The first controlled clinical trial of medical marijuana to treat post-traumatic stress disorder (PTSD) in U.S. military veterans is in jeopardy if the Phoenix Veterans Administration Health Care System doesn’t participate with patient recruitment efforts, a lead researcher for the study said.
Arizona-based scientists have almost completed research with 22 veterans and now need to screen 6,000 to 8,000 vets to enroll an additional 54 qualifying PTSD patients in order to move the study forward, according to an Aug. 21 letter sent to VA officials by Dr. Sue Sisley, site principal investigator with Multidisciplinary Association for Psychedelic Studies (MAPS), administrator of the federally approved study.
“There will be no improvement in veteran volunteers until the Phoenix VA hospital agrees to start cooperating with us,” she wrote in the letter shared with The Cannabist. “They have blocked access to appropriate Phoenix-area veterans with PTSD for the past two years now.”
Phoenix was chosen as an investigation site because the city’s VA hospital has the highest density of treatment-resistant PTSD patients: those who continue to suffer symptoms despite undergoing VA-administered medical treatment and/or therapy, Sisley told The Cannabist in a phone interview. But hospital officials have been uncooperative in helping inform veteran patients about the study or referring them to the research team, she said.
“All we get from them is polite responses about marijuana being federally illegal,” she said.
Sisley spoke to The Cannabist late last week from Reno, Nevada, where she was attending the American Legion’s national convention. She had hoped to meet with VA Secretary Dr. David Shulkin to follow up on an Aug. 6 letter she sent him requesting his intervention with Phoenix VA Health Care System director RimaAnn Nelson.
“We are asking for your assistance in ordering the VA in Phoenix to allow us to … share vital information about how veterans suffering with treatment-resistant PTSD may be able to volunteer for this research,” Sisley wrote to Shulkin in the letter shared with The Cannabist.
That meeting with Shulkin didn’t materialize, but MAPS researchers did receive a critical boost from the country’s largest veterans service organization. The American Legion passed a resolution Thursday urging the federal government to “permit VA medical providers to be able to discuss with veterans the use of marijuana for medical purposes and recommend it in those states where medical marijuana laws exist.”
Attempts in Congress to pass legislation or budget amendments lifting restrictions on VA doctors to discuss medical marijuana with their patients and make recommendations have thus far fallen short.
Other VA facilities are more open to learning about the MAPS study and exploring the possibility of patient referrals for her clinical trials, Sisley said. Researchers have also reached out to other veterans service organizations to find volunteers who would meet her study’s exacting requirements. But so far Sisley feels her efforts have been stymied by a combination of politics and the stigma still surrounding marijuana – and she’s frustrated that a groundbreaking study is being hobbled by VA lip service.
“If Shulkin doesn’t intervene here, this will be a classic example of science being shackled by politics,” Sisley said. “I hope he’ll call the Phoenix director.”
Shulkin’s public remarks on the issue of medical marijuana indicate he’s still on the fence. During his “State of the VA” address at the White House in May, Shulkin said that while federal law currently prevents the VA from looking at medical cannabis as an option for veterans, he believed that “everything that could help veterans should be debated by Congress and by medical experts.”
Veterans organizations that support the MAPS study are less diplomatic regarding the obstacles facing research.
Last April, the American Legion sent a letter to the White House requesting marijuana be rescheduled under the Controlled Substances Act to open more opportunities for research into its medical efficacy for treating vets suffering from traumatic brain injury and PTSD.
“It’s time the federal government took action to remove barriers to scientific research on this very important subject,” Joe Plenzler, American Legion director of media relations, previously told The Cannabist.
Sean Kiernan, president of the Weed for Warriors Project, accused the Trump administration of stonewalling legitimate efforts by the VA to examine medical marijuana’s benefits for veterans.
“Without help from the VA, this study won’t get done,” he said in an email to The Cannabist. “To a lot of us veterans and their loved ones, it’s unconscionable.”
The MAPS study is believed to be the first and only randomized, placebo-controlled trial looking at the efficacy of smoking cannabis for treating PTSD. It is funded by a $2.156 million Colorado marijuana research grant and has earned the approval of the Drug Enforcement Administration, the Food and Drug Administration and the National Institute on Drug Abuse.
This isn’t the first setback the MAPS study has faced.
MAPS started planning the study in 2009. At the time, Sisley was a psychiatrist on the faculty of the University of Arizona. In 2012, their research proposal was approved by that university’s scientific review board. But in 2014, the university fired Sisley and said her position as a physician educator for medical marijuana would no longer be funded.
The study moved forward under MAPS, and after receiving funding from Colorado, Johns Hopkins University joined the study in September 2015. However, in March the Baltimore university pulled out of the study without enrolling any veterans. Researchers had hoped to draw from Maryland’s large population of veterans, but a dispute reportedly arose over federal drug policy, and whether to openly challenge federal rules on medical cannabis research.
For medical marijuana advocates such as Kiernan, the time for talk is over. Action is required, he said, calling the current death rate among U.S. veterans, “the existential crisis of a generation.”
By Weed for Warriors’ estimates, America loses more than 15,000 veterans each year to overdoses and suicide, he said.
“My fellow veterans are going to need to take a long hard look at what the Trump administration has done to help veterans, and admit his accomplishments so far are pretty flimsy to nonexistent — or worse, potentially harmful,” he said.
Original article via TheCannabist