Summary: The Daily Wildcat reports on MAPS’ medical marijuana research, highlighting Dr. Sue Sisley, who will be coordinating part of MAPS’ three-year study of medical marijuana to treat posttraumatic stress disorder (PTSD), expected to begin in early 2016. “Fortunately, after five years, we have persevered and we are now in a position to finally implement this study,” says Dr. Sisley.
Originally appearing here.
Dr. Sue Sisley was wearing red scrubs and a smile as she strode into the marijuana-emblazoned office of a company called Weed Depot in a north Scottsdale business park.
Sisley started seeing patients via video out of a conference room in this office that serves as a headquarters for a marijuana dispensary after the UA terminated her contract last summer, which set off a controversy that turned into a cause célèbre for pot activists.
For years, Sisley attempted to begin research on the effects of marijuana in treating post-traumatic stress disorder, only to be faced with setback after setback—the biggest of which being her dismissal from the UA College of Medicine.
The end may now be in sight, however. Sisley and fellow researchers said they expect to begin the three-year study in January or sometime in early 2016.
“Fortunately, after five years, we have persevered and we are now in a position to finally implement this study,” Sisley said.
The last thing that’s needed is final approval from the Drug Enforcement Administration so marijuana plants can be provided for the study, the researchers said. That approval can only be given once the renovations to Sisley’s research site in Phoenix are complete.
Dr. Sisley
She said there are plenty of good people doing good work at the UA. She’s a graduate of the UA College of Medicine, class of 1995, and worked at the College of Medicine–Phoenix campus.
Sisley’s interest in using marijuana to treat PTSD began because, she said, she has spent about 20 years treating veterans—at the Phoenix Veterans Administration hospital and her own private practice.
Working with these veterans, she noticed the debilitating effects of PTSD on their lives. She estimates that dozens of the veterans she treated over the years committed suicide.
Some veterans would tell her that they felt smoking marijuana helped when it came to coping with PTSD.
“I have people in my practice who are reporting that marijuana has saved their lives, and I’m as skeptical as anyone,” Sisley said. “I felt a duty to at least study the plant rather than just dismissing claims as erroneous or as coming from a bunch of drug-seeking stoners.”
So, working with the Multidisciplinary Association for Psychedelic Studies, or MAPS, she crafted a study to look at the effects of marijuana in treating PTSD about five years ago.
The Food and Drug Administration approved the study in 2011, followed by the UA’s Institutional Review Board, which is needed to conduct research at the university.
Funding the study was another matter.
Sisley lobbied the Arizona State Legislature in spring 2014 to use money from the state’s medical marijuana revenues to fund her study, an effort that ultimately failed.
In late June 2014, Sisley received notice that her contract with the UA had been terminated. She said the UA caved to political pressure from the Legislature and ousted her from her position the College of Medicine–Phoenix.
Sisley said state Senate President Andy Biggs, R-Gilbert, and other legislators took issue with her lobbying style at the state Capitol. She cited an August 2014 report in the New York Times that quoted Biggs as saying that a UA lobbyist told him that there “will not be a problem going forward” after he complained about Sisley’s lobbying.
“This is a classic case of science being trumped by politics,” Sisley said.
The UA contests that version of the story.
Chris Sigurdson, vice president of communications at the UA, said in an email that the university did not reject Sisley’s research and offered to host it with another principal investigator—the lead researcher for a study.
MAPS, which sponsors Sisley’s research, declined the UA’s offer to do the study with another researcher at the helm, Sigurdson says.
“Had they agreed,” Sigurdson said, “we would be working on the study today.”
He also points out that the UA successfully lobbied the state Legislature in 2013 to allow medical marijuana to be studied on university campuses, laying the groundwork for the study to take place.
“The UA unreservedly supports academic freedom in research and instruction,” Sigurdson said. “Political pressure has not been a factor in our willingness to conduct medical marijuana research or influenced the assignment of any of our employees.”
After the UA
Whatever the reasons were for her termination, Sisley said she needed another site in Arizona that would host the research.
“Other people would have been devastated and walked away but there was no way I was going to turn my back on this study,” Sisley said.
Sisley said she reached out to Northern Arizona University and Arizona State University, but couldn’t work out a deal for research with either. She then turned to hospitals around Arizona to host the study with no luck.
As she searched for a new site that would allow her to conduct the research, Sisley’s fame grew among marijuana legalization activists. MAPS counted about 400 media reports about her in the months after her dismissal from the UA, she said.
Sisley joked that she should send UA administrators a gift basket because her termination brought widespread media attention to her research efforts. However, she said she never wanted to be a marijuana activist and that she was “forced” into becoming one because she encountered so many obstacles to trying to do research with marijuana.
She has spoken at events from a conference at Walter Reed Military Medical Center to a pro-marijuana rally in Seattle and has been interviewed on CNN.
Sisley maintains an official Facebook page for herself that has accrued more than 2,400 likes. The page’s cover photo imposes an image of Sisley against a backdrop featuring depictions of marijuana plants.
Howard Baer, founder and owner of Weed Depot, is one pot supporter who was drawn to Sisley’s cause.
He said he learned about the UA controversy and offered the office space in Scottsdale for the study. Sisley declined the offer, because she said she didn’t want to be associated with the marijuana industry.
He then offered Sisley space in a conference room in the office for Sisley to use personally for her telemedicine practice. She accepted that offer.
“She can have anything she wants from us,” Baer said.
Sisley said she had been trying to find a space to do the study in Arizona that was not associated with pot legalization advocates, but found it difficult without the backing of a university or a hospital. She said she didn’t want the optics of “being in bed” with the marijuana industry.
After months of difficulties in finding a place, Sisley finally relented. The study will be housed in a warehouse near the Deer Valley Airport in north Phoenix that is located next to a marijuana grow site, satisfying city zoning regulations, she
says.
More construction is still needed inside the warehouse to clearly separate the marijuana grow from the study before final DEA approval, Sisley said.
Rick Doblin, founder and executive director of MAPS, said this is the culmination of a long-fought effort to begin a critical piece of marijuana research.
“It’s been like pushing a boulder up a hill,” he said. “It’s been extremely slow and problematic, but we’re getting there inch by inch, step by step.”
A ‘redesigned’ study
Marcel Bonn-Miller, an adjunct assistant professor of psychology in psychiatry at the University of Pennsylvania, heard about Sisley’s dismissal from the UA last summer and reached out to MAPS to offer his assistance on the research.
He brought in Dr. Ryan Vandrey, an associate professor in the Behavioral Psychology Research Unit at Johns Hopkins University, who has experience in research with marijuana.
After looking at the study, the two determined that they would need to redesign the study in order to maximize the “meaningful findings” that could be discovered with the research, said Bonn-Miller, who also works at the Philadelphia VA hospital.
“The only thing that stayed the same was that we were looking at different types of marijuana on PTSD symptoms,” Bonn-Miller said.
Bonn-Miller will be the coordinating principal investigator for the research, meaning he will be overseeing the entire study.
He said Sisley doesn’t have the experience Bonn-Miller and Vandrey have in marijuana research, because she has worked as a clinician, not a researcher.
This isn’t to discount the efforts Sisley had put into getting the research started, Bonn-Miller said. Sisley’s study as it was had been approved by the FDA and the UA’s institutional review board.
The study will take place at two locations—in Phoenix with Sisley and in Baltimore at Johns Hopkins with Vandrey. 38 patients will be seen at each site for a total of 76 subjects.
Patients, who have been screened and vetted for the study, will come into the sites to smoke different strains of cannabis, Vandrey said. The study will take three years to complete once it begins.
Bonn-Miller, as principal investigator, will write the findings when the research is complete.
Bonn-Miller and Vandrey emphasized they don’t have an agenda going into this study and added that they’re not interested in marijuana activism. Sisley said she wants to present the findings from the study whether it bodes well or not for marijuana legalization advocates.
“We’re trying to streamline these things and give a balanced view of what’s going on without the agenda,” Bonn-Miller said.
The redesigned study also received a $2.2 million grant from the Colorado Department of Health in December, securing the funding that eluded Sisley and MAPS before.
“It’s a good collaboration,” Bonn-Miller said about working with Sisley and MAPS. “I think their enthusiasm and stick-to-itiveness and coupled with our background has really helped push this forward relatively quickly.”
The trouble with pot research
The hurdles to this study aren’t unfamiliar territory for Doblin.
Doblin founded MAPS in 1986 originally to develop medicinal uses for MDMA and then marijuana. In 1992, Doblin worked with a researcher from the University of California, San Francisco, to try to study the effects of marijuana on AIDS patients, only for the research to be stonewalled by federal regulators for four years.
Vandrey said he’s encountered extremes on both sides of the debate on marijuana’s effectiveness—people who are totally for pot and people who are totally against it.
The state of marijuana in the U.S. now is much different than it was even five years ago when Sisley began her efforts.
Arizonans may see marijuana legalization on the ballot in 2016, where they could join Colorado, Washington, Alaska and Oregon as states that allow marijuana for recreational use. Several other states have legalized medical marijuana and decriminalized its use.
This trend of state legalizing pot, however, does not necessarily indicate research on marijuana will be easier in the near future, Doblin said.
The problem is marijuana remains federally illegal and is classified a Schedule I substance by the FDA. Doblin said that momentum may prove to better legitimize marijuana’s medicinal purposes.
“That’s going to change the dynamics and will build even more support for research into marijuana’s medical uses,” he said, “because hopefully the resistance to it will be reduced.”
As for MAPS’s original goal of turning marijuana into a legal prescription drug in the U.S., Doblin estimated that may be about 10 years away.
“It’s still a long road,” he said.
Sisley said after the years of trying to get the research started and her activism for marijuana, her primary concern remains with helping the veterans she’s treated over the years.
“I feel the weight of these veterans on my shoulders every day,” she said.
For now, construction awaits completion at the Phoenix warehouse where patients will soon be coming to smoke marijuana for the study and Sisley and fellow researchers will begin compiling data.
The DEA requires secure storage for the cannabis that will be used in the study. For that Sisley, acquired a safe, one of the only things inside the warehouse now that’s not construction equipment.
That gray safe sits on the concrete floor, waiting for marijuana to be stored inside.
