Impending Ban on Herbal Painkiller Could Hamper Research

Sep 29, 2016
Originally published on September 29, 2016 5:37 pm

As of the September 30, a relatively unknown herbal supplement called kratom will likely join the ranks of Schedule 1 drugs in the U.S. - alongside drugs like heroin, LSD and marijuana.

This supplement has been traditionally used in Southeast Asia, but has recently gained popularity in the United States as a way to manage opioid withdrawal or chronic pain without the use of prescription medications.

Researchers and people using the herb decry the DEA’s move to criminalize it, which they say will stall research and deprive many Americans of a presumably harmless substitute to stronger prescription painkillers.


There is no count of kratom users in the country, but one pro-kratom petition listed on Whitehouse.gov after the DEA’s ban was announced has garnered more than 138,000 signatures in about a month. And this week, 51 members of Congress signed a letter urging the DEA to reconsider.

Kratom has been available for years at smoke shops and online retailers around the country. Retro Active Smoke Shop in Columbia, Missouri, has a regular customer base for the herb, says Jeni Slane, the manager of the store. Regulars include people like construction workers who come in every few days to buy kratom products as a way to deal with chronic pain.

Slane says that even though kratom is sold alongside other products like hookah, tobacco, and e-cigs, it is still "one of our most popular sellers."

Andrew Grafeman is the buyer for the Retro Active stores in Missouri. He says customers say the herbal supplement isn’t as addictive a prescription drugs, but still manages pain effectively.

"So it really helps in that sense – that they [kratom users] can still get that same feeling without the addiction part."

But the DEA disagrees, calling kratom an “imminent threat to public safety.” In its proposed rule published in the Federal Register on August 31, the DEA cited 15 kratom-related deaths between 2014 and 2016 and an increase in calls to poison centers about exposure to kratom as evidence of its dangerous nature.

According to DEA documents attached to their announcement, many of the kratom-related deaths between 2014 and 2016 were attributed to a mixture of drugs.

Russ Bear, a DEA spokesperson, says that anecdotal evidence from kratom users about its effectiveness doesn’t fulfill the FDA or DEA’s requirements for “approved medical use.” The DEA believes kratom needs to go through the same strict FDA approval process as other medicines intended for human consumption.

“We’re not saying kratom is more dangerous than some of your schedule 2 prescription opioids. We’re not saying kratom is as dangerous as heroin – as fentanyl,” Baer says. “We’re simply saying that at this point, until the FDA determines otherwise, fulfills the statutory criteria for a schedule 1 controlled substance.”

Those criteria include having a high potential for abuse and no approved medical uses.

There have been a few studies about kratom and its uses, but some researchers are curious about the potential uses of the compounds within kratom. In one preliminary animal study conducted at Memorial Sloan Kettering Cancer Center, a kratom-derived compound showed efficacy as a painkiller, according to Scientific American.

 

The main compounds in kratom, mitragyine and 7-hydroxymitragyine, which were singled out by the DEA’S ban, act on some of the opioid receptors in the brain. It’s similar to the effect of opioids like heroin or prescription pills, but they aren’t as strong, explains Oliver Grundmann, a professor of medicinal chemistry at the University of Florida who studies kratom.

Grundmann, and a few colleges published an article last year with information from both kratom users and enforcement agencies about what is currently known about the toxicology of kratom – and included discussions of the herb’s traditional uses and anecdotal benefits.

Grundmann stresses that the research community is just starting to take a look at kratom. “We don’t know enough about kratom, as of yet, to label it the same way as heroin,” he says.

He and other researchers would like to see more research on kratom before such a serious designation is given to the herbal supplement.

“The research community wants to know more about potential medical benefits and how these drugs actually influence the human body,” he says.

Grundmann says he understands the DEA’s concerns about another unregulated drug being on the street – especially during the current opioid epidemic. But, at the same time, he worries that by making kratom a schedule 1 drug, the DEA will make the substance completely unavailable to researchers for further study.

Once a drug is made schedule 1, researchers would have to receive special permissions from the DEA to continue study of the drug.

Other critics of the decision include the Drug Policy Alliance, which advocates for drug policy and regulation rooted in “science, compassion, health and human rights.” Jag Davies, its director of communications strategy, says the DEA’s “knee jerk” reaction to kratom could set this potentially useful drug up for the same struggles as cannabis – making it difficult to research and therefore difficult to identify medicinal uses.

“Kratom suffers the same fate that every other medicinal plant faces in the medical system,” Davies says. “Which is that there’s no financial incentive for pharmaceutical companies to put a plant that anyone could grow through clinical trials.”

Back in Columbia, Missouri, the Retro Active smoke shops are preparing for the ban. They have warned regular customers about the change by text, email and word of mouth. Andrew Grafeman, the stores’ buyer, says they are also planning to hand over their kratom stock to local law enforcement before the ban goes into effect.

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