A funny thing happened the other day. Minutes after we published a look into the 50-year-old agreement preventing marijuana from treating post-traumatic stress disorder, the US Public Health Service approved an application from the Multidisciplinary Association for Psychedelic Studies to acquire research-grade cannabis to study the treatment of post-traumatic stress disorder in veterans.
It's a big win for Dr. Sue Sisley, the University of Arizona researcher we spoke with in the article; with help from MAPS, she's now one step closer to starting her study, which will measure the effects of five distinct pot potencies, both in smoked and vaporized form, in alleviating PTSD symptoms in 50 veterans. Approval from the Drug Enforcement Administration, which would seal the deal, is pending.
I caught up with MAPS' Rick Doblin, who's been advocating on the frontlines of psychedelic research for decades, about how it happened, what it all means, and where we go from here.
MOTHERBOARD: Why is this decision by the PHS a historical shift?
Doblin: We’ve been at this for 22 years, trying to start the research and trying to make the marijuana plant a real prescription medicine, in plant form. And since the last time, since the early 1970s, that marijuana was shown to be effective for nausea control in chemotherapy, the effort to try and make marijuana as a plant into a prescription medicine has dropped. We’ve had several protocols since 1992 onward that were FDA approved, IRB approved, but the National Institute on Drug Abuse, which has the monopoly on marijuana, refused to let it through.
For us, we’ve been working on it for 22 years. But for other marijuana advocates, it’s been over 40 years. I think what happened is that we have two states that legalized marijuana, we have 20 medical marijuana states, and finally it just got to be the point where blocking research was too difficult to defend. And it had all of these negative consequences, because we were pretty linked in with all these drug policy reform groups.
The decision has finally been made by the Obama administration, and it’s a massive step. So far it’s just us; everybody else has been discouraged. We’re looking forward to other researchers now trying to apply to do FDA-approved research as well.
What were the biggest previous protocols you attempted that were denied?
The first one was marijuana for AIDS wasting. That was in the early- to mid-90s, before the protease inhibitors came. A lot of AIDS patients were dying from AIDS wasting, and marijuana would stimulate appetite and they would eat more and survive longer. That was something that was really an important way to start the research, but we couldn’t.
The second study was marijuana for migraines. There was the historic fact that Queen Elizabeth used marijuana for migraines, there were a lot of people that used marijuana for migraines. We had an FDA-approved and IRB-approved study, but we couldn’t get the marijuana. Then I realized there were two prerequisites to breaking the code to trying to make marijuana plants medical. The first one was to break the NIDA monopoly and the independent source of supply. That’s why we can go forward with our MDMA research and our LSD research, or our psilocybin research. There are multiple private producers for everything except marijuana.
I realized we needed to break the NIDA monopoly but also get vaporizers approved for research. Vaporizers use the plant, but they’re a non-smoking delivery system. Then we had seven years that we tried to buy 10 grams of marijuana for vaporizer research and were rejected that way, and in 2001 we applied with Professor Lyle Craker at Amherst to get a license to grow our own marijuana, and that ended in 2013. Over 12 years and we lost in the appeals court, even though we won with the administrative law judge. We said it would be in the public interest for the NIDA monopoly to end. Now, we have been approved for this PTSD study.
I should make a point here, that our preferred approach for PTSD is MDMA. Because with MDMA and psychotherapy, you only have to give people the MDMA a couple of times and they can get to the heart of the problem. At the end of it, hopefully they don’t get MDMA anymore. Whereas with marijuana, it’s more about chronic dosing, and it’s more about symptom reduction than it is about cures. But at the same time that’s legitimate, and they [patients] prefer that and don’t want to do the painful work of having to work through MDMA. A lot of people that do the MDMA say ‘I don’t know why they call this ecstasy,’ because it’s working through grief and working through pain. Patients should certainly have options.
So, marijuana is a slower process of just treating the PTSD symptoms?
MDMA helps people deal with the fear that blocks them from processing the trauma in a different way, in a more fundamental way, than marijuana does. If your goal is to reduce the symptoms, marijuana is easier, faster and cheaper. People smoke and then they can sleep through the night, they don’t have nightmares, they’re able to focus more on the present, and they’re not as focused on what happened in the past. In our study, it’s not combined with therapy. Marijuana itself is the treatment. With MDMA, it’s MDMA in combination with the therapy.
Do you believe this study went through because of the pressure from states legalizing marijuana and such?
Yes, but not only that. The FDA for the last 20 years has been science over politics, and the FDA approved it, but the Public Health Service people rejected it for reasons that we consider to be bogus but also because of their perspective. These were reviewers that are used to reviewing grant applications that are from people that want federal money to do basic science, where the key is to try and understand how something works. When you do drug development research with the FDA, they don’t care how it works, you just have to show safety and efficacy.
The FDA is comfortable with pharmaceutical companies trying to do drug development, where how much certainty you get, how you size the studies, how you do your exploratory studies is a business decision. How much money do you want to spend on these studies? How much are you willing to risk? When you get approval from the FDA and then you go to these Public Health Service people, they have a different perspective, which is completely opposite. The PHS rejected it, and then we went to an Institutional Review Board in Arizona and shared with them all the reasons the Public Health Service rejected and our responses to that, and then the IRB approved our protocol as we had designed it.
They added a few safety measures, which we were glad to have, and so we resubmitted to the Public Health Service, and for them now to reject the protocol after the IRB had approved it the way we designed it, as well as the FDA, it would have been so blatant they were blocking us. The changing political dynamic played a major role, the major role. But also, we made it very clear that if they were objecting to it, then it wasn’t for scientific reasons. It was an arbitrary decision. Also, we chose veterans. There are a lot of people with PTSD, but there’s such a concern now in the United States about veterans.
The changing political dynamic played a major role, the major role. But also, we made it very clear that if they were objecting to it, then it wasn’t for scientific reasons. It was an arbitrary decision.
Do you foresee any problems with the DEA letting it go through?
You never know. The only thing that the DEA could object to is that this is a study that is what’s called an outpatient study. Meaning that people are given a weeks' supply of marijuana, which means a half ounce. People are given a half ounce to take home and do at home. We didn’t choose to hospitalize patients for three months, which is how long this study takes.
The DEA could claim that there is drug diversion possibility, with the outpatient nature of the study, but I don’t think they will. The FDA has a Controlled Substances Act and what we’ve proposed is that we give a video camera to every subject and every time they smoke it, they have to video tape themselves smoking it and video tape themselves putting the marijuana back in the little safe that they get. They bring in the video tape at the end of the week, when they want to get their new weeks’ supply. We have a staff member review the video tape to make sure that they used it and didn’t give it to somebody else.
If your study does go through, how do you intend to fund it?
The state of Arizona has collected about five or six million dollars in fees from medical marijuana programs, and they recently opened some of it up for grants. We submitted a grant about a month ago for this study, about $750,000. It’s kind of nerve-racking because we had to do all this work and we knew that if the study was rejected, they would of course not fund the study. And we weren’t sure when they would make the decision. If that doesn’t work, and they reject it, I’m not sure exactly where we’ll get the money from.
I believe that there is such enormous, pent-up demand for FDA-regulated medical marijuana research and support from PTSD patients that will go to the marijuana industry probably. The medical marijuana industry, that would be my guess, or philanthropists.
That’s only the first step. We’d need $15 or $20 million to make marijuana into a prescription medicine, approved by the FDA. That will probably take five to seven years. What does that $15 to $20 million go toward? This is just a Phase II pilot study, an exploratory study. We’re figuring out what the doses are, whether CBD helps, whether THC is effective on its own, what are the side effects. The money would go then to what is called the Phase III study, and those are the ones that are used to prove safety and efficacy. With that we’ll probably have to treat 400-500 people or more.
This study will give us results and we’ll see how clear the signals that we get are. Is there marijuana helpful a lot or a little? If it’s helpful a lot, then you need fewer people for the bigger study.