Nearly a year after the Drug Enforcement Agency announced it would allow more organizations to grow cannabis for sanctioned studies, there’s still only one federally authorized cultivator in the United States.
The agency has received 25 applications from interested cultivators, according to DEA spokeswoman Katherine Pfaff. All of those applications are still being processed, she said, with no estimate for when any decisions might be made.
“Because this is a new registrant category, DEA cannot speculate on a timeline for each application,” Pfaff said.
Meanwhile, as more states legalize both medical and recreational cannabis, demand for research into the plant’s potential benefits and harms continues to grow.
Eight researchers requested and received supplies of marijuana for testing in 2015, according to the National Institute on Drug Abuse, with many asking for multiple shipments during the year. That number rose to 17 researchers in 2016. And nine have already requested shipments halfway through 2017.
There’s also growing demand for more potent cannabis, more diverse strains and higher quality products than what researchers can currently get their hands on.
Since 1968, the University of Mississippi — operating under a contract with National Institute on Drug Abuse — has had a monopoly on growing cannabis to supply researchers doing studies on people, which must be approved by the Food and Drug Administration. The university in 2015 went through a competitive bid process and once again won the contract, which is valued at $68 million.
The DEA said it’s never turned down a qualified request for cannabis research, with plans to grow 901 pounds of marijuana for studies in 2017. And the NIDA says it typically ships supplies to researchers within a few weeks.
But scientists have long complained that the cannabis being supplied by Ole Miss isn’t great. John Hudak, a senior fellow with the Brookings Institution who specializes in marijuana policy, pointed out there are no federal standards or quality control tests in place. And of course there aren’t any market forces at play, since no one else can legally cultivate cannabis for research.
The pot hit the fan this spring, when PBS ran a story about Arizona researcher Sue Sisley’s attempts to study how medical marijuana help veterans with PTSD. Sisley said the government-approved weed she received was weak and moldy. And photos of the supply look more like dried thyme than the chunky, dark green cannabis flowers on sale at dispensaries.
“The levels of THC and CBD in cannabis that is now available to researchers are much lower than those of cannabis sold in dispensaries around the country,” said Dr. Daniele Piomelli, a professor at UC Irvine who studies marijuana’s effect on the body. “This creates a big problem: how relevant to the real world are the studies we can do now?”
Amid mounting pressure, the DEA said last August that it wanted to increase the number of cultivators registered to grow marijuana for authorized research. But that news was delivered at the same time the agency announced it was once again denying requests to take marijuana out of the Controlled Substances Act’s Schedule I, a category used for the most dangerous drugs that have no medical value. So instead of that day’s headlines being just about the lack of scheduling change, many articles included a positive turn on the DEA eliminating its cultivation monopoly.
“They were clearly trying to blunt the impact of the rescheduling denial,” Hudak said.
Since he believes ditching the monopoly was more about political pressure than a change of heart on the DEA’s part, Hudak said he’s not at all surprised that there hasn’t yet been any forward motion on actually allowing more people to grow marijuana for research.
The agency also gave itself lots of wiggle room. Hudak pointed out that the DEA only said they “could” grant additional grow licenses, not that they “would.” They also didn’t give any deadlines or much in the way of specific criteria that would be taken into consideration for applicants to get the green light.
Individuals or institutions interested in applying for a license to grow research cannabis must submit a nonrefundable $3,047 fee, lengthy documentation and fill out a four-page form, which includes providing proof of a state license to cultivate cannabis and answering questions about past drug convictions. The instructions note that prior drug crimes won’t automatically disqualify applicants, but “may weigh heavily against” them. Since cannabis is a Schedule I drug, they also have to agree to a particularly strict set of guidelines for record keeping, facility security and more.
The DEA is “not at liberty” to provide the names of the 25 individuals or companies that have applied to become registered marijuana growers, Pfaff said. The agency also declined to provide general information about the applicants, such as where they come from or what type of organizations they represent.
Most of the applicants aren’t talking either — something Hudak said is probably wise.
“The DEA can be vengeful,” he said. “If I were applying, I would keep my head down and not politicize this.”
Brad Burge, spokesman for the Multidisciplinary Institute for Psychedelic Studies, said his Santa Cruz-based nonprofit submitted an application about two months ago in partnership with Lyle Craker, a professor of plant and soil sciences from the University of Massachusetts at Amherst.
Craker and MAPS first applied in 2001 to grow cannabis for research. They waited three years for a decision only to be told in 2004 that the DEA had turned them down. They appealed that denial with help from the ACLU, but the DEA turned them down two more times. Craker and MAPS finally sued the agency, but an appeals court rejected the lawsuit in 2013.
Not having a variety of high-quality cannabis products readily available has had a “chilling effect” on research, Burge said, with many scientists not even applying to study the plant since they know they won’t be able to get useful supplies.
If the DEA approves their new application, Burge said Craker aims to oversee a marijuana farm at his university that will allow them to quickly supply specific types of cannabis at low cost for qualified studies.
“We want to be able to provide any strain that researchers want,” he said.
Piomelli is also interested in becoming a licensed cultivator down the road. But the doctor hasn’t submitted an application either, with plans on hold as he works to launch an interdisciplinary cannabis research institute at his Irvine university.
Many other likely candidates are being cautious.
The Humboldt Institute for Interdisciplinary Marijuana Research has no plans to apply, according to Prof. Joshua Meisel. Neither does Boston’s McLean Hospital, which boasts a Marijuana Investigations for Neuroscientific Discovery team.
Researchers at UC San Diego’s Center for Medicinal Cannabis Research haven’t decided whether they want to seek a license. Neither has the team at UC Davis, which is widely known for its agriculture programs.
“Before we move forward with any research, we want to be sure we are following all the proper processes set forth by state and federal agencies,” UC Davis spokeswoman Kimberly Hale said.
Given Attorney General Jeff Session’s staunch opposition to marijuana, Hudak said he suspects officials such as DEA Chief Chuck Rosenberg are less anxious than ever to stick their necks out on this issue.
But if the agency keeps dragging its feet while applications and the clamor for research continue to mount, he predicts legal challenges will come.
“You’re going to get to the point where someone is going to crack and someone is going to say, ‘I’m going to sue the DEA,’” Hudak said.
Original article via TheCannifornian