies combined in 16 years, from 2004-2020. There were 16 LSD clinical trials started between 2020 and 2022, with seven in 2021 alone—the most trials of any year since a single LSD trial in 2004. Ketamine has by far the most number of U.S. clinical trials (493) since 2002, with 34 so far in 2022, nearly matching the total of all ketamine clinical trials in 2021 (37). Elsewhere, there were nine psilocybin clinical trials begun in the United Kingdom between 2019 and 2022.

 

  1. Governments around the world signal they are OK with psychedelics. Government-funded psychedelics work in the U.S. made headlines late in 2021 when Johns Hopkins Medicine got the first federal grant for psychedelic treatment research in 50 years from the NIH. In May, the University of California/Davis (UC Davis) and the University of Colorado Anschutz Medical Campus got a $2.7 million grant from the National Institute on Drug Abuse, which is part of the NIH, to research psychedelics. The researchers will use the funding to screen hundreds of compounds to discover new, non-hallucinogenic treatments for substance use disorders. 

In Australia, there are seven clinical trials testing psychedelics that will receive a total of almost $15 million from the Australian Government’s Medical Research Future Fund (MRFF), according to an announcement in January. In Canada, the Canadian Institutes of Health Research (CIHR) launched a psilocybin-assisted psychotherapy $3 million funding opportunity in early 2022, led by CIHR’s Institute of Neurosciences, Mental Health and Addiction (INMHA) with funding provided by the Canadian Drugs and Substances Strategy (CDSS). And in Germany, the German Federal Ministry of Education and Research (BMBF) funded a psilocybin study done in 2021 at the Central Institute for Mental Health in Mannheim together with the Department of Psychiatry and Psychotherapy at Charité Campus Berlin Mitte and the MIND Foundation. It was reportedly a first for Germany and a large project at the highest scientific level.


Dave HodesFebruary 4, 2022
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9min970

Leading psychedelics advocacy groups are tasked with goals of demonstrating and influencing the way that the psychedelics business operates. 

They create conferences, organize wellness seminars, provide teaching and training courses as a way of not only introducing psychedelics to people who may not have heard about their natural healing power but to outline principles and methods of collaboration. 

Some look at the work of advocacy groups as stepping stones to the broader goal of psychedelics reform, complete with a solid ethics framework.

But for all the good that these advocacy groups are doing, there have been bumps in the road along the way when it comes to the products and therapies that the industry is producing—products that are predicted to create a multi-billion industry, with already millions being invested in development. 

But it’s a slow process to bring a drug to market. Any pharmaceutical designed for humans takes years of research and millions of dollars in expenses. This is especially true of any drugs targeting the central nervous system. They are not a slam-dunk kind of business. They are more of a wait-and-see deal while investors hope for the payoff.

With so much at stake, there was a fear that new psychedelic product discoveries, new methods of synthesizing such substances as psilocybin, could get locked up within a company’s intellectual property vaults, effectively slowing down or blocking innovations by other companies that are, after all, part of a bigger mission of psychedelics: treating human mental health conditions with novel drug therapies.

There should be a stopgap of some sort when confronted with this goal of making something for the greater good. There needs to be guardrails on how the industry develops.

Indeed, one of the earliest and well-known advocacy groups, Multidisciplinary Association for Psychedelic Studies (MAPS), was and continues to be focused on that greater good goal through its outreach work and its wholly-owned subsidiary, MAPS Public Benefit Corporation (MAPS PBC). MAPS PBC does psychedelic drug development, therapist training programs, and sales of prescription psychedelics “prioritizing public benefit above profit.”

But as the nascent industry continues to find its footing, one company, Compass Pathways (NASDAQ: CMPS), found that the temptation to become a lead player in the multi-billion-dollar psychedelics industry created a red alert for industry activists and advocates who believed they were witnessing a monopoly being formed.

London-based Compass Pathways was started as a non-profit in 2015 by co-founders George Goldsmith (now also chairman and CEO) and Ekaterina Malievskaia (now also chief innovation officer) to assist with psilocybin therapy based on “painful effects of depression within their own family,” according to their website. A fair enough incentive to start a non-profit. 

Then on June 13, 2016, Compass became a for-profit company, with a co-founder, president and chief business officer, Lars Wilde, and financing from PayPal co-founder and billionaire Peter Thiel who helped guide the company to their IPO on NASDAQ in September, 18, 2020—the first psychedelics company to be listed on NASDAQ. 

MAPS congratulated Compass on their IPO, and noted that they had built their company “upon the innovative work of non-profit organizations including the Heffter Research Institute, Usona Institute, the Beckley Foundation, and MAPS.”

Then, in April, 2021, Compass did the unthinkable: they filed an international patent application for psilocybin. The company claims the patent is just for their formulation of synthetic psilocybin. But patent lawyers who reviewed the document say that it reads as broadly asserting a patent on any sort of psilocybin administration.

Now their patent has been challenged by the non-profit group Freedom to Operate with a filing on December 15, 2021, requesting a post-grant review (a post grant review is a trial proceeding to review the patentability of one or more claims in a patent). The review process could take up to 18 months. It’s a case being carefully watched by the industry.

As the psychedelics industry continues evolving, and dealing with the growing pains that any nascent industry experiences, industry leaders know that they need to assert and protect the ethical cause of what they are doing and continue to remind each other about the help their work means for people suffering from mental health problems like treatment-resistant depression. Advocacy groups drive and sustain that cause.

One example of the industry getting on the same page: In December 2017, just a few months after Compass decided to change to a for-profit company, a number of non-profit company leaders, along with dozens of scientists, scholars, practitioners, and philanthropic organizations, signed a statement committing to various principles of research and therapy work in psychedelics. The statement, led by Robert Jesse, a psychedelics researcher, was developed “in response to concerns that, as psilocybin and MDMA progress through clinical trials showing promise as medicines, commercial enterprises will form in ways that incentivize them to not share materials or knowledge, to prioritize profits, or to act competitively against others.”

The statement reads, in part, that signatories to the statement will “place the common good above private gain” and will “strive to place our discoveries into the public domain, for the benefit of all.”

Maybe this psychedelics industry declaration of intent will become the document on which psychedelics companies will build their businesses. Maybe it will get dismissed as just wishful thinking by those who don’t fully grasp the concept of capitalism. But at least it’s a good start for an agreed-upon ethical base that this industry needs going forward into what promises to be a very busy year for the psychedelics industry.


StaffNovember 30, 2021
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This week, Horizons – Perspectives On Psychedelics the largest and longest-running psychedelic conference will take place in New York City. It is a five-day conference that includes credit coursework for professionals as well as sessions on medical research. The event has grown from its original one-day conference with the addition of classes and business talks. The initial three days are held at the prestigious New York Academy of Medicine.

The days generally break down as follows:

  • (Wed/Thurs) Classes: in-depth intros to psychedelic therapy from researchers and practitioners in small class environments.
  • (Thurs) Business Forum: first-of-its-kind gathering about creating purpose-driven and value-centered organizations that are also pro-business and profitable.
  • (Fri) Focus on Clinical Research: a briefing on psychedelic-assisted therapy research and practice.
  • (Sat) Psychedelics in Medicine: insights, big ideas on moving the market, and visions for the future.
  • (Sun) Psychedelics in the World: a survey of psychedelics in society.

One of the reasons, people are drawn to this conference is that it targets its panels to just one to two people. The sessions end up delivering more information as speakers aren’t limited to just a few sentences. 

If you are considering attending this conference, here are the five things you don’t want to miss. 

Classes

The classes will be held on Wednesday and Thursday and they are specifically for people who want to learn about Psychedelic therapy. There are introductions to MDMA, psilocybin, and ketamine therapy, plus attendees can get CME credit. The classes are introductions on how to work with these types of therapy. 

Business Forum

Thursday is the business forum, which is mostly talks geared toward people in the space already. The sessions will be targeted to shaping the ecosystem, focusing on integrity, and including sessions on ethics. There will also be a focus on a values-oriented approach, specifically on how to operate with integrity. There will also be discussions on how to get funding. This day will be great for networking.

Clinical Research

Friday’s sessions will focus on clinical research and specifically taking psychedelics from the lab to the clinic. One speaker that attendees shouldn’t miss is Dr. Charles Raison, an author at the Usona Institute. He will be talking about psilocybin for treating depression. Another speaker that shouldn’t be missed is Gul DolenAssociate Professor Johns Hopkins University, School of Medicine, who is also speaking on Friday. Her topic is The pharmacology and neuroscience of psychedelics. 

Medical Research

Saturday is the most medical day of the conference and the conference moves its location to Cooper Union and the landmarked Great Hall, built in 1859 and is one of the most prestigious auditoriums in the nation, having been graced by such eminences Abraham Lincoln, Mark Twain, Frederick Douglass, Susan B. Anthony, and Barack Obama. Dr. Raison will lead another discussion on this day. It is expected that Saturday will lean into the issue of patents over the various compounds in the psychedelic world. It is a heavily debated subject with the leader of the industry MAPS against patents, while the Usona Institute is open to the idea. 

Culture

Like the cannabis industry, there is a bifurcation in the psychedelics industry concerning medical versus culture. Many within the industry see psychedelics as a spiritual experience, while some see it as recreational and others as purely medical. Sunday will focus more on the cultural aspects of the psychedelic world with sessions on history and indigenous communities. 

In Closing

Dr. Julie Holland, MD, a psychiatrist, psychopharmacologist, and medical advisor to the psychedelic investment fund Palo Santo said, “I come away learning things I didn’t know, whereas most conferences I feel they are already preaching to the choir. Horizons is my favorite conference.” She also noted that what makes this conference unique is that it isn’t afraid to talk about the failures in therapy. “It addresses the shortcomings and where we’re having problems. There is a lot of attention paid to ethics,” she added.


Julie AitchesonMay 5, 2021
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5min2220

The Multidisciplinary Association of Psychedelic Studies (MAPS) has worked for the last 35 years to shift the perception around psychedelics as a treatment tool for mental health issues. Now, with the release of data from its Phase III trial with the FDA for the use of MDMA (ecstasy) to treat PTSD, MAPS’ work has coalesced into findings that could change the mental health treatment landscape as we know it. 

MDMA is on the cusp of FDA approval to treat PTSD, not just for military veterans, but for an array of people who have suffered from abuse and other trauma-inducing events. In 2017, the FDA granted MDMA “breakthrough therapy status” in anticipation of approving it as a medication for mental health, and the release of MAPS’ latest statistically significant findings constitutes a huge leap towards legalization. 

The conversation around the legalization of psychedelic drugs is not new to the mental health community. Trials testing the efficacy of psychedelics such as LSD for mental illness began as early as the 1950s. By the 1960s more than 1,000 papers had been published about LSD as a treatment for depression, alcoholism, schizophrenia, and as an adjunct to psychotherapy. These trials lacked the scientific rigor necessary for legitimacy in the eyes of the FDA, but due in no small part to the work of MAPS, legitimacy is no longer the stumbling block it once was.

 MDMA showed efficacy for treating PTSD in six MAPS Phase II trials, providing a cost-saving and clinically beneficial treatment for those with severe or extreme chronic PTSD resulting from any cause. The Phase III trial is the first of any psychedelic-assisted therapy. It was a randomized, blinded study designed under an FDA-approved Special Protocol Assessment. 90 patients with severe, chronic PTSD were enrolled in the trial and randomized to receive either MDMA or a placebo. The results, according to the lead author of the paper, Jennifer Mitchell, Ph.D., were significant. “People with the most difficult-to-treat diagnosis, often considered intractable, respond just as well to this novel treatment as other participants. In fact, participants diagnosed with the dissociative type of PTSD experienced a greater reduction in symptoms than those without the dissociative subtype.”

The Phase III trial data revealed that 67% of the group who received MDMA no longer qualified for a PTSD diagnosis after three treatment sessions (compared to 32% of the placebo group). 88% of participants in the MDMA sessions experienced a clinically significant reduction in symptoms, as opposed to 60% of the placebo group who received therapy alone. Mitchell attributes MDMA’s effectiveness to its role as a catalyst in therapy, which often involves recalling, and frequently reactivating, previous trauma. “The unique ability of MDMA to raise compassion and understanding while tamping down fear is likely what enables it to be so effective.”

Researchers are currently enrolling participants in a second Phase III trial and MAPS is formulating plans for additional studies to evaluate MDMA’s efficacy for mental health conditions not yet explored, as well as other protocols beyond one-on-one sessions, including group therapy and cognitive behavioral therapy focused on couples. The fact that MDMA is currently classified as a Schedule I drug and defined as having “no medical benefit” means that the only way to receive MDMA-assisted therapy right now is through clinical trials. However, the FDA has given its blessing to an expanded access program so that 50 patients can access MDMA-assisted therapy before it is approved and MAPS has committed to confronting accessibility and equity issues from its own side of the table. While not a sure thing, with MAPS’ latest data and continued efforts in alignment with FDA requirements the hoped-for 2023 FDA approval of MDMA-assisted therapy for PTSD is closer to becoming a reality than ever before.


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