Last updated: 13 เม.ย 2563 |
PUBLISHED : 13 Apr 2020 - 10:34
Dr. Sue Sisley is leading the next generation of cannabis medical science, taking the fight directly to the FDA and DEA to help cut through the red tape that hinders research.
In order for a drug to get FDA approval, the data on said drug’s effects must be reviewed by the Center for Drug Evaluation & Research (CDER) and the drug must be determined to provide benefits that outweigh its known and potential risks. Now, what if research is impeded by a variety of governmental red tape? That is exactly the case with cannabis. And this is where Dr. Sue Sisley comes in. Dr. Sisley, a trailblazer in cannabis research, has been working for 14 years to push cannabis flower through the FDA drug development process – and has been hindered nearly every step of the way.
As one of the few scientists in the country holding a DEA Schedule 1 researcher license, Dr. Sisley has an intimate knowledge of not only cannabis science, but the steps it takes to conduct this kind of research. In this exclusive interview, Dr. Sisley discusses how she is helping cannabis research progress, how she’s motivating young scientists to embrace this field, and what the industry can do to help.
Cannabis & Tech Today: How did you get involved in cannabis research?
Dr. Sue Sisley and her trusted research assistant, Dodger. (Courtesy of Dr. Sisley)
Dr. Sue Sisley: I always end up crediting military veterans because they shared their personal experiences with cannabis for years in my medical practice, and I was super skeptical. My thinking was so blocked at that time because I had been trained in a really conservative medical environment where you don’t distribute anything as a medicine unless it’s been put through the FDA drug development process. I had only been taught that cannabis was dangerous, addictive, and should be avoided.
So, it was tough for me to embrace the idea that this plant was a medicine and these veterans just never gave up on me. They kept coming back; they’d bring in family, friends who would corroborate their story, and I just couldn’t ignore it anymore. Over time, I realized there has to be something here…
I don’t know if you’re aware, but there has not been a new treatment for PTSD approved in 18 years. So since Paxil and Zoloft initially got approved, nothing else since then. And so, all these other meds that we use to treat PTSD are all just being used off label and they’re mostly very disappointing.
But I was interested in cannabis not just for PTSD, but also for treating pain, and as a substitute for opioids and other addictive meds. But again, it took me a long time to get motivated enough to actually start doing clinical trials.
It was only when I met the people at MAPS – MAPS is a non-profit based out of Santa Cruz – and that was when I really got inspired, or enthusiastic, about doing trials because MAPS offered to be my study sponsor and to help me navigate all the barriers to research.
That’s what I needed, because I was a clinician. I mean, I’m seeing 20 patients a day in clinic. I wasn’t a traditional researcher. But when MAPS teamed up with me, I suddenly had the ability to start looking at this.
That’s when I started to develop a firsthand knowledge about the barriers to efficacy research in the U.S., and that spurred me on to start questioning our government and realizing that we’re not going to be able to have meaningful reforms in the cannabis space until we have more data. Yet, the data that’s needed to look at cannabis as a medicine, that research has been systematically impeded by our government for so many decades, really ever since the night a monopoly was created.
Back in 1968, they made University of Mississippi the only federally legal drug supply for all clinical trials. And as soon as that monopoly was created, I think that really was the final nail in the coffin for being able to study cannabis as a medicine because scientists need access to options. That’s the whole point. And when you only have one domestic supplier, you’re suddenly limited … So we were forced to buy this moldy, diluted cannabis, this plant material from University of Mississippi through the National Institute on Drug Abuse (NIDA).
All the clinical trials looking at cannabis flower have been forced to use this substandard or
sub-optimal plant material. And now, I’m starting to question whether all of these clinical trials may have been sabotaged by this low-quality study drug.
So that’s why I started to try to ignite a national conversation… 2009, I think, is when we first submitted the study design to FDA. It was really in 2011 that we got FDA approval. It still took us eight years after that to complete the trial. Can you believe that? So that just shows you the ridiculous, redundant layers of government red tape that are involved in approving cannabis research. But it’s not that way for safety studies. If you’re just looking at the harmful effects of cannabis or addiction potential, those studies get easily greenlit. They get almost unlimited government funding and government cannabis.
But, if you dare say you want to study efficacy of cannabis, and do non-profit drug development research to help evaluate cannabis through the FDA process, those are the studies that have been impeded by the government for so long, and will continue to be impeded until this monopoly has ended.
The monopoly doesn’t exist for any other drugs in Schedule 1. So the other drugs in Schedule 1 like mushrooms, LSD, MDMA, all of those, you can easily access those. It’s only cannabis that has this bizarre situation where it’s the least toxic of all the drugs on Schedule 1, but it has the most ridiculous, harshest barriers to studying it as a medicine.
C&T Today: What has to happen for the monopoly to be dispersed, for the barriers to come down, and for cannabis research to become more accessible?
Dr. Sue Sisley: There are two options we have. Everybody assumed that the monopoly was ended in the 2016. Remember, the DEA announced that they would finally license other growers for research? This was an official announcement on the Federal Register. So you see all these people applying to become growers for research. But sadly, here we are, three years later, and they still haven’t moved one inch toward licensing other growers.
The only real solution at this point is getting a remedy through the court system because we were one of the, I don’t know, 30-plus applicants that submitted back in 2016, and they processed my credit card for a $3,000 application fee, but they never processed my application. And so, what they’ve done, effectively, is they kept us in this limbo where we can’t even appeal it because they haven’t made a decision; there’s nothing to appeal.
So, the lawsuit is one strategy, but there’s another option that I have, which is to import cannabis flower from a foreign country. That was really my last resort because I want to push our government to legalize other domestic growers. I’m not interested in supporting the companies in other countries. That doesn’t make any sense. We have all these talented farmers right here on our soil that could easily be providing high quality flower for study drugs.
But the government has blocked this. And so, now, they’re forcing U.S. scientists to go source cannabis from other countries, and you see that many of the universities have announced this. UCSD just announced they’re importing cannabis oil from the Canadian companies.
The point is there are others who brought in oil and extract, but the monopoly is around flower. So nobody has brought in the dried bud material. And that seems to be the real impediment here. They’re comfortable with pills, and extracts, but they don’t want the flower.
The question is, can they block it? If we have an approved clinical trial in the U.S. and we have a source of flower from Canada or Israel, it’s going to be impossible for the DEA to block that. You can see that if we succeed, then suddenly, we’ve ended the monopoly, and we’ve opened the door for all these other foreign manufactures to come in.
C&T Today: You’re one of the only female scientists in the country studying whole plant flower as medicine. How can we get more women into the cannabis science space?
Dr. Sue Sisley: I think that’s our main purpose… Outside of just being able to do the trials with whatever study drug we choose, it’s also being able to pave the way for young scientists, or emerging scientists, to put their toe in this field, because right now, I can’t persuade any. I allow medical students, undergrad, even high school students to rotate to our labs so they can see how this works and how this is real science. This is no different than any other pharmaceutical company trial, just as rigorous.
But right now, it’s so hard to get them excited about it because even though they care about this work, they don’t see any funding behind it. And we all know that these trials are so expensive and scientists migrate to where the funding is, and if there’s no government money to study cannabis as a medicine, what are they going to do? They’re going to study what government money is available, to study cannabis as a drug of abuse.
So, when you say, “What do we do?” We’re trying to make our laboratory, these studies, available, mentoring young students at all levels, from high school to medical school, and seeing if we can persuade them to come to the lab to get exposed to this early in training so maybe they can gain a passion for it. And whether there’s easy money available or not, they may still pursue it just like we did.
C&T Today: Over the years, how have you seen the medical community’s view of cannabis change?
Dr. Sue Sisley: Well, the medical community, privately, will tell you that they realize that cannabis does have medical properties and it should be employed, especially over more addictive prescriptions. But they won’t say that publicly because they’re so afraid of a backlash on their medical license or their ability to get federal funding for Medicaid dollars, or Medicare.
Whether it’s physicians or hospitals, they still seem to recoil at the word cannabis, unless they’re talking privately. Everybody’s trying to avoid this. So that’s why I focus on the control trials, because that’s our only hope.
Randomized control trials are the only thing that will help change public policy because if we can get flower through the FDA process, that will be the biggest game changer. That will force insurance companies to have to pay for flower in the same way they pay for conventional pharmaceuticals. So, that’s why we’re so committed to this, because right now we see so many cannabis patients impoverished just trying to buy their monthly medicines in addition to whatever other conventional meds they have to pay for.
C&T Today: If cannabis still has so much stigma, what can the industry do to add more validity to cannabis research?
Dr. Sue Sisley: What happens is we have a lot of people in the industry that claim to care, but don’t really want to do anything, or offer any financial support. A lot of these companies have tons of financial resources; they’re not just startups anymore. These companies are swimming in millions of dollars, some of them, and they could easily be funding the type of clinical trials that would help. I mean, they’re not going to have validity until they invest in the control trials that are needed to confirm cannabis is a medicine…
Otherwise, it’s just a movement, and if we’re going to change that and really get insurance companies to cover it and all that, we have to have the randomized control trials, and eventually the FDA approval for certain products, and then things will start to change. But until then, this will just continue to be a dynamic movement.
I do a lot of speaking in foreign countries, so I’m seeing the blockades to patient access. I mean, I was in Australia a few weeks ago teaching a CME course to physicians about cannabis, trying to teach them how to prescribe, and you can’t believe that these folks, they’re in a federally legal country and they still don’t want to come near it. There are probably several million patients in Australia that are already using cannabis. And the point is, how do you get them into a regulated market? It’s not going to be possible with all these barriers and they’ll remain on the illicit market until they see that it’s safe or that it’s not so complicated anymore. And so, that’s the reality.