Sue Sisley, a primary care physician in Scottsdale, Arizona, recalls the moment she picked up the carefully wrapped package fresh from the delivery truck. Nearly two years after Sisley and her colleagues were awarded a grant to study marijuana as a treatment for 76 military veterans suffering from chronic post-traumatic stress disorder, her shipment of the drug was finally in hand.
But minutes later, as she opened the packets to weigh the drug – as required by the federal Drug Enforcement Administration – her enthusiasm turned to dismay. It didn’t look like marijuana. Most of it looked like green talcum powder.
“It didn’t resemble cannabis. It didn’t smell like cannabis,” Sisley says. What’s more, laboratory testing found that some of the samples were contaminated with mold, while others didn’t match the chemical potency Sisley had requested for the study.
There’s only one source of marijuana for clinical research in the United States. And “they weren’t able to produce what we were asking for,” Sisley says.
In January — four months and three rounds of testing after that first delivery — Sisley and researchers working with the Multidisciplinary Association for Psychedelic Studies (MAPS) were finally able to enroll their first subjects. But the delay and the reasons behind it have raised questions about the reliability of the facility responsible for supplying marijuana to every clinical study in the country.
The marijuana came from a 12-acre farm at the University of Mississippi, run by the National Institute on Drug Abuse (NIDA). Since 1968, it has been the only facility licensed by the DEA to produce the plant for clinical research. While eight states and the District of Columbia have legalized marijuana — and all but a handful allow at least some medical cannabis — growing the plant in large quantities remains forbidden under federal law. For all practical purposes, that means that any medical study that wants to use marijuana on human subjects must go through the University of Mississippi.
Rick Doblin, MAPS’ director, says this recent episode “shows that NIDA is completely inadequate as a source of marijuana for drug development research.”
“They’re in no way capable of assuming the rights and responsibilities for handling a drug that we’re hoping to be approved by the FDA as prescription medicine,” he says.
The demand for the facility’s product has surged in the past year, mirroring interest from medical researchers. Through mid-October 2016, the agency says it had fulfilled 39 requests for marijuana, from 10 different researchers. That’s a jump from the 23 requests it filled in 2015, the most recent numbers available, according to an April letter from the DEA to Sen. Elizabeth Warren (D-Mass).
A video from the University of Mississippi shows its cannabis garden.It’s unclear whether mold, lead or discrepancies in potency has been a problem in prior cannabis studies, because until now, it appears that no one looked.
NIDA says this is the first time researchers have expressed concern about mold or potency testing. Neither the agency nor the University of Mississippi tests samples for mold before they’re shipped.
Sisley says researchers have taken too much for granted. “There’s no telling how many subjects in past studies were exposed,” she says.