A pair of California lawmakers introduced a bipartisan bill on Tuesday to allow people 21 and older to consume psychedelic mushrooms under professional supervision as part of an agenda to tackle the state's mental health and substance use crises.
It comes after Democratic Gov. Gavin Newsom last year vetoed legislation that would have decriminalized the possession and personal use of several plant-based hallucinogens, including psychedelic mushrooms. It was the first time the proposal by Democratic Sen. Scott Wiener made it through the legislature after years of stalling. In his veto message, Newsom, who championed legalizing cannabis in 2016, asked lawmakers to work on therapeutic guidelines and regulations.
Now Wiener has teamed up with Republican Assemblymember Marie Waldron on a proposal to allow participants to consume psilocybin — the hallucinogenic component in what’s known as psychedelic mushrooms — under the supervision of a licensed therapist. The bill also would include dimethyltryptamine (DMT), MDMA and mescaline.
Colorado and Oregon have already decriminalized psychedelic mushrooms and established regulated systems for therapeutic use of the substances. In California, San Francisco, Oakland and Santa Cruz have effectively decriminalized possession of psychedelic mushrooms, meaning a person cannot be arrested or prosecuted for possessing limited amounts of plant-based hallucinogens.
“We know that Californians are struggling with mental health and addiction challenges, and we know that psychedelics, particularly when combined with therapeutic support, can be a powerful tool to help people get their health back,” Wiener said at a Monday news briefing. “We know that California veterans and first responders have particularly benefited from these substances, and we know that many more people can as well.”
Waldron, who introduced a different bill to study the use of psychedelic therapy, said the bipartisan bill aligns with Newsom’s vision by providing safeguards around psychedelic therapy. A person would have to go through a comprehensive screening to determine if they’re fit to consume hallucinogens for therapy and engage in follow-up assessments.
The bill also would shift the state’s response to mental health crisis away from criminalization and punishment, Waldron said.
California already has “a massive network” of underground therapists who provide psychedelic therapy, Wiener said. He added the bill would “bring them above ground” through a new state licensing board that regulates the services.
The legislation does not allow for personal possession and use. That means clients can't buy the substance to go. The drugs would still be illegal under federal law. Wiener said he doesn't want to wait on actions from the federal government and that state lawmakers could authorize such regulated psychedelic use, similar to previous efforts to legalize therapeutic use of cannabis to treat cancers or HIV.
Touted as a mind-bending drug in the 1960s, psychedelic mushrooms have been used in religious or spiritual practices in some cultures for centuries and possibly thousands of years. Some researchers believe psilocybin and other drugs show promise in treating depression, anxiety and post-traumatic stress disorder. The Food and Drug Administration in 2018 designated psilocybin a “breakthrough therapy” and published draft guidance last year for researchers designing clinical trials for psychedelic drugs.
The bill is sponsored by Heroic Hearts Project, a nonprofit working with veterans to overcome trauma. Juliana Mercer, a Marine Corps veteran and a Heroic Hearts Project board member, said she's used psychedelics to manage her PTSD through programs outside of the U.S. Her organization recently sent a group of veterans to Oregon for regulated psilocybin use.
“Through education and through regulation, we'll be able to take people from doing this underground, where it may not be safe, into a place where they can do it safely,” Mercer said.
She added that will allow them to “access the healing that they deserve without fear of negative repercussions.”
The California Coalition for Psychedelic Safety and Education, which opposed the measure to decriminalize psychedelics last year, also joined to support the bipartisan bill this year. Susan Sagy, executive director of the group, called it an approach “that balances the potential benefits of therapeutic treatment with the potential risks to public health.”
Proponents of the bill anticipate it would take 18 to 24 months to implement the program if the bill becomes law. The bill would also create an education program focused on harm reduction and the potential adverse effects of psychedelics.
As investors pile into psychedelics, idealism gives way to pharma economics
Money is pouring into the fledgling psychedelic medicine industry, with dozens of startup companies vying to be among the first to sell mind-expanding drugs for depression, addiction and other mental health conditions.
While psychedelics are still illegal under federal law, companies are jostling to try and patent key ingredients found in magic mushrooms, ayahuasca and other substances that have been used underground for decades or — in some cases — for millennia by indigenous cultures.
Wall Street's sudden exuberance for hallucinogens has rankled longtime advocates and philanthropists, who dreamed of making low-cost psychedelics widely available for mental health and personal growth. Instead, many now see a very different future for drugs like psilocybin and LSD: as expensive, specialty medications controlled by a handful of biotech companies.
“It’s disappointing,” said Carey Turnbull, an investor and philanthropist who sits on the board of several psychedelic nonprofits. “All the air is getting sucked out of the room by these for-profit companies who say, ‘Wow, this stuff is awesome, if I could patent it I’d make a fortune.’”
Since 2010, Turnbull and his wife have donated millions to fund psychedelic research at New York University, Yale and other top academic centers.
Promising results from those studies have sparked a wave of popular interest in psychedelics, amplified by books, documentaries and articles touting their potential to reshape care for mental illness, trauma and end-of-life care.
But in recent years, Turnbull has pivoted to challenging what he and other advocates consider frivolous patents filed by companies entering the field.
Most psychedelic startups are backed by venture capitalists or tech investors looking for the next industry “disruptor.” Behind one of the biggest companies, Atai Life Sciences, is PayPal billionaire Peter Thiel, whose enthusiasm for psychedelics is shared by many in Silicon Valley.
About 50 such companies now trade on public stock exchanges, including developers of psychedelic drugs, retreats and training programs. Some analysts project the industry could grow to over $10 billion within the decade.
But recently investors have pulled back, amid reminders of the stark challenges of converting illegal drugs into money-making medicines.
Atai laid off 30% of its staff last March after its depression treatment failed in a key study. Stocks are down 80% to 90% from their highs across the industry with several smaller companies restructuring or declaring bankruptcy.
“They’re in this hype cycle, but then the reality of running a biotech company catches up with you,” said Chris Yetter of Dumont Global, which trades in cannabis and psychedelic companies. “You do drug trials and some of them succeed and some fail and every quarter your cash drains away.”
The cash crunch recently forced fundamental changes at the field's leading nonprofit, the Multidisciplinary Association for Psychedelic Studies.
For more than 30 years, MAPS’ efforts have been funded almost entirely by donations from wealthy individuals and foundations — including Republican political donor Rebekah Mercer and the Steven and Alexandra Cohen Foundation, created by the hedge fund manager and New York Mets owner with his wife.
The group’s pharmaceutical arm, the MAPS Public Benefit Corp., is expected to win U.S. approval this year for the first psychedelic medicine accepted for review by the Food and Drug Administration: MDMA, or ecstasy, to help treat post-traumatic stress disorder.
But as investment opportunities have multiplied, charitable donations have dried up. The group was recently forced to take on private investors to continue funding the drug company, which changed its name to Lykos Therapeutics.
“We’re a victim of our own success,” said MAPS founder Rick Doblin. “It’s heartbreaking because I had hoped to go the whole way with philanthropy, but I was unable to raise the mega millions to do that.”
Psychedelics never fit the business model of the traditional blockbuster drug: an exclusive, patent-protected medicine that patients take regularly for years.
None of the psychedelics currently being studied are new. Synthetic drugs like LSD and ecstasy have been off patent for decades. Naturally occurring substances like psilocybin, found in certain mushrooms, can’t be patented by themselves.
And then there’s the challenge of administering drugs that bring about intense, disorienting visions and experiences. All the drugs vying for FDA approval will have to be given under professional supervision, typically during several therapy sessions lasting about six to eight hours each.
All those hours and professional fees will drive up costs, which many analysts say could range from $5,000 to $10,000 for one course of treatment.
Psychedelic executives say the only way to defer those costs is to conduct large, rigorous clinical studies needed for FDA approval, which could compel insurers to pay for psychedelics. But funding those studies requires raising tens of millions from investors, who typically only back drugmakers with strong patents.
“The only way you’re going to bring about that broad and equitable access is with robust intellectual property,” said Kabir Nath, CEO of Compass Pathways, which is studying laboratory-made psilocybin for depression, anorexia and other disorders.
Compass is among the most aggressive companies in terms of trying to patent its technology, with dozens of applications filed with the U.S. Patent and Trademark Office.
One submission describes the “soft furniture” and “muted colors” that would decorate rooms where patients take psilocybin. Another patent lays claim to a specific, microscopic structure found in Compass' synthetic psilocybin, which the company claims is uniquely suited for mass production.
The company's efforts have drawn ridicule from some researchers, who note that as early as the 1970s, psychedelic therapists had codified the settings and techniques described in Compass patents.
“It just seems like a blatant power grab,” said Frederick Barrett, a neuroscientist who directs Johns Hopkins University’s psychedelic center.
But attempts to challenge the patents on Compass' synthetic psilocybin have been unsuccessful, despite years of work by Turnbull’s patent watchdog group, Freedom to Operate.
Other companies are taking more creative approaches to patenting psychedelics, such as reformulating them as dissolvable lozenges or films — or combining LSD and ecstasy into a combination pill. Skeptics note that that approach, dubbed “candyflipping,” has been used recreationally for decades.
One of the more intriguing reformulation efforts involves trying to shorten the duration of the psychedelic experience, or even do away with it entirely, while retaining the psychological benefits for patients.
The rush to innovate worries some psychiatrists who point to the many fundamental questions about psychedelics that remain unanswered, including exactly how they affect the brain and how long their benefits might last.
As companies develop more psychedelic derivatives and combinations, deciphering their strengths and weaknesses will become more challenging, says Dr. Jeffrey Lieberman of Columbia University. Unless researchers can clearly demonstrate their benefits, they risk another backlash like the 1970 federal ban that wiped out psychedelic research for decades.
“Psychedelics could have tremendous benefit for treating a number of illnesses,” Lieberman said. “But if we mess it up and rush the process, these drugs are going to get banned again and you lose that opportunity.”
