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The Journal of the American Osteopathic AssociationDecember 2016, Vol. 116, 802-809. doi:10.7556/jaoa.2016.156


 






 






Abstract

Kratom (Mitragyna speciosa) is a plant indigenous to Southeast Asia. Its leaves and the teas brewed from them have long been used by people in that region to stave off fatigue and to manage pain and opioid withdrawal. In a comprehensive review published in 2012, Prozialeck et al presented evidence that kratom had been increasingly used for the self-management of opioid withdrawal and pain in the United States. At the time, kratom was classified as a legal herbal product by the US Drug Enforcement Administration. Recent studies have confirmed that kratom and its chemical constituents do have useful pharmacologic actions. However, there have also been increasing numbers of reports of adverse effects resulting from use of kratom products. In August 2016, the US Drug Enforcement Administration announced plans to classify kratom and its mitragynine constituents as Schedule 1 controlled substances, a move that triggered a massive response from kratom advocates. The purpose of this report is to highlight the current scientific and legal controversies regarding kratom.






Keywords: DEA, kratom, opioid, pain management, withdrawal






In December 2012, I was the lead author of a review published in The Journal of the American Osteopathic Association that focused on an emerging botanical agent called kratom.1 The species, Mitragyna speciosa, is a tree indigenous to Thailand and other areas of Southeast Asia.2 When ingested or consumed in the form of teas, kratom leaves produce complex dose-dependent stimulant and analgesic effects.1 In Southeast Asia, kratom has been used to stave off fatigue and to manage pain, diarrhea, cough, and opioid withdrawal.2-6 Our analyses of the medical literature and websites in 2012 revealed that kratom had been increasingly used for the self-management of opioid withdrawal and pain in the United States. We also reported on the pharmacologically active constituents of kratom, most notably mitragynine, 7-hydroxymitragynine, paynantheine, and speciogynine, along with more than 20 other substances.1,3 These compounds have complex and potentially useful pharmacologic activities. In addition, we found many anecdotal reports and testimonials posted online suggesting that kratom may have beneficial effects, particularly in the management of both opioid withdrawal and pain.1 



At the time our review was published, kratom was not banned by the US Drug Enforcement Administration (DEA), although it was on their Drugs and Chemicals of Concern watch list.1,7 We summarized the potential therapeutic benefits of kratom, but we also emphasized that no well-controlled scientific studies on the safety and efficacy of kratom had been published.1 We noted an increase in the number of reported adverse effects attributed to kratom and highlighted the lack of regulation and quality-control measures in the production and sale of kratom products. Our conclusions from these analyses were that even though kratom or its active constituents could have potential for development as therapeutic agents, it would not be appropriate for physicians to recommend kratom for their patients. 



In the 4 years since the review1 was published, several major developments have been made regarding the pharmacology and legal status of kratom.8 Given the widespread use of kratom and the extensive media attention it is receiving,8-11 it is important for physicians and other health care professionals to be knowledgeable about the subject. The purpose of this review is to update readers about key developments in this rapidly evolving area. 


Legal Status of Kratom

 


The most controversial development regarding kratom is the recent decision by the DEA to classify kratom and the kratom-derived drugs, mitragynine and 7-hydroxymitragine, as Schedule 1 controlled substances.8 Over the years, kratom has been regulated as an herbal product under US Food and Drug Administration and DEA policies. As such, it has been considered a legal substance in most of the United States, although a handful of states, such as Alabama, Florida, Indiana, Arkansas, Wisconsin, and Tennessee, have recently passed legislation banning the local sale and possession of kratom.9,10 



Despite the uncertainties regarding the legal status of kratom, over the past 4 years it is apparent that kratom use in the United States has increased measurably. More than half of all literature on kratom has been published in just the past 4 years. In our 2012 review,1 we reported that a search of the US National Library of Medicine’s PubMed database, using the keyword kratom, yielded a total of 35 published articles and reviews. A similar search conducted in October 2016 showed that 44 additional articles had been published. Results of several analyses4,11,12 published within the past year indicate that large numbers of people are using kratom for the management of opioid withdrawal and pain. A cursory review of the many patient comments on websites such as The Vaults of Erowid,13 Sage Wisdom,14 and Speciosa15 indicates that many users believe that kratom has been a relatively safe and effective way to manage these conditions. However, no controlled clinical trials on the safety and efficacy of kratom have been published. At the same time, increasing numbers of adverse effects and toxic reactions associated with the use of kratom products have been reported.8,16,17 



It was in the context of these uncertainties regarding safety and efficacy of kratom that, in August 2016, the DEA announced its plans to move kratom and mitragynines to Schedule 1 status.8 This category includes drugs such as heroin and LSD, which have no valid medical uses and a high potential for abuse. The DEA’s announcement sparked vigorous opposition from many patients and patient advocacy groups who claim that kratom had helped them manage opioid withdrawal or chronic pain.9-11,18,19The advocates’ responses included a march and demonstration at the White House on September 13, 2016, and a petition with over 130,000 signatures that was sent to President Barack Obama. In addition, several congressional representatives and US senators signed letters asking the DEA to reconsider the kratom ban, which was to go into effect on September 30, 2016.20,21 In response to these challenges, the director of the DEA announced that the kratom ban would be temporarily placed on hold.21-23All of these events have received extensive coverage by news media and have raised public awareness of the issue. As a result of my familiarity with kratom, I have been contacted by several news reporters and writers for my thoughts and opinions about the kratom controversy.9-11,18,19 Even though there are far more questions than answers, I hope that I can accurately frame some of the most important questions. 



The 2 most obvious questions are “why is kratom so controversial?” and “why is the DEA planning to ban it?” From my analysis of the literature1 and the DEA’s announcement,8 it is readily apparent that the controversies and the DEA’s position are based on the reported opioidlike effects of kratom, questions about its toxicities and addictive potential, and uncertainties about its efficacy and safety in the management of opioid withdrawal and pain. 


Should Kratom or Its Mitragynine Constituents Be Classified as Opioids?

 


In describing their rationale for banning kratom, the DEA emphasized that kratom and mitragynines have been reported to produce some opioidlike effects. Most of the scientific evidence that kratom may have opioidlike activity is derived from the results of animal studies and ligand-binding studies, which have suggested that mitragynines may interact with opioid receptors.1,3,24,25 In addition, anecdotal reports and commentaries indicate that some of the effects of kratom in humans resemble those of opioid agonist drugs.4,5,26 Although no well-controlled clinical trials have been done, strong evidence demonstrates that the effects of kratom are actually quite different from those of classic opioids.4,5,26 For example, at low to moderate doses, kratom has mild stimulant properties, unlike opioids, which are mainly sedating. In addition, kratom does not usually produce an intense high or euphoria.1,2,13-15 Importantly, even at very high doses, kratom does not depress respiration.4 At the molecular level, mitragynines are structurally quite different from traditional opioids such as morphine.1,27 Moreover, recent studies indicate that even though the mitragynines can interact with opioid receptors, their molecular actions are different from those of opioids. In 2 elegant studies, Váradi et al28 and Kruegel et al29 showed that several mitragynine analogs acted as agonists at µ opioid receptors and antagonists at δ opioid receptors. Most notably, even though they activated the G-protein–mediated signaling pathway, much like traditional opioids, they did not “recruit” β-arrestin-2, which has been implicated as a mediator of opioid side effects and dependence.30Using a mouse model, Váradi et al28 showed that kratom-based drugs had marked analgesic effects but with far fewer side effects, slower development of tolerance, and lower potential for dependence than morphine. Based on all of the evidence, it is clear that kratom and its mitragynine constituents are not opioids and that they should not be classified as such. 


Is Kratom Effective for the Management of Opioid Withdrawal or Pain?

 


The current epidemic of opioid abuse and addiction in the United States has recently been highlighted in several major commentaries,31-33 and it has prompted action by the federal government and the Centers for Disease Control and Prevention. The most decisive action has been the development of new guidelines by the Centers for Disease Control and Prevention for the prescribing of opioids.34 In this environment, physicians are being discouraged from prescribing opioids, especially for long-term use, and patients with chronic pain conditions are seeking alternatives.11,12 In addition, many patients who have taken opioids for chronic pain are seeking alternatives that lack the side effects and addiction potential of opioids.11,12 Many people have turned to kratom with the belief that it may provide an effective and reportedly safe alternative to prescription or street opioids. It should be emphasized that most of these claims are on websites such as The Vaults of Erowid,13 Sage Wisdom,14 and Speciosa.15 The few scientific studies that have addressed this issue have been summaries of patient experiences or clinical reports.4,6,12 Swogger et al12conducted a systematic analysis of kratom user reports on The Vaults of Erowid website.13 Whereas some users reported negative effects, particularly nausea and vomiting, mainly from higher doses, the vast majority of users reported beneficial effects in the management of opioid withdrawal and pain, depression and anxiety. I find the many positive experiences on The Vaults of Erowid, Sage Wisdom, and Speciosa websites to be compelling. In my opinion, the therapeutic potential of kratom is too large to be ignored. Well-controlled clinical trials on kratom or the many active compounds in kratom are needed to address this issue. 



One strong piece of evidence suggesting that kratom may have extensive therapeutic potential is that several US patents have either been issued or are pending for companies and individuals who are interested in developing kratom-based drugs.35-37These patents would not have been submitted or issued unless there was evidence for medicinal applications of kratom-derived substances. 



Before considering the potential use of kratom in the management of opioid withdrawal, several major therapeutic controversies need to be addressed. Many kratom advocates have claimed that kratom is a safe and effective alternative to opioids for the management of opioid withdrawal.4,13 However, some addiction treatment specialists have noted that kratom may be a “crutch” or a “gateway” drug that can increase the likelihood that individuals will graduate to hard-core opioids such as heroin.10 In this regard, it is not clear how kratom would be any different from agents such as methadone and buprenorphine, which are widely used as maintenance agents in the management of opioid withdrawal even with their great potential for abuse.38 This issue is at the center of a major debate in addiction medicine. Should the goal of treatment be abstinence or harm reduction?39 If the goal is harm reduction, kratom may have a potential role, especially because kratom is less toxic than drugs such as methadone. 


How Serious Are the Abuse and Addiction Potentials of Kratom?

 


Studies have shown that people may seek kratom for its mind-altering effects and, with long-term use, may become dependent or addicted.25,40,41 Even though these reports indicate that the effects as well as withdrawal symptoms from kratom can resemble those of opioids, many users have reported that the subjective effects of kratom are different from those of opioids. As noted previously, low to moderate doses of kratom tend to be somewhat stimulating and do not produce the “high” or euphoric effects associated with opioids.4,12-15 In addition, many users have reported that withdrawal symptoms from kratom are much milder than symptoms from traditional opioids.4,13,41 Most notably, even at high doses, kratom does not depress respiration as do traditional opioids.4,41 Although kratom has potential for abuse and addiction, several investigators who closely examined these issues concluded that kratom is not as dangerous as traditional opioids and that the potential benefits may outweigh the risks.4,12,26,41 


Are Kratom Products Safe?

 


With the increasing use of kratom in recent years, the number of reports of adverse effects resulting from the use of purported adulterated “kratom” products has also been increasing.16,17,42,43 These reports were cited as one of the major concerns in the DEA’s decision to ban kratom.8 At low to moderate doses (5-10 g of raw leaves), the adverse effects vary markedly from one person to another, but they generally appear to be mild.1,4,16,41 The most common effects are anxiety, irritability, nausea, and vomiting.1,12,16,41 More troubling have been reports of serious toxic reactions associated with high doses or the use of concentrated extracts. Some of the reported effects include tachycardia, seizures, and liver damage.44-48 In addition, there have been several deaths attributed to the use of purported kratom products.8,16,43,49-51 



From the foregoing summary, it is understandable why the DEA would be concerned about the safety of kratom. However, several factors need to be considered in evaluating whether the DEA’s proposed ban is justified. First are the simple statistics. When it announced the decision to ban kratom, the DEA emphasized that between January 2010 and December 2015, 660 calls had been made to poison control centers regarding adverse reactions to kratom products.8 This might seem to be an alarming number, but it is rather small considering that in 2014 alone, more than 28,000 people died of opioid poisoning.52 In addition, it is not totally clear how much of a factor kratom was in the few case reports in which it was implicated as a cause of death. In most of these case reports of possible fatal reactions to kratom, the patients may have had confounding health conditions or may have been using other drugs along with kratom.1,4,26,40 One of the major problems in evaluating the potential uses and safety of an herbal agent such as kratom is the lack of understanding how substances in kratom may interact with prescription medications, drugs of abuse, or herbal supplements.1,17 



The lack of regulations and standardization of the production and sale of adulterated kratom products compounds the lack of understanding. Increasing evidence shows that unscrupulous purveyors of adulterated kratom may actually be contaminating their products with potentially toxic drugs.53-55 Probably the most notorious example of such adulteration involved a product known as krypton, which was touted as a highly potent form of kratom. It was sold mainly in Europe and was found to be a factor in at least 9 deaths.47,56 However, detailed forensic analyses revealed that krypton contained high amounts of the exogenous pharmaceutical agent O-desmethyltramadol, which has opioid and neuromodulator activity.56 Evidently, the exogenous O-desmethyltramadol had been added to the plant material. Even though mitragynine was also detected in the products, it was not determined how the 2 substances may have interacted to cause death. The key point is that without some type of standardization and quality control, people who use adulterated kratom products cannot be sure what they are taking. This is obviously a problem that needs to be resolved. Nevertheless, several scientists who have studied kratom indicate that in its pure herbal form, it appears to be relatively benign, especially in comparison with opioids such as hydrocodone, oxycodone, and heroin.4,26,57 


Discussion

 


It is readily apparent that kratom is being widely used in the United States, especially for the management of opioid withdrawal and pain. Reports from kratom users and limited basic science and clinical studies suggest that kratom and its constituent compounds may have beneficial pharmacologic effects. However, no well-controlled clinical trials have been done. In response to growing concerns about the safety and addiction/abuse potential of kratom, the DEA is planning to classify kratom and its major mitragynine constituents as Schedule 1 controlled substances despite many patient reports and a few research studies that indicate that kratom is much less harmful than prescription opioids. While it is easy to understand the DEA’s perspective, it is also easy to understand the response by kratom users and many in the kratom research community. 



One point that is very clear is that these key issues can only be resolved through additional research. However, many experienced kratom researchers have expressed concern that the DEA’s plan to move kratom to Schedule 1 will almost certainly make it more difficult for investigators in the United States to address these issues.58 In this regard, the legal situation with kratom is similar to what has happened with so called “medical marijuana,” in which federal policies, including its classification as a Schedule 1 substance, have impeded research.59 Many institutions and government agencies are reluctant to fund research on Schedule 1 substances. In addition, many practical issues complicate research on herbal products such as kratom. For example, after the publication of our review in 2012,1 one of the coauthors, Shridhar Andurkar, PhD, and I were planning on conducting basic research on the pharmacologic actions of kratom. With Dr Andurkar’s experience using animal models of opioid dependence and withdrawal, we hoped to develop a study to determine whether kratom could suppress symptoms of opioid withdrawal. However, we soon realized that this would not be an easy issue to address. Which kratom product would we evaluate? How would we confirm that the product was actually kratom? Resolving that issue would necessitate evaluation by a botanist. How would the product be standardized for activity when it contains a mixture of active compounds? One solution might be to focus on specific chemicals isolated from kratom, but then we would not be able to determine how all of the many active constituents in kratom might interact to produce effects that could differ from those of the individual constituents. Another major issue was how we would administer a plant material such as kratom to laboratory animals in a way that would naturally mimic human consumption. 


Conclusion

 


The only way kratom can be unequivocally studied is through well-controlled clinical trials in humans. Who would fund this type of study? Given that kratom is a tree, would pharmaceutical companies support such work? Would institutional review boards be reluctant to approve trials for a schedule 1 substance? Even though I have no answers to these complex questions, it is my sincere hope that this commentary will facilitate an informed discussion about kratom and foster the necessary research to resolve questions about the safety and utility of kratom in the management of opioid withdrawal and pain. If kratom contains pharmacologically active compounds (which it clearly does), it would certainly have potential toxicities. After evaluating the literature, I can reach no other conclusion than, in pure herbal form, when taken at moderate doses of less than 10 to 15 g, pure leaf kratom appears to be relatively benign in the vast majority of users. Without reported evidence, however, it would not be appropriate for physicians to recommend kratom for their patients. That said, physicians should be aware that their patients may be using kratom. 


Acknowledgments

 


I thank Victoria L. Sears; Laura E. Phelps, MS; and Peter C. Lamar, BS, in the Department of Pharmacology at the Midwestern University Chicago College of Osteopathic Medicine for their help in preparing the manuscript. 


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Chittrakarn S, Penjamras P, Keawpradub N. Quantitative analysis of mitragynine, codeine, caffeine, chlorpheniramine and phenylephrine in a kratom (Mitragyna speciosa Korth.) cocktail using high-performance liquid chromatography. Forensic Sci Int. 2012;217(1-3):81-86. doi:10.1016/j.forsciint.2011 [CrossRef] [PubMed]





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The Journal of the American Osteopathic AssociationDecember 2016, Vol. 116, 802-809. doi:10.7556/jaoa.2016.156

 

While this article by Dr. Walter Prozialeck refutes everything the DEA has used to try and make this herb illegal, the question remains: What is the DEA going to do? Will they actually listen to the people and professionals or will they remain an obstinate government organization and continue with the scheduling unimpeded?

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What Happens Next?

 

 

Due to the volume of questions we anticipate, we had this prepared by our law firm:

The DEA docket for comments closed on December 1st at 11:59pm. The docket will continue to be updated with the comments that were filed before the docket was closed, so we should expect to see additional comments added. Note, it is likely that the number of total comments submitted is not likely to be the same as the number of comments actually posted. Comments that are duplicative, contain personal privacy information or proprietary information or inappropriate language are typically not posted.

As noted in the DEA’s Federal Register notice, DEA has 2 main questions before it: Should kratom be scheduled? If so, under what process: the permanent scheduling process or the emergency scheduling process, concurrent with or followed by the permanent scheduling process. To reach a conclusion on those questions, DEA will do the following:

DEA will review all comments in the docket, review the HHS (Health and Human Services) 8 Factor analysis and scheduling recommendation, once it receives the document, and depending on the recommendation in the HHS 8 factor analysis, do it’s own analysis.

· The HHS 8 factor analysis will be completed by FDA in consultation with NIDA for review and transmission to DEA from the HHS Assistant Secretary for Health

· The Controlled Substances Act provides that if HHS recommends that a substance not be scheduled, DEA cannot control the substance.

· If HHS recommends that kratom be controlled, DEA will do it’s own analysis of the 8 factors and determine if there is substantial evidence supporting scheduling.

If DEA concludes that kratom should be scheduled, it will have to also decide what process it will follow:

· If DEA determines that it meets the criteria for emergency scheduling, it will post a new notice of emergency scheduling, announcing control of kratom in schedule I in 30 days

· If DEA determines that kratom should be controlled through the process for permanent scheduling, it will draft and publish in the Federal Register a proposal for the control of kratom in a particular schedule (I-V). That proposal will address the evidence supporting the need for control and will provide for a comment period and an opportunity to request a hearing. After the comment period closes, DEA will evaluate the comments and determine whether to grant any hearing requests. If a hearing is granted, the process for a hearing before a DEA administrative law judge will proceed – this is typically a lengthy process. If a hearing is not granted and DEA concludes that nothing in the comments has altered its proposal to control kratom, it will draft and publish a final order scheduling kratom. The order will likely provide for a 30 day period after it is published for the scheduling order to be effective.

The timing of any decision is difficult to predict at this point. Some factors that will influence the timing of any decision:

· When DEA gets the HHS recommendation and what it says (as noted above, if HHS recommends no scheduling, DEA cannot schedule the substance)

· The time it takes DEA to review all the comments. DEA has to decide what resources to put to this process – is it one person or a team of people?

· The transition to the new administration. In general, federal government agencies have been asked to delay significant regulatory actions until the new administration is in place and able to review. That being said, my sense is that some agencies are not heeding that request for certain decisions. Given the difficulty of this decision and the volume of comments, it seems that DEA will not be able to get its work done before the next administration is in place, even if it wanted to. How quickly DEA will work on this decision after the inauguration is also difficult to predict and will depend on the leadership at DOJ and DEA and the priorities for the agency.

Next thing to look for:

· The news that HHS has forwarded its analysis and recommendation. HHS is not always willing to publicly acknowledge that it has sent a recommendation to DEA. HHS and FDA typically decline to comment on whether they have finished their work and transmitted it to DEA. However, DEA has publicly acknowledged receipt of the HHS – particularly when pressed on the matter from members of Congress.

Note – Even if HHS recommends no control and DEA is barred from controlling kratom or DEA decides on its own not to schedule kratom, such a decision doesn’t close the door forever on scheduling – HHS/FDA/DEA can gather additional data and start the process all over. Or an interested party could submit a petition to DEA requesting scheduling and trigger a new review. This would be something to look out for down the road as additional data and experience on the use of kratom are developed.

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The DEA has just released its annual National Drug Threat Assessment. It's 194 pages long. And there's not a word in it about kratom!

 
By Pat Anson, Editor A steady decline in the abuse and diversion of prescription pain medication is being offset by a “massive surge” in the use of heroin and counterfeitpainkillers, according to a comprehensive new report by the U.S. Drug Enforcement Administration. The DEA’s 2016 National Dr...

The DEA’s 2016 National Drug Threat Assessment paints a stark picture of the illicit drug trade in prescription medication, fentanyl, heroin, marijuana, methamphetamine and cocaine.  Interestingly, the 194-page report doesn’t even mention kratom, the herbal supplement the DEA attempted to ban in August before postponing its decision after a public outcry.

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PLEASE SIGN THIS PETITION URGING PRESIDENT-ELECT TRUMP TO STOP THE REGULATORY ASSAULT ON KRATOM!

 

WASHINGTON, D.C. December 19, 2016  Americans who don’t want to see the Drug Enforcement Administration (DEA) and the Food and Drug Administration (FDA) prevail in the agencies’ “war” against the coffee-like herb kratom are being urged to sign a petition to President-Elect Donald Trump at http://www.PetitionTrumpForKratom.org.  The petition asks the incoming President to either halt the DEA/FDA push to criminalize kratom or to reverse any 11th hour ban that might be imposed in the waning days of the Obama Administration.

The deadline for signers to add their names to the petition is 11:59 p.m. EST on January 22, 2017.  The list of those signing www.PetitionTrumpForKratom.org will be presented to President-Elect Trump in his first full business day in office: Monday, January 23, 2017.

AKA is working hard to get as many people as possible who have benefited from kratom to share their opposition to the classification by the DEA of the coffee-like herb as a Schedule I drug. Late last month, AKA released a report by a leading addiction expert who concluded that kratom has as low or even lower potential for abuse and dependence as nutmeg and St. John’s Wort.

 

American Kratom Association Director Susan Ash said: “The kratom community in the United States is looking for ways to continue to speak out and be heard which is why we created this additional avenue to take our message to President-Elect Trump. Supporting similar petition drives, this petition makes it quick and easy to ensure our voices continue to be heard, particularly if any action occurs before the new Administration takes office.”

Ash added: “We are asking America’s incoming leader to end the unwarranted and unfair attempt to criminalize kratom and to protect those who process and sell kratom, along with the estimated three-five million consumers who benefit from it.  We urge everyone who wants to keep kratom legal to go to www.PetitionTrumpForKratom.org and sign their name.”

The petition at www.PetitionTrumpForKratom.org reads in part:

“President-elect Trump:

Your promise to end excessive government regulations and restore the limited role of government in the lives of Americans is the reason that we are appealing to you today.

The three-five million Americans who choose to use the natural herb kratom to maintain their well-being desperately need your help.  We are concerned that the Drug Enforcement Administration may soon choose to curb access to this herb.  If such an ‘eleventh hour’ step is taken during the waning days of the Obama Administration, we ask that you reverse it upon taking office.  If the DEA has not acted by January 21st, we ask that you put an end to regulatory proceedings targeting kratom.

The DEA and the U.S. Food and Drug Administration have openly declared war on kratom consumers, and these agencies are blatantly abusing their powers to criminalize both those who produce and sell kratom products, and those who purchase and consume them.  These federal regulators are doing all they can to deny American consumers their freedom to make individual choices on the safe products they want to use to maintain their health and well-being.

Despite credible evidence proving kratom is no more addictive than a cup of coffee, and its use presents no threat to the public health, the DEA and the FDA are continuing their efforts to classify kratom as a dangerous drug – with the same classification as heroin or cocaine.

Who are we?

We are veterans … and lawyers ... and factory workers … and school teachers … and health care professionals.  We are mothers and fathers … and grandparents and senior citizens. 

We are the real face of America.  Our choice to consume kratom does not make us “drug abusers” any more than drinking a cup of coffee would

Unfortunately, this regulatory nightmare for millions of Americans could get worse.  If kratom is effectively banned, the door will be open for the DEA and Food and Drug Administration to go on a “regulatory jihad” to prohibit hundreds of products and substances – such as nutmeg, hops, St. John’s Wort, and chamomile -- now widely used by Americans.  If the DEA and FDA ban kratom and take no action on other products and substances of equal or greater concern than kratom, they will be singling out kratom consumers in a grossly harsh and unbalanced manner.

A Trump Administration order for the DEA and FDA to cease the unwarranted persecution of the millions of consumers who choose to consume the botanical herb kratom would be a declaration that individual liberty will be respected in America, that consumers will have the freedom to make informed choices, and that powers of government should be restrained and used only when absolutely necessary. 

We the undersigned citizens ask for your immediate action to protect our rights and our freedoms.”

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  • 2 weeks later...

It is exactly idiots like this lady, no surprise that she works in the VA Healthcare system, spouting off ill-informed propaganda that makes it hard for people to take care of themselves as they see fit! She advocates using prescription drugs and states that Kratom costs $1000 a kilo ($30 an ounce). I have been successfully using Kratom the past 3 months for chronic pain  and am no longer on opioids. If these kind of mindless drones get what they want, myself and countess others are going to be hurt!
 

Kratom: The new alternative to opioids

Sherril Sego, FNP-C, DNP, is a staff clinician at the VA Hospital in Kansas City, Mo., where she practices adult medicine and women’s health. She also teaches at the nursing schools of the University of Missouri and the University of Kansas.

Safety, interactions, side effects
The safety of this product is definitely in question. Due to its known opioid action, addiction and overdose are easily possible. In August 2016, the DEA published a notice of intent to classify this compound as a schedule I drug.9 Due to a huge public response, however, a formal retraction of that intent was published in October 2016, pending further review.9
Regardless of regulation, kratom should be considered an opioid compound and, as such, possess all of the potential side effects and interactions of the class. Until such studies are conducted that more clearly show safety and efficacy for specific uses, there is no current indication for this compound.
How supplied, dose, cost
Kratom is widely available in the United States either online or in most ‘head shops.' It is available in a variety of forms including extract, powder, or capsule. Due to the lack of any quality control, there is no way to establish a ‘recommended dose.' Also, the concentration of the active ingredient, mitragynine, varies widely based on the form of the product. Extracts tend to be more concentrated, while powders and capsules are weaker.
Those who report sporadic use for anxiety or other episodic concerns may only use 1 to 2 g at a time, whereas daily users managing chronic pain or intense withdrawal from other opiates report using as much as 15 to 20 g or more per day. The type of product and the amount used dictate cost, with an average cost per ounce of about $30.
Summary
With the abundance of approved medications at the disposal of healthcare providers, the use of an unproven and potentially dangerous product such as kratom is not justified. However, providers must be aware of the growing use of this compound in the United States and, when opioid use is either ongoing or newly initiated, screen for use of this product.
 

Edited by swamper
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Now that it has been brought to national attention, all the do-gooders will want to promulgate the all of the false propaganda to make themselves feel better. In the case of  Florida freshman Democratic State Rep. Kristen Jacobs, she is using the suicide death of 1 person to further her political career by trying to link Kratom to the death, despite the fact that this person had several antidepressant drugs known to cause suicidal thoughts in his system, and history of substance abuse. Kratom does not make people jump off of bridges!

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On Friday, Florida Politics brought you the first look at a House bill that would add Kratom to the state’s controlled substance list.


House Bill 183 would add Mitragynine and Hydroxymitragynine, constituents of Kratom, to the schedule of controlled substances, offering an exception for any FDA approved substance containing these chemicals.


Bill sponsor Rep. Kristin Jacobs, a Coconut Creek Democrat who has filed anti-Kratom legislation in three straight sessions, framed this bill as a “fall on the sword issue” for her, while framing the Kratom lobby in the harshest possible terms.


“They have a story,” Jacobs told us Monday via phone. “Just like Hitler believed if you tell a lie over and over again, it becomes the truth.”


For Jacobs, the issue is personal: a legislative quest against a “lie machine … a powerful lobby with a lot of money,” undertaken by one representative who isn’t being backed financially to fight this issue.


“It’s not just what they’re doing here,” Jacobs said. “They’re doing [the same thing] around the country.”


Jacobs, who believes Kratom is a “scourge on society,” expects the DEA to temporarily schedule Kratom as Schedule 1 now that its period for public comment has elapsed; that would leave it up to state legislators to move toward rulemaking in the session.


Jacobs also stresses that her legislation is intended to punish the industry, not the “unfortunate people who [are] addicted.”


That said, she sees no functional difference between the use of Kratom and opiate addiction. Jacobs is comfortable talking about Kratom in the same breath as heroin and the late and unlamented pill mills.


Kratom, said the representative, “is an opiate.” And Jacobs believes it’s used because it’s legal, and “people turn to something.”


Jacobs paints nightmare scenarios: babies born with withdrawal symptoms to pregnant mothers who enjoyed kava tea during their pregnancy; emergency room physicians treating Kratom addicts who are in the throes of withdrawal symptoms.


And, implies Jacobs, it is that dependency on a drug that leads activists to mobilize in Kratom fights outside of their home areas.


“Why do addicts in Michigan care about what’s happening in Florida?”


Meanwhile, says Jacobs, “the Kratom Association stands to lose a lot of money if they aren’t able to continue profiting off the misery of addicts.”


Those “addicts with glassy eyes and shaky hands,” claims Jacobs, are having to go to the same places that sell “bongs and gasoline” for their fixes.


“How come pharmacies don’t sell it? How come GNC doesn’t sell it?”


Jacobs is girding up for a presence of Kratom advocates in Tallahassee this session, complete with “cute little t-shirts.”


Those are the tactics, the representative says, that are being used across the country.


But to her, the fight is worth it.


“How many more are going to die?”


MICHIGAN???? I wonder why she said Michigan? Hmmm


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This democrat is pure evil.  She makes rick jones and bs look like saints.. 

 

Doing the same thing over and over expecting different results, she is the definition of insane! Not to mention the absurd Hitler comment and calling the AKA a powerful lobbying group trying to get wealthy off of Kratom. Nothing could be further from the truth.

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http://www.prnewswire.com/news-releases/pinneyassociates-scientific-abuse-potential-assessment-of-kratom-finds-evidence-of-public-health-benefit-and-little-harm-300392756.html 

 

BETHESDA, Md.Jan. 18, 2017 /PRNewswire/ -- Kratom leaves, from a South East Asian tree in the coffee family, are often used to prepare tea-like beverages and commercially manufactured products which are consumed by several million Americans annually to increase alertness, enhance well-being and occupational performance, and as a natural remedy for minor aches and pains. PinneyAssociates' review of the scientific evidence regarding kratom's effects is intended to assist FDA and DEA in determining the most appropriate regulatory approach within FDA authority to permit appropriate use, minimize unintended effects, encourage research, and contribute to the enhancement of public health.

DEA had proposed placing kratom in Schedule I (which includes drugs such as heroin and LSD), the most restrictive category of the Controlled Substances Act. In practical terms, this would have banned the sale of kratom and posed a major roadblock to research. The American Kratom Association petitioned the DEA to withdraw its proposal. PinneyAssociates' was then contracted to review the available information about kratom and develop an "8-factor analysis", the legal  framework used to assess the abuse potential of substances, about kratom for submission to the FDA, DEA, and National Institute on Drug Abuse to inform the deliberations regarding regulation of kratom. See more about this in press coverage by Wired, Forbes, and the Washington Post.

One of the authors of the kratom 8-factor analysis was Dr. Jack Henningfield, Vice President of Research, Health Policy and Abuse Liability, at PinneyAssociates, and Adjunct Professor of Behavioral Biology, Johns Hopkins University School of Medicine. Dr. Henningfield commented, "It's important to understand that although kratom has some mild effects similar to opioids,  its chemical make-up is different, and it appears overall much safer, with apparently relatively small effects on respiration. In fact, kratom's  analgesic effects and impact on energy, combined with its favorable safety profile supports continued access by consumers to appropriately regulated kratom products while research on its uses continues." Furthermore, he said "surveys suggest that kratom products are used by many former opioid users as a naural remedy to help them abstain from opioids."

Dr. Henningfield concluded, "Our work on kratom is an example of how we help regulators and industry make scientifically informed decisions about the risks and benefits of pharmaceuticals and nutritional supplements. This is a key facet of the work we produce at the intersection of science and public health policy." The kratom abuse potential assessment is an example of the comprehensive abuse potential assessments and CSA 8-factor assessments that PinneyAssociates scientists develop for pharmaceutical companies to submit to the FDA in support of CNS-acting products including opioids, ADHD stimulants, anti-epileptics, and sedative sleep aids.

About PinneyAssociates

PinneyAssociates is a pharmaceutical and consumer healthcare consulting company that helps clients to reduce their regulatory risk and enhance the commercial value of their life sciences products. PinneyAssociates consults with pharmaceutical companies that market a wide variety of prescription and over-the-counter medications. PinneyAssociates' experts have extensive expertise in abuse-deterrent drug formulation evaluation, abuse potential assessment, as well as pharmaceutical risk management, Rx-to-OTC switch, and tobacco harm reduction.

For more information about PinneyAssociates, please contact us at +1.301.718.8440 or info@pinneyassociates.com, or learn more about our work at www.pinneyassociates.com

SOURCE PinneyAssociates

Related Links

http://www.pinneyassociates.com

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I'm sure that this has been noted before, but it seems like coffee, if it wasn't already so deeply ingrained in society, would be a candidate for the controlled substance list. It is already illegal for Mormons...

 

Religious zealots: I don't care what you do with your bodies. Why are you so obsessed about what I do with mine? And what is your problem with science? Could it be that it casts doubt upon your infantile religious beliefs?

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kratom's  analgesic effects and impact on energy, combined with its favorable safety profile supports continued access by consumers to appropriately regulated kratom products

 

 All well and good until we get to this part:

 

 

while research on its uses continues

 

Which tells us what exactly?

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And another Democrat, from the party of compassion, has jumped on board the "Ban Wagon."


 



Senate companion filed for controversial Kratom ban bill

One of the more controversial bills filed in the Florida House this session, a proposed ban of constituent elements for kratom, saw a Florida Senate companion emerge Monday.


Senate Bill 424, filed by Democrat Darryl Rouson, mirrors the House bill.


Both bills would add Mitragynine and Hydroxymitragynine, constituents of Kratom, to the schedule of controlled substances, offering an exception for any FDA approved substance containing these chemicals.


Selling, delivering, manufacturing, or importing these Kratom chemical constituents into Florida would be considered a misdemeanor of the first degree under either bill.


Even before Rouson’s version was filed, the House bill filed by Rep. Kristin Jacobs, a Democrat from Coconut Creek, got national scrutiny.


Jacobs, in a no-holds-barred interview with FloridaPolitics.com, compared kratom advocates to one of history’s greatest villains.


“They have a story,” Jacobs told us via phone. “Just like Hitler believed if you tell a lie over and over again, it becomes the truth.”


Contrary to the many assertions from kratom users that the herbal remedy helps them manage pain, anxiety, and other debilitating conditions, Jacobs brought forth a “kratom madness” style of rhetoric when dismissing those who use the substance.


Jacobs described kratom users as “addicts with glassy eyes and shaky hands.”


Kratom advocates forcefully countered such descriptions soon after that.


Rouson received campaign contributions in 2016 from at least one party with a vested interest in a kratom ban.


Mark Fontaine, the former executive director of the Florida Alcohol and Drug Abuse Association, gave Rouson $400.


“Caremark Rx,” a division of the CVS drugstore chain, gave Rouson $1,000.


ABC Fine Wine and Spirits, which sells liquor, gave $1,000 on two occasions during the 2016 cycle. Meanwhile, the Beer Distributors Committee, Wine and Spirits Distributors, and Southern Wine and Spirits all gave $1,000 once.


Betty Sembler, the wife of anti-cannabis crusader Mel Sembler, gave Rouson $500.


We’ve reached out to Sen. Rouson to ask if he aligns with Rep. Jacobs’ comments, and whether or not his campaign’s financial backing factored into his decision to file companion legislation to a bill bounced out of the Florida Legislature in each of the last two sessions.


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http://www.cnbc.com/2017/01/12/trump-met-silicon-valley-insiders-about-fda.html   We do have hope..

 

The two tech investors tied to Peter Thiel met with president-elect Donald Trump on Thursday, and discussed, among other things, the possible future of the FDA.

Balaji Srinivasan, CEO of bitcoin start-up 21.co, and Jim O'Neill, the managing director of investment firm Mithril Capital Management, were both scheduled to meet with Trump Thursday afternoon. Both "are being considered for positions in the FDA," incoming White House press secretary Sean Spicer said on a daily briefing call. 

Srinivasan, also a partner at venture firm Andreessen Horowitz, is an expert in the subjects of digital payments and computational biology, and teaches at Stanford University. Srinivasan's expertise in health regulation stems back to a start-up he co-founded, Counsyl, which offers DNA screening, especially for people considering having children. 

Paypal founder Peter Thiel becomes marijuana's first big investor

 A long time and marijuana industry known silicon valley marijuana advocate Jim O’Neil could be the new head of the FOOD & DRUG ADMINISTRATION (FDA).

Trump could select biotech executive Balaji Srinivasan to lead the Food and Drug Administration. Sources close to the situation add that the enigmatic Srinivasan is the second candidate for the FDA post — after billionaire Silicon Valley investor Jim O’Neill — to have strong connections to tech mogul Peter Thiel, a staunch supporter of both Trump and the legal marijuana industry.

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