Statement to Presidential Commission on Combating Opioid Crisis

David Herman

Chairman, American Kratom Association

Statement to the

Presidential Commission on

Combating Drug Addiction and the Opioid Crisis

August 31, 2017

Governor Christie and members of the Commission, my name is David Herman, Chairman of the American Kratom Association (AKA), a consumer advocacy group representing millions of American consumers who advocate for the freedom to make informed choices on our health and well-being, and to promote the benefits of kratom as a natural botanical alternative to chemical formulations. I am joined by thousands of AKA supporters as co-signers to this statement to the Commission to support the recommendations referenced herein.

Kratom has gained broad market acceptance in the United States, and is today consumed by millions of Americans as a part of their diet. Kratom is, in fact, a well-researched and beneficially enjoyed herbal substance that has a broad loyal following among consumers in the United States. Today, kratom consumers include Americans with disabilities, veterans of our armed forces, and consumers seeking natural and herbal alternatives for their personal well-being, including substantial numbers of consumers who find kratom useful for pain management.

Kratom (Mitragyna speciosa) is a deciduous tree of the coffee family (Rubiaceae). The kratom tree grows abundantly in tropical Southeast Asia, especially Vietnam and Malaysia. Kratom has been used for hundreds of years by the indigenous people of Southeast Asia as an herbal supplement and traditional remedy. Indeed, in that region of the world, kratom “is a part of the way of life embedded in local custom and tradition.”¹ The leaves of the plant are typically chewed, steeped into a hot tea, or dried and prepared into a dosage unit or added to a beverage.

Used in a responsible way and in moderate amounts, kratom has been reported to provide increased energy and an increased sense of well-being. Among Southeast Asian communities, kratom leaves are often used to provide analgesic and antipyretic effects.

In the Interim Report of the Commission issued on July 31, 2017, one of the key recommendations of the Commission was to identify opportunities to "combat the epidemic and enhance treatment options, including alternative pain management strategies . . .” When America was confronted with a similar crisis in the 1980s to deal with the emerging HIV public health catastrophe, the Reagan Administration challenged the FDA, NIH, CDC, and the healthcare community to do the same thing in identifying and making available alternative therapies to address that emerging crisis.

A growing body of evidence suggests kratom may be such an alternative pain management strategy, but, as is the case in many plants and herbal remedies, their effects are poorly understood. Such is the case with kratom where this plant has been demonized by false and materially misleading claims made by the FDA and DEA that incorrectly attribute adverse medical events and even deaths to kratom consumption.

KRATOM: A CASE OF MISTAKEN IDENTITY

On August 31, 2016, the Drug Enforcement Agency (DEA) published its Notice of Intent to use its statutorily authorized emergency scheduling powers to classify kratom as a Schedule I controlled substance. It was a decision predicated on inaccurate, mischaracterized, and poorly defined reports on more than 30 deaths associated with kratom consumption and concerns with what was reported to be an escalating number of adverse events associated with kratom.

None of those reports were accurate, and none relate to kratom use by consumers.

To date, there have been no reports of a fatal overdose from kratom per se.² (Raffa, 2014, and references cited therein). Although, there has been little systematic study of the pharmacodynamic effects of kratom, there is little evidence of respiratory depression and this would be consistent with the absence of documented overdose deaths attributable to kratom.

The Control Substances Act (CSA) requires the FDA and the Department of Health and Human Services Assistant Secretary for Health to collaborate with the National Institute on Drug Abuse at the National Institutes of Health on any recommendation to the DEA for scheduling a substance as provided in the CSA. Any scheduling recommendation must be based on scientifically verified and legally defensible data that documents the actual and potential for abuse, and any public health risks associated with the use of the substance proposed for scheduling.

The DEA withdrew its Notice of Intent to schedule kratom on October 13, 2016, and directed the FDA to produce the statutorily required 8-Factor Analysis (8FA) by December 1, 2016 to support any scheduling of kratom under regular scheduling procedures. As of the date of this statement, some 10 months past that deadline set by the DEA, the FDA has not produced the requested 8FA,

However, the AKA commissioned Jack E. Henningfield, Ph.D., to produce an 8FA for kratom utilizing the statutory requirements contained in the CSA that mirrors the same literature and data that would be relied upon by the FDA if they were to produce their own 8FA. Dr. Henningfield is one of the world's leading experts on addiction, and the behavioral, cognitive, and central nervous system effects of drugs. Dr. Henningfield frequently works with the FDA on issues concerning drug scheduling and addiction; has made numerous presentations to FDA Advisory Committees; and has contributed to numerous comments to the FDA on topics including prescribing opioids for chronic pain, and development and regulation of abuse-deterrent opioid formulations.

The 8FA report on kratom was produced by Dr. Henningfield and submitted to the DEA on November 29, 2016, and the entire report is included as an attachment to this statement. Significantly, Dr. Henningfield concluded as follows:

•      Although kratom and its primary alkaloids MG and 7-OH-MG share certain characteristics with controlled substances, as do many nonscheduled substances, there does not appear to be a public health risk that would warrant control of kratom products or their alkaloids under the CSA.

•      The long history of use of kratom demonstrates a pattern of use consistent with other consumer products such as coffee and botanical dietary supplements. The history of use combined with the pharmacology of kratom lead to the conclusion that kratom has a very low potential for abuse, and that its abuse potential is on par with, or lower than, other unscheduled substances.

KRATOM: A CASE FOR RESEARCHING KRATOM AS A REMEDY FOR OPIOID WITHDRAWAL

Today, millions of people in the United States consume kratom regularly, as they do other herbal supplements and traditional remedies. In addition, and of relevance to the Commission, is a substantial and growing body of evidence that has led researchers to conclude kratom may have real potential in treating opioid addiction and withdrawal. In a recent interview on PBS Newshour, Christopher McCurdy, Ph.D., a University of Florida Medicinal Chemistry researcher, discussed his research in collecting samples and studying craving for more than a decade, concluding that while there was no toxicity with the plant material itself, there is "clear medicinal potential for this to treat opiate addiction and withdrawal."^{3 4}

Dr. McCurdy’s research into kratom has been funded, in part, by the National Institutes of Health Centers of Biomedical Research Excellence⁵, and his research has produced promising results. Of significance to the Commission, Dr. McCurdy’s research has led him to conclude that kratom “is also used as a replacement for opium when opium isn’t available and has been used to wean people off (that narcotic); and that mitragynine completely blocked all withdrawal symptoms and could provide a remarkable step-down-like treatment for people addicted to hardcore narcotics such as morphine, oxycodone or heroin.”

The crisis in deaths attributed to opioid addiction requires our best efforts to identify a swift solution that applies all our collective resources to clear the way for alternative therapies using a similar model that was the catalyst in the AIDS crisis where the regulatory scheme was adjusted to allow the use of products when a reasonable judgment that some evidence of therapeutic benefit was available. Using that baseline, the AKA is hopeful we can add these essential tools to address this crisis.

As noted herein, the FDA has failed to produce its requested 8FA that was due on December 1, 2016, and the DEA maintains the posture that it is rulemaking proceeding is still "open." This has created a significant chilling effect on both consumer access to kratom products and potential research initiatives that would investigate the efficacy of using kratom as an alternative pain management therapy for opioid users. Additionally, it is our understanding that the FDA has maintained its view that kratom poses a public health threat and that has limited review of kratom products at the Dietary Supplement Office.

In a survey conducted by the Pain News Network and the AKA of 6,150 kratom consumers⁶, nine of ten reported that the herb was a “very effective treatment for pain, depression, anxiety, insomnia, opioid addiction and alcoholism.” Many other kratom consumers report the herb has allowed them to stop using opioids and even saved them from a dangerous opioid addiction. The Henningfield 8FA included patient reports documenting personal patient experiences in using kratom as an alternative pain management therapy to opioids.

We, the undersigned, petition the Commission to consider the following:

RECOMMENDATIONS:

1.      The Commission should request from NIDA a report on its existing research on the potential value of kratom as an alternative therapy to opioid addiction and pain management.

2.      The Commission should recommend that NIDA authorize additional research grants for investigations into the effectiveness of kratom use as an alternative therapy to opioid addiction and pain management, and to measure how such use of alternative therapies could reduce the deaths associated with opioid addiction.

3.      The Commission should direct the FDA to undertake a review of its current regulatory procedures to identify new potential pathways for approval of new dietary ingredient products that offer alternative therapy options for pain management for patients who otherwise would use prescription opioids, and provide recommendations for implementing these new accelerated approval pathways for such products to the FDA Commissioner at a date prior to the Commission’s Final Report to the President.

Respectfully submitted,

David Herman, Chairman

American Kratom Association

And the following AKA supporters:

(your name here)

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References:

¹      Satariya Trakulsrichai et al., Pharmacokinetics of Mitragynine in Man, 9 Drug Design, Dev. and Therapy 2421, 2422 (2015).

²  “Kratom and Other Mitragynines,” published in 2014, edited by Robert B. Raffa, Ph.D., Professor of Pharmacology in the Department of Pharmaceutical Sciences at Temple University School of Pharmacy.

³  PBS Newshour, January 15, 2017, “If kratom helps opioid addicts, why might DEA outlaw it?”

⁴  Self-treatment of opioid withdrawal using kratom (Mitragynia speciosa korth), Edward W. Boyer, Kavita M. Babu, Jessica E. Adkins, Christopher R. McCurdy, and John H. Halpern, Addiction. 2008 Jun;103(6):1048-50. doi: 10.1111/j.1360-0443.2008.02209.x.

⁵  Funding for this study was provided in part by NIDA grants DA022677 and DA014929 (P. I, Boyer); also by National Center for Research Resources grant P20RR021929 (C. R. McCurdy).

⁶  Pain News Network, Kratom Survey, https://www.painnewsnetwork.org/kratom-survey/, September 2016.

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