April 22, 2018
What does the future hold for kratom in the U.S.? Right now, it seems like the issue has come to a stalemate between federal agencies pushing for a ban, and the millions of people attesting to kratom’s positive medicinal properties.
When asked, kratom users praise it’s medicinal qualities, providing a natural alternative for potentially dangerous prescription drugs for relief of anxiety, depression, pain, and opiate withdrawal. However, some high-ranking government officials argue that kratom is a deadly opioid, and is as dangerous and addictive as heroin.
In February, the U.S. Food and Drug Administration announced that kratom has “opioid properties” and claimed it had been associated with 44 deaths between April 2011 and December 2017. FDA Commissioner Dr. Scott Gottlieb’s statement claimed that the agency used scientific research and computational modeling technology to conclude that kratom has “potential for abuse, addiction and serious health consequences, including death.” Further claiming that one case of death showed no “historical or toxicological evidence of opioid use, except for kratom.”
After Gottlieb’s public statement vilifying kratom, nine addictive behavior scientists sent a letter to DEA Acting Administrator Robert W. Patterson, stating that the FDA’s conclusion was wrong in connecting kratom and opioids and there remains no proof that kratom alone caused any deaths. Dave Herman, Chairman of the nonprofit American Kratom Association, states”The 44 deaths are not attributable to kratom,” adding that an estimated 3 to 5 million people in the U.S. have used the supplement. “The FDA is saying people died and they found kratom in their system. It’s like if I drank a Coke and got hit by a truck. There’s not even one death from kratom.”
The FDA’s recent criticism of kratom has caused a few members of Congress to speak out in favor of its use to treat opioid addiction. In his report, Gottlieb said that kratom is not an FDA-approved supplement, a message regurgitated from a public health warning last November when he linked kratom to 36 deaths and rejected it’s positive use for opioid withdrawal. Just a month later, Jared Polis, a Democratic congressman from Colorado, signed a bipartisan letter, asking Gottlieb to rescind this absurd health warning on kratom, citing that the “beneficial potential, safety, and efficacy of kratom has been discussed, studied, clinically researched, and found to be as safe as coffee” according to studies funded by the National Institutes of Health.
In 1012 the FDA put kratom on an “import alert” for unapproved drugs. Since kratom is a natural botanical, the agency can only restrict its sale if it is proven to be dangerous, or is marketed as a medical treatment. Without definitive proof that kratom is dangerous, the agency proceeded to temporarily label it as a “suspicious substance”, banning imports into the U.S. in 2014, and seizing 25,000 pounds in Los Angeles. Fast forward to 2016; the DEA had plans to place the “active materials” in kratom (the alkaloids mitragynine and 7-hydroxymitragynine) into the Schedule I of the Controlled Substances Act to “avoid an imminent hazard to public safety.” This proposed scheduling was met with considerable opposition from advocates, and the DEA withdrew its efforts, and proceeded to ask the FDA to conduct medical and scientific evaluations.
The FDA continues to desperately cling to its belief that kratom is dangerous, partly because of a computational model that uses the Public Health Assessment via Structural Evaluation (PHASE) method. This method uses 3-D technology to simulate the effect of a chemical at the molecular level in the body and brain. Using the data from their PHASE model, they claim that kratom alkaloids are predicted to have the same effect as opioids – allowing the claim that kratom is a dangerous opioid, and furthering the idea that it should be put on the controlled substance list.
The information reported to the FDA regarding the deaths involving kratom is limited. Many cases concluded “could not be fully assessed” because of lacking information. The “few assessable cases” show kratom was combined with prescription opioids, benzodiazepines and other otc medications. Dave Herman, of the American Kratom Association (AKA), is frustrated by the FDA’s claims. “Kratom is not an opioid,” Herman says. “The FDA just needs a victory in the ‘War on Opioids’ and we have been deemed a part of that. But we we should be part of the solution.”
Former National Institute on Drug Abuse addiction expert, Jack E. Henningfield, now works for the health consulting group Pinney Associates and contracts with the AKA. He believes that the conclusions made from the scientific studies managed by federal agencies are wrong. Henningfield believes that Dr. Gottlieb isn’t being well advised, as the FDA has not provided evidence from human clinical trials or laboratory studies that prove kratom mimics the ‘narcotic-like opioids’ that lead to addiction or death. Henningfield, along with millions of advocates, see potential in kratom to help relieve opioid addiction and believe banning the herbal botanical would create a black market trade without any federal regulation.
While the PHASE method used by pharmaceutical companies can estimate receptor binding qualities, the data doesn’t support the actual effects of the substances. For example, two FDA-approved over-the-counter medicines: Imodium (for diarrhea) and dextromethorphan (in cough suppressants) bind to the body’s opiate receptors like the deadly drugs heroin and fentanyl. However, these substances vary widely regarding the risk of addiction or death.
On Feb. 26, 2018, Gottlieb made another public declaration, reiterating that “kratom is not a safe, benign plant” and that vendors should not be misleading people into using it as a remedy to relieve pain or opioid addiction. “On the contrary, we have concerns that for some, kratom can become a gateway to continued addiction to opioids; or prevent some people from seeking safe and effective treatment for their addiction,” Gottlieb said.
The FDA claims to continue to review research and other literature about kratom, but there seems to be no available research to date that has changed its opinion that this natural substance is dangerous enough to require adding it to the list of schedule 1 drugs. Following the FDA’s lead, the DEA has listed it as a “drug of concern“, and kratom advocates and organizations like the AKA continue to work towards protecting our right as American citizens to use kratom, a natural botanical.
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