The US Drug Enforcement Administration plans to name a new Schedule I drug: a Southeast Asian plant known for its opiate-like effects called kratom. The move may slow down medical research into a promising painkiller, or discourage it altogether.
Schedule I is the DEA’s most restrictive classification, and places kratom alongside heroin, LSD, ecstasy, and marijuana, which the agency says have no acceptable medical uses. The reason is "to avoid an imminent hazard to public safety," the agency says.
Kratom has been consumed in Southeast Asia for centuries, either as a tea or a powder. The plant, which is related to coffee, contains alkaloids that bind the same opioid receptor as morphine, meaning it can treat pain. But that’s not all. Kratom can also be a mild stimulant in small doses and it may help people with addiction, depression, anxiety, and PTSD, according to the American Kratom Association, an organization founded in 2014 to represent kratom users. Most of these reports, however, are anecdotal.
In fact, there isn’t a lot of information on kratom — positive or negative. "We just don’t know very much," says Andres Roman-Urrestarazu at the University of Cambridge, who has researched kratom. "Without any evidence it’s very difficult to make a scientific assessment" either in favor or against the plant.
The DEA and the Food and Drug Administration, which oversee dietary supplements, have had kratom on their radar for years, according to Russ Baer, a DEA spokesperson. The DEA says the plant is addictive and possibly fatal. In its proposed rule for listing the plant as Schedule I, the DEA noted that there have been 15 deaths linked to kratom since 2014. "[The decision is] based on evidence that we’ve collected from the medical and scientific community throughout the world in terms of deaths associated with kratom," Baer tells The Verge. "It also relates to the potential for abuse and the trends associated with the abuse."
"Without any evidence it’s very difficult to make a scientific assessment."
The ban could go into effect on September 30th and last two to three years — unless more medical research is conducted in the meantime to prove that kratom has medical benefits. "That’s hopefully the pathway by which we’ll determine conclusively whether or not kratom is a medicine," says Baer. "We can’t make those determinations through public opinion and anecdotal evidence."
Some experts say that there’s not a lot of hard scientific evidence on the drug, positive or negative. But kratom does look promising, says Edward Boyer, a professor of emergency medicine at the University of Massachusetts Medical School, who’s done research on kratom. The plant acts like an opioid painkiller without one of the worst side effects: difficulty breathing. In opioid overdoses, patients stop breathing. But when rats were given kratom’s major chemical compound (called mitragynine) in substantial doses, they breathed freely. The results suggest that kratom could one day be developed into a pain medication that doesn’t pose the same risks as opioids. "I think it’s worthy of additional scientific research," Boyer says.
The DEA is creating a sort of Catch-22
The problem is that once a substance is listed as Schedule I, doing medical research with it becomes tricky. So the DEA is creating a sort of catch-22, sabotaging its own need for more rigorous scientific research into kratom by making the plant illegal. "The Schedule I status has historically made it more difficult for researchers to gain access to the compounds," says Brad Burge, the director of communications and marketing at the Multidisciplinary Association for Psychedelic Studies (MAPS), a nonprofit that supports scientific research into psychedelics. "The DEA’s rule to schedule it to make it less available is just completely opposed to the best interest of research and completely opposed to the best interest of public health."
Many government organizations, like the National Institutes of Health, and other funding agencies are more cautious about funding studies on Schedule I drugs, says Burge. And that’s the primary way that DEA’s scheduling undermines scientific research. "Clearly the stigma associated with a Schedule I drug can make it more difficult for funding," Burge says. (That’s not true for marijuana, Burge says. MAPS, for example, has a $3.1 million grant from the state of Colorado to study marijuana for the treatment of PTSD.) And when the research is funded by the NIH, the focus of the research is mostly on the illicit drug’s risks or abuse, rather than its potential benefits, says Jag Davies, the director of communications strategy at the Drug Policy Alliance.
To do research with illicit drugs, scientists also have to get permission from the DEA and submit a "research protocol" detailing what security precautions are being used. Burge says the DEA has gotten better at approving these research requests in recent years, but some of the requirements are burdensome. The DEA requires Schedule I drugs to be stored in special ways, like in a refrigerated safe that’s bolted to the floor with an alarm, Burge says. That can be costly. For one of their MDMA studies at MAPS, researchers had to spend $40,000 worth of additional equipment to store the drug in a DEA-approved way, Burge says. Those kinds of sums could scare off small research institutions.
Some DEA requirements are burdensome
"Researchers are perfectly capable of doing everything the DEA needs for the license to be granted," Burge says, "but it is an extra step."
And that extra step can take time — and slow down research. Mitul Mehta, a researcher at King’s College, London, says that similar requirements on Schedule I drugs in the UK have delayed one of his researches on psilocybin, a psychedelic found in mushrooms, by as much as eight months. "It’s just more bureaucracy," Mehta says.
Others don’t think that scheduling drugs has such high repercussions. Marijuana is a Schedule I drug, but that hasn’t stopped researchers from looking into it, says Roman-Urrestarazu. "Yeah, it’s gonna be a little bit more complicated, it’s gonna be a little bit more bureaucracy, but it’s not something that I think might affect the research on what kratom is. That’s just nonsense," he says. "If there is an interest in the research community in doing so, there will be research."
America faces an opioid crisis: 78 people die daily of overdoses, which is four times as many as in 1999. That means that alternatives for pain that don’t have the same risks are urgently needed. And the possibility that kratom might help people leave their addictions behind makes it seem even more promising as a target for research. So many researchers are wondering why the DEA has chosen Schedule I, instead of a less-restrictive classification. "By restricting our research really you’re restricting the potential for discovery of compounds which could benefit patients who are severely ill," Mehta says.