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    June 16th, 2021 

    We often encourage elected officials to follow the science on kratom, but what are some of the most impactful scientific articles for us to read and share? To help answer that question we've compiled a top ten list that kratom advocates can read and share with family, friends, and our elected officials. 

    Citation and online link: 

    Obeng, S., Kamble, S. H., Reeves, M. E., Restrepo, L. F… & McCurdy, C. R. (2020). Investigation of the Adrenergic and Opioid Binding Affinities, Metabolic Stability, Plasma Protein Binding Properties, and Functional Effects of Selected Indole-Based Kratom Alkaloids. Journal of medicinal chemistry, 63(1), 433–439.

    https://pubmed.ncbi.nlm.nih.gov/31834797/

    Wilson,  Harris, Eans, Brice-Tutt, …. and  McCurdy, Lyophilized Kratom Tea as a Therapeutic Option for Opioid Dependence, Drug and Alcohol Dependence, Volume 216, 2020.

    https://pubmed.ncbi.nlm.nih.gov/33017752/

    Behnood-Rod A, Chellian R, Wilson R, Hiranita T, Sharma A, Leon F, McCurdy CR, McMahon LR, Bruijnzeel AW. Evaluation of the rewarding effects of mitragynine and 7-hydroxymitragynine in an intracranial self-stimulation procedure in male and female rats. Drug Alcohol Depend. 2020 Oct 1;215:108235.

    https://pubmed.ncbi.nlm.nih.gov/32889450/

    Harun, N., Johari, I. S., Mansor, S. M., & Shoaib, M. Assessing physiological dependence and withdrawal potential of mitragynine using schedule-controlled behaviour in rats. Psychopharmacology, 237, 2020.

    https://pubmed.ncbi.nlm.nih.gov/31832720/

    Hassan, R., Pike See, C., Sreenivasan, S., Mansor, S. M., Müller, C. P. & Hassan, Z. Mitragynine Attenuates Morphine Withdrawal Effects in Rats-A Comparison with Methadone and Buprenorphine. Frontiers in Psychiatry, 11, 2020.

    https://www.frontiersin.org/articles/10.3389/fpsyt.2020.00411/full

    Hemby, S.E., McIntosh, S., Leon, F., Cutler, S.J., & McCurdy, C.R., Abuse liability and therapeutic potential of the Mitragyna speciosa (Kratom) alkaloids mitragynine and 7-hydroxymitragynine. Addiction Biology, 24, 2019.

    https://pubmed.ncbi.nlm.nih.gov/29949228/

    Yue, K., Kopajtic, T.A. & Katz, J.L., Abuse liability of mitragynine assessed with a self-administration procedure in rats. Psychopharmacology (Berl), 235, 2018

    https://pubmed.ncbi.nlm.nih.gov/30039246/

    Garcia-Romeu, A., Cox, D.J., Smith, K.E., Dunn, K.E. & Griffiths, R.R. Kratom: User demographics, use patterns, and implications for the opioid epidemic. Drug and Alcohol Dependence, 2020

    https://pubmed.ncbi.nlm.nih.gov/32029298/

    Henningfield, J.E., Fant, R.V., and Wang, D.W., The abuse potential of kratom according the 8 factors of the controlled substances act: implications for regulation and research. Psychopharmacology, 235, 2019.

    https://pubmed.ncbi.nlm.nih.gov/29273821/

    Henningfield, J.E., Grundmann, O., Babin, J.K., Fant, R.V., Wang, D.W. & Cone, E.J., Risk of death associated with Kratom use compared to opioids. Preventive Medicine, 2019.

    https://europepmc.org/article/med/31647958

    Grundmann, O. Patterns of Kratom use and health impact in the US—Results from an online survey. Drug and Alcohol Dependence, 176, 2017.

    https://pubmed.ncbi.nlm.nih.gov/28521200/

    Kruegel, A.C. & Grundmann, O., The medicinal chemistry and neuropharmacology of Kratom: A preliminary discussion of a promising medicinal plant and analysis of its potential for abuse. Neuropharmacology, 134, 2018.

    https://pubmed.ncbi.nlm.nih.gov/28830758/

    Prozialeck, W.C., Avery, B.A., Boyer, E.W., Grundmann, O., Henningfield, J.E., et al. Kratom policy: The challenge of balancing therapeutic potential with public safety. International Journal of Drug Policy, 2019.

    https://pubmed.ncbi.nlm.nih.gov/31103778/

    News
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    June 11th, 2021 

    WebMD has a public and influential user review section for kratom, and we need your help in adding to it! We want to double the number of user reviews by next week! Share your story on how kratom has impacted your life and then share this post!

     
     
    Also, if you haven't signed and shared our WebMD petition, WHAT ARE YOU WAITING FOR!?!:
     
    News
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    June 9th, 2021 

    Read "A Sensible, Evidence-Based Proposal for Kratom Reform"- from Bill of Health by the Petrie-Flom Center at Harvard Law School

    The FDA's war on kratom relies on the Agency's naked power, and its penchant for abusing that power, rather than on any evidenced-based science. A recent commentary by Dustin Marlan, an Assistant Professor of Law at the University of Massachusetts School of Law, is worth a read.

    Read it Here or below

    A Sensible, Evidence-Based Proposal for Kratom Reform

    By Dustin Marlan

    In May 2021, the U.S. Food and Drug Administration (FDA) announced the seizure of 37,500 tons of adulterated kratom in Florida, worth an estimated $1.3 million.

    But rather than focusing on the fact that the seized substance was adulterated, FDA Commissioner Janet Woodcock emphasized the alleged toxicity of kratom. This telling choice falls in line with recent efforts by the FDA to end U.S. kratom sales, distribution, and use, including a failed 2016 attempt to have kratom placed into Schedule I of the Controlled Substances Act, along with other federally prohibited drugs such as cannabis, psilocybin, and heroin.

    This reactionary prohibitionism is likely to do more harm than good. Moreover, it does not reflect the state of the science, which remains unsettled as to kratom’s risks and benefits.

    Kratom is an herb derived from Mitragyna speciosa, a tree native to Southeast Asia related to the coffee plant. It is estimated that between ten and fifteen million people in the U.S. use kratom, which is commonly sold as a powder or in capsules. While some states have banned kratom, in most it remains an unregulated dietary supplement, and is becoming increasingly popular. The primary effects and safety profile of its two main psychoactive compounds—mitragynine and 7-hydroxymitragynine — are controversial and the subject of intense debate.

    The American Kratom Association (AKA) and other kratom advocates, including many physicians, legislators, and public health experts, view Mitragyna speciosa as a relatively benign natural resource effective in assisting with opioid addiction and withdrawal.

    Its effects, when taken at relatively low doses, are like a mild stimulant. To the extent serious medical issues do arise with kratom use, they are, according to advocates, due to severe misuse, the combined presence of other drugs, such as alcohol or benzodiazepines, or impurities. Unlike other substances exhibiting opioid-receptor mediated effects, kratom rarely, if ever, causes respiratory depression. And while kratom may cause symptoms of withdrawal in some users, such symptoms are rarely life-threatening. Advocates generally believe the plant should be appropriately researched and regulated to assure that kratom products are pure and consumed responsibly by adults.

    On the other side are kratom’s critics. Critics claim that, at higher doses, psychoactive compounds in kratom create an addictive, morphine-like euphoria, rather than a stimulant effect.

    Former FDA commissioner Scott Gottlieb recently tweeted that he “is convinced [kratom is] fueling the opioid crisis.” Based on innovative — if somewhat dystopian — technology, the FDA simulated how kratom acts as an opioid in the body and brain. Gottlieb and other critics point out that the plant has been linked to adverse medical conditions and even, occasionally, death.

    Thus, because “no reliable evidence to support the use of kratom as a treatment for opioid use disorder and significant safety issues exist,” the FDA currently believes kratom should be classified as a Schedule I substance.

    But attempting once again to prohibit kratom would be a mistake, regardless of whether it is harmless or prone to misuse.

    If it is a safe and helpful plant medicine, like caffeine, which is derived from kratom’s relative, the coffee bean, there is no reason to schedule it. But even if kratom is a dangerous, opioid-like substance, banning it would exacerbate, rather than relieve, the overdose crisis.

    Because millions in the U.S. depend on kratom for pain relief, and especially if it causes dependence and addiction, if prohibited, individuals would be forced to turn to a heavily-adulterated illicit market, either for kratom, or more potent pain killers, like fentanyl. Forcing those who have found relief in kratom to do so is cruel and unusual, and would likely result in significant pain, suffering, and death.

    Moreover, if the FDA tried and again failed in its misguided quest to prohibit kratom, it would be an enormous setback for the agency and further erode consumer confidence. The FDA’s previous attempt to encourage the Drug Enforcement Agency to schedule kratom failed due to “embarrassingly poor evidence [and] data.” And more recent scientific research has found that kratom is “relatively safe” and can assist in reducing problematic opioid use.

    Instead of fueling the long-failed War on Drugs by repressing kratom, the FDA should strengthen consumer confidence by creating uniform federal regulations for kratom, similar to state-level legislative efforts that have been passed already. Those involved in the kratom supply chain should not be able to sell or distribute adulterated versions of the substance — impure kratom has been linked to problems including salmonella, and nickel and lead poisoning. Labeling guidelines should exist so that users are able to accurately track the amount of kratom they are consuming. Kratom brands should not be able to tout unproven claims about health benefits. Minors under the age of 18 should not be allowed to purchase kratom without a parent or guardian present.

    It is through these sorts of sensible regulations that both advocates and critics can come to a non-dualistic understanding of kratom reform, which accounts for potential risks without introducing needlessly punitive measures.

    Dustin Marlan is an Assistant Professor of Law at the University of Massachusetts School of Law.

    News
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    June 7th, 2021

    Get caught up with the kratom community!

    There's a lot happening in the kratom and AKA community. We know it can be tough to keep track of everything going on, so watch a quick recap of some of the biggest things. 

    Remember to sign and share the AKA's petition to WebMD-

     
    Just this past month we've seen the FDA take dramatic action against kratom vendors, and they're not going to stop there. We are actively working with the vendor community to make sure kratom consumers are kept safe and vendors are following the right rules to stop truth in labeling violations.
     
    Articles about recent events (FYI there is a paywall for some HBW articles)
     
    https://www.bloomandoil.com/news/american-kratom-association-helping-kratom-fend-off-fda/
     
     
    https://hbw.pharmaintelligence.informa.com/RS151362/With-Seizure-in-Florida-FDA-Targets-Kratom-As-Unsafe-For-Any-Use
     
    https://hbw.pharmaintelligence.informa.com/RS151363/Schedule-Kratom-Promoted-By-Former-US-FDA-Commissioner-Opposed-By-Former-Top-HHS-Official
     
    News
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    May 25th, 2021

    We're very excited to announce that Oklahoma is the latest state to pass the Kratom Consumer Protection Act. The Governor of Oklahoma has approved HB 1784, the Kratom Consumer Protection Act in May 2021.

    Oklahoma is the 5th state to pass the KCPA. Congratulations to the Oklahoma kratom team!

    View the whole map here

    american kratom legality and legislation 4

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    May 24, 2021

     "A Twitter Tiff Between Former Federal Health Officials Highlights the Weakness of the Case for Banning Kratom"

    Former Assistant Secretary for Health Brett Giroir says former FDA Commissioner Scott Gottlieb's support for a ban was based on "embarrassingly poor evidence."

     | 

    Scott Gottlieb, former head of the Food and Drug Administration (FDA), says he is "convinced" that kratom, a pain-relieving leaf from Southeast Asia, is "fueling the opioid addiction crisis." To the contrary, kratom enthusiasts argue, the plant is "the cure for the opioid epidemic."

    There is not much evidence to support either position. But as a recent Twitter tiff between Gottlieb and former Assistant Secretary for Health Brett Giroir shows, the argument about whether the federal government should ban kratom hinges on the question of where the burden of proof belongs.

    Gottlieb seems to think any potentially dangerous psychoactive substance should be banned unless it meets the FDA's strict criteria for approval as a medicine. If a drug is not explicitly permitted, in other words, it should be prohibited by default. Giroir, by contrast, thinks the federal government has an obligation to present compelling evidence that kratom poses an intolerable threat to public health and safety.

    Kratom—which acts as a stimulant or a sedative, depending on the dose—has been used for centuries in countries such as Thailand, Malaysia, and Indonesia to ease pain, boost work performance, and wean people from opiate addiction. In recent years, kratom has gained a following in the United States, sold by online merchants and head shops as an herbal medicine, a dietary supplement, or a legal high.

    In August 2016, the Drug Enforcement Administration (DEA), invoking its emergency powers under the Controlled Substances Act, announced that it planned to put kratom's active ingredients in Schedule I. That category supposedly is reserved for drugs with "a high potential for abuse," "no currently accepted medical use," and "a lack of accepted safety" even under medical supervision. The fact that Schedule I drugs still include marijuana, which is legal for medical or recreational use in 36 states, suggests how loosely and arbitrarily those criteria are applied.

    The DEA's announcement, which claimed kratom posed "an imminent hazard to public safety," provoked an uproar among consumers, businesses, and members of Congress, prompting the agency to backtrack two months later. Instead of imposing an emergency ban on kratom, the DEA said, it would seek advice from the Department of Health and Human Services (HHS), which includes the FDA, about how to proceed.

    Gottlieb thought the answer was obvious. In October 2017, HHS recommended that kratom join marijuana in Schedule I. But Giroir rescinded that recommendation in August 2018, saying there was not enough evidence to justify it.

    "We were prevented by HHS from moving forward with the scheduling of Kratom," Gottlieb complained on Twitter last Friday, "and I'm convinced it's fueling the opioid addiction crisis." He urged the Biden administration to proceed with a kratom ban.

    "FDA's recommendation was rejected [because] of embarrassingly poor evidence & data, and a failure to consider overall public health," Giroir replied. "If #Kratom is fueling opioid addiction, prove it; and then [HHS] should reconsider."

     

    Giroir's strong language is fully justified in light of Gottlieb's weak case for banning kratom, which leaned heavily on unverified anecdotes. The FDA claimed kratom, which according to federal survey data is consumed by about 2 million Americans every year, had been implicated in 44 deaths worldwide over nine years. But those cases typically involved multiple drugs and/or underlying medical conditions.

    In a 2018 paper commissioned by the American Kratom Association, Jane Babin, an attorney and molecular biologist, noted that "the FDA did not independently verify or perform any due diligence on the death reports" and that the "FDA's own documents indicate that every reported case involved other factors." This example, which Kayla Stetzel described in a 2018 Reason piece, gives you a sense of how rigorous the FDA's approach was:

    A 22-year-old man consumed a kratom mixture he ordered online along with an "unknown tablet." This consumption "was followed by an incident, during which the patient fell from a window of the first floor before going to bed" without receiving medical treatment. He was found dead the next morning, and the medical examiner determined that he choked on his vomit while he slept. The man had a history of mental illness, and a prescription drug history that included pipamperone (an antipsychotic used for treating schizophrenia), fluoxetine (an SSRI used to treat anxiety, OCD and depression), queiapine (another antipsychotic), olanzapine (another antipsychotic), etizolam (a benzodiazepine analog), pregabalin (a nerve pain medication often used to treat seizures), lorazepam (a benzodiazepine) and triazolam (a benzodiazepine used to treat severe insomnia that can also cause psychotic episodes). Oh, and he also used kratom. The FDA report does not discuss the extent to which these drugs may have contributed to the man's mental state, instead summarizing his demise with this line: "The patient was found dead in his bed on the morning following the consumption of an herbal mixture."

    Babin concluded that "the FDA has relied on a strategy of manipulating, obscuring, and ignoring science in its inexplicable zeal to impede public access to the natural botanical kratom." While you might dismiss that gloss as self-interested pleading by the kratom industry, it is consistent with earlier research on kratom's hazards.

    "Kratom is considered minimally toxic," noted a 2015 literature review in the International Journal of Legal Medicine. "Although death has been attributed to kratom use, there is no solid evidence that kratom was the sole contributor to an individual's death." As Giroir noted in 2018, the FDA never performed "a scientifically valid assessment of causality in the current few deaths in which kratom was co-utilized with known lethal drugs such as fentanyl."

    Even if the FDA's tally of deaths is accepted at face value, it suggests that kratom is far less hazardous than many commonly used intoxicants and medications. The FDA cited an average of fewer than five possibly kratom-related fatalities per year worldwide.

    According to the Centers for Disease Control and Prevention (CDC), alcohol causes about 88,000 deaths a year in the United States alone. The CDC counted nearly 50,000 opioid-related deaths (primarily involving fentanyl and heroin) in 2019, and it expects the 2020 total will be substantially higher. Commonly prescribed benzodiazepines such as Xanax, Valium, and Ativan were involved in nearly 10,000 drug-related deaths in 2019. Even FDA-approved, over-the-counter analgesics such as aspirin, ibuprofen, and acetaminophen are implicated in thousands of deaths a year.

    Kratom looks pretty benign by comparison. Perhaps recognizing that fact, Gottlieb is now emphasizing an alleged link between kratom use and opioid addiction. But as Giroir pointed out in 2018, the FDA never made "a scientific determination based on data" of whether kratom "actually serves as a gateway drug that promotes further use of more dangerous opioids." It had not even done "a scientific assessment of the actual scale of dependence and/or addiction" to kratom itself.

    Giroir cited an animal study that found mitragynine, kratom's main psychoactive ingredient, "does not have abuse potential and actually reduced morphine intake," which is consistent with the notion that kratom is a harm-reducing alternative to more dangerous drugs. He suggested such findings, if confirmed, indicate that kratom does not meet the "high potential for abuse" criterion for inclusion in Schedule I.

    Giroir warned that banning kratom could cause "adverse consequences" such as "intractable pain, psychological distress, [and] risk of suicide"; "transition to proven deadly opioids"; or "transition to other potent or harmful drugs." That is what he means when he refers to the FDA's "failure to consider overall public health." Giroir also worried that placing kratom in Schedule I could stifle "critical research" on kratom's "complex and potentially useful chemistry."

    Gottlieb's position, by contrast, is that kratom should be banned until someone invests millions of dollars and years of research to persuade the FDA that it is safe and effective as a treatment for a specified condition. "It's very troubling to the FDA that patients believe they can use kratom to treat opioid withdrawal symptoms," he said in 2017. "I understand that there's a lot of interest in the possibility for kratom to be used as a potential therapy for a range of disorders. But the FDA has a science-based obligation that supersedes popular trends and relies on evidence. The FDA has a well-developed process for evaluating botanical drug products where parties seek to make therapeutic claims and is committed to facilitating development of botanical products than can help improve people's health. We have issued guidance on the proper development of botanical drug products. The agency also has a team of medical reviewers in the FDA's Center for Drug Evaluation and Research that's dedicated to the proper development of drug applications for botanicals. To date, no marketer has sought to properly develop a drug that includes kratom." 

    In the meantime, even if kratom remains unscheduled, the FDA will continue to treat dietary supplements that contain it as "adulterated." The Twitter spat between Gottlieb and Giroir was prompted by the FDA's announcement that it had seized "207,000 units of dietary supplements and bulk dietary ingredients that are or contain kratom, including over 34,000 kilograms of bulk kratom." Citing "substantial concern regarding the safety of kratom, the risk it may pose to public health and its potential for abuse," Judy McMeekin, the FDA's associate commissioner for regulatory affairs, promised that the agency "will continue to exercise our full authority under the law to take action against these adulterated dietary supplements." She noted that "there are currently no FDA-approved uses for kratom."

    The FDA cannot abide the idea that Americans might use psychoactive substances, regardless of how dangerous they actually are, that have been neither approved as medicines nor, like alcohol and tobacco, explicitly exempted from scheduling. But that is exactly the opposite of the presumption that should prevail in a free society.

    JACOB SULLUM is a senior editor at Reason.

    DAYS THE FDA HAS IGNORED AKA’S MEETING REQUEST

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