GREAT FALLS — One month ago, we published an article about the Cascade County Substance Abuse Prevention Alliance’s plan to deliver letters to retailers in Great Falls, asking them to reconsider selling Kratom in their stores. A lot of people reached out to us advocating for Kratom and/or voicing their disagreement with some of the information in that story. We heard you.
There’s a lot that we don’t know about Kratom - possibly even more than we do know.
We know that Kratom is a plant that’s native to some Southeast Asian countries such as Thailand and Indonesia. We know that it first made its way into the United States sometime in the 1970s, when American soldiers in the region brought it back home with them following the end of the war.
Kratom users and activists claim that Kratom has many benefits, including relief from acute and chronic pain, and use as a healthier alternative to opioids.
While the FDA does not support those claims, and parties on both sides of the debate agree that further clinical testing and scientific studies are needed, there are a number of studies that support claims that, at certain doses, Kratom could be beneficial in several capacities.
Furthermore, researchers concluded that Kratom leaves exert a “dose-dependent and complex range of pharmacological effects.” While there are alkaloids in Kratom that these studies describe as similar to opioids, it is also important to note that some of the alkaloids found in the plant are either poorly characterized, or not yet identified.
But what about the deaths? Yes, there are plenty of recorded deaths, both in the United States by the Food and Drug Administration, and overseas in countries like Sweden. However, in a study titled “The medical chemistry and neuropharmacology of Kratom: A preliminary discussion of a promising medical plant and analysis of its potential for abuse,” Neuroscientist Andrew Kruegel from Columbia University in New York and Dr. Oliver Grundmann, a professor of Chemistry at the University of Florida’s College of Pharmacy assert that there is a knowledge gap when it comes to the effects of the two main alkaloids found in Kratom, mitragynine and 7-Hydroxymitragynine, and that, based only on isolated human observations, the best that scientists can do at this point is hypothesize about the addictive potential of Kratom plant extracts. They go on to claim that, to date, no human fatality can be solely attributed to the ingestion of Kratom.
Mac Haddow with the American Kratom Association (AKA) addressed a cluster of nine deaths in Sweden in 2009 that were originally attributed to Kratom. In 2011, Swedish researchers concluded that it was an adulterated version of Kratom called “Krypton” that was responsible for those nine deaths. The main difference between Kratom and Krypton is that Krypton includes the opioid analgesic O-desmethyltramadol, which Haddow says is not found in pure Kratom.
“If you were to use that same dosage of O-desmethyltramadol and put it in a cup of coffee or a glass of orange juice, you would be dead in minutes,” explained Haddow. “So, the idea that the FDA would take an adulterated death, product death, and then say we’re going to ban the underlying, otherwise safe product, makes no sense from a public policy standpoint.”
The claims that Kratom is an “otherwise safe product,” are controversial, and would immensely benefit from further research by federal agencies like the FDA or the National Institute on Drug Abuse. In fact, The NIDA awarded researchers at the University of Florida College of Pharmacy a $3.5 million grant in December 2018 to further research on Kratom, and its potential to treat opioid misuse and physical dependence.
Advocates hope that these studies are a step towards gaining a better understanding of Kratom, and convincing the FDA to conduct additional studies on the plant.
There have been discussions about scheduling Kratom several times, which would place it on a list of drugs that have a high potential for addiction, and are considered dangerous for consumption.
The argument against scheduling actually comes from both sides of the debate.
“Right now, the Kratom has been on the DEA's radar to make this a schedule one controlled substance for some time,” said Cascade County District Judge Greg Pinski. “And we're worried about if that occurs, which, there are certainly some people who believe that it should, that that's going to add a market for it that is going to impact the law enforcement community.”
On one hand, the argument is that scheduling Kratom would prevent further scientific studies from being done, which could increase the amount of adulterated Kratom that is purchased and sold illegally around the country. Pro-Kratom advocates hope that by avoiding scheduling, those same scientific studies will take place, and prove that, at certain doses, Kratom does have a place in the pharmaceutical industry, and could start being prescribed by healthcare professionals.
That’s a huge “if”, because it would mean that not only was Kratom not scheduled by the DEA, but it also underwent extensive scientific research, likely over a period of many years. Then, the use and prescription of Kratom products would have to be heavily regulated by the FDA, as other drugs and supplements are.
The natural question that arises from this situation is, “why has the FDA insisted on scheduling Kratom instead of committing to further research?”
When the FDA submitted their scheduling request to the DEA in 2016, Kratom consumers across the country spoke out. Then, 51 members of the U.S. House of Representatives, 26 Republicans and 25 Democrats who wrote a letter to the DEA objecting to the scheduling recommendation and disputing the scientific basis for it.
“On one hand, you had Senator Bernie Sanders, who’s probably the most liberal member of the United States Senate, and then-Senator Orrin Hatch, who was probably at the time the most conservative,” explained Haddow. “So, it wasn’t a philosophical issue, it was about the regulation and about the science.”
The DEA declined to schedule Kratom at that time. Since then, the FDA has resubmitted an 8-factor analysis to the DEA (which has been scrutinized by several members of the scientific community), asking them, once again, to schedule Kratom. That came in November 2017, and to this day, the DEA has not taken any action to move forward with the scheduling of Kratom.
The American Kratom Association argues that, if Kratom were as potentially dangerous as the FDA claims that it is, the DEA would have taken action within a short period of time, as they typically do with scheduling requests from the FDA.
Dr. Deborah Rose, an addiction medicine specialist at Benefis Health System, is not in favor of Kratom use in the pharmaceutical industry, but says that she would support further research on the plant.
“The biggest problem is that there is no quality control,” said Dr. Rose. “This isn’t like getting something, even at a health food store, where some of the products actually, on the label, will have the labs or whatever. Those are standardized to an active ingredient. For example, if you were using...Valerian Root, for example, it’s standardized to have x-percent of the dried root in the product, and that’s how you know that there’s some quality control and standards. With Kratom, there isn’t that.”
She explained that she would like to see more testing and the standardization of manufactured products before she could even consider Kratom as an alternative to any other medication.
She admitted that, while she has seen some negative reactions from patients taking Kratom, she only sees a subset of the population; those that have struggled or are currently struggling with drug abuse.
“There’s an individual constellation of factors that adds to that (drug addiction), so if you don’t have any of those risk factors in your life, and you had a safe product, maybe you could use it every now and then,” she said. “If you’re someone who has a history of problems with drinking or gambling or addiction to drugs, it may never be a safe thing to use.”
From a law enforcement perspective, Kratom is legal in 44 states, although legislation both for and against Kratom has been considered recently in several states.
That, plus the complicated mix of information available online, muddies the relationship that drug task forces have with Kratom.
Great Falls Police Department Trainer Coordinator Lieutenant Doug Otto explained that one area of concern for the GFPD is the ease of access for anyone under the age of 18. In Tennessee, Kratom is legal, but only for residents over the age of 21. In Illinois and New Hampshire, the age restriction is 18 (except for the city of Jerseyville, IL, which interestingly enough banned Kratom within city limits.)
“You find youth that experiment with things or you find people that are experimenting with things and not getting the desired effect of something that they want, they may overdo it and overdose, they may go into a state where they’re operating a vehicle, they’re doing risky behavior, obviously, that is of concern,” explained Lt. Otto. “We want to make sure that people are educated that it’s out there, that there are properties on it, that the information that is on the internet and any of the studies that are there, it’s a wide piece, so there’s a lot of work still to be done on the research on it and what the levels are of it to really get people to understand more about it.”
Judge Pinski says that Kratom is very easy to obtain within the county, and he’s concerned about the potential effect it could have on people at higher doses. The lack of quality controls also concerns him, just like it does Haddow and the AKA.
That’s what might be the most fascinating piece in this whole controversy. No one seems to be against federal regulation when it comes to Kratom. In fact, if the FDA, DEA, and the National Institute on Drug Abuse were able to come together and complete comprehensive scientific studies on the addiction potential of Kratom, and at what dosage it can be used safely and effectively, it’s possible (I said possible, not guaranteed by any stretch of the imagination), that every person mentioned in this article could come to an agreement on the role that Kratom plays in the pharmaceutical industry.
In statistic reports provided to MTN by the Judge Pinski, the crime lab in Cascade County reported a consistent year-over-year increase in the number of DUID’s (Driving Under the Influence of Drugs) involving Kratom. From 2 in 2017, to 6 in 2018, to 17 in 2019. That being said, according to the DUID laws on the EMS.gov database, in Montana it is unlawful for any person who is under the influence of a “dangerous drug” to drive a vehicle, or for any person under the influence of “any other drug” that drive a vehicle.
While reports differ and people will claim to either strongly agree or disagree with this, pro-Kratom advocates claim that Kratom is, in fact, not a drug at all. Without further research to confirm or deny those claims (or the claims of people who are anti-Kratom and say that it is a drug), the definition of a “dangerous drug” does not seem to entirely fit when it comes to Kratom, calling into question the validity of the numbers above.
All things considered, the problem with Kratom in Montana, in the United States, and in the entire world, is that we don’t know what we don’t know, and without ongoing scientific studies to help us know more, we are stuck in a grey area from both a legal and a medical standpoint.
But there is hope for the science.
“The research is needed, and it is ongoing right now, funded by the National Institute on Drug Abuse, to the tune of 15 million dollars a year, and more studies are in the pipeline,” said Haddow. “In the FY (fiscal year) 2020 budget, there was an additional allocation made for Kratom research, including clinical trial work, so we need to do an investigation to determine whether or not a use of Kratom at high levels is a non-addictive, powerful and effective formula to manage pain as an alternative to opioids.”
Not an answer just yet, but a step in the direction of one.