Summary: Vice interviews MAPS-sponsored researcher Dr. Sue Sisley, M.D., to discuss how political obstacles have affected MAPS’ upcoming clinical study into medical marijuana for veterans with posttraumatic stress disorder (PTSD). The article describes how current federal policies and bureaucratic delays affect the progression of medical marijuana research. "I can’t tell you the number of veterans I have seen in my practice who have walked away from all of their prescription drugs in favor of using medical marijuana alone to treat their ailments," says Sisley.
Originally appearing here.
In the newest episode of Viceland’s Weediquette series, host Krishna Andavolu follows a group of US combat veterans as they travel to Washington, DC, to advocate for research into medical marijuana as a treatment for post-traumatic stress disorder (PTSD). Specifically, they want the federal government to begin supplying cannabis to an FDA-approved phase II clinical trial headed by Dr. Sue Sisley, who says she was abruptly fired in 2014 from a faculty position at the University of Arizona—where she also earned her medical degree—when the study became a political hot button among local politicians.
After losing her job, and the original home for her research, Sisley is now serving as one of two site principal investigators in a multi-site study sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS) and funded by a $2.1 million grant from the Colorado Department of Public Health and Environment. The money for the study comes directly from taxes collected on Colorado’s thriving medical marijuana retail sales, but the state can only pony up the cash, not the cannabis. Only one facility in the country, on the campus of the University of Mississippi, can currently grow and process cannabis legally on the federal level, making it the sole source of "research material" for any FDA-approved study. And that sole supply can only be accessed with the express written consent of the Drug Enforcement Administration (DEA).
For years, Sisley and her allies at MAPS have been actively seeking to end this monopoly by suing the DEA to force the creation of additional federally licensed cultivation facilities, and calling for an end to a set of cumbersome review processes that make pot much harder to study than MDMA or LSD. In 2007, a DEA administrative law judge ruled that this marijuana monopoly was indeed harmful to the public interest and should end, but as a report called The DEA: Four Decades of Impeding and Rejecting Science chronicled in detail, the head of the DEA roundly rejected this ruling, maintaining the monopoly.
At the moment, despite all these obstacles, Sisley believes she’s about to finally push through the last of the barriers and start signing up veterans for the study. She spoke with VICE on Monday, while attending a medical cannabis conference in Israel, to offer the latest word on her ongoing quest to prove whether or not cannabis works safely and effectively to treat PTSD.
VICE: What’s the current status of the clinical trial?
Dr. Sue Sisley: Basically, we still need a DEA schedule one license, because without that, we can’t purchase marijuana for the study, and without a study drug, we’re not allowed to start screening patients. The DEA has inspected us a few times already, and there was a new problem each time. First, they wanted us to have a safe bolted to the ground with an alarm system to hold the cannabis. Then they said we needed to finish our build-out entirely before getting approval. Then they wanted us to have a freezer safe, not just a regular safe. So we had to order a special freezer from China.
We first submitted the study design to the FDA back in 2010, and here we are six years later still unable to enroll our first veteran.
Do you think the DEA has been moving the goalposts, coming up with new reasons not to approve the facility, or is the process just taking longer than you’d hoped?
In my opinion, the DEA doesn’t want any research that might legitimize whole-plant marijuana as a medicine, so these delays are all small victories for them. The DEA director recently called medical marijuana a joke, meaning this attitude clearly starts at the top. They find our research study especially threatening because it would eventually be published in peer reviewed medical journals. Meanwhile, studies looking for marijuana’s harmful side effects or addiction potential get green-lighted and move through the process rapidly.
We are going to win, though. I want to emphasize that. We will persevere, not only until we get our first veteran enrolled, but until the entire study is complete and all of the data enters the public record for everyone to examine. We will never give up, and I believe that has been a big source of frustration for the government.
How about at the Veterans Administration? As more and more vets come forward to support medical cannabis, have you seen any positive change in their attitude?
No, not at all. We’ve tried, and tried, and tried to reach out to Robert A. McDonald, the secretary of the VA, to speak with him about this study. But he doesn’t want to know about it. He just keeps shutting us out.
The VA supplies individual veterans with an often staggering amount and array of painkillers, antipsychotics, and other potentially dangerous and addictive prescription drugs. Do you think the pharmaceutical industry could be influencing the government to put up blockades against medical marijuana research?
The vast influence of the pharmaceutical industry in this country is shocking, and they certainly must see cannabis as a huge threat to their business model. I can’t tell you the number of veterans I have seen in my practice who have walked away from all of their prescription drugs in favor of using medical marijuana alone to treat their ailments, and Big Pharma would certainly rather they went back to getting pummeled with piles of prescriptions.
I definitely do not encourage vets to go off their meds, but I do work with them to see what meds might be redundant, or totally ineffective, or causing lots of side effects, and we try to eliminate them when we can. These vets are sick and tired of being treated like guinea pigs, and turned into zombies. They feel completely abandoned by the medical community and the VA, which basically tries to subdue them with mega-doses of pain meds and other drugs. The government will pay huge sums to keep them on all these different prescription drugs, but won’t pay for legal medical cannabis. I think that is really an outrage, especially to disabled vets functioning on a shoestring budget, who can’t afford to buy cannabis from a dispensary.
What role have veterans played in pushing for this research and making this a political issue?
We wouldn’t be where we are today, finally on the cusp of implementing the study, without a lot of veterans choosing to get directly involved and fight for this research, including many who appear in the new Weediquette episode. They see a lot of their brothers and sisters with PTSD refusing to try cannabis because of the lack of scientific data about efficacy, or they’re afraid of ramifications legally or with the VA, so they want to see this plant put through the FDA process. We now have troops of vets around the country committed to standing side-by-side with us as we struggle to move forward.