Study on marijuana for vets’ PTSD hits obstacles

Two major research universities have cut ties with a Valley doctor’s efforts to answer this question: Does smoking marijuana help veterans struggling with post-traumatic stress disorder?

Dr. Sue Sisley, who was fired by the University of Arizona in 2013 after her study was underway, learned in March that Baltimore-based Johns Hopkins University has dropped plans to partner on the first-ever study of cannabis for veterans.

Beyond Sisley losing a prestigious research partner, the Johns Hopkins departure means study back-

ers won’t have access to Baltimore-area veterans and must recruit study participants from Arizona.

However, Sisley’s efforts to tap veterans seeking treatment at the U.S. Department of Veterans Affairs hospital in Phoenix have gone nowhere.

“We still haven’t been allowed to get in the VA hospital,” Sisley said. “This study is actually enrolling patients after seven years of being stonewalled at all levels. A lot of people (veterans) aren’t even aware that it is underway.”

Phoenix VA Health Care System administrators told Sisley two years ago that referring veterans to her study would violate the VA’s national policy and federal law.

A Phoenix VA spokesman said this week that hasn’t changed over the past two years.

“We are not permitted to prescribe, promote or discuss the use of medical marijuana with our veterans,” said Paul Coupaud, a Phoenix VA public affairs officer.

Sisley began her study at the UA, but the school declined to renew her contract for unspecified reasons. She alleged she was let go because of political pressure from some state lawmakers, whom she had lobbied as she sought funding for the study from the Arizona Department of Health Services.

Sisley’s study is still moving ahead, for now, without the help of Johns Hopkins or the VA.

The study is sponsored by Santa Cruz, California-based Multidisciplinary Association for Psychedelic Studies (MAPS) and funded with a $2.1 million grant from the Colorado Department of Public Health and Environment.

Sisley said the main challenge is screening hundreds of veterans to find those who fit the study’s criteria.

Possible candidates must have a service-connected disability with chronic post-traumatic stress disorder. And they must be willing to commit themselves to the randomized, placebo-controlled study for 14 weeks and a six-month follow-up.

So far, the study has signed up 16 veterans, with a goal of enrolling 76 veterans by August 2018. Sisley’s Scottsdale Research Institute research team is conducting the study in a small industrial space near Deer Valley Airport. She doesn’t have a large budget, and her research team had to recruit more staffers because Johns Hopkins dropped out.

“We don’t have any budget for advertising,” Sisley said. “I’m worried we will not get all 76.”

Sisley and Rick Doblin, founder and executive director of MAPS, acknowledged that Johns Hopkins’ departure and a lack of cooperation from the VA have both been barriers.

Doblin pointed to VA Secretary David Shulkin’s remarks last month during a press briefing that medical marijuana “may be helpful” for veterans and that “everything that could help veterans should be debated by Congress and by medical experts.”

However, Shulkin also stressed that the VA is unable to prescribe marijuana under federal law.

Sisley has appealed to the American Legion, with the goal of arranging a meeting with Shulkin to discuss her study and the lack of access to the Phoenix VA.

The veterans organization has advocated for medical-marijuana research as a possible treatment for veterans with PTSD. The American Legion has requested a meeting with the Trump administration to seek loosened restrictions on federal research of marijuana, which the U.S. government groups with other Schedule 1 drugs, such as LSD and heroin, that have a potential for abuse.

Doblin said the inability to inform Phoenix VA veterans — particularly those whose PTSD has resisted pharmaceutical therapies — is a large barrier to his group’s study.

“Recruitment is the key issue for us,” Doblin said. “They will not let veterans know about the study. They say they do this because of federal law. That is absolutely absurd.”

Johns Hopkins officials said the university’s goals for the study did not align with those of MAPS.

Ryan Vandrey, the Johns Hopkins researcher who was paired with MAPS, declined to discuss why he left the study. He deferred to the university’s mediarelations department, which issued a statement.

“Johns Hopkins elected to withdraw from the MAPS study of cannabis in veterans with PTSD prior to any participant enrollment because our goals for this study weren’t in alignment,” the university’s statement read. “Johns Hopkins remains dedicated to helping military veterans, finding improved treatments for PTSD, and conducting innovative research to enhance our understanding of both the risks and benefits of cannabis/ cannabinoids.”

Johns Hopkins dropped out of the study after Sisley, in a media interview, criticized the quality of the marijuana used in the study. The federal government’s only approved source of marijuana for clinical trials is a National Institute on Drug Abuse-run farm at the University of Mississippi.

The Obama administration signaled that it would expand the number of federally-approved marijuana manufacturers, but it is unclear whether President Donald Trump’s administration will continue with that policy.

In an interview with PBS in March, Sisley complained that the government’s marijuana contained mold and lead and had inconsistent potency levels. Within days of that interview, Johns Hopkins dropped out of the study.

MAPS officials and veterans groups suspect that public criticism prompted Johns Hopkins to leave the study.

In a progress report to the Colorado state agency that is funding the study, MAPS said that it felt it was necessary to “focus both on the science and on the politics of the quality of marijuana,” but Johns Hopkins wanted to exclusively focus on the science.

Veterans groups were critical of Johns Hopkins’ decision to leave the study.

“I think they took the easy route out and decided to keep their federal relationships for money,” said Ricardo Pickering, founder of the Battlefield Foundation.

Sisley said that she, too, is focused on the science. She said she publicly criticized the quality of government-provided cannabis because she wanted to be transparent about her group’s study.

“I grind every day to make sure this study is successful,” Sisley said. “I want people to understand I am not an activist. I am a scientist. The only thing I care about is collecting objective data and getting that data in the public domain.”