Consider the roadblocks encountered by Dr. Sue Sisley, who has spent the last two decades working with military veterans suffering with PTSD.
Sisley has a $2.2 million grant from the Colorado Department of Public Health and Environment to test whether cannabis is a safe, effective treatment for PTSD. But she can’t begin the study because of delays imposed by the federal government.
“Our study is a triple-blind, randomized control trial to look at four different strains of smoked marijuana,” she said. Triple-blind means the veterans participating in the the study, the people administering the substances they receive and the people evaluating the results won’t know what substances each test subject receives. The study participants will be 76 military veterans with treatment-resistant PTSD who have failed to respond to medicine, psychotherapy or both.
“The only thing standing in our way,” Sisley said during a recent interview, “is the NIDA monopoly.” NIDA is the National Institute on Drug Abuse, which has a government-enforced monopoly as the sole provider of cannabis for any FDA-approved research trials.
Sisley’s been waiting 16 months for NIDA to provide the CBD-rich marijuana she’s requested for her study.
“We have to wait for marijuana study drug from the federal government, who seems to be incompetent to grow this plant,” she said.
“This is to me classic federal government overreach,” Sisley added. “We have a situation where any of these expert growers here in Colorado could have had marijuana grown to spec for me within three months. But only our federal government is incapable of growing these various common strains that we’ve requested from them. And here we are 16 months after our initial request still waiting for marijuana. Still sitting with an empty DEA-approved safe waiting for study drug. We can’t even begin to screen patients until we get marijuana.”
“It’s a really frustrating situation for everyone in the marijuana industry because they all know that they have some very exquisite raw marijuana that they can sell us,” she said. “In fact, they want to donate it to us. The study could be supplied entirely by donations from these growers. But they’re not allowed to do that. And we’re not allowed to accept it.”
“What’s interesting about this whole situation is that marijuana is the only Schedule 1 drug that is subject to these ridiculous blockades,” she said. “When I go to study any other drug in Schedule 1, I don’t have to purchase study drug from NIDA. I could purchase research-grade LSD from any lab in the country. Marijuana is the only one that is forced to go through this absurd system.”
And it’s the least dangerous drug on Schedule 1, Sisley said. “Marijuana seems to be less harmful that most of the medications I prescribe to patients every day,” she said. “The toxicity of marijuana is remarkably low.”
Why the obstruction? Because opponents of cannabis legalization “don’t want any data from studies like ours to ever see the light of day because that data could be used to legitimize marijuana as medicine,” Sisley said. “That might persuade the medical community to actually view it as a mainstream treatment.”
Is it deliberate? “I think most people believe that this is a deliberate attempt to sabotage marijuana efficacy research,” Sisley said.
In addition to the delays involved, she said, the marijuana provided by NIDA is consistently substandard.
“The strains they’ve offered us are often half the potency of the strains that are currently available on the street or through a dispensary,” she said. “We’re trying to do a real-world study and examine what patients are really doing day-to-day.”
“We’re stuck with these strains that don’t really mimic the real world at all but that’s what we’re legally allowed to work with.” she said. “Many people in the medical community argue that being forced to utilize this marijuana will sabotage an efficacy study from the very beginning.”
“It’s very obvious what’s happening,” she said. “The U.S. government is systematically impeding marijuana efficacy research.”