Funders at Johns Hopkins Shape The Future of Psychedelic Research
By any measure, Matthew Johnson is one of the most influential scientists in the world of psychedelics. He is a professor of psychiatry and top researcher at Johns Hopkins Center for Psychedelic and Consciousness Research, the leading psychedelic research institution in the U.S., where more than 40 physicians, psychologists, social workers, guides and support staff are conducting five clinical trials and preparing to begin six more. Johnson leads the team of researchers that last year secured the first government grant in more than half a century to investigate the therapeutic benefits of a classic psychedelic.
Johnson has soft power, too. His research has been widely cited. He writes broadly about psychedelics, exploring such topics as safety guidelines for hallucinogen research on humans and the pitfalls of psychedelic medicines. He speaks frequently and often eloquently. As the Susan Hill Ward Professor in Psychedelics and Consciousness, he also holds what is thought to be the world’s first endowed professorship with psychedelics in its name.
Yet Johnson’s influence is limited in one crucial respect. He cannot, on his own, set the scientific agenda for the psychedelic studies center at Hopkins. Johnson’s got a strong voice, of course, but for the most part the center’s investigations – like research into psychedelics underway at other institutions – is shaped by donors. These donors, including companies who are seeking to own the intellectual property generated by research conducted at Hopkins, have a lot to say about what the future of psychedelic science will look like.
Until recently, philanthropists paid for virtually all of the research into psychedelics. These days, Johnson pursues corporate and government funds as well. “A huge part of the job is hustling up money,” says Johnson.
Faculty and donor interests must align for work to go forward. Johnson’s Hopkins colleague, Albert Garcia Romeu, an assistant professor of psychiatry, notes that funders directly impact the direction of scientific inquiry. “Whoever the money is coming from is going to shape the science,” says Romeu. “Whether that be the government or philanthropy or business, everyone’s got an angle. There’s a lot to chew on about all this.”
Agreements between funders and research organizations not only shape what scientists examine; they also impact how the raw data from psychedelic research is shared. Some scientists support the release of this information into the public domain. Other researchers, who embrace corporate funding, are sometimes hesitant to sign agreements that limit the ability of potential patent holders to control these findings.
Philanthropist Bob Jesse, whose nonprofit Council on Spiritual Practices has financed research at Hopkins since the early 2000s, has circulated a Statement on Open Science, published in December 2017, calling on researchers to develop psychedelics “for the common good and to share freely whatever related knowledge we may discover or develop.”
The statement says that if supporters have patents or patents pending, they will license that intellectual property for no more than administrative costs “to anyone who will use it for the common good.”
Luminaries in the field – Ram Dass, Ralph Metzner, James Fadiman, Ann Shulgin, Rick Doblin and others – signed the document, as did eight Hopkins researchers and dozens of scientists including Roland Griffiths, the founding director of the Hopkins center. Johnson’s name is conspicuous by its absence. He did not respond to a request for an explanation but said later, on Twitter, that he doesn’t think psychedelics needs its own set of ethics.
Funders Set Research Agendas
Some critics worry that for-profit corporations exercise too much control over what scientists choose to investigate. There’s great need for basic research into psychedelics – precisely how and why they act on the brain is not well understood – but industry tends to “prioritize lines of inquiry that focus[ed] on products or activities that can be commercialized,” say the authors of a survey of industry research across different fields published in 2018 in the American Journal of Public Health.
“The biggest threat to academic freedom may be the influence industry funders have on the very first stage in the research process: establishing research agendas,” says Lisa Berow, a study author who is a professor at the University of Sydney and an expert on research integrity.
Given the limits of philanthropic funding and the intense competition for government grants, however, partnerships between corporations and universities like Johns Hopkins are increasingly important. Dozens of startup companies are now seeking to develop psychedelic medicines in a market which has received almost $2 billion in capital in the last two years. This funding is expected to speed up the process of gaining regulatory approval for psychedelic therapies, while adding to the storehouse of knowledge about these substances.
“You have an emerging psychedelic startup industry with billions of dollars of investment,” Johnson says. “That’s going to turn into both good and bad. It’s upping the ante.”
Tim Ferriss, the author and podcaster who organized a group of private donors to give $17 million to launch the Hopkins center in 2019, says he welcomes follow-up funding from business so long as the science is spread widely.
“Right now,” says Ferriss, “researchers tend to need to choose between smaller checks from independent philanthropists or corporate-sponsored research that comes with a lot of strings attached but tends to offer more money. The latter can sometimes be short-term easy and long-term problematic. There’s definitely an important role for market-driven solutions, but my hope is that seven-figure federal and state-level funding will be more forthcoming soon and provide a viable third option.”
Griffiths agrees that getting psychedelic therapies to market requires support from a range of funders. “Undertaking Phase 3 trials (the final set of studies needed to gain FDA approval) is a hugely expensive effort and that needs to be driven by groups other than ourselves.”
Johnson, 47, who has a PhD in experimental psychology from the University of Vermont, joined the faculty at Johns Hopkins in 2004, a decade before the arrival of what’s now called the psychedelic renaissance. Johnson recalls that at the time, money was scarce. “We basically limped along for a number of years,” he says.
Jesse’s Council on Spiritual Practices funded the landmark 2006 study that found psilocybin can reliably lead to mystical-type experiences with deep meaning. “Something you can schedule for next Thursday may be one of the most meaningful experiences of your life,” says Johnson. These findings laid the groundwork for the research into psilocybin that followed at Hopkins.
Pioneering donors including Ferriss, Jesse, businessman Carey Turnbull, T. Cody Swift of the Riverstyx Foundation, and the nonprofit Heffter Research Institute were indispensable in the early years of psilocybin research. “These are the people who have been keeping the flame alive through the darkest years,” Johnson says.
While scientific research into the psychedelic properties of LSD stretches back to the early 1940’s, there was scant interest in psilocybin from business or government. A small grant from the National Institute on Drug Abuse (NIDA) did help fund the 2006 psilocybin study as well as Griffith’s subsequent work.
Funding A Pivotal Smoking Cessation Study
To gain perspective on how the increase in funding for psychedelic research has influenced the process of scientific inquiry, consider the research led by Johnson into the question of whether psilocybin-assisted therapy can help tobacco smokers quit. This inquiry is arguably the most important work underway at the center. According to the Centers for Disease Control and Prevention, cigarette smoking remains the single largest cause of preventable death in the U.S., causing an estimated 480,000 deaths a year.
Johnson began studying smoking as a graduate student. He has published 20 scientific papers on tobacco, including an online survey of smokers who reported quitting after taking psilocybin or LSD. In the late 2000s, the UK-based Beckley Foundation and Heffter funded Johnson’s open-label pilot study of 15 longtime smokers who tried to quit with cognitive behavioral therapy and three sessions of psilocybin. Twelve of the 15 smokers quit and remained abstinent six months later – a success rate that far exceeds those of conventional quit-smoking interventions.
That initial study grew into a randomized clinical trial to compare psilocybin-assisted therapy with nicotine replacement therapy, a popular approach to quitting smoking. Preliminary results from that trial, which will involve more than 100 longtime heavy smokers, show that 59 percent of the first group of participants quit and stayed off cigarettes for at least a year. These are unprecedented numbers for a quit-smoking intervention. “I’m super-excited,” Johnson told a crowd at the Horizons 2021 conference in New York.
Heffter provided the vast majority of the money for those two studies, providing $885,000 in funding to Hopkins. Heffter operates as a middle man, raising money from others to support its own research into psychedelics and to fund the work of academics, including scientists at Hopkins, New York University, and Yale University. Riverstyx Foundation, which has supported seven clinical trials at Hopkins, was the leading donor to Heffter for the tobacco work.
Heffter’s only mission is to advance science, says George Greer, Heffter’s co-founder, board chair and former medical director. But neither Heffter nor Riverstyx had the cash to take the tobacco research to the scale required by the FDA, which will ultimately decide whether to approve psilocybin-assisted therapy as a treatment for tobacco use disorder.
Last October, Johnson and colleagues at the University of Alabama, Birmingham, and New York University secured nearly $4 million from the National Institutes of Health to fund a three-year psilocybin and tobacco study at all three institutions. In a statement, Hopkins called it “the first NIH grant awarded in over a half century to directly investigate the therapeutic effects of a classic psychedelic.” The study will test the same combination of therapy with two doses of psilocybin that showed promise in the smaller trials.
Greer notes that Heffter played a critical role in moving the scientific inquiry into psilocybin forward until the NIH funding was granted. “That never would have happened without the research we supported,” he says.
In August 2021, Mydecine Innovations Group, a small, publicly-traded biotech company, announced a five-year funding agreement with the Hopkins center. Mydecine agreed to support a 20-month clinical trial to expand Hopkin’s smoking cessation study combining therapy with a single psilocybin experience. This proposed treatment which includes just one session is less expensive than the NIH-funded study which planned to include two psilocybin experiences in its protocol. Mydecine will also work with Hopkins to investigate other mental health treatments using psilocybin.
Mydecine touted the deal to investors in its most recent earnings release, while reporting that it had just $1.6 million in cash on hand. Hopkins and Mydecine declined to say how much the company has committed over the five-year agreement, but Joshua Bartch, Mydecine’s CEO, said it is in the “single-digit millions.” The company is losing money and needs to issue more shares to stay alive, Bartch said
Bartch is confident that the research will pay off for investors. “Smoking is the largest market of all addictions, by far,” he says. Sales of Chantix, an anti-smoking pill, topped $1.2 billion a year before Pfizer stopped producing it last year because of health concerns. “We’re definitely the front-runners for tobacco cessation,” says Bartch.
Mydecine’s IP Agreement With Hopkins
In an effort to stay ahead of potential competitors, Mydecine will “own all of the data and IP (intellectual property)” from the research it is funding, Bartch explains. Johnson, Garcia-Romeu and their colleagues will publish their findings, but the underlying data needed for the FDA to approve psilocybin as a medicine is not in the public domain.
What’s more, while the Mydecine-sponsored trial will use conventional psilocybin, the company is also developing a proprietary tryptamine compound, dubbed MYCO-004, that has a more rapid onset and a shorter duration for which it will seek a patent.
As the findings from the Hopkins study will be owned by Mydecine, the company could have a period of exclusive use for this therapy and, if approved by the FDA, could license it to others at a rate they choose. Does the Mydecine-Hopkins deal violate the Open Science principles?
“We will not withhold, nor will we require others to withhold, materials or knowledge (experiences, observations, discoveries, methods, best practices, or the like) for commercial advantage,” reads the agreement. “This does not preclude the appropriate management of raw data or the exercise of data exclusivity rights, but we will make those decisions for the common good rather than for private gain.”
Limiting Access to Research Data
In addition to Mydecine, two other companies are funding research at Hopkins. Love Pharma, a Vancouver, CA-based firm that “specializes in mental health and sexual wellness by licensing and distributing psychedelic and hemp–infused products,” is sponsoring a trial led by Garcia-Romeu into psilocybin-assisted treatment for cannabis use disorder. Love Pharma did not respond to emails seeking comment.
“Whatever the study outcomes are, we will publish them in a peer reviewed journal,” says Garcia-Romeu “Hopkins owns the data and will share those with the sponsor, but likely not share them outside that besides our published findings. This is typical for industry-sponsored trials.”
PharmDrug, a Toronto-based company, last year announced an agreement with Hopkins to study the subjective and neural effects of DMT in healthy people. Fred Barrett, an associate professor of psychiatry, will lead that trial.
Daniel Cohen, the company’s chief executive, said during an interview with a web-based business program that the company wants “to understand the biochemistry of how DMT works” and expects to own the IP from the study. The clinical trial will not focus on a particular disease, but Cohen said that “whatever we come up with at the end, we’re obviously going to have the first rights to that IP.” Neither he nor Barrett responded to requests for further information.
Some companies, such as Compass Pathways, say that they are serving the common good by financing scientific research and the costly process of seeking FDA approval. They argue that patents allow them to control a sector of a market for a certain period of time – and therefore lure investors who give them the funding to make emerging therapies widely available. “Without IP,” reads the Compass website, “there would be little incentive to take the risk to fund the research and development of new products, given the large number of drug candidates that fail during the development process.”
Other investors say that patents, such as those claimed by Compass, can skew or stifle research and innovation. Carey Turnbull, a philanthropist and former corporate executive who signed the Open Science document, has become so concerned about patents in the psychedelic sector that he formed the nonprofit Freedom to Operate to challenge overly broad patents. So far, Freedom to Operate has challenged patents from just one company, Compass Pathways.
“Publishing a study doesn’t mean it is in the public domain,” Turnbull says. “The secret, quote unquote, is the raw data.” An exclusive license to the raw data gives a company a head start in developing a drug.
Then again, as Turnbull knows, philanthropists also can help steer the direction of scientific research. He donated to Hopkins to support research into anorexia nervosa after a friend’s daughter suffered from the disease. Natalie Gukasyan, a psychiatrist at the center, is leading a clinical trial testing psilocybin-assisted psychotherapy for anorexia.
It’s also surely no coincidence that the Hopkins center will study the effectiveness of psilocybin to treat what’s now called post-treatment Lyme disease syndrome. The Steve and Alex Cohen Foundation – he’s a hedge fund billionaire and the owner of the New York Mets, she’s the foundation president and someone who suffered from Lyme disease – is the largest private funder of Lyme and tick borne disease in the country. The Cohen Foundation is also one of the largest funders of psychedelic research. The foundation donated half of the $17 million grant that endowed the Center for Psychedelic Medicine and Consciousness.
Meanwhile, Jesse’s Council for Spiritual Practices has underwritten a study on psilocybin and religious professionals. “Not infrequently, people use spiritual or religious terms to describe their experiences with classic psychedelics,” he explains. “In the religious leader study, people from a variety of faith traditions draw upon their rich expertise to more fully characterize their psilocybin experiences. We hope the study will shed new light on such experiences, how they might be helpful, and their risks.”
If Hopkins scientists had unrestricted money to fund their work, would they have chosen to study anorexia, Lyme disease and religious professionals? Universities, even those with large endowments, generally do not pay for faculty research, although they will share costs when required to by donors. Nor does the government give scientists unrestricted money, except under the rarest of circumstances.
Many researchers expect that more government funds will be forthcoming. The National Institutes of Health in January held a two-day workshop on psychedelics, signaling its interest. “I have no doubt that’s going to grow,” Johnson says.
Corporate money will also play an increasingly larger role, as large pharmaceutical companies engage with psychedelic therapies, as Johnson & Johnson has done with its Spravato ketamine treatment. From the perspective of mainstream drug development, getting psychedelic medicines to those in need will require working within the U.S. healthcare system and with the FDA.
As the science of psychedelics continues to be driven by access to funding, there is little doubt that investors will continue to fund companies seeking to control access to the data – and ultimately market share. “It’s very idealistic to say that psychedelics should be free for everyone,” says Turnbull. “Well, they’re not going to be free. Money will change hands. Fortunes will be made.”