Updated: Apr 3
This is a reprint of an article written by Marc Gunther on March 21, 2021. Originally posted in MAPS in the Media. MAPS and Marc are doing amazing work. Please consider donating to MAPS. This article is
Summary: In the Spring 2021 edition of the Stanford Social Innovation Review, journalist Marc Gunther dives into the decades-long history of MAPS, discussing its founding in 1986 by Rick Doblin, Ph.D., the recent rapid growth within both the organization and the larger psychedelic field, and the wide range of ongoing efforts that make MAPS' work multidisciplinary. "Today, Doblin and MAPS are on the verge of a breakthrough—actually, more than one," writes Gunther.
As the decade of the ’60s wound down, psychedelic drugs frightened many Americans—at least those who had never tried them. Congress in 1970 passed the Controlled Substances Act, which classified the most popular drugs of the counterculture, including LSD (lysergic acid diethylamide), mescaline, psilocybin, and marijuana, as Schedule 1 drugs, meaning that they have a high potential for abuse and no medical value. Drug abuse, President Richard Nixon intoned, was “public enemy number one.”
It was about this time that Rick Doblin—a rebellious 18-year-old who had smoked a lot of pot, experimented with psychedelics, and refused to register for the draft—decided to quit New College of Florida, an experimental school in Sarasota where students have the freedom to design their coursework and get written evaluations instead of grades.
“I want to drop out of college, and I want to study LSD,” Doblin told his parents. “And I want you to pay for it.”
Improbably, they agreed. His father, a pediatrician whose hero was community activist Saul Alinsky, and his mother, a liberal schoolteacher, had always encouraged their children to think for themselves. Young Rick, who was raised Jewish and had relatives in Israel, had been deeply troubled by the Holocaust, was unnerved by the threat of nuclear war, and was opposed to the US intervention in Vietnam. He had an intuition, after experimenting with drugs, that the mystical experiences occasioned by psychedelics could bring people closer to one another and help end tribal conflicts.
“Psychedelics have been the center of my life ever since,” Doblin says.
That was nearly half a century ago. Since then, Doblin has never wavered from the mission he set for himself: to use psychedelics to heal a broken world. “I didn’t know if I would succeed or not, but it didn’t really matter,” he says.
The year that President Ronald Reagan signed into law the Anti-Drug Abuse Act of 1986, which enacted mandatory minimum sentences for drug possession, including marijuana, Doblin started the Multidisciplinary Association for Psychedelic Studies, or MAPS, a research and advocacy group that aimed to promote the careful, beneficial use of psychedelics and marijuana. The college dropout went on to earn a PhD from the Harvard Kennedy School, where his dissertation explored the regulation of psychedelics and marijuana. Stymied by the politics of the drug war, he decided to use science and evidence as his tools of change: MAPS sponsored research intended to demonstrate to regulators and the broader public that psychedelic medicines could, in fact, alleviate suffering. Along the way, Doblin consumed prodigious amounts of psychedelics, even after they were forced underground.
Today, Doblin and MAPS are on the verge of a breakthrough—actually, more than one.
MAPS, which for years consisted of little more than Doblin and a newsletter he published every few months, has grown into an organization of more than 100 people that spent $18.6 million in its most recent fiscal year. Drug development is its most important work. Last November, MAPS announced the latest results from its long-running clinical trials of MDMA, a synthetic chemical sometimes called Ecstasy or Molly that appears likely to become the first psychedelic medicine approved for prescription use by the US Food and Drug Administration. Psychotherapy assisted by MDMA has proved to be an effective treatment of post-traumatic stress disorder, or PTSD, for military veterans and victims of sexual trauma or abuse. If MDMA is approved as a medicine, other psychedelic drugs are all but certain to follow.
MAPS is also an advocacy group, building a coalition of true believers in the power of psychedelics. Here, too, progress has been dramatic, as we learned on Election Day 2020. Voters in Oregon approved a ballot measure to decriminalize the possession of all drugs, arguably the biggest blow to date against the war on drugs. In a separate ballot measure, they also voted to permit the regulated, medical use of psilocybin, the active ingredient in so-called magic mushrooms. In four other states, including South Dakota, which was carried easily by former President Donald J. Trump, voters approved legalizing the recreational use of marijuana. That brings to 15 the number of states where adults can smoke weed and eat marijuana-infused chocolate or gummy bears.
Meanwhile, medical research into psychedelics is blossoming. A government registry lists nearly 300 clinical trials examining the effects of psychedelics that are either completed, ongoing, or about to get underway. Many are being done in the medical schools of prestigious universities such as New York University, the University of California, Yale University, and Johns Hopkins University, whose Center for Psychedelic and Consciousness Research calls itself the leading psychedelic research institution in the United States.
Psychedelics could transform mental health, evangelists argue. Early indications suggest that, when combined with talk therapy, psychedelics can effectively treat a broad array of ailments, including depression, end-of-life anxiety, and addiction to alcohol or tobacco. Future studies will seek to find out whether they can be used to treat opioid addiction, anorexia nervosa, even Alzheimer’s disease.
To be sure, Doblin and MAPS have not come this far on their own. The George Soros-funded Drug Policy Alliance has led the political fight against the drug wars. The Heffter Research Institute, a nonprofit formed by Purdue University pharmacologist David Nichols, has organized and financed research into psychedelics, particularly psilocybin. An eclectic mix of donors—ex-hippies, Silicon Valley millionaires, descendants of John D. Rockefeller, conservatives, liberals, and libertarians—bridged political and cultural divides to support MAPS. Lately, pharmaceutical start-ups have joined the fray, hoping to profit from the drugs.
Doblin has been at or near the center of it all. “Rick was the real instigator,” says Tom Shroder, author of Acid Test: LSD, Ecstasy, and the Power to Heal, a book about psychedelics anchored by Doblin’s story. “He had this vision—this certainty—that psychedelics were too important to be kept underground. He’s the reason why all this is happening.”
Paranoia and Criminalization
Psychedelics are not new, of course. Some scholars argue that plant-based hallucinogens triggered supernatural experiences described in ancient religious texts. (A headline in The Times of Israel: “Was Moses tripping when he saw the burning bush? Should you try?”) Ayahuasca, a brew made from a shrub containing DMT, has long been used in religious rituals by indigenous people in the Amazon region, while people in northern Mexico and the southwestern United States used (and still use) peyote as part of religious ceremonies. During the 1950s and 1960s, LSD, a synthetic chemical, and psilocybin, which is the active ingredient in magic mushrooms, were legal in the United States; they were given to more than 40,000 patients and analyzed in more than 1,000 scientific papers, according to the Drug Enforcement Administration (DEA). In a foreshadowing of today’s studies on psychedelics and addiction, Bill Wilson, a cofounder of Alcoholics Anonymous, experimented with LSD and tried unsuccessfully to bring the drug to AA.
All that research had come crashing to a halt by the end of the 1960s. Some scientists blame Timothy Leary, the Harvard psychology professor turned counterculture hero. He exaggerated the benefits and downplayed the risks of psychedelics, urging his followers to “turn on, tune in, and drop out.” The government, with the help of a credulous media, did just the opposite, spreading tales of bad trips and LSD users who went blind after staring into the sun.
Doblin rejected the scare tactics, particularly after he had begun using LSD and mescaline. Yes, there were bad trips, even terrifying trips, but when used with sufficient caution, he knew, the drugs could be life-changing.
“The common narrative is that the backlash of the 1960s took place because psychedelics had gone bad,” Doblin says. “What I realized was that it was psychedelics going right that caused the crackdown. Psychedelics were part of the counterculture, with the protests against the Vietnam War, the environmental movement, the women’s rights movement. Psychedelics were motivating people to challenge the status quo.”
Doblin was all in. Back in Sarasota, he found work as a contractor and spent an inheritance from his grandfather to build a home (which he still owns) before returning to New College. Hoping to become a therapist, he attended workshops at the Esalen Institute, a New Age retreat in the hills overlooking Big Sur, California, where he studied with Stanislav Grof, a celebrated Czech psychotherapist who had given psychedelics to his patients. It was there, during a 1982 workshop called “The Mystical Quest,” that Doblin came across MDMA—the drug that would become his focus.
Officially known as 3,4-methylenedioxy-methamphetamine, MDMA has a peculiar history. Discovered and patented in 1912 by Merck, which saw no value in it, MDMA fell into obscurity, only surfacing briefly in the 1950s when the Central Intelligence Agency researched psychedelics for use as chemical weapons. It was resynthesized in 1976 by Alexander “Sasha” Shulgin, a brilliant and eccentric chemist who concocted hundreds of psychoactive drugs in his home-based laboratory in the hills of Berkeley, California.
Shulgin loved MDMA. “I feel absolutely clean inside, and there is nothing but pure euphoria,” he wrote in his lab notes after taking the drug. “I have never felt so great, or believed this to be possible. The cleanliness, clarity, and marvelous feeling of solid inner strength continued throughout the rest of the day and evening. I am overcome by the profundity of the experience.”
Shulgin gave MDMA to a psychotherapist named Leo Zeff, who was equally enraptured. Zeff postponed his planned retirement and discreetly trained, by his estimate, more than 150 therapists in the use of the drug, which he rechristened Adam, an anagram that evoked the innocence of the Garden of Eden. He insisted that any therapist who intended to make use of the drug try it first.
MDMA is not a classic psychedelic. Unlike LSD or psilocybin, it is unlikely to provoke hallucinations, altered perceptions, or a loss of control; instead, it tends to generate feelings of openness, well-being, and compassion.
Julie Holland, MD, a psychopharmacologist, psychiatrist, and author of a book called Ecstasy: The Complete Guide, says, “MDMA is just an exquisitely perfect chemical for augmenting the process of psychotherapy. ... MDMA helps people to feel more relaxed and more open and trusting and more trusting of the therapist. ... It helps people be awake, alert, verbal, want to talk, want to explore.”
Doblin, who is open to a fault, saw this firsthand. In a TED Talk, he described how he gave MDMA and LSD to a woman named Marcela, who was the girlfriend of a college friend, to help her recover from a vicious sexual assault. (This was in 1984, when the drug was legal.) He has taken MDMA more than 120 times, he says.
MDMA was too alluring to remain underground. In the early 1980s, Michael Clegg, a former Catholic priest, rebranded MDMA as Ecstasy and began producing and selling the drug on a vast scale. It could be had at elite nightclubs from Manhattan’s Studio 54 to Dallas’ Starck Club. Ecstasy’s popularity grew even as first lady Nancy Reagan was urging people to “just say no” to drugs and the D.A.R.E. (Drug Abuse Resistance Education) program spread through schools, so it was no surprise when authorities cracked down. In 1985, the DEA took emergency action to ban MDMA and said it intended to permanently classify it as a Schedule 1 drug.
Doblin fought back. With the hubris of a 31-year-old who had yet to finish college, he raised money from, among others, the widow of Aldous Huxley, whose 1954 book The Doors of Perception helped popularize psychedelics, and collected letters from therapists attesting to the benefit of MDMA. He hired a lawyer, pro bono, and sued the DEA. (New College gave him course credit for working on the suit.) Before the ban took effect, Doblin also ordered a kilo of MDMA for $4,000 from David Nichols, the Purdue pharmacologist who had a DEA license to make Schedule 1 drugs. It would turn out to be enough to support decades of MDMA research. “He was prescient in putting all of his eggs in that basket,” Nichols says.
The DEA held hearings and collected thousands of pages of evidence. In a 71-page ruling, an administrative law judge ruled against the agency, finding that the drug had accepted medical uses and only a low potential for abuse. But the ruling was advisory, and it was spurned by the DEA.
Doblin didn’t know that no drug had ever been made into a medicine by a nonprofit. Had he known, it probably would not have mattered.
“We went through that whole process and won the case,” Doblin says, “and, in the end, we lost. That was just heartbreaking.” Criminalization halted the therapeutic use of MDMA but had little effect on its recreational use. MDMA, often adulterated with other drugs, became popular at festivals and dance parties known as raves.
Doblin was disheartened but not deterred. That was fortunate because the defeat at DEA was the first of many. With little more than the research he’d collected from therapists about MDMA and the stash of the drug being held for him by David Nichols at Purdue, Doblin started MAPS to make MDMA into a legal medicine. “The only way forward was going to be the FDA,” he says.
Doblin didn’t know then that no drug had ever been made into a medicine by a nonprofit. Had he known, it probably would not have mattered.
The Right to Change Your Consciousness
MAPS—the Multidisciplinary Association for Psychedelic Studies—struggled for years to live up to its name. It began not as an association but as a one-man show. Doblin, the only staff member, was unpaid for seven years; in fact, he lent MAPS money to pay operating expenses. “Fundraising was really hard,” he says.
As for psychedelic studies, while some scientists gave MDMA to mice, rats, guinea pigs, and monkeys, the US government made it all but impossible to conduct experiments with people. The 1980s and 1990s were dark days for psychedelics; any glimmers of hope were covered in the MAPS Bulletin, which Doblin published three times a year while pursuing his PhD at the Harvard Kennedy School. The publication became a must-read for those following the scientific, political, and cultural debates around psychedelics.
The Summer 1992 edition of the MAPS Bulletin brought one such glimmer. “A new era in psychedelic research is dawning,” Doblin declared. The FDA had just granted permission to Dr. Charles Grob, a psychiatrist at UCLA who was working with MAPS, to begin a study of MDMA-assisted therapy to treat pain and distress in patients with late-stage pancreatic cancer. Doblin was so excited—this was a “historic opportunity,” he wrote—that he took a leave from his PhD studies to concentrate fully on MAPS.
His confidence was misplaced. Grob completed a safety study of MDMA in healthy volunteers, but the FDA twice denied him permission to give the drug to cancer patients. Questions had surfaced about the neurotoxicity of MDMA. Grob decided to run trials of psilocybin instead, with support from the newly formed Heffter Research Institute, which had emerged as a friendly rival to MAPS—but a rival nevertheless.
Heffter’s founders positioned themselves as scientists in white coats. They wanted to distance themselves from Timothy Leary and other psychedelic researchers of the 1950s and 1960s whose work was sloppy, at least by today’s standards. “We were mostly academics,” says David Nichols, a Heffter founder. “Our paradigm was to encourage and support scientific research of the highest quality, done at top institutions.”
Some at Heffter wanted to keep their distance from Doblin, his antiestablishment roots, and his opposition to the drug wars. Hoping to keep the conversation about psychedelics entirely apart from the debate about harmful drugs like heroin and cocaine, they strongly discouraged Doblin from allying with the Drug Policy Alliance, for example. “We don’t advocate anything,” Nichols says.
Carey Turnbull, an entrepreneur who made his fortune in energy markets, has been a major donor to Heffter and is now its president. He admires Doblin’s work and has donated to MAPS, but most of his charity has gone to research at NYU, Johns Hopkins, and Yale. “My inclination has been to go to a major university and meet with psychiatrists in coats and ties,” he says.
Doblin occasionally dons a tie, but he is more often found in an open-necked shirt, with his curly hair askew, framing a bald spot. He cheerfully cops to the charge that MAPS does politics as well as science. “Our strategy is twofold,” he says. “One is making drugs into medicines. But we are also very interested in drug policy reform.” Partly that’s a matter of principle. “It’s a fundamental human right to change your consciousness,” Doblin likes to say. But there were strategic reasons, too, to marry pharmaceutical research with political activism.
Legal and policy work were sometimes required to drive drug development. MAPS, for example, lobbied the FDA to allow a doctor at the University of California, San Francisco, to study the use of marijuana to treat AIDS patients, hoping to demonstrate through science the drug’s medical benefits. MAPS also led a successful legal effort to end a monopoly on growing marijuana for research that had been held by the National Institute on Drug Abuse, which contracted with a single lab at the University of Mississippi since 1968. MAPS wanted to change the cultural narrative around drugs—marijuana then, psychedelics now—by demonstrating that they had therapeutic value. “Legalization follows medicalization,” Doblin says.
There were fundraising benefits, too, to the political work. Strait-laced donors may have recoiled at Doblin’s freewheeling approach, but veterans of the counterculture recognized a fellow traveler. “I had used psychedelics for recreation and personal growth,” says John Gilmore, a cofounder of the Electronic Frontier Foundation, which defends civil liberties on the Internet. “I knew that the whole drug war and prosecution of these drugs was not grounded in reality.” Gilmore, who was an early employee of Sun Microsystems, committed $10 million of his fortune to drug-policy reform and now chairs the MAPS board. He estimates that well over 90 percent of the money raised by MAPS comes from psychonauts, a term used to describe those who have taken psychedelics to explore their minds.
Framing access to psychedelics and marijuana as a human rights issue also appealed to the Libra Foundation, a family philanthropy established by Nicholas and Susan Pritzker that had a human rights focus. Libra gave more than $1.3 million to MAPS during the 2010s as part of its support for criminal justice reform. By then, MAPS was—at last—making headway with the FDA.
Dr. Michael Mithoefer met Rick Doblin at a conference on ayahuasca in San Francisco in 2000. It was a pivotal moment for the two men and for MAPS. Together they began the work that remains the focus of the organization: Turning MDMA into an FDA-approved medicine.
They were kindred spirits. Mithoefer had experimented with LSD and ayahuasca, and he had studied holotropic breathwork, a technique that uses rapid breathing to achieve altered states of consciousness, with its inventor and Doblin’s mentor, Stanislav Grof. Mithoefer, who began his career in medicine as an emergency room doctor, switched to psychiatry because he wanted to explore the healing potential of psychedelics. He had a special interest in PTSD.
If the goal was to win support for psychedelic medicines from regulators, donors, and the public, MDMA and PTSD were an ideal marriage of drug and disorder.
“We very quickly agreed that MDMA had some particular qualities that might make it good for PTSD,” Mithoefer recalls. MDMA improves mood and builds trust between the subject and the therapist, helping the subject revisit and work through traumatic memories. “It’s like re-creating a supportive parental environment,” Doblin says. Put simply, the science looked promising.
So did the politics. MDMA is the gentlest psychedelic and the least likely to produce bad trips. Therapists who were afraid of LSD or psilocybin might be persuaded to work with MDMA, Doblin thought. What’s more, while MDMA was controversial because of its widespread recreational use as Ecstasy, the drug had been analyzed in more than 1,200 peer-reviewed studies, most by researchers seeking to document its harms. There was debate about the damage MDMA could do to heavy users or partygoers who exhausted themselves while on Ecstasy, but there was little evidence that it caused harm when used sparingly in clinical settings.
Awareness of PTSD, in the meantime, was growing. Trauma-induced suffering in soldiers has long been recognized as a problem—it was called “shell shock” during World War I—but the condition did not appear in the Diagnostic and Statistical Manual of Mental Disorders (DSM), published by the American Psychiatric Association, until 1980. The suffering of Vietnam veterans called attention to the problem in the 1970s, at about the same time as trauma caused by the rape or sexual assault of women became understood as a form of PTSD.
“We needed a sympathetic patient population,” Doblin says.
Still, Doblin and Mithoefer struggled mightily to get their Phase 2 clinical trials off the ground. (Phase 1 trials, focusing on safety, had been done by Charles Grob.) Phase 2 trials seek to define a treatment protocol, determine the optimal dose, identify the patient population, and assess the drug’s effect. They lay the foundation for the Phase 3 trials, which evaluate the drug’s effect and safety by comparing it with a current treatment or a placebo.
This time, the FDA was not the problem. The agency promptly approved MAPS’ protocol. This was in part due to Doblin’s years of cultivating relationships with the regulators, as well as his knowledge of how the system worked. His PhD dissertation, which he submitted in 2000, was called “Regulation of the Medical Use of Psychedelics and Marijuana.”
But Mithoefer’s plan to base the trials at the Medical University of South Carolina, where he taught, blew up when they attracted publicity. He was pained, he said at the time, “to see the degree to which academic freedom in a university can be constrained by prejudice and political pressure.” They moved the trials to his private office.
Without access to the university or its Institutional Review Board (IRB), Doblin and Mithoefer searched for an independent IRB to approve the trials, as required by the FDA. (IRBs review medical research involving human subjects to ensure that the rights and welfare of the subjects are protected.) No fewer than seven IRBs turned them down. Doblin turned to a for-profit IRB called the Copernicus Group, hoping that, given its name, it would support a scientific endeavor facing political headwinds. Copernicus did approve, but not before stipulating that it did not want its name on the MAPS website or any other materials.
It did not help their case when Dr. George Ricaurte, a neurologist and prominent expert on MDMA who was funded by the National Institute on Drug Abuse, published a primate study in Science in 2002 alleging that a single dose of MDMA could cause permanent brain damage. The study was challenged by Doblin, among others, and retracted after it was determined that Ricaurte had overdosed his monkeys with methamphetamine, not Ecstasy. Says Doblin: “There was a perversion of science in service of the drug wars.”
The last remaining impediment was the DEA. The agency took months to decide whether Mithoefer would adequately guard the small amount of MDMA kept in his office. (It was worth less than $100 on the street.) A DEA official told him that they planned to do a background check on a therapist who rented an office next door to “be sure she’s not going to drill through the wall or anything,” Mithoefer wrote in his notes at the time. When he told the therapist to expect an inquiry from the DEA, she responded, “Tell them I’m not very good with tools.”
Finally, on April 16, 2004, Mithoefer and his wife, Annie, a registered nurse, gave a dose of MDMA—or, perhaps, a placebo—to their first subject. Thus began the first of six randomized, double-blind, Phase 2 trials of MDMA-assisted therapy that would over time be expanded to other sites in the United States, Canada, Switzerland, and Israel. The Mithoefers kept refining the treatment protocol, publishing seven versions of a manual that eventually grew to 69 pages and covered everything from the setting (quiet, private, comfortable, with the subject seated or lying on a couch) to the music (usually instrumental, some quiet and tranquil, some more dramatic) to the therapist’s role as an empathic listener.
MAPS eventually settled on a protocol of three and a half months that includes three all-day sessions during which the subject is given MDMA. Three 90-minute sessions of talk therapy precede the first experience with the drug, and three 90-minute sessions follow each drug experience.
Two therapists, usually a man and woman, provide the therapy. Two are deployed for practical reasons—someone needs to be with the subject at all times during the long days on MDMA—and also because some subjects relate better to men or women. Therapists are encouraged to try MDMA, and most do.
“We think the therapist will be more effective if they’ve done the drug themselves,” Doblin explains. “You wouldn’t go to a yoga teacher who never practiced yoga.” (True, but it’s a poor analogy. Many perfectly capable ob-gyns have never had children.)
Precisely how MDMA affects the brain remains unclear. Scientists say that MDMA enhances the release of neurotransmitters, including serotonin and dopamine, and hormones, including oxytocin and cortisol, that can reduce activity in brain regions implicated in the expression of fear- and anxiety-related behaviors, namely the amygdala and insula. MDMA may allow for reprocessing of traumatic memories and for emotional engagement with therapeutic processes.
In any event, all agree that what matters is the therapy, not the drug. “MDMA is never going to be a take-home medicine,” Doblin says. “MDMA helps the therapy become more effective.” The Phase 2 trials were designed, in part, to see whether therapy with a placebo worked as well as therapy with MDMA: It did not.
In a 2019 study published in Psychopharmacology, Mithoefer, Doblin, and colleagues reported that 54 percent of the subjects who received therapy with MDMA—more than twice as many as in the control group—no longer met the diagnosis for PTSD two months after their final dose of MDMA. Better yet, people kept getting better on their own. A year later, two-thirds of them no longer met the diagnosis for PTSD.
The FDA was persuaded that, at the very least, the treatment had potential. The agency gave MAPS permission to conduct Phase 3 trials—the first ever for a psychedelic drug. It also granted what it calls Breakthrough Therapy Designation to MDMA-assisted therapy for PTSD. The agency reserves the designation for treatments of serious conditions that appear to offer substantial improvement over existing therapies; most drugs designated as breakthroughs go on to win approval as medicines. Finally, MAPS and the FDA agreed on benchmarks for the Phase 3 trials that, if met, would support regulatory approval by the FDA.
David Nutt, a neuropsychopharmacologist at Imperial College London and the founder of the nonprofit Drug Science, told Science: “This is not a big scientific step. It’s been obvious for 40 years that these drugs are medicines. But it’s a huge step in acceptance.”
As MAPS pursues its research into MDMA, other scientists have been learning more about classic psychedelics. In studies at Johns Hopkins and NYU, psilocybin-assisted therapy has shown promise for the treatment of cancer-related depression and anxiety, tobacco and alcohol addiction, and treatment-resistant depression. Excitement about psychedelic medicines is mounting in part because it’s unusual for a single medicine to treat so many ailments.
“Psychedelic therapy seems to be very potent for a lot of different conditions,” says Dr. William A. “Bill” Richards, a veteran psychedelics researcher who is now affiliated with Johns Hopkins. “It’s not reliant on our DSM nomenclature. It speaks to human beings who are estranged from their own inner resources. It helps us wake up and come alive when it is used intelligently and skillfully.”
Unlike many psychiatric drugs, which are taken for months or years, psychedelic medicines are taken no more than a handful of times, and they are always accompanied by talk therapy. This is a pioneering treatment model, one in which the biological effect of the medicines prompts new insights and enables changes in behavior. Matthew Johnson, another Johns Hopkins researcher, calls it “a paradigm shift in psychiatric treatment.”
The novel nature of this research, along with the stigma attached to psychedelics, helps explain why it is taking so long to get regulatory approval for psychedelic medicines. Back in 2001, Doblin estimated that it would take five years and $5 million to turn MDMA into a medicine. Twenty years and about $75 million later, he’s still not there. “I’m constitutionally prone to optimism,” he says.
But the end is in sight. The first set of Phase 3 trials confirmed the favorable results from Phase 2 as well as the expectations from an independent interim analysis that determined there was a 90 percent or greater probability that the trial, when completed, would detect statistically significant results. MAPS is so confident that the treatment works that it has begun a second and final set of Phase 3 trials at 11 sites in the United States, 2 in Canada, and 1 in Israel, involving about 100 subjects. If all goes well, the FDA will approve MDMA as a medicine during the first half of 2023. Importantly, MAPS has blazed a trail through what had been virgin territory for the FDA.
The trials are being carried out by the MAPS Public Benefit Corporation, a wholly owned, for-profit subsidiary of MAPS that will be responsible for the commercial rollout of MDMA-assisted psychotherapy. Amy Emerson, a former executive at the pharmaceutical company Novartis, is chief executive of the public benefit corporation. Its Delaware charter requires the company to operate in ways that serve the public good, which means, among other things, that any profits it generates will be returned to MAPS to fund research and advocacy.
Barring unexpected setbacks, commercialization will be the next major undertaking for MAPS. The organization will have to train hundreds of therapists or license others to provide the training. Many questions about just how this will work remain unresolved: The FDA and MAPS are haggling, for example, over what qualifications will be required of the therapists. States can apply their own licensing laws; they could, for instance, require an MD to be present when the drug is administered. Still unanswered, too, is the critical question of whether private insurers or the government, through programs like Medicaid and Medicare or the Veterans Administration, will pay for a course of treatment that is estimated to cost about $15,000, depending on the rates charged by the therapists. Citing a peer-reviewed study published in the journal PLOS One, MAPS argues that its MDMA-assisted therapy for severe PTSD would actually save money when compared with more conventional treatment methods.
As MAPS has moved closer to making MDMA a medicine, its fundraising base has expanded beyond psychonauts to prominent Silicon Valley and Wall Street donors with connections to mental-health issues, particularly PTSD. The prospect of helping veterans appealed to the Steven & Alexandra Cohen Foundation, led by the billionaire hedge-fund founder and his wife, which gave $5 million to MAPS; and to Rebekah Mercer, a donor to conservative causes whose family foundation gave $1 million. (The Cohens’ son Robert, a US Marine, served in Afghanistan.) Bob Parsons, founder of GoDaddy and golf equipment maker PXG, is a Marine Corps veteran who has struggled with PTSD; he and his wife, Renee Parsons, the president of PXG Apparel, gave $2 million to MAPS through their family foundation. Hedge fund managers Alan Fournier and John Griffin gave $1 million each in honor of their fathers, who served in World War II.
Other major donors say that using psychedelics has changed their lives. David Bronner, the progressive, pony-tailed CEO of family-owned soap maker Dr. Bronner’s, remains MAPS’ biggest individual donor, having pledged $5 million. Podcaster, author, and investor Tim Ferriss, who has struggled with depression and found relief from psychedelics, is another leading evangelist for the cause, giving $1 million of his own money and helping to lead a $30 million campaign last year that will fund the rest of the Phase 3 work in the United States. Another $30 million campaign is underway to pay for Phase 3 research in Europe that, if successful, would make MDMA a medicine available in most of the world.
As more people learn about the therapeutic potential of psychedelics, drugs once demonized as threats to America’s kids are now seen as instruments of healing. Establishment outlets like The New York Times, 60 Minutes, and CNN direct respectful attention to the university scientists who study the drugs. “We’ve gotten over the ghost of Timothy Leary,” Doblin says. One sign of the turnaround: The Medical University of South Carolina, which once spurned Michael Mithoefer, has asked him to help establish a center to study psychedelic medicine.
The MAPS model will keep business interests in check, by making its treatment widely available at a reasonable cost.
Graham Boyd, an attorney and founder of New Approach PAC, which funded the Oregon ballot measure to legalize psilocybin treatment, has tracked shifting attitudes toward drugs. “Almost equally, MAPS and Michael Pollan have contributed to an atmosphere of public curiosity and receptivity around psychedelics,” he says. Pollan’s 2015 New Yorker article “The Trip Treatment” and 2018 bestseller, How to Change Your Mind: What the New Science of Psychedelics Teaches Us About Consciousness, Dying, Addiction, Depression, and Transcendence, transformed public discourse on the subject. But Doblin has probably reached more people through popular podcasts like The Joe Rogan Experience and The Tim Ferriss Show and with his TED Talk, which has 2.8 million views.
Investors have taken notice. In the last several years, money has poured into for-profit companies hoping to capitalize on the potential of psychedelics. Their backers say the task of bringing psychedelic medicines to market is too costly and complex for nonprofits. “When there’s a market failure, you need philanthropy. When you see promise, you need a different model,” says George Goldsmith, the cofounder of Compass Pathways, a psychedelic start-up. “That’s why pharma companies exist.” Compass Pathways, which is researching psilocybin therapy for depression, raised $147 million last year when it sold shares to the public. A website called Psychedelic Finance tracks the shares of a dozen publicly traded companies and an equal number of private start-ups seeking to make money from the drugs.
Some have approached MAPS. “We have been turning down investors right and left,” Doblin says. The reason, he says, is that the MAPS model—a for-profit company owned by a nonprofit—will keep business interests in check, by making its treatment widely available at a reasonable cost. MAPS intends to make money by selling MDMA for at least five years, before generic manufacturers can join in, but it has no desire to monopolize the market. “The scale of the suffering is so great that we need everybody to get involved,” Doblin says. “We want the for-profits to succeed.”
In the latest MAPS Bulletin, Doblin strikes an ebullient tone: “We are now in the midst of a renaissance of psychedelic research, a flourishing of nonprofit and for-profit psychedelic companies, and successful psychedelic drug policy reform efforts.”
That said, plenty of work lies ahead. Doblin’s ultimate goal remains mass mental health. Just how this will come to pass isn’t clear, to say the least, but he talks about a future that includes a global network of psychedelic clinics where, with guidance, adults seeking personal or spiritual growth could have access to psychedelics. He envisions a post-prohibition world of “licensed legalization,” where adults need to study and pass a test to obtain permission to experience the drugs, just as they now must be tested to get a driver’s license. He’s speculated that psychedelics could be widely—and legally—available by 2035.