Summary: Tonic covers MAPS’ ongoing clinical trial as we continue to recruit participants to test marijuana as a potential treatment for symptoms of PTSD in veterans at the Scottsdale Research Institute in Phoenix, Arizona. The trial enrolled the 30th participant and still needs 46 veterans with chronic, treatment-resistant PTSD. Principal Investigator of the study Sue Sisley, M.D., of MAPS is interviewed about bureaucratic barriers to enrolling eligible participants into the study. “Folks with severe PTSD are at home, isolated, living in fear every day, dealing with these dark, horrific thoughts,” explains Sisley. “They’re not the ones who venture out every day so it’s really hard to find them.”
Originally appearing here.
One morning a few weeks ago I walked through the cool air around Rushcutters Bay and buzzed myself up to my therapist’s apartment nearby. I hugged him when he opened the door and we chatted while he made me some green tea and put more in the fridge to chill for later. Making myself comfortable on his long sofa, I lined up my accessories on the coffee table beside me: headphones, a padded eyemask, a notebook, my water bottle, and a capsule containing 125mg of pure MDMA.
In December 2014, Marcel Bonn-Miller, a longtime cannabis researcher at the VA in Palo Alto, California, sent a casual email to the head of research at the VA in Phoenix, Arizona. He, along with a team of researchers, had just received a $2 million grant from the state of Colorado to conduct the first-ever clinical trialinvestigating cannabis as a treatment for post-traumatic stress disorder (PTSD) in veterans.
Bonn-Miller’s message was brief and straightforward: we just received this money to do research on veterans near your hospital and we’d appreciate some help in recruiting volunteers. After doing cannabis research for nearly a decade at his local VA, he anticipated a supportive reply. Instead, after a follow-up call to Phoenix’s chief of research , Samuel Aguayo, he hadn’t heard back.
“I even put my fancy title in there to be like, ‘Hey, I’m a VA employee, I’m one of you guys,’” Bonn-Miller recalls. “When I didn’t hear back, I thought, this is kind of weird.”
Then, finally, he got a response. The Phoenix VA couldn’t help, Aguayo said, because cannabis is federally illegal.
Cannabis remains classified as a Schedule I substance which means, according to the federal government, it has no accepted medical use. However, the PTSD cannabis trial—the first of its kind to rigorously investigate the safety and efficacy of veterans’ claims about using cannabis for PTSD—is an FDA-approved study using cannabis given to the researchers by the federal government. These types of seemingly contradictory policies have created confusion and, some cannabis advocates argue, bureaucratic excuses which prevent progress in the arena of cannabis research.
After seven years of regulatory hurdles, the researchers finally began sending veterans through their trial in February without recruitment assistance from the VA. But now, they say they’ve exhausted all the veterans organizations near their lab and they won’t be able to find the roughly 50 more volunteers needed for the study without help from the Phoenix VA.
The leadership at the VA in Phoenix—the closest VA to the trial’s lab—still will not permit the researchers to hang flyers in their facility, talk to their clinicians, or do anything else that would inform veterans who go to their site about the study. According to Phoenix VA chief public affairs officer Paul Coupaud, that would change if Veterans Affairs Secretary David Shulkin told them to allow it.
That’s why the American Legion, the country’s largest veterans organization with more than 2 million members, has been calling on Shulkin for more than a year to tell the Phoenix VA to help. (It’s up to the Phoenix VA’s Director Rima Nelson to agree.) In late September, the Legion ramped up its efforts with a letter sent to Shulkin’s office: “…the Phoenix VA is in the best possible position to…reveal the existence of the study to potential participants,” the letter says. “We ask for your direct involvement to ensure this critical research is fully enabled.”
The trial’s principal investigator, Sue Sisley, and her team have screened more than 4,000 applicants, but only found 28 so far who are eligible. This is largely because the trial is only recruiting veterans with treatment-resistant PTSD, meaning people who have not gotten relief from the available medications and therapies. “Folks with severe PTSD are at home, isolated, living in fear every day, dealing with these dark, horrific thoughts,” Sisley says. “They’re not the ones who venture out every day so it’s really hard to find them.”
Meanwhile, inquiries about the situation to the VA’s Press Secretary Curt Cashour, who is at the federal level, have led to curt replies, including one most recently sent to Tonic stating:
“We have a hospital to run in Phoenix, and frankly [the] VA is not [Sisley’s] personal recruiting agent.” (It’s commonplace for VAs to refer veterans to non-VA studies.)
This recruitment challenge follows four years of approval processes for the study protocol and then another two years post-approval of waiting for the government to deliver the necessary cannabis. When the cannabis finally arrived last year, it was contaminated, delaying research for another four months until they confirmed it was not harmful for their volunteers.
“It’s not enough to just be a researcher when you’re trying to study cannabis,” Sisley says. “Cannabis is such a politically radioactive word that you’re forced to be in the public policy arena or you’ll never be able to do this work.”
Sisley and Rick Doblin, the founder of the Multidisciplinary Association of Psychedelic Studies (MAPS), the nonprofit sponsoring the study, say it’s their duty to not only fight for the approval to conduct their trials, but to help reform undue burdens for future researchers. That’s why, in March, after the PTSD cannabis trial was already underway in Arizona, they decided to publish the results of their independent testing of the federal government’s contaminated cannabis.
Just after they did, their trial faced another setback. Their partner, Johns Hopkins University—which was supposed to enroll half of the veterans and bolstered the study’s reputation because of their institutional prestige—withdrew from the study, citing research differences. This prompted two protests by veterans and a slew of letters from Weed for Warriors demanding a more thorough explanation. Sisley and Doblin say they think the university was concerned that being associated with researchers who criticized the government would put the federal funding they receive for other studies at risk.
Kiernan, president of Weed for Warriors and a veteran with post-traumatic stress disorder, sees Hopkins’ decision to withdraw and the Phoenix VA’s refusal to help recruit veterans as two branches of the same tree. They’re both part of the convoluted federal bureaucracy that prevents progress in cannabis research, he says.
“Is there a smoking gun?” Kiernan says. “Well, I would say it’s the lack of any movement.”
Cashour, the VA Press Secretary, has repeatedly sent the same statement to Tonic saying: “Federal law restricts VA’s ability to conduct research involving medical marijuana, or to refer Veterans to such
research projects.” But Sisley and her team continue to have some unanswered questions about how this is possible when other VA sites around the country are currently conducting medical marijuana research. For example, Bonn-Miller, a co-investigator on the PTSD cannabis trial, is part of an ongoing observational study looking at veterans who use medical marijuana for their post-traumatic stress disorder at the VA in Denver, Colorado.
“I mean, if you read [Cashour’s statement] straight up for what it says then how have I been doing medical cannabis research within the VA for the past ten years?” Bonn-Miller asks.
Bonn-Miller says he’s also told the Phoenix VA that the federal government’s statement prohibits research involving medical marijuana from a state-licensed dispensary, not marijuana, which, like theirs, was provided by the federal government for a federally-approved study. The VA, locally and federally, has yet to clarify or expand their statements to account for this distinction.
“It’s like they’re saying ‘you can’t do a study on oranges’ and then I’m saying ‘well, I’m doing a study on apples’ and they’re saying ‘but you can’t do a study on oranges,” says Bonn-Miller, who’s also an adjunct assistant professor of psychology at the University of Pennsylvania.
The researchers now wonder if there’s some other reason the Phoenix VA is distancing itself from their trial, such as a bias against cannabis or their team specifically. Sisley hypothesizes it’s the former after having dealt with barriers to cannabis research for nearly a decade. But Coupaud, the head of public affairs at the Phoenix VA, implied in a phone conversation with Tonic that it’s the latter:
“I do know discussing with the director of our research department here, he has concerns about the research aspect of it. For example, Dr. Sisley operates a dispensary on her own and so that’s kind of a conflict of interest in research circles…it can kind of looks bias. I mean if she says [cannabis] is helpful, it’s like, well, obviously she’s going to say that because she owns a dispensary.”
When Tonic followed up with Coupaud about this statement, he replied via email saying that he’d heard concerns about Sisley’s bias among the research community more broadly, but not from the director specifically.
Doblin says leadership at the Phoenix VA has also told him they’re concerned Sisley might be biased because she owns a dispensary. He’s clarified with them that Sisley does not own a dispensary, but rather serves as a medical consultant for dispensaries. This is a common role among cannabis researchers and something Sisley declared to the FDA. But Doblin says that even if Sisley did own a dispensary, it would not be a valid scientific reason for hesitancies about the trial because the study protocol is designed to account for bias.
Sisley, along with the rest of the team, will be “blinded,” as required by the FDA. This means the researchers don’t have any control over the PTSD symptoms veterans report before or after the trial, and they won’t know which veterans have been given placebo and which ones received cannabis. They’ve also brought Paula Riggs, a substance dependence professor at University of Colorado School of Medicine and a vocal cannabis opponent, onto the trial to ensure that it is designed to eliminate bias.
“You have to criticize the methodology, you can’t just criticize the people, because that’s the whole point of science…the methodology eliminates bias,” Doblin says.
After months of back and forth like this with the Phoenix VA, Bonn-Miller finally decided to appeal to his contacts at the federal level in the VA’s clinical research department. His email was simple: “Thoughts? I remain perplexed by the existence of legal issues here.” They replied saying they understood the situation, but would not get involved, he says.
“Local says ‘we’re not going to do it.’ Oversight says ‘we’re not going to force their hand.’ I’m stuck,” Bonn-Miller says.
The fate of the trial now rests solely in the hands of Secretary Shulkin who, like the policies of his department, has been vague about his stance on cannabis. He said at a press briefing in May that “federal law does not prevent us at VA to look at [marijuana] as an option for veterans” and that “if there is compelling evidence that this is helpful, I hope that people take a look at that and come up with the right decision, and then we will implement that.” (If the trial cannot enroll enough veterans, it will not shut down, but rather will start recruiting non-veterans with PTSD.)
Doblin said he and the rest of the team need to pressure Shulkin to tell the Phoenix VA to help them. “It’s our responsibility,” he says. “Because the VA is not doing its job.”
Meanwhile, some veterans feel like this fight is just one more development in a never-ending political saga: The government’s interference with the basic research needed to close the gap between the stories about cannabis’ efficacy and the science that could back it up.
Kiernan says that while the drama continues, dozens of vets continue to die daily from suicide and drug overdoses. Cannabis, he believes, can play an integral role in changing this, but the federal government just doesn’t care enough.
“Everyone says we need research, including the prohibitionists,” Kiernan says. “At some point we’re going to call you out on that and be like are you just being disingenuous?”