Is Kratom Dangerous? Not According to the Facts.

Is Kratom Dangerous?

Not According to the Facts

The following is a copy of a letter emailed to the Editor in Chief of a certain alternative medicine website. I share his views, but the way the article was written left a significant opportunity for the anti-kratom crowd to run with the negative government propaganda. I wanted to share because, well, I spent a lot of time researching the facts inside and I thought (hope) someone may find some of them useful. Thanks for reading.

I set a reminder to come back to this tonight after reading it earlier in the day. I am not sure how many people will read this, but as an importer and vendor of kratom (I’ll remain anonymous), I have to say something. I want to first say that I commend you for specifying that this involved some sort of mitragynine drink, which I presume was not accompanied by sort of laboratory testing data or a certificate of analysis. Unfortunately, there are many who have condemned kratom altogether based on the many lies, embellishments, and overall negative propaganda the FDA has been assaulting our industry with for a long time now.

Relying on credible, empirical data from transparent sources, I have yet to find a single case of death where mitragynine was the absolute, sole cause of death. Of course I have heard of it, but never has it been verifiable by any means. Yes, I do realize this could change at any time. This hasn’t stopped the team over at the FDA from spinning stories worthy of a Pulitzer.

Every case of alleged kratom overdose shares some similarities:

  • other, often multiple, heavy recreational drugs present in the toxicology report (fentanyl being the most common) – (FOIA case 3421666 involved 10 drugs, a fall out of a window resulting in serious injury, and a subsequent refusal of medical treatment)

  • adulterated or fake kratom products, nine or so in which “kratom deaths” were actually caused by tramadol metabolite (Kronstrand et al., 2011)

  • an absence of any information that could be used to verify the case in any way

  • major discrepancies between facts proposed by the FDA and the empirical findings presented by actual experts and made available in peer-reviewed publications

  • astronomical exaggerations (when the claim is actually based on a real event)

Of course, I would be remiss if I didn’t mention the following cases in which kratom was cited by the FDA as the cause of death. The following were discovered by molecular biologist and attorney, Dr. Jane Babin (2018):

  • FDA Adverse Event Reporting System (FAERS) case #12639316, which featured 14-pages, all of which were redacted, and described cause of death as kratom overdose although the subject presented with gunshot wound(s) to the chest

  • several suicides by hanging, acute Tylenol overdose, and the use of other chemicals when no kratom was detected in the subject’s system

  • another where hanging was listed by Medical Examiner as cause of death yet the FDA blamed kratom (FAERS ID No. 12639556)

  • actual cause of death was loperamide, a/k/a Imodium (FAERS ID Nos. 12665823 and 12665824)

  • FAERS ID No. 14449343, which again redacted the fact that well over fatal amounts of U-47700, a synthetic opioid similar to fentanyl and about eight times stronger than morphine (Coopman et al., 2016), were present

  • sudden cardiac arrest caused by heart arrhythmia while swimming (FAERS ID No. 191303)

  • a polysubstance abuser with an enlarged heart died from deep vein thrombosis (FAERS ID No. 12639594)

Another case not mentioned by Dr. Babin in her paper was that involving a 25-year old from West Chester, PA, who was a long-time opioid abuser according to his parents.. The man died in a car crash, yet somehow kratom was blamed (Cook, 2018).

While the FDA has been publishing all of their fiction, actual experts have been researching the true potential of kratom. Here are just a few highlights:

  • five different, accomplished scientists found that mitragynine, the most abundant alkaloid found in kratom and the one most desired by consumers, has no abuse potential and is a valuable alternative to opioid medications (Hemby et al., 2019)

  • very accomplished kratom experts Dr. Reginald Fant and Dr. Jack Henningfield, who is also an Adjunct Professor of Behavioral Biology at The Johns Hopkins School of Medicine and VP of Research, Health Policy, and Abuse Liability at PinneyAssociates, completely discredited the FDA’s 8-factor Analysis of kratom in their own report, which was supplied to the FDA without response (Fant & Henningfield, 2016)

  • kratom researchers Dr. Marc Swogger, Dr. Jack Henningfield, and seven other doctors addressed the House and Senate to officially propose anti-kratom legislature and dispel the FDA’s myths (Henningfield et al., 2018). This letter has gone unanswered.

  • despite the FDA’s stories of “kratom psychosis,” the leaf has actually shown great potential as an anti-psychotic and could serve as an alternative to current typical and atypical anti-psychotic prescription medications (Weihrich, 1982), but without the side effects of tardive dyskinesia (TD), risk of dementia, increased cholesterol, and reduced white blood cell count associated with these FDA-approved drugs

  • mitraphylline, another kratom alkaloid, proved to be toxic to cancer cells (Gaveau et al., 2014)

  • mitragynine may be an effective treatment for depression and was found to be equally as beneficial as fluoxetine (Prozac) and amitriptyline (Elavil) (Farah Idayu et al., 2011)

  • the kratom leaf has proven to be a great anti-inflammatory (Kong et al., 2011) and antimicrobial agent (Parthasarathy et al., 2009)

  • the hematological profile of long-term kratom users is the same as those who have never used it (Singh et al., 2018)

I don’t want to get into conspiracy theories here, but I do want to point out that Congress receives an incredible amount of donations from most of the pharmaceutical industry. The Kaiser Family Foundation has put together some figures and more are available through OpenSecrets and Political Money Online. The most aggressive anti-kratom presence at the FDA was former commissioner, Scott Gottlieb.

He was one of the founders of the FDA’s “profits over people” generic drug user fee program (Sullivan, 2018), opposed prescription drug price regulations and government assistance in paying for medications (Gottlieb, 2016), and fully supports a complete kratom ban (no reference needed – just Google “Gottlieb kratom”).

Any anti-kratom legislation would be, if anything, a benefit to the pharmaceutical industry as they are currently working on the most cost-effective method of extracting mitragynine for use in future prescription drugs (Spetea & Schmidhammer, 2019).

On another note, Thailand will soon be decriminalizing kratom. According to their Justice Minister, this should have actually taken place on June 10th (Laohong, 2020), although I don’t speak Thai or know much about Thai legal research so it is difficult to find proof that it officially took place yet.

Again, the reason I am writing this is to emphasize the importance of critical thinking and researching source credibility because our right to choose to use kratom, a leaf with hundreds of years of safe usage behind it internationally, is under real threat of being taken away by a government that claims to protect us. In my position, it is my family’s livelihood at stake, and there are other very honest and transparent vendors out there like me. This type of flagrant misrepresentation and spreading of fictional science is insulting to our intelligence, in my personal opinion of course, and, in a perfect world, we would be able to hold these agencies accountable. Until that ever-elusive day, the least I can do is help spread the truth.

Thank you for your time and, if anyone is reading, please never blindly accept things as fact, even if they come from your government. Keep thinking critically.

References

Babin, J. (2018). FDA Fails to Follow the Science on Kratom [White paper]. Retrieved fromhttps://docs.wixstatic.com/ugd/9ba5da_54f08e1805c34c108ad7199481507d88.pdf

Cook, B. L. (2018, June 28). Caleb J. Sturgis, 25, care manager for the deaf, dies in car accident. Retrieved from https://www.inquirer.com/philly/obituaries/caleb-j-sturgis-25-care-manager-for-the-deaf-dies-in-car-accident-20180628.html

Fant, R., & Henningfield, J. (2016). Assessment of Kratom under the CSA Eight Factors and Scheduling Recommendation (p. 126) [8-factor Analysis]. PinneyAssociates. Retrieved from https://www.pinneyassociates.com/wp-content/uploads/2017/07/Kratom-8-Factor-by-PinneyAssoc-11.28.16.pdf

Farah Idayu, N., Taufik Hidayat, M., Moklas, M. A. M., Sharida, F., Nurul Raudzah, A. R., Shamima, A. R., & Apryani, E. (2011). Antidepressant-like effect of mitragynine isolated from Mitragyna speciosa Korth in mice model of depression. Phytomedicine, 18(5), 402–407. https://doi.org/10.1016/j.phymed.2010.08.011

García Giménez, D., García Prado, E., Sáenz Rodríguez, T., Fernández Arche, A., & De la Puerta, R. (2010). Cytotoxic Effect of the Pentacyclic Oxindole Alkaloid Mitraphylline Isolated from Uncaria tomentosa Bark on Human Ewing’s Sarcoma and Breast Cancer Cell Lines. Planta Medica, 76(02), 133–136. https://scihub.wikicn.top/10.1055/s-0029-1186048

Gaveau, D. L. A., Sloan, S., Molidena, E., Yaen, H., Sheil, D., Abram, N. K., Ancrenaz, M., Nasi, R., Quinones, M., Wielaard, N., & Meijaard, E. (2014). Four Decades of Forest Persistence, Clearance and Logging on Borneo. PLOS ONE, 9(7), e101654. https://scihub.wikicn.top/10.1055/s-0029-1186048

How Regulatory Barriers Inhibit Pharmaceutical Competition, 14 (2016) (testimony of Scott Gottlieb). Retrieved from https://www.aei.org/wp-content/uploads/2016/10/HELP-Written-Testimony-FINAL-10-7-16.pdf

Hemby, S. E., McIntosh, S., Leon, F., Cutler, S. J., & McCurdy, C. R. (2019). Abuse liability and therapeutic potential of the Mitragyna speciosa (kratom) alkaloids mitragynine and 7-hydroxymitragynine: Kratom abuse liability. Addiction Biology, 24(5), 874–885. https://scihub.wikicn.top/10.1111/adb.12639

Henningfield, J. E., Swogger, M. T., Walsh, Z., Kruegel, A. C., Grundmann, O., Garcia-Romeu, A., Raffa, R. B., Griffiths, R. R., & Brown, P. N. (2018, June 21). Kratom Scientist Letter to US House and US Senate Leadership June 21 2018.pdf. https://www.americankratom.org/images/file/Kratom-Scientist-Letter-to-House-and-US-Senate-Leadership-June-21-2018.pdf

Kong, W. M., Chik, Z., Ramachandra, M., Subramaniam, U., Aziddin, R. E. R., & Mohamed, Z. (2011). Evaluation of the Effects of Mitragyna speciosa Alkaloid Extract on Cytochrome P450 Enzymes Using a High Throughput Assay. Molecules, 16(9), 7344–7356. https://scihub.wikicn.top/10.3390/molecules16097344

Kronstrand, R., Roman, M., Thelander, G., & Eriksson, A. (2011). Unintentional Fatal Intoxications with Mitragynine and O-Desmethyltramadol from the Herbal Blend Krypton. Journal of Analytical Toxicology, 35(4), 242–247. https://scihub.wikicn.top/10.1093/anatox/35.4.242

Laohong, K.-O. (2020, January 16). Somsak: Medical kratom to be legal soon. https://www.bangkokpost.com/thailand/general/1836609/somsak-medical-kratom-to-be-legal-soon

Parthasarathy, S., Bin Azizi, J., Ramanathan, S., Ismail, S., Sasidharan, S., Said, M. I., & Mansor, S. (2009). Evaluation of Antioxidant and Antibacterial Activities of Aqueous, Methanolic and Alkaloid Extracts from Mitragyna Speciosa (Rubiaceae Family) Leaves. Molecules, 14(10), 3964–3974. https://scihub.wikicn.top/10.3390/molecules14103964

Singh, D., Müller, C. P., Murugaiyah, V., Hamid, S. B. S., Vicknasingam, B. K., Avery, B., Chear, N. J. Y., & Mansor, S. M. (2018). Evaluating the hematological and clinical-chemistry parameters of kratom (Mitragyna speciosa) users in Malaysia. Journal of Ethnopharmacology, 214, 197–206. https://scihub.wikicn.top/10.1016/j.jep.2017.12.017

Spetea, M., & Schmidhammer, H. (2019). Unveiling 7-Hydroxymitragynine as the Key Active Metabolite of Mitragynine and the Promise for Creating Novel Pain Relievers. ACS Central Science, 5(6), 936–938. https://scihub.wikicn.top/10.1021/acscentsci.9b00462

Sullivan, T. (2018, May 4). United States House of Representatives Passes PDUFA. Policy & Medicine. https://www.policymed.com/2017/07/united-states-house-of-representatives-passes-pdufa.html

Weihrich, H. (1982). The TOWS Matrix—A Tool for Situational Analysis. Long Range Planning, 15(2), 54–66. Retrieved from https://www.frontiersin.org/articles/10.3389/fphar.2016.00464/full

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