Veterans are finding that seeking treatment for PTSD is a harder proposition than being on the battlefield. Cannabis might be the answer, but we won’t know until more research is conducted. Dr. Sue Sisley has a federal grant, federally grown plant and the approval of the FDA so why can’t she get her study of the efficacy of cannabis on PTSD done?
by Beth Schwartz

Let’s start with the facts, well, as best we know them. The Department of Veterans Affairs (VA) estimates 22 veterans commit suicide every day from the effects of PTSD (post-traumatic stress disorder). And, sadly, that startling number is most probably higher since death certificates from only 21 states were analyzed in the VA’s 2012 Suicide Data Report conducted from 1999 to 2011.

“Twenty-two a day is a horrific number and a true public health crisis. That was shocking to everyone. Nobody knew that it was of that magnitude and, sadly, that was a low estimate. Under half of all the states reported, and some of the big states like California and Texas were left out, and so there’s a lot of missing data. It is just sickening to me that our federal government has not made this a top priority and that a study like ours would not be expedited given the epidemic of veteran suicide in this country.” Enter Dr. Sue Sisley.

In fact, when Dr. Sisley does enter a room it’s akin to a rock star making a public appearance. Her admirers stand in line – almost in awe – to have just a second to shower her with gratitude and accolades. She takes it all in stride, receiving her enthusiastic public like a pontiff. And she might as well be a pontiff in the eyes of the military’s PTSD sufferers.

Reasons for the awe and appreciation vary. It could be because she is the first scientist with the gravitas to get a federal grant and plant to study the efficacy of cannabis on PTSD; it could be because the lifelong Republican was fired from her University of Arizona professorship in 2014 due to her pursuit of the study; or it could be that she not only has the potential to help a lot of veterans suffering from PTSD, but her study could save countless lives.

When Dr. Sisley does consider all of the lives that could have been saved — from the time she received approval from the Food and Drug Administration (FDA) to pursue her study in 2011 until now — she is incredulous. She wonders aloud if marijuana could have helped curb this epidemic.

Maybe so.

Dr. Sisley is principal investigator over the Arizona site for the only FDA-approved randomized controlled trial looking at the use of whole-plant marijuana, grown by the National Institute on Drug Abuse (NIDA), in combat veterans with treatment-resistant PTSD. Her study will measure the effects of four different strains of smoked marijuana in treating symptoms of PTSD in 76 veterans ussing cannabis with a ratio of 7% CBD to 7% THC.

Sisley had asked the government-run cannabis farm in Mississippi for plant with a ratio of 12% THC vs. 12% CBD but they grew 7%. “It is not close to what we asked for but we didn’t want to wait another grow cycle so we accepted it. It could be an ideal strain, but it’s not what we requested,” relays Sisley.

Giving her study additional credibility, private research university Johns Hopkins in Baltimore signed on to become a study partner in 2014 and will be splitting the protocol, enrolling 38 of the patients. “That will be a terrific opportunity because a multi-center trial is so much better when you are dealing with the FDA. For us to have two completely independent functioning sites collecting the data with similar results is very compelling,” notes Dr. Sisley.

Even as she forges ahead with a $2.2-million-dollar grant from the Colorado Health Department to study cannabis, Dr. Sisley is not 100 percent sure cannabis is the cure-all many claim it to be. “I am not sold on this yet because there is still conflicting data. Ultimately, as scientists, we have to look at the data, but I am also a human being so I have to weigh that against this mountain of anecdotal evidence and these incredibly compelling and heart-wrenching stories from these vets and their families.”

She continues, further making her point, “I am not a cheerleader for medical marijuana. I am not pro-marijuana, I am just pro-research. I am trying to enter the study objectively,” explains Dr. Sisley, who has never used marijuana personally. “I am not part of the industry; I don’t own dispensaries or co-own any grows. I am really just interested in the science. We owe it to these veterans to collect objective data on how this plant is performing in humans and not just in rats.”

In addition to treating patients, Dr. Sisley is a volunteer Medical Director for five dispensaries in Arizona. But her interest in studying if cannabis reduces the severity of PTSD came as a result of seeing what it did for vets, in spite of her own bias against cannabis.

“It was just a gradual flood of reports over the last 10 years,” recalls Dr. Sisley of vets disclosing to her that they used cannabis to manage a variety of symptoms, not just PTSD. Admitting, “I was very judgmental. And I say ‘reluctantly disclosing to me’ because they knew how conservative I was, I am a lifelong Republican and have never used any street drugs and I don’t condone that with my patients. I think they understood I was going to be highly discouraging so they slowly began to persuade me that this plant must have some merit.

“Keep in mind, these were really credible historians, too. These vets who were talking to me came out of a really conservative background and had also never used drugs and some of them were even in DEA details and a lot of them were anti-drug. They were desperately seeking relief and had learned about cannabis from their fellow veterans and that was what impressed me. Many years ago veterans started teaching each other how to use this plant and how to save themselves because they realized they weren’t going to get help from me or the VA and that I wasn’t capable of providing the kind of relief they needed. All I have at my fingertips is FDA-approved meds and I can’t veer beyond that. They were the ones who finally enlightened me, it took them years, though, because I was so blocked.”

It wasn’t just the vets themselves who enlightened Dr. Sisley. The veterans’ ability to eschew most of their pharmaceutical prescriptions also played a role in changing her mind.

“The veterans in my practice have walked away from most or all of their prescription drugs,” she reveals. “They have not visited a VA hospital in years and they are healthy. It’s astounding. They are using cannabis, in many cases, as a monotherapy to treat a myriad of illnesses and not just PTSD, but their TBI (traumatic brain injury), their chronic pain, all sorts of ailments. That’s why I am so fascinated by this plant because I am curious to see how is it that this single intervention is working.”

Curious because, the fact is, when vets return from active duty they aren’t finding a cure of any kind — much less relief for anything from depression to night terrors.

“Many of these vets come back from service and we end up putting them on the combat cocktail. We pummel them with all these prescription meds because we don’t know what else to do. Each target a symptom, whether it’s a headache or anxiety, and each is treated with a different prescription. So slowly, they snowball onto 12 or 15 different prescriptions in the course of their first year back and they feel completely useless. With all that polypharmacy, they just become non-functional. That’s what is so empowering about the plant, they realize there is a natural God-given remedy that seems to treat most of their symptoms.”

Dr. Sisley has spent over five years combating federal government red tape, the stigma of marijuana, and even being fired from her position as clinical assistant professor of psychiatry at the University of Arizona to get this study off the ground. Which, of course, begs the question, at this point, is she a scientist or an activist?

“In the beginning I just wanted to study the plant. When we ran into these relentless barriers throughout this process it forced me to become an activist. The injustice of science being shackled by politics was so obvious that I just couldn’t walk away, especially with the weight of all these veterans on our shoulders, it was clear that we needed to push through,” Dr. Sisley explains. “Every waking moment when I am not taking care of patients, I am striving to get this study underway. I am gathering clinical experiences from patients in my various roles as medical director of these dispensaries. When I am not seeing patients, I am trying to move the needle and basically trying to build awareness about the barriers of marijuana advocacy research.”

But, at last, Dr. Sisley may finally be done clearing hurdles. She’s got the grant money, the plant from NIDA, and now it appears she has finally found a place to house her study. She had wanted to conduct the study on a university campus but both Arizona and Nevada begged off. Universities in both states were concerned for their federal funding, in spite of the fact that Dr. Sisley has lined up federal money, federally grown plant, and is being monitored by the FDA.

“Nothing nefarious or outside of the legal boundaries is taking place. It shows you that even in the face of real facts, of accurate information, these universities still run scared because nobody wants to stick their neck out for science especially when it comes to marijuana efficacy research,” Dr. Sisley contends.

The Arizona portion of the study will be housed at a cannabis grow facility. “In the end we got zoned out of existence because the cities didn’t know what to do it with us. They zoned us worse than a dispensary. They zoned us as a marijuana use because of the fact we had smoking on the premises as part of the study protocol. So we ended up co-locating in a grow facility. It’s my least optimal solution because we are a federally legal study collocated in a federally illegal environment. I don’t want it to look like I am in bed with industry, but the restrictions made it impossible for us to be in an appropriate environment such as in a medical plaza so we ended up there.”

The study’s housing at the grow facility should be ready by the end of the year and Dr. Sisley is looking forward to enrolling the first veterans in January and starting to collect objective data. The study will take a minimum of two years so there won’t be any published data for 2-1/2 years.

So in spite of Dr. Sisley’s heroic efforts, the public health crisis surrounding our veterans will continue unabated. It will be a few more years and many more lives lost before any definitive research will provide the answers necessary to end our veterans’ fight with the domestic terrorist that is PTSD.