A significant amount of money is being invested in a new class of mental-health treatments.
The inventor of the popular canvas footwear brand Toms Shoes in Los Angeles, Blake Mycoskie, declared that he will donate $100 million to assist psychedelic research and access.
The funds will support charitable organizations that help people in need get access to psychedelic medicines as well as academic institutions looking into the possibility of using psychedelics to treat anxiety, depression, post-traumatic stress disorder, and other mental health problems.
Hallucinogens like LSD and psilocybin, also known as “magic” mushrooms and newly authorized in Oregon and Colorado, are examples of traditional psychedelics. While not traditional psychedelics, other chemicals that might affect mood and perception, such ketamine and MDMA, or ecstasy, are widely discussed in research and policy debates that are sparking a rise in interest in this category of treatments.
For instance, the U.S. Food and Drug Administration has given MDMA and psilocybin “breakthrough therapy” status, a classification intended to speed up the creation and review of medications for serious diseases. MDMA treatment for PTSD could be approved as early as next year.
Given the field’s quick advancements, Mycoskie said, “we really need to get this right, and we really need to have these foundations and nonprofits funded properly,” adding that clinics must be operational and therapists properly trained. He added, “I felt a real sense of urgency,” and he inquired, “What’s the most that I can give?” from his wealth manager.
The $100 million provided in response to that inquiry is a significant turning point in the delicate image change of psychedelics and makes up around 25% of Mycoskie’s total wealth. Psychedelics are getting attention from prominent pharmacologists, the scientific community, biotech businesses, and investors who see them as an essential component of the solution to a U.S. mental-health crisis, shedding some of its dangerous-party-drug reputation.
Mycoskie, 46, claimed that his fascination with hallucinogens began in 2017, when a friend who had just returned from a trip to Central America detailed his encounter with ayahuasca, a plant-based hallucinogen that was prepared into a tea.
Mycoskie claimed that under the enormous pressure of being an entrepreneur, he chose to give it a shot. The encounter “cracked me open, connected me more to my faith in God, made me feel that we were all connected, and everything was fine and perfect,” he said. Wow, I thought when I got back, that was more effective than any therapy I’d ever received. Later, he attempted MDMA-assisted therapy, which, according to him, also assisted him in processing problems that conventional talk therapy had left open-ended.
Mycoskie began donating money to academic organizations and the Multidisciplinary Association for Psychedelic Studies, or MAPS, a nonprofit organization, as he thought that many people could profit from similar treatments. Additionally, he participated in the Colorado ballot measure from the previous year that legalized psilocybin and a number of other psychedelic drugs, including ibogaine, which has the potential to cure substance use disorders. He claimed that Mycoskie has already donated roughly $10 million to psychedelic research and access and that he intends to continue to donate about $5 million each year for the next 18 years.
Mycoskie admits that he was initially hesitant to publicly support research on primarily illegal drugs. He recalled thinking, “Am I going to get held up at TSA every time I go through the airport?” LSD, MDMA, and heroin are all classified as “Schedule I” substances by the U.S. Drug Enforcement Administration, which is short for “drugs with no currently accepted medical use and a high potential for abuse.” However, he claimed that as public understanding and acceptance of the medications’ potential as mental-health therapies grew, he felt empowered to make a significant public statement and that “the research has caught up.” “It’s important that people like me put their names and their money out there to show that this really is a path forward,” he said.
Mycoskie’s $100 million pledge “is the biggest that we’ve ever seen in the psychedelics space,” according to Joe Green, president of the Psychedelic Science Funders Collaborative, a non-profit promoting philanthropy in the field and a member of the MAPS board. That money can aid in making sure that “these actually come to the world in a safe and beneficial way,” according to Green, as research has advanced significantly to support usage of the medications as mental-health treatments. In Oregon and Colorado, for instance, the use of some treatments is now allowed, so “the system requires licensed guides, facilitators, and licensed service centers,” he said. “You won’t be able to take the mushrooms outside the service center. It’s not like cannabis medical.”
By 2028, the market for psychedelic therapies might be valued at more than $8.3 billion.
The Multidisciplinary Association for Psychedelic Studies held what was dubbed “the largest psychedelic conference in history” in Denver, where Mycoskie announced his vow. The talks covered topics such state policy and regulatory considerations, clinical studies of psilocybin and MDMA-assisted treatment, and “sex and psychedelics: weaving altered states for healing and pleasure.”
As part of the National Defense Authorization Act for fiscal year 2024, senators on both sides of the aisle are urging new funding for research into the use of psychedelics to treat PTSD in military service personnel.
Psychedelic-based medicines are already being developed by publicly traded businesses like Atai Life Sciences ATAI, -7.10%, Compass Pathways CMPS, -3.56%, and Cybin CYBN, +5.63%. According to InsightAce Analytic, the market for psychedelic therapies might be valued more than $8.3 billion by 2028. Even the federal government is financing research to create psychedelic mental-health medicines without the hallucinogenic side effects, pouring money into this sector.
According to the National Institute of Mental Health, more than one in five U.S. adults suffer from a mental disorder, and only about 58 million of those individuals are receiving treatment. According to the Centers for Disease Control and Prevention, suicide rates, which have been on a sustained increasing track, momentarily decreased between 2018 and 2020 before climbing again to their highest levels in 2021. According to a survey conducted by CNN and KFF, a nonprofit organization that promotes health policy, nine out of ten American adults believe that the nation is experiencing a mental-health crisis. Additionally, many people may not respond well to routinely given antidepressants such selective serotonin reuptake inhibitors (SSRIs).
The CEO and founder of Mindbloom, which provides a telemedicine ketamine treatment program, Dylan Beynon, declared that mental illness “is truly an epidemic, and we are losing the fight.” While some current remedies, according to him, are assisting in bending the curve, additional study and patient and provider education are required.
In fact, there are still several significant obstacles standing between psychedelic mental-health medicines and many of the individuals they could help. These obstacles include the fact that the currently legal treatments are not covered by insurance and the ongoing controversy about the safest ways to use them. For instance, some healthcare professionals prefer in-person guided sessions when using the off-label anesthetic ketamine, while others, like Beynon, support the telemedicine prescribing paradigm, which experienced a boom during the epidemic.
Recently, several scientists have expressed concern that the use of psychedelic medication may be progressing faster than the research can keep up. According to the American Psychiatric Association’s position statement on psychedelic and “empathogenic” agents, which includes MDMA, “there is the risk that use of psychedelics for purported clinical goals may outpace evidence-based research and regulatory approval,” given the growing public and commercial interest.
Mycoskie has also invested in the psychedelics industry, despite his claim that financial gain is not his primary goal. He has invested in Mind Medicine Inc. MNMD, -0.61%, a company that claims to be creating “psychedelic-inspired medicines” to address the fundamental causes of mental anguish. Additionally, Mycoskie sent funding to a public benefit corporation associated with MAPS, which is guiding MDMA through the FDA clearance process. This investment will pay off when the medication is made available for purchase, according to Mycoskie.
As soon as MDMA and other treatments in the category are authorized, providers who already offer ketamine treatments believe they’ll be keen to expand.
For instance, Mindbloom presently provides a ketamine treatment program through telehealth in a number of states and plans to start providing MDMA-assisted therapy late next year after FDA approval is confirmed, according to Beynon. Two years later, he suggested, psilocybin-assisted therapy might start.
In addition to providing ketamine-based therapy administered by in-person IV infusions, Nushama, a psychedelic wellness center in New York City, hopes to expand into MDMA when it is authorized, according to co-founder Jay Godfrey.
New therapies that potentially mimic the positive effects of psychedelic drugs on mental health are still in the works. Bryan Roth, a professor of pharmacology at the University of North Carolina School of Medicine, is leading an initiative to develop new drugs for depression, anxiety, and substance abuse that function similarly to psychedelics without the confusing, hallucinatory side effects.
A $27 million funding from the Defense Advanced Research Projects Agency supports his work. Such therapies, according to Roth, could benefit the many people who find such psychedelic effects repulsive or unwise, such military personnel. Psilocybin or ketamine shouldn’t ever be given to someone who is carrying a weapon, according to Roth.
Roth said he is acutely aware of the need for safe and effective treatments since during his training as a psychiatrist earlier in his career, he worked with Vietnam soldiers suffering from PTSD. Nothing could be given to treat their symptoms, he claimed. “The best we could do was give them drugs to prevent their dreams so they wouldn’t have nightmares,” said the doctor. That’s pretty much it.
According to Roth, his research has already created chemicals that have demonstrated antidepressant efficacy in rats without any hallucinogenic side effects. He added the group is currently searching for a clinical candidate suited for testing on people.
Treatments that may “break bad emotional or psychological patterns without scary, high-friction psychedelic experiences would be a great thing for patients, providers, and the healthcare system,” according to Mindbloom’s Beynon.
Experts agree that much more needs to be done to lessen the stigma attached to psychedelics. President Richard Nixon designated drug usage as “Public Enemy No. 1” 52 years ago, and since then, billions of dollars have been spent spreading the message that “these medicines are dangerous, that they’re addictive, and that they’ll fry your brains,” according to Godfrey. Removing 52 years of propaganda is a difficult task, but I have reason to be upbeat because the results are beginning to speak for themselves.”