Last year, Arizona became a leader in psychedelic research for treatment for things like PTSD and pain management when the Legislature allocated $5 million to research whole mushroom therapy. The Scottsdale Research Institute and the University of Arizona will carry out the studies once they get FDA approval.
But, just last week, the FDA declined to approve the psychedelic drug MDMA for treatment of PTSD, requesting more research be done. It was seen as a major setback for advocates who said approval would have been a potential breakthrough moment for psychedelics into mainstream medicine.
Dr. Sue Sisley is one of the researchers who sees the potential in psychedelics, and she doesn’t see it as a setback. Sisley is president and principal investigator of the Scottsdale Research Institute and, she told The Show, she thinks it should make people like her work harder to do this kind of research right.
The Show spoke with her recently about where her state-funded research stands — and what’s next for psychedelic treatment.
Full conversation
DR. SUE SISLEY: We're hoping to understand more about how natural psilocybin mushrooms work because what's happened is there's a ton of hype around psilocybin in general. But if people look closely at the studies, they'll see that they're actually just studying one molecule out of this very complex mushroom that actually is loaded with dozens of different alkaloids and tryptamines that all are exerting different effects on the human body.
So we wanna the real world mushrooms that people are actually using underground and be able to learn more about how they work and don't work. So we're gonna be publishing both the good and the bad about these mushrooms, which is different than big pharma studies. A lot of people are not aware that there's never been a single study anywhere in the world, looking at whole natural psilocybin mushrooms.
There's a lot of enthusiasm around psilocybin as a potential medicine, and you saw we even passed a bill in the Legislature this last session that would have created a treatment program around psilocybin. But it's a little premature because we still don't have any initial data on how natural psilocybin mushrooms affect humans.
LAUREN GILGER: OK. So that's where your research fits into all of this. Do you have any preliminary results? Obviously, you must think this is promising to be doing this kind of research. And I know you've done research on the same kind of effects for cannabis in the past. What are you seeing? What are your hopes?
SISLEY: Well, we hope that we'll be able to understand more about how this can work for treating both pain and trauma like post traumatic stress disorder. So our study is going to be specifically looking at patients with life-threatening illness.
These studies actually usually take years to get approval, and I'm hoping that the FDA will feel the amount of public pressure and enthusiasm around psilocybin and hopefully move more quickly to green light this study by the end of the year.
GILGER: But there was just a setback in this, right, just late last week, the FDA rejected MDMA, one of these psychedelic drugs for PTSD treatment, saying they need to see more research. It was widely seen as a pretty big blow to, you know, people who are pushing for this to be legalized and studied. It would have been a pretty breakthrough decision if the FDA had allowed it, it sounds like. Tell me your reaction.
SISLEY: Yeah, I think the biggest concern is that there was a lot of overhyping of MDMA and psychedelics in general. And a lot of people when they talk about MDMA are often omitting the risks of these drugs.
And so we have to get back to the rigorous science. We need to be humble and really try to dig into the design of the studies and make sure that they're properly organized in a way that will appeal to the FDA and show them that we're doing the highest kind of gold standard controlled trials and there's no sloppiness.
I, I think the reality is that this fight, you know, this psychedelic movement is not just a scientific battle, but it's also a cultural and political struggle. You know, people fear what they don't understand. And I'm a neutral scientist. I don't have any dog in this fight. I, I just want to see good data collected and published and, you know, go through peer review and, and make sure that we're putting forward the most accurate information for the public to scrutinize.
I, I'm hoping that this doesn't deter people. This decision should actually enliven the research and motivate us to double down and be even more fervent about doing good quality research that is reliable and hopefully that that's what you're going to see going forward. This is really generational work, you know.
GILGER: Let me ask you about the, the downside there, like the risks that the, the concerns that people have and that the FDA panel that led up to this rejection of this MDMA treatment had. Like they talked about things like abuse of the drugs, heart problems, injury. What are the risks involved from your point of view, at least based on what you've seen in your research?
SISLEY: Yeah. Well, the cardiac risks were not fully vetted. So that is something they need to explore more intensively in these next trials. Certainly, anytime you go under a drug and you're being guided by a therapist, you have to hope that that therapist is ethical and not a predator and it's very difficult when you're dealing with human beings, you really don't know how they will behave and we hope that people will adhere to the proper, you know, professional standards. But it, it is very concerning.
And so I'm hoping in these next rounds of studies on psychedelics that we will find ways to minimize the role of the therapists when people are under the influence of these medicines, because people are very vulnerable during that time and they can be put in harm's way by bad actors. But yeah, it's bottom line, though, is all drugs, all medicines, even the ones that are FDA approved, all have risks and benefits.
These psychedelics clearly have great medical potential, but we have to learn to harness them and minimize those side effects or threats and and to, to enable them to finally be legally available on the market.
GILGER: So let me ask you about the big picture here, which you mentioned a little bit earlier as well. But I mean, in terms of these broader efforts by researchers, like you, who believe in the potential of these kinds of treatments, like where do you think we are especially given this most recent FDA decision, like where do you think we are in terms of getting psychedelics into the medical mainstream and using them for the potentials they may be, you know, really helpful for?
SISLEY: Well, I think the best laboratories we're seeing are the States. You know, you're already seeing Oregon’s psilocybin program underway for a year and they've treated over 5,000 patients and it seems to be fairly successful. Although sadly, they never implemented a registry to actually document the good and the bad of that program. So that was a, a huge mess.
But luckily the Colorado program is about to go live in January, and I happen to sit on the State Commission in Colorado that's building the regulations around that program. And I can tell you that that is a very comprehensive solid framework that I think other states will want to emulate.
Luckily, the philanthropists are not waiting for the government to step in. We're seeing a lot of charitable donations coming into various universities and nonprofit organizations to start conducting the work because they know it's gonna take time for the government to step forward.
But that's what's so impressive about Arizona authorizing this funding. You know, in the face of a huge state budget deficit, these elected officials chose to still stabilize that $5 million to be able to be the first state in the country to conduct naturals suicide and mushroom research. And I think that is so commendable that our state sees the potential of this medicine but also wants to lead with the science first rather than creating some kind of state marketplace prematurely.
