For decades, American researchers had to use only marijuana grown at a facility in Oxford, Mississippi. A few other approved producers have been added in recent years.
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For decades, American researchers had to use only marijuana grown at a facility in Oxford, Mississippi. A few other approved producers have been added in recent years.
Brad Horrigan/Hartford Courant/Tribune News Service via Getty Images
As the Biden administration moves to reclassify marijuana as a less dangerous drug, scientists say the change will lift some of the restrictions on the study of the drug.
But the change won’t lift all restrictions, they say, nor will it diminish the drug’s potential risks or help users better understand what those risks are.
Marijuana is currently classified as a Schedule I controlled substance, defined as a substance with no accepted medical use and a high potential for abuse. The Biden administration this week proposed classifying cannabis as a Schedule III controlled substance, a category that recognizes that it has certain medical benefits.
The current Appendix I status places many regulations and restrictions on scientists’ ability to study weeds, even as state laws increasingly make them available to the public.
“Cannabis as a Schedule I substance is associated with a number of very, very restrictive regulations,” says neuroscientist Staci Gruber of McLean Hospital and Harvard Medical School. “You have very strict requirements, for example, for storage and security and reporting of all these things.”
These requirements are set by the Food and Drug Administration, the Drug Enforcement Administration, the Institutional Review Board and local authorities, she says. Scientists interested in studying the drug must also register with the DEA and obtain a state and federal license to conduct research on the drug.
“It’s a tedious process and it’s certainly a process that has prevented a number of fairly invested young researchers from pursuing (this kind of work),” Gruber says.
The reclassification of the drug to Schedule III places it in the same category as ketamine and Tylenol with codeine. Substances in this category are used medically in the United States, have a lower risk of abuse than in higher categories, and abuse could lead to low to moderate levels of dependence on the drug.
This reclassification constitutes “a very, very big paradigm shift,” believes Gruber. “I think it has a big trickle-down effect in terms of perspectives and attitudes in terms of what the real differences are between the study of Schedule III substances versus those in Schedule I.”
Gruber welcomes the change, not least because of what it will mean for his younger colleagues. “For researchers who want to get in the game, it will be easier. You don’t have to have a Schedule I license,” she says. “It’s a big problem.”
The rescheduling of cannabis “will also result in more research into the benefits and risks of cannabis for treating medical conditions,” Dr. Andrew Monte wrote in an email. He is associate director of Rocky Mountain Poison and Drug Safety and an emergency physician and toxicologist at the University of Colorado School of Medicine.
“This will also help improve the quality of research since more researchers will be able to contribute,” he adds.
Senate Democrats are holding a news conference Wednesday to outline new, less strict marijuana laws. From left: Senators Cory Booker of New Jersey, Majority Leader Chuck Schumer of New York and Ron Wyden of Oregon.
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Tom Williams/CQ-Roll Call, Inc via Getty Imag
Senate Democrats are holding a news conference Wednesday to outline new, less strict marijuana laws. From left: Senators Cory Booker of New Jersey, Majority Leader Chuck Schumer of New York and Ron Wyden of Oregon.
Tom Williams/CQ-Roll Call, Inc via Getty Imag
But the classification change won’t significantly increase the number of sources of the drug for researchers, Gruber says. For 50 years, researchers were allowed to consume cannabis from only one source: a University of Mississippi facility. Then, in 2021, the DEA began adding a few more companies to this list of approved sources for medical and scientific research.
Although she expects more sources to be added over time, she and many researchers she knows have yet to benefit from the recently added sources because most have limited products.
“And what we haven’t seen is the ability of researchers – cannabis researchers, clinical researchers – to study the products that our patients and our recreational or adult consumers are actually using,” she adds. “It remains impossible.”
There is very little information known about the composition of cannabis products currently on the market. Some studies show that the level of THC, the main intoxicant in marijuana, sold to consumers today is significantly higher than what was available decades ago, and high levels of THC are known to present more health risks.
And Monte cautions that the reclassification itself does not mean cannabis poses no health risks. Monte and his colleagues documented some of these risks in Colorado by studying people who showed up to emergency rooms after using cannabis. Intoxication and cyclical vomiting (cannabinoid hyperemesis syndrome) and alarming psychiatric symptoms such as psychosis are among the main problems that land some marijuana users in the hospital.
Cannabis research has lacked monitoring of these kinds of impacts for decades, he says. And rescheduling the drug will not fill this “gaping hole in risk monitoring,” he writes.
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