At a pivotal moment for psychedelic medicine, a challenge for philanthropy
MDMA, the man-made drug often called ecstasy or molly, has a colorful history. It was patented in 1914 by the German drug company Merck, and set aside for decades. The US Army studied it during the Cold War, perhaps seeking a chemical weapon or interrogation tool. Alexander “Sasha” Shulgin, an iconoclastic chemist, rediscovered MDMA during the 1970s and gave some to a psychotherapist friend, who in turn shared it with hundreds of therapists around the world; some called the drug “Adam” because it returned patients to a more innocent state. Only after MDMA gained popularity as a party drug did the US Drug Enforcement Administration ban it in 1985, declaring that it had no medical use and a high potential for abuse.
Now MDMA is on the verge of making history again — as the first psychedelic drug to become available as a prescription medicine.
First, though, the Multidisciplinary Association for Psychedelic Science, a nonprofit seeking to develop psychedelic medicines, must raise about $7.5m by September as part of what it calls the MAPS Capstone Challenge. The funds are needed to unlock a challenge grant of $10m and to complete a final round of clinical trials, now underway in the US, Canada and Israel, that are designed to demonstrate that psychotherapy assisted by MDMA is safe and effective for the treatment of post-traumatic stress disorder (PTSD).
All signs from the FDA have been encouraging. MDMA-assisted therapy was granted “breakthrough” status in 2017, which means that it has substantial advantages over existing treatments for a serious or life-threatening condition. In March, an interim analysis found a 90 percent or greater probability that MAPS will generate statistically significant results from the first of its two Phase 3 trials. In the world of pharmaceutical drug development, “this is what you dream about,” said Rick Doblin, MAPS’ founder and executive director.
FDA approval, which could come in 2022, is important for two reasons. First, MDMA-assisted therapy will almost surely bring relief to millions of people suffering from PTSD: Military veterans, victims of sexual assault, first responders, perhaps even doctors or nurses who today are treating COVID patients.
Second, FDA approval of MDMA will open the door for other psychedelic drugs, particularly psilocybin, that, when combined with talk therapy, can alleviate the suffering from a remarkable range of mental ailments, including depression and anxiety.
Tim Ferriss, the author and podcaster, donated $1m of his own money and put together the $10m challenge grant with Joe Green, the co-founder of the Psychedelic Science Funders Collaborative. On a podcast with Rick Doblin, Ferriss acknowledged that the FDA’s approval is not a sure thing, but said the upside could be enormous:
There are some risks but the asymmetric risk-reward is just incredible. If you have MDMA reclassified, the ice is broken for a dozen other things, for the entire field, for the entire industry. If you are interested in any of these other compounds like psilocybin, as I am…you have to be interested in the outcome of this Phase 3 trial of MDMA. It’s going to be the precedent setter.
Doblin agreed, saying:
“What a lot of people don’t realize is that MDMA was a therapy drug before it became a party drug under the name Ecstasy. I think it will become one of the most widely used psychedelics once we make it into a medicine.”
“MDMA is just an exquisitely perfect chemical for augmenting the process of psychotherapy….It allows people to be more open and vulnerable and also to feel strong enough and calm enough that they can really explore their traumas, that is incredibly helpful for the field of psychiatry. We’ve never had anything like this before.”
MAPS is also pioneering a new pharmaceutical model: It plans to deliver the treatment through the MAPS Public Benefit Corporation, which is chartered to put the public interest first and required to return any profits to the parent nonprofit.
This would appear to be a compelling opportunity for philanthropy. The suffering is widespread. There’s clear evidence that psychedelics can help. There’s a pathway to success through the FDA. And few philanthropic dollars flow into the cause. Funding research into psychedelics requires taking a risk, but that’s what philanthropy — often called society’s “risk capital” — is supposed to do.
Yet major foundations, with a couple of exceptions, have declined to support psychedelic research. Good Ventures, the giving arm of Facebook co-founder Dustin Moskovitz and his wife Cari Tuna, who are guided by the principles of effective altruism, has given about $1m to MAPS. The Steven & Alexandra Cohen Foundation, which is funded by a Connecticut hedge fund billionaire, contributed $5m to the MAPS Capstone challenge grant and previously supported research into psychedelics at Johns Hopkins University.
“Not a penny from the VA”
The Cohens have long been funders of groups that support military veterans. More than 1 million veterans with PTSD get disability payments from the Veterans Administration, at a cost of billions of dollars a year. More than 6,000 U.S. veterans committed suicide every year from 2008 to 2017, the most recent year for which a count is available.
Even so, the VA has declined to support research into MDMA. So has the National Institute of Mental Health, which supports basic research into how drugs work, but not drug development studies.
“We have tried the traditional sources of funding and it has not worked,” Doblin says. “We have not been able to get a penny from the VA.”
So who has stepped up?
The Psychedelic Science Funders Collaborative (PSFC), a group of about 30 well-to-do donors organized in 2017, is composed of entrepreneurs and investors, most based on the west coast. Some have personal or family experiences with addiction or depression. Most are interested in mental health and consciousness, open to new ideas and eager to challenge convention.
MAPS calculated that it would need about $30m to complete the clinical trails and begin to commercialize MDMA. To reach that goal, MAPS first raised $10m from board members and longtime donors. They include David Bronner of Dr. Bronner’s, the natural soap company, which previously made a $5m pledge, and Genevieve Jurvetson, the co-founder of artificial intelligence startup Fetcher, who has committed $3.4m. Some but not all their donations will go to the work on MDMA.
Jurvetson attended a fundraising event organized by PSFC with Michael Pollan, the author of How to Change Your Mind, and met Doblin and Ferriss, among others. She says there’s growing interest in psychedelic medicines in the Bay Area.
“A lot has changed, culturally,” she told me. “I really credit Michael Pollan’s book. I believe it’s now our duty to talk about the incredible potential of these therapies.” Her husband, Steve Jurvetson, through his firm Future Ventures, is an investor in Atai Life Sciences, a biotech company that invested in Compass Pathways, a UK-based firm that is developing therapy assisted with psilocybin as a treatment for depression.
Then, Ferriss and PFSC’s Joe Green put together the $10m challenge grant in just a few days. They enlisted James Bailey, the founder and managing partner of Bail Capital ($1m), Peter Rahal, the founder of RxBar ($1m), Blake Mycoskie, the founder of TOMS ($1m) and John Griffin, the founder of Blue Ridge Capital ($1m), along with the Cohen Foundation.
Since the Capstone Challenge was announced on Ferriss’s podcast on June 11, MAPS has brought in another $2.5m. Majors donors include Justin Rosenstein, a co-founder (with Dustin Moskovitz) of Asana, who wrote about his donation on Medium, and from George Goldsmith and Katya Malievskaia, the founders of Compass Pathways. The challenge grant expires in September, so MAPS has a little more than two months to raise the remaining $7.5m. That’s a lot for an organization that has raised about $80m since its founding in 1986.
But the times have changed. Thirty five years after the government banned MDMA, the drug is moving closer to becoming a medicine. For the millions who suffer from PTSD, that can’t come soon enough.