A clinical study on the effects of cannabis as a treatment for veterans suffering from post-traumatic stress disorder was finally released in March, after more than a decade of work—slowed by frustrating delays—by former UA assistant professor Dr. Sue Sisley and a network of organizations advocating for veterans' access to medicinal cannabis.
While the study was likely adversely affected by the low-grade weed that is legally available for research in the United States, Sisley and her network have helped spur an easing of government restrictions that have been in place for decades.
"I've been taking care of military veterans for about 20 years in my medical practice, and I was super anti-cannabis my whole life," Sisley said. "I couldn't believe these veterans were claiming they were getting benefit from this and I was really skeptical. ... But I became very sympathetic with them when I saw the shitty meds that were available. The FDA has not approved a single new med for PTSD in 19 years now. So that sucks."
The approved medications are Zoloft and Paxil, but many veterans who tired of being dosed with pharmaceuticals have opted to self-treat with cannabis, even though many political corners (including the Veterans Administration) are still skeptical and often downright hostile to the use of weed as medicine.
But Sisley, through the auspices of the Scottsdale Research Institute she founded in the wake of her dismissal from the UA in 2014, is working to change the dynamics and determine how effective cannabis is as a treatment for PTSD as well as other afflictions.
The backdrop to the Sisley saga is the federal prohibition on cannabis that has led to a lot of bad policy for weed aficionados and a headache for researchers seeking scientifically sound data on the plant.
Given marijuana's status as a Schedule I narcotic on the same level as heroin, the U.S. government has spent decades doing its best to squash any research studies that do not include those geared toward connecting cannabis use to violent behavior, crime, addiction potential or various psychoses. Many of the studies that do get approved are anecdotal in nature and not "randomized clinical trials." According to the National Institutes of Health, an RCT is "a study in which the participants are divided by chance into separate groups that compare different treatments or other interventions" so "that the groups will be similar and that the effects of the treatments they receive can be compared more fairly."
In order for researchers to study marijuana, they must jump through a number of hoops and bureaucratic red tape just to get lousy weed to study. No distillates or edibles are available either, only flower.
For SRI to apply to get product for the study, it first had to have the approval of an institutional review board connected to Health and Human Services, and then revise its study proposal for submission to both the state of Arizona and the Federal Drug Administration.
Once those applications were reviewed and approved, the proposal went to the Drug Enforcement Agency for a final approval. Only after the DEA bestowed its blessings, SRI was able to order cannabis through the National Institute on Drug Abuse to acquire quantities of low-grade weed, grown in the only federally sanctioned source in the US: the University of Mississippi. That is due to the "Single Convention," a policy put in place in 1961 to limit the manufacture and distribution of marijuana for medical and research purposes.
Often referred to as "lawnmower clippings," UOM weed has been derided for years as sub-standard, as it contains stems and seeds and oftentimes mold. THC content caps out at about 9% potency compared to the 20% to 30% pot found in the local dispensary. The stock used at UOM was first acquired more than 30 years ago and pales in comparison to modern weed as far as potency and smokeability.
The cannabis Sisley used for the SRI study was "moldy and diluted," after spending an "unknown number of years" in a freezer at the grow facility.
While Sisley cannot posit that the poor-quality weed undermined her study, there were plenty of indicators pointing to that, not the least of which was the return of unsmoked pot from study subjects.
"I'm not allowed to explicitly make that [statement] because, as a scientist, I'm only allowed to report the data, and not really editorialize," she said. "You'll notice in some of the commentary we did mention things like how many veterans return the majority of the cannabis because it was very ineffective. ... It was just so diluted, it wasn't worth putting the energy into."
That dynamic is changing, though, as in May, the DEA announced it has finalized new regulations and is in the process of certifying a number of growers to produce cannabis for research in the U.S.
Sisley's Scottsdale Research Institute has been able to get approval to grow its own marijuana for study—the next cannabis-related work SRI plans is for cancer patients and Phase 2 of the PTSD trials coming sometime in 2022—but until Sisley's group gets its own strains up and running, she is using a more expensive alternative, importing cannabis from Canada, a legal alternative that not many people take due to the complexity and amount of time it takes for approval.
Sisley's research, published in a peer-reviewed paper titled "The short-term impact of 3 smoked cannabis preparations versus placebo on PTSD symptoms: A randomized cross-over clinical trial," took a decade to complete: seven years to navigate the bureaucracy, including a delay of at least three years due to the intransigence of the UA. The actual study took an additional three years and included 80 veterans being treated for PTSD, coming at a cost of $2.2 million acquired in a grant from the Colorado Department of Public Health and Environment through the California-based nonprofit Multidisciplinary Association of Psychedelic Studies.
Participants were broken into four groups, one group using weed with 9% THC; one with 11% CBD; one group using an 8% THC/8% CBD hybrid, and a group that was administered a placebo.
The results were considered negative because there was insufficient statistical variance to confirm the efficacy of the drug for treatment. However, there were sufficient positive returns that further studies are justified and Sisley hopes to initiate Phase 2 in the near future. She also hopes to do that with marijuana that is more reflective of what's available for consumers in the Arizona marketplace.
"Even though I can't say it explicitly, I can say we think there were enough positive signals in the study, enough promising elements that we think that we are on the right track," Sisley said. "If we had a level playing field to actually study real-world cannabis, we wonder if the results would be different. So that's why we want to keep pursuing this path."
Longtime readers of the Weekly may remember the trials and tribulations of Sisley, when back in 2014 the UA unceremoniously released her when she was on the cusp of getting the study underway.
Sisley is a dedicated Wildcat and holds no grudges against the university, despite the institution's rough handling of her over the cannabis study she has devoted the past 12 years of her life completing.
"It took us seven years to get all the regulatory approvals to conduct the trial, but part of the delay was being terminated from the UA," she said. "The IRB at the university approved the study, so the UA had said the study was safe, ethical and OK to do there."
But then-president of UA Ann Weaver Hart, whose motto that year was "Never Settle," apparently buckled to alleged political pressure from then state Sen. Andy Biggs (who now serves in the U.S. Congress) and refused to renew Sisley's contract, thus driving a stake through the heart of the study.
At the time, the university was trying to raise its national profile as a "grant-producing super-research center of higher learning ready to grow economies and minds," according to a Weekly report in the wake of Sisley's termination.
"They kept saying there was no room on campus to do the trial, no labs available," Sisley said. "Meanwhile, I was working at the UA College of Medicine campus in Phoenix where we had miles of unused, empty labs and offices sitting there perfect for us, so we knew that they were just bluffing and just trying to block this as long as possible."
It took a year for her to find a place in the private sector to conduct the research, and eventually she was able to continue her work in an environment where she could pursue "scientific freedom" outside the bounds of academia.
PTSD and war go hand in hand.
Throughout history, war-scarred veterans have suffered the effects of the brutality foisted on them or that they foist on others in service to the alleged interests of their countries.
From the 18th century through the Civil War, what we now know as PTSD was called "nostalgia," which became "soldier's heart" and "shell shock" or "battle fatigue" in later wars, according to the National Center for PTSD.
In classic literature, consider Shakespeare's Henry IV, where Lady Percy describes her husband Hotspur's behavior upon his return from war to include everything from isolation to unwarranted rage and sexual frustration, classic symptoms of PTSD. Then there is Stephen Crane's Red Badge of Courage, where protagonist Henry Fleming runs from the field of battle in the heat of the Civil War, thus sealing his fate.
Yet despite its long existence as a human condition, PTSD has only recently been afforded status as a treatable condition. It was not until 1980, in the wake of the Vietnam War, that PTSD made its way into the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders (DSM-III). Until WWI, wartime PTSD sufferers were accused of cowardice that often ended with a fatal "fragging" from fellow soldiers. In subsequent American wars though, soldiers became too valuable a commodity and a burgeoning recognition of the disorder allowed affected soldiers to take alternative duty behind the lines in non-combat roles.
That has not reduced the suffering though, as attested by veteran suicides in the wake of the Bush wars in Afghanistan and Iraq.
While a popularly accepted number of 22 veterans a day, about 8,000 a year, is used as a baseline to illustrate the problem, the Department of Veterans Affairs released its 2020 National Veteran Suicide Prevention Annual Report last November reporting that from 2017 to 2018, veteran suicides per day rose from 17.5 to 17.6 with 6,435 suicides reported in 2018.
Due to the effects of the COVID-19 pandemic though, the Department of Defense reported a 25% increase in the number of deaths by suicide in the last quarter of 2020, after the year 2019 had a record number of suicides, according to a report on military.com.
A press release from SRI estimated that 6% to 10% of the general population and 13% to 31% of U.S. veterans experience PTSD, which can lead to substance abuse, depression and suicidality. Oftentimes veterans who receive traditional drugs regimens still qualify for a diagnosis by the end of treatment.
When word went out in 2014 that Sisley was let go, the extensive veteran community in Tucson and the UA rallied to her support and still stick by her side to this day.
"I've been advocating for veterans' access to cannabis since 2013, when I teamed up with Dr. Sisley upon completion of my classes and induction as a fellow in the Flinn-Brown Arizona Center for Civic Leadership," Army veteran Ricardo Pereyda said. "Once I graduated into that program, she and I started working together, and that's when I came out of my [cannabis] closet. I was on campus at the University of Arizona, running the vets center, so I was already advocating for services or resources for our veteran community, doing a bunch of community service work."
Pereyda, a Tucson native and die-hard Wildcat, was attending UA after a six-year stint in the military left him much the worse for wear after multiple blasts he survived in Iraq left him 100% disabled in the eyes of the DoD.
Pereyda began secretly using cannabis after rejecting the cocktail of drugs he was given by the VA and a bout of self-medicating with alcohol.
"A lot of veterans on campus were using it, but again, it was taboo so you didn't talk about it," he said. "These are people trying to get professional degrees and consideration for employment after college, and that's the case with a lot of people that are still serving either in the military or as contractors. They use it on some really iffy terms because they don't want to put themselves on the record. But what are you gonna do when the pills don't work? The booze makes it worse. Right?"
Sisley's work and mentorship helped give Pereyda direction and the confidence he needed to go public about his cannabis use. In the wake of her firing, he tried to convince UA leadership that they had made a mistake getting rid of a preeminent research professor. But it came to no avail and Pereyda said he was "blackballed" by people at the university.
In the years since then, he has increased his advocacy work to get the VA to provide medical cannabis for suffering veterans and has done what he can to help SRI studies move forward.
He now works with the Veterans Action Council, an advocacy organization that works with legislators and fellow veterans, and plans to return to UA to finish his educational aspirations someday.
"When you go into college, you figure out during your undergraduate years what your passion is, what you're interested in," he said. "And then you find a mentor: In this case Dr. Sisley was my mentor, a doctor in an amazing field, doing something that's interesting to me, something I'm passionate about."
The Veterans Action Council and similar organizations have a lot of work to do though, as the VA recently indicated it is not softening its stance on medical cannabis.
In late April, a bipartisan bill that would require the VA to conduct clinical trials on the efficacy of cannabis for treatment—the VA Medical Cannabis Research Act, sponsored by Sens. Jon Tester (D-MT) and Dan Sullivan (R-AK)—was reintroduced into the Senate. A month later in a Senate committee hearing, VA officials declined to discuss the bill, but offered written testimony in opposition, stating that the Biden Administration is against the reform.
VAC member Tony Landry does not suffer from PTSD but has chronic pain from his years of service. He eventually had to detox from the pills the VA was giving him and the alcohol he was using as a coping mechanism. Living in Louisiana, he did not have access to medical cannabis so he moved to Arizona, where he still fights for access both here and for his fellow vets in Louisiana.
"It's a lifesaver for me, because I went through the pharmaceutical cycle with the VA for 20 years," he said. "You build up tolerance to the opiates and then it really takes a humongous dose for you to accomplish the same pain relief."
As to Sisley, in the ensuing years since she left UA, she's seen a dearth of legitimate research and, if anything, many academic institutions are shying away from it during a crucial time. She will always be grateful to UA. She spent four years there as a medical student and another eight as a faculty member and is proud of her deep ties there. In hindsight, she sees her firing as a "huge gift" that has helped forward her research.
"We have over 300,000 patients that have cards, and they have serious questions about how cannabis works, how it doesn't, and none of that is getting addressed by our universities," she said. "Many of them have dropped the ball on this, but others are happily collecting the ball and running with it."
For more information on the Scottsdale Research Institute, visit fieldtohealed.com.
For more information on the Veterans Action Council, visit veteransactioncouncil.com