Cannabis and PTSD
Arizona-based Dr. Sue Sisley has just finished shepherding a historic clinical trial regarding medical marijuana through years of research, federal scrutiny, political infighting and straight-out social opposition.
Funded by a multi-million-dollar grant from the state of Colorado to the California-based Multidisciplinary Association for Psychedelic Studies (MAPS), Sisley’s research is a first: an FDA-approved study of whole-plant marijuana as a potential treatment for PTSD in military veterans.
Sitting on a sofa with her service dog Dodger, a golden Labrador rescued from the desert near Tucson, Sisley describes all the hoops her group had to jump through to get their groundbreaking study completed.
“We estimate it took us seven years to get through all the regulatory hurdles,” she tells DOPE Magazine. “It was always designed to be a three-year trial, so we were grateful to be able to finish the trial on time.”
And that trial, she adds, was completed with “zero cooperation from the VA [the U.S. Department of Veterans Affairs], from universities, hospitals. None of them would come near this. They all just thought this was so radioactive that they couldn’t touch it.”
She’s not kidding.
Sisley, a medical doctor, began her cannabis and PTSD study as a researcher at the University of Arizona after UA ethics officials approved the study’s protocol.
But the university dismissed her in 2014 after the study began, for unspecified reasons. And to make matters more complicated, Johns Hopkins University, which was partnering in the research, dropped out of the clinical trial in 2017 — apparently over a dispute regarding the quality of the National Institute on Drug Abuse (NIDA)-supplied marijuana being used in the PTSD trials.
Despite the setbacks, the clinical trials proceeded. And now that the clinical trials are complete, Sisley and her colleagues are writing up their results. And there’s another reason her cannabis-based research is unique.
“Normally, most government money you could get [for cannabis research] is to study harmful side effects and the addiction potential of cannabis,” she says. “You could almost only study it as a drug of abuse, not as a medicine.”
But due to the national legalization movement and increased public education about cannabis, more people are looking positively at the concept of medical cannabis. And Sisley knows from firsthand experience that many Americans are frantically searching for alternatives to mainstream pharmaceutical drugs.
“I think there’s a level of desperation when people are sick, which I see every day at my clinic,” she says. “You know, we’re taking care of people that are often facing very serious illness, and conventional medicines are failing them.”
“If we just focus on PTSD for a second,” she continues, “we have not had a new medication for PTSD approved in 17 years. So I get it. The public is desperate to find solutions and the pharmaceutical companies are not providing them.”
Dr. Sisley believes that we do not hear about studies on cannabis by U.S. pharmaceutical companies for a wide variety of reasons — many of which come down to the corporate bottom line.
“When Big Pharma does trials that don’t go well, they never see the light of day,” she explains. “They’re not going to publish trials showing their study drugs are inadequate. So what happens is, I think, they have been pouring millions and possibly billions into studying cannabis for the last several decades, and most of them have abandoned their efforts, because what they’ve found is that they cannot replicate the efficacy of the natural plant.”
“When Big Pharma does trials that don’t go well, they never see the light of day. They’re not going to publish trials showing their study drugs are inadequate. So what happens is, I think, they have been pouring millions and possibly billions into studying cannabis for the last several decades, and most of them have abandoned their efforts, because what they’ve found is that they cannot replicate the efficacy of the natural plant.” – Dr. Sue Sisley, cannabis researcher and advocate
Sisley also mentions a conversation she had recently in Arizona with a lobbyist for a big pharmaceutical company.
“She said that they talk about this constantly … about cannabis usurping their market share,” she remembers, “and that they see that the only way they can prevent this, this trend, is by keeping prohibition in place and by keeping marijuana illegal, by keeping the barriers to research [in place].”
And given that powerful groups are trying to maintain the pharmaceutical status quo, she adds, “the more cannabis looks like medicine, the more it softens the public attitude about cannabis, which is very dangerous for their revenue stream.”
So if the drug companies cannot make money off a product like cannabis, says Sisley, then funding dries up, and the crucial research and development phase doesn’t happen.
And as Big Pharma cuts corners on research and development for new drugs, they’ve come up with other money-making mechanisms.
“You’re just seeing what we call ‘Me Too’ drugs; where they just take the same drug … reformulate it and put it back on the market. Now instead of being a pill, it’s a transdermal strip, but it’s the same medicine. And then they suddenly get a new 10-year patent on it, and they can make a bunch of money. But there’s hardly any new medicines coming to market, and especially when it comes to PTSD, when it comes to pain.”
As her cannabis and PTSD study wraps up, Sisley’s next effort is to examine how cannabis can help late-stage cancer patients with pain relief, especially when compared with some of the powerful opioid painkillers already on the market.
When people are dealing with severe pain, she says, “They don’t have hours; we don’t want people suffering for hours while we’re waiting for an opioid to kick in. So the idea is, if you can get relief from smoked flower within five to 10 minutes, that’s huge. I mean, that’s really crucial to quality of life issues.”
Sisley has been criticized for being outside of the medical research mainstream. But she has a proven track record, and an FDA approval, when it comes to clinical trials of cannabis. And she believes that while cannabis has therapeutic benefits, it’s not a cure-all.
“It’s a drug, like anything else,” she says. “There are benefits, but there are also side effects. So people have to realize it’s an imperfect drug. Because the plant is so complex it does have the potential to target numerous different organ systems in the body, so that’s why it’s helpful possibly for treating different ailments.”
And because of those issues, along with the federal illegality and the social stigma surrounding cannabis, she thinks it’s still unrealistic to expect “your mainstream physician, a conservative M.D., to yet be able to counsel you on it.”
She advises people interested in medical marijuana to educate themselves — by talking to their peers, getting coaching from people currently using medicinal cannabis, doing research on the internet and talking with patient liaisons at dispensaries that handle medical pot.
“Ultimately, what it boils down to is each patient has to go on their own personal odyssey,” she says, “because there is no way that we can generalize any of this data to fit. Each patient is unique, their brain chemistry, everything. So there’s no way any Doc can tell them this variety will be perfect for treating your pain, your whatever. Each person has to go on an odyssey and experiment with different varieties, different delivery methods, until they find that best fit. And they have to realize that it’s a long journey.”
Cannabis and Alzheimer’s
The Salk Institute for Biological Studies in San Diego was founded by Jonas Salk, the American researcher who, in the 1950s, discovered and then helped develop the vaccine for polio — a terrifying disease that caused paralysis and death worldwide for centuries.
Before his death in 1995, Salk had been looking for a possible vaccine for AIDS.
Nowadays, one lab at the Salk Institute is looking at the potential benefits of cannabis in treating Alzheimer’s — a degenerative brain disease that affects 5.7 million Americans. By 2050 the number of Americans with Alzheimer’s is projected to rise to nearly 14 million, with 100 million cases expected worldwide.
In 2016, Salk Institute scientists announced they had found preliminary evidence that THC (tetrahydrocannabinol) and other compounds in cannabis could “promote the cellular removal of amyloid beta,” a toxic protein in the brain associated with Alzheimer’s.
That study’s lead investigator, Professor David Schubert, tells DOPE Magazine that while their preliminary study looked at inflammation in the brain, national and international attention soon focused on their findings regarding THC.
“I still get, many times a week, people asking me about it,” he says.
And many of those calls, according to Schubert, are from people who are suffering from pre-dementia conditions or who have friends and family coping with Alzheimer’s — and who want to know the best dosage for treating the disease.
So why isn’t Big Pharma looking more closely at cannabis as a potential Alzheimer’s treatment? The answer, says Shubert, is complicated and quite frustrating.
Between 2002 and 2012, more than 400 clinical trials on Alzheimer’s medications were run, but after all those tests only one drug was approved to treat Alzheimer’s symptoms. And while the big pharmaceutical companies have invested huge amounts of time and money in Alzheimer’s research, all of their efforts have so far failed.
Due to that failure rate, says Schubert, it’s become exceptionally challenging to get venture capital for alternative treatments such as cannabis. At the same time, many big pharmaceutical companies are pulling back financially on a lot of innovative research programs, making it hard for future Alzheimer’s drug discoveries.
“They’re shutting a lot of their CNS [central nervous system] studies, their research facilities,” he says. “It’s just extremely difficult.”
Cannabis is also a plant, a natural product, which means pharmaceutical companies are having difficulties in coming up with patents that successfully replicate the effects of the cannabis flower.
With the availability of potent cannabis flower in many states, Schubert says people can go around the bottlenecks created by Big Pharma and “self-medicate” by experimenting with different doses of cannabis flower, tinctures, extracts, etc.
“This is why nobody’s willing to pay the millions of dollars for the clinical trials,” he says.
Schubert believes there is a need for continued medical research working with cannabis, but that the current corporate landscape will have to change.
“We’re trying to understand how compounds in the plant are working … whether we can find these compounds and test them in animal models. Once that is done, if we could show that these things work in models of Alzheimer’s, or Parkinson’s or whatever, then that’s a good basis for pushing these into the [clinical trial phase] and trying to get people to sponsor this. But that’s going to be a very difficult chore.”