In this photo illustration, capsules of the herbal supplement Kratom are seen on May 10, 2016 in Miami, Florida. Photo by Joe Raedle/Getty Images
As opioid overdoses continue to skyrocket across America, many chronic pain patients and people with addiction are seeking safer ways to cope. Too bad the feds—with a broken system for scheduling drugs of all kinds—are standing in the way.
In August, the Drug Enforcement Administration refused to move marijuana out of its most restricted category of drugs, Schedule I. And at the tail-end of that month, the agency announced plans to add Kratom—a South Asian herbal remedy that is frequently used to treat both chronic pain and addiction—to the same list. The ban could start as early as September 30, and is expected to last at least two years.
Substances included in Schedule I are said to have both a high potential for abuse and "no currently accepted medical use," and sales and possession are illegal. While some medical research can still be conducted, the bureaucratic process involved is both expensive and time-consuming, creating a catch-22 that makes "no currently accepted medical use" a self-fulfilling prophecy.
"I don't know of any instance of them reversing themselves, "Jag Davies, director of communications strategy for the Drug Policy Alliance, told me of the government and scheduling decisions. Forty-five members of Congress have written the DEA and federal officials asking them to delay the move.
Meanwhile, data favoring both marijuana and Kratom as pain-relieving alternatives to drugs like Oxycontin and heroin continues to build. First, weed: The most recent study, published this month in the American Journal of Public Health, found a 50 percent reduction in the number of drivers aged 21 through 40 involved in fatal car accidents who tested positive for opioids in medical marijuana states. A 2014 study, published in JAMA Internal Medicine, found a 25 percent reduction in the opioid overdose death rate in states that legalized medical marijuana between 1999 and 2010, a reduction that grew over the years after the state legalized. A Rand Corporation study bolstered the apparent link between greater marijuana access and reduced opioid-related deaths, while a study of Medicare claims found that spending on pain medication fell by $165.2 million in medical marijuana states.
There is much less data on Kratom, but its centuries-long history of use as a replacement for opium in South Asia is reassuring. In fact, it was banned by Thailand in 1943 because the government found that its use was cutting into opium tax revenues. A 2015 study of 293 Malaysian Kratom users found that their reliance on the drug did not interfere with their ability to function at work or at home. And while studies suggest the active ingredients in Kratom do act on the same opioid receptors associated with euphoria and pain relief affected by typical opioids and can cause physical withdrawal symptoms in chronic users, they seem to do so in a milder way.
Critically, Kratom doesn't seem to have the effect that is most likely to prove fatal in overdose: slowing respiration until it eventually stops entirely. When I spoke to Oliver Grundmann, clinical associate professor of medicinal chemistry at the University of Florida and the author of a 2016 review of the toxicology of Kratom earlier this year, he said, "Direct Kratom overdoses from the life-threatening respiratory depression that usually occurs with opioid overdoses have not been reported." This strongly suggests that the drug does not pose anywhere near the danger associated with typical opioids.
While the DEA says there have been 15 deaths associated with Kratom in the past two years— and this in the context of millions of doses floating around the US—at least 14 of them occurred when the drug was taken in combination with other substances.
So why ban it now? Part of the blame, I think, falls on media coverage like that in the New York Times, which reported in January that some in Florida's rehab community felt legal Kratom was a threat to their recovery. The paper portrayed Kratom relapsers as innocent victims of sellers who, as one woman in recovery put it, are "preying on the weak and the broken." But this is disingenuous at best: Every abstinence program and 12-step group spells out clearly that non-prescribed (and sometimes, even prescribed!) mind and mood altering substances are forbidden.
The irony here is that a relapse that occurs with Kratom is far less likely to be deadly than one with street or prescription opioids, because of its reduced effect on breathing. Ingesting large amounts of Kratom is difficult itself: It causes nausea and vomiting so that if high doses were to be dangerous in other ways, it's hard to achieve them without throwing it all back up.
Kratom is also being used by some addicted people as a form of opioid maintenance, and unlike the two proven medications for that purpose—Suboxone and Methadone—it doesn't carry a well-established risk of overdose death if it gets into the wrong hands. Obviously, much more data is needed on long-term effects, but placing it into Schedule I will impede such efforts, not energize them.
Meanwhile, the CDC has also weighed in a less-than helpful manner, reporting that calls to poison centers related to Kratom increased from 26 in 2010 to 263 in 2015 and labeling it "an emerging public health threat." In contrast, however, there were nearly 29,000 deaths involving legal and illegal opioids in 2014 (the latest data available)— and poison centers received more than 40,000 calls related to opioids between January and the end of August 2016 alone. In that context, does it really make sense to ban the less dangerous stuff first?
Fundamentally, America's regulators seem incapable of placing risks in context. They see a "new" drug "threat" and determine that it should be banned—regardless of whether it might substitute for a far more dangerous substance. They don't understand that the tools we have for dealing with psychoactive substances are not fit for that purpose.
Take the scheduling system itself: It makes no sense to declare that a drug has no accepted medical use when it hasn't first been systematically studied. By law, the DEA's hands are tied in defining an "accepted medical use." The only medications that qualify are those that have passed through the FDA's approval process, according to spokesperson Rusty Payne.
"Until the FDA tells us that it's a medicine, it meets statutory criteria for Schedule I controlled substances," he told me of Kratom. This means herbal medicines like Kratom and marijuana, which are not patentable, will probably never be federally OK for pain relief because no one seems likely to spend the billions needed to try to get FDA approval. And there's also no legal regulatory pathway for introducing a new recreational drug, if sellers wanted to go that route.
Another problem is the fact that the DEA, the agency that's supposed to enforce drug prohibition, is also in charge of deciding which drugs should be banned. "The DEA somehow retained the right to make these determinations, even though what they are is a law enforcement body and not scientific researchers or physicians," says Caroline Acker, professor emeritus of history at Carnegie Mellon University, who has studied the history of drug laws.
"Bureaucracies, once created, want to survive," Acker adds, noting that this means that they will tend to try to expand their mission, no matter what. "The do have a conflict of interest in wanting that mission to live on even if it's shown to be counterproductive or harmful."
If we want to change that and actually reduce the death toll from the opioid crisis, we need to rethink our drug scheduling system entirely. For starters, the DEA's conflict of interest means it shouldn't be tasked with determining which drugs are banned—that job belongs to scientists, not cops. Second, science (and not historical racism) should be used to develop a more sensible way to determine which recreational drugs are allowed and which drugs are safe for medical use.
Human beings are going to continue to search for and experiment with chemical ways of getting high. We can either recognize this and come up with ways to regulate it based on a rational assessment of risk, or else continue with failed policies that can't even adapt to minimize harm.
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