Last week, the Obama administration announced a major step forward in medical marijuana research regulations — or, so it seemed.
While the Drug Enforcement Agency neglected to deschedule marijuana as a Schedule I drug, a move many in the medical and political community were hoping for, the agency did promise to improve access to researchers studying the plant. At first, scientists applauded the move, excited to finally expedite sorely-needed studies. But then they heard the details.
“DEA has concluded the best way to satisfy the current researcher demand for a variety of strains of marijuana…is to increase the number of federally authorized marijuana growers,” the agency wrote in its August 12 statement.
To researchers, this is actually the least important roadblock facing them. Ryan Vandrey, a professor of psychiatry and behavioral sciences at Johns Hopkins University, has been studying cannabis for years, but he’s never needed much marijuana to accurately study the drug.
“The problem is not a lack of supply, it’s the regulatory hoops we have to jump through to obtain it.”
In his current collaborative study of marijuana’s affects on PTSD symptoms, Vandrey said he only needs 20 grams of the drug to conduct experiments.
“[Adding growers] will make very little change going forward in my research,” he said. “The problem is not a lack of supply, it’s the regulatory hoops we have to jump through to obtain it.”
Of course, jumping through hoops is standard in any scientific research process. But Vandrey said this process is unnecessarily laborious for cannabis studies.
First, researchers go through the regular steps to approve any drug research: Secure grant funding, obtain a scientific review of the study’s merits, and get approval from an ethics board and the Food and Drug Administration.
But to study marijuana, which is still categorized as a narcotic with no accepted medical use by the DEA, a researcher must obtain a Schedule I license both from the federal government and from the state where the study is located. To do so, a lab must met stringent requirements like having a safe to store the drug that is bolted to the ground — something Vandrey said few facilities, aside from major research hospitals like his, can afford.
The Schedule I license approval process can take up to a year. Then, the DEA analyzes the study itself, along with the “scientific merits” of the researcher.
“My last study took a year and a half to be approved,” Vandrey said. “And now I’m waiting again.”
Any small change in the study requires another lengthy reevaluation from the DEA, a process that has forced Vandrey to put his current project on hold. And the feds don’t make this process easy, either.
“Not only do we have to jump through regulatory hoops to do our science, but there’s also no time limit on the DEA to review our work,” Vandrey said. “I’ve been on the phone with the DEA every day, checking on the status. They’d never call us.”
Last week’s announcement was far from a solution, Vandrey said. Real change, he added, would come in the form of descheduling the drug and creating an entirely separate entity to control it, like how alcohol is currently regulated in the United States. Or, if that’s too big of a jump, the government could simply rewrite the rules around marijuana research — even while it remains a Schedule I drug — to simplify researchers’ access.
To Vandrey, this isn’t about the quickest path to legalization. In fact, he’s actually concerned that so many states have already legalized a drug that has been so poorly studied.
“We have a crazy problem. States have legalized this drug without the existence of adequate data on its safety as a form of medical treatment,” he said. “We have an inordinate amount of anecdotal reports. I am sympathetic to the people who have found it to help cure medical symptoms, but we are going about this in a unsafe matter.”
Which is, ironically, why the DEA refused to deschedule marijuana in the first place. “There are no adequate safety studies; there are no adequate and well-controlled studies proving efficacy; the drug is not accepted by qualified experts; and the scientific evidence is not widely available,” wrote DEA head Chuck Rosenberg in last week’s release. But he did not explain how these studies could exist with such stringent regulations keeping researchers waiting months for a green light.
There is no other type of scientific research that requires a sign-off by a non-scientific agency like the DEA.
However, researchers aren’t fighting alone. Despite last week’s decision, lawmakers continue to push for access to medical marijuana research with active legislation. One of these bills, introduced by Sen. Brian Schatz (D-HI) in June, would streamline the research approval process by placing time limits on agencies’ review time.