Rick Doblin first dreamed of the therapeutic potential of the psychedelic drug MDMA in a hippie house in downtown Santa Cruz, in an era when fears of bad trips and ruined lives loomed large in the public imagination.
On Tuesday, 38 years later, his vision will go before a U.S. Food and Drug Administration’s advisory committee of medical experts who will make a recommendation about whether the drug, when combined with talk therapy, should be a legal part of modern medicine.
Approval is far from guaranteed. But it’s a major step for a controversial drug, also known as Ecstasy or Molly, that has long lingered in the shadows of counterculture and shown promise in highly regulated UC San Francisco-based studies.
On its long strange trip, the drug has been transformed. This MDMA is nothing like the illegal stuff shared, for free, at all-night raves. Rather, it’s a prescription capsule made by San Jose-based biotech company Lykos Therapeutics, funded by venture capital — with patents, and profits, on the horizon.
“There’s a sense of things coming to potential fruition,” said Doblin of the nonprofit group Multidisciplinary Association for Psychedelic Studies (MAPS), founded in a converted three-bedroom house on Santa Cruz’s Mission Street, that created Lykos Therapeutics. “Looking back, I had no idea how long it would take. This feels incredible.”
Additional psychedelics for therapeutic uses are expected to be reviewed by the FDA in coming years.
MDMA is currently classified by the Drug Enforcement Agency as a Schedule 1 drug, like heroin, with “no currently accepted medical use and a high potential for abuse.”
But a growing number of clinical trials show that MDMA-assisted therapy seems to be effective in reducing symptoms of post-traumatic stress disorder. It’s not a classic hallucinogen like LSD; instead, it triggers feelings of intimacy, connection, and euphoria.
In the initial review of the drug on Friday, ahead of the meeting, FDA scientists wrote that patients who received MDMA and talk therapy showed “rapid, clinically meaningful, durable improvements in their PTSD symptoms,” according to the Associated Press.
But they also called the research “challenging to interpret” because it’s difficult to know whether improvement came from the drug or talk therapy. They also raised several safety concerns, including MDMA’s heart risks and potential for abuse.
The FDA is due to make a decision by August 11. If approved, MDMA-assisted therapy would be the first novel treatment for PTSD, which occurs after exposure to a violent or traumatic event. Antidepressants are now the only approved drugs for PTSD. But fewer than 60% of patients respond to this approach, and only 20% to 30% of patients are cured, according to a 2009 article in the journal Progress in Neuro-Psychopharmacology and Biological Psychiatry.
“MDMA allows you to access these really deep traumatic memories in a way that is not anxiety-provoking,” Jennifer Mitchell, a UCSF neuroscientist who led the study being presented to the FDA, told the Mercury News in 2022.
Doblin, now 70, was inspired on the cliffs of Big Sur’s Esalen Institute, a cathedral to the personal growth movement, where he attended a workshop in 1982 with LSD researcher Stanislav Grof. Grof and some other psychiatrists believed that, in combination with psychotherapy, psychedelics could help some patients reframe a traumatic experience. But former President Nixon’s “War On Drugs” stifled research.
***** He decided it would be more effective to work within the legal system, not outside it. He founded the scrappy grassroots nonprofit MAPS in 1986 to promote MDMA’s study and legalization.
The chemical structure of the drug, invented and patented by the pharmaceutical giant Merck in 1912, had long been in the public domain.
Doblin adopted an “anti-patent” strategy, raising money from wealthy donors to fund clinical trials. But donations weren’t enough to support MDMA research, regulatory review and integration into the healthcare system.
Under a little-known FDA designation called “new drug product exclusivity,” designed to provide companies an incentive to develop drugs that are off patent, Doblin saw the promise of financial returns.
The organization, rebranded as Lykos Therapeutics, is now unambiguously profit-focused. Under the leadership of CEO Amy Emerson, formerly of pharma giants Novartis and Chiron, it has raised about $150 million and grown to over 120 employees.
If its product is approved, Lykos would have the sole rights to commercialize it for five years.
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Meanwhile, cultural norms have shifted. Once-fringe practices of yoga, meditation, and “mindfulness” are now mainstream. Drug laws have loosened, with decriminalization efforts in cities such as Oakland, Denver, and Seattle. With mental health problems like depression, addiction, and anxiety often resistant to treatment, a growing number of pharmaceutical companies are testing mind-altering drugs.
MDMA research got the nod from the FDA in 2017 when it was granted “breakthrough therapy” status, which allowed experiments to be fast-tracked.
In the UCSF trial funded by Lykos, patients received MDMA as part of an intensive, four-month course of talk therapy lasting more than a dozen sessions, of which three involved taking the drug. By the end of one study, 86% of people in the MDMA group improved and 71% no longer met the criteria for a PTSD diagnosis. Of those who took the placebo, 69% improved, and 48% no longer qualified for a PTSD diagnosis.
But in criticism that could pose a major obstacle to approval, FDA’s staff analysis said there are flaws in the study because it was not truly “blinded.” Participants and therapists were able to figure out who got MDMA versus the placebo.
Still, retired Army Sgt. Jonathan Lubecky, who lives in Washington, D.C. and was a trial participant, is convinced. After a year in Iraq, loud noises and people wearing backpacks triggered flashbacks, and he regularly woke up from nightmares in a cold sweat. He tried to take his own life five times between 2006 and 2013.
MDMA tamed his symptoms. “I thought it’d be fun to do and it might help for a month or two,” said Lubecky, 45. “I was wrong. It’s a f—— miracle.”
There will be future chemical changes that improve the product, said Lykos spokesperson Caroline Rigdon. This means that a patent for the drug, once a symbol of the counterculture, is now on the horizon — protecting and extending corporate exclusivity.
The world of psychedelics is no longer charity, said Doblin.
“Once you have investors, then you have to balance the return to shareholders,” he said. “We cleared the way to the FDA.”
