NEW YORK -- If the road to legally selling marijuana at convenience stores were like a row of dominos, the first tile to fall would be doing the research necessary to better understand its effects on the human body.
Unfortunately, two new, seemingly contradictory federal rules approved by the U.S. Drug Enforcement Administration (DEA) could slow that process. One rule that emerged last week was designed to allow for more studies, according to an article in Live Science. A second ruling that emerged last week denied two petitions from state governors to lower marijuana’s status as a “Schedule I” drug. That move essentially maintained current restrictions on federal funding for marijuana research.
Convenience-store retailers are watching as states one-by-one legalize medicinal and even recreational marijuana, They envision the day when they can sell the new subcategory of OTP. They may even be encouraged with at least one of the DEA's recent rulings, because even as the DEA upheld current research restrictions, it simultaneously appeared to soften its rules—specifically, allowing more universities to apply to grow marijuana intended for use in medical studies, the report said. As of now, only the University of Mississippi, Oxford, Miss., is allowed to grow and supply marijuana for research in the United States.
In its original wording, the rule “severely constrains the access and the number and type of people who can do research with cannabis,” said Ryan Vandrey, an associate professor of psychiatry and behavioral sciences at The Johns Hopkins University School of Medicine, Baltimore. “The unfortunate result of that is that we’re now in a situation where you have literally millions of people using a drug for which we don’t have established safety or efficacy data.”
Marijuana's illegal status makes it very difficult to carry out rigorous studies on the drug, the report said, especially the type of studies that are needed to definitively test its merit as medicine.
“Every research protocol we design and want to do has to go through a number of extra regulatory approval before we can do them,” Vandrey said. “The consequence of that is we have major delays in getting done what we need to get done.” The supply of marijuana available for research—which the new rule seems to address—doesn’t change any of that, he said.
Vandrey said it took him a year and a half to get all of the necessary regulatory approvals for a recent medical-marijuana study involving 76 people at two research facilities. Larger studies involving more hospital sites (the kind of studies that are generally looked upon as a gold standard for research in testing out any new drug) would be incredibly difficult, he said.
The new policy allowing more universities to apply to grow marijuana “doesn’t change how easy research generally is, because it doesn’t change the regulation required for research,” Vandrey said.
Jacci Bainbridge, a clinical pharmacy specialist at the Skaggs School of Pharmacy, University of Colorado Anschutz in Aurora, Colo., agreed. The new DEA policy “might not make it more feasible to do the research, because there are other regulatory hurdles … that may prevent you from doing the research the way you would want to do it,” Bainbridge said.
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