Tuesday, February 20, 2018

Federal Agency Kills Kratom


By Dr. Mercola

The U.S. Food and Drug Administration (FDA) is continuing its crusade to take down kratom (Mitragyna speciosa), a plant in the coffee family that’s earned the reputation for being an alternative to opioids. Native to tropical Southeast Asia, people in the area have used kratom leaves as an herbal remedy for centuries not only to relieve pain but also to increase energy and enhance well-being.

According to the American Kratom Association (AKA), a grassroots advocacy organization that is trying to keep kratom legal, kratom is not a drug, an opiate or a synthetic substance. In fact, they state it’s more like coffee and tea than any other substances. That said, kratom binds to some of the same opioid receptor sites as opioid drugs, which may be why many people find it so effective.

“Chocolate, coffee, exercise and even human breast milk hit these receptor sites in a similar fashion,” AKA notes.1 The FDA, however, in their latest statement against this age-old plant, is using this fact to “underscore its potential for abuse” and otherwise warn people to stop taking the remedy.2

FDA Says Scientific Analysis Provides ‘Even Stronger Evidence’ Against Kratom

In November 2017, the FDA issued a public health advisory regarding risks associated with kratom use, suggesting that its usage could “expand the opioid epidemic.” The FDA claimed at the time that calls to U.S. poison control centers regarding kratom increased tenfold from 2010 to 2015 and said 36 deaths were associated with the use of kratom-containing products.3

They also cited “serious side effects” like seizures, liver damage and withdrawal symptoms associated with its use although, as the Huffington Post noted, “[T]hese potentially deadly symptoms don’t appear in any sort of discernible pattern in the cases the FDA cites, and they’re not well-documented elsewhere.”4 In February 2018, the FDA’s latest warning was released, this time with supposedly “even stronger evidence” of kratom’s potential for abuse.

The agency tested kratom using its Public Health Assessment via Structural Evaluation (PHASE) methodology, a 3-D computer program normally reserved for evaluating the abuse potential of newly identified street drugs. The technology looks at how a substance is structured at a molecular level, how it might behave inside your body and how it may affect your brain.

When testing kratom, the FDA analyzed the 25 most prevalent compounds in the plant, concluding “all of the compounds share the most structural similarities with controlled opioid analgesics, such as morphine derivatives.” They then moved on to determine the plant’s potential targets in the body, predicting that 22 of the 25 compounds bind to mu-opioid receptors and two of the top five most prevalent compounds in kratom activate opioid receptors.

“The new data provides even stronger evidence of kratom compounds’ opioid properties,” the FDA said, noting that some of the compounds may bind to receptors in the brain that impact neurologic and cardiovascular function, which they said could contribute to side effects like seizures and respiratory depression.

In addition, the agency said kratom binds strongly to mu-opioid receptors, “comparable to scheduled opioid drugs.” Taken together, the FDA then decided that kratom should be deemed a drug: “Based on the scientific information in the literature and further supported by our computational modeling and the reports of its adverse effects in humans, we feel confident in calling compounds found in kratom, opioids.”5

Yet, as kratom researcher Andrew Kruegel, a Columbia University chemist, told the Huffington Post, “They don’t have to do this to claim that kratom is an opioid, because it is … But the question is whether it’s an atypical opioid, which is my preferred terminology. Does it have a better side effect profile than the classical opioid drugs like morphine that we use every day? That’s the key question here.”6

Kratom Has Mild Risks Compared to Opioids

In August 2016, the U.S. Drug Enforcement Administration (DEA) issued a notice saying it was planning to ban kratom, listing it as a Schedule 1 controlled substance. Massive outrage from kratom users who say opioids are their only alternative followed, including a petition with over 140,000 signatures against it, so the agency reversed its decision.

But the FDA’s latest warning seems to be a clear push to make kratom illegal in the U.S. after all. It’s a sad fact that more than 91 Americans fatally overdose on opioids every day,7 and of the more than 33,000 Americans killed by opioids in 2015, nearly half of them involved a prescription for the drugs.8 Yet, the FDA allows opioids to be dispensed with abandon while now singling out kratom, which many believe to be a safer alternative for those struggling with chronic pain or even opioid addiction.

AKA points out that kratom’s risk profile appears far safer than that of opioids or even other pain relievers like acetaminophen. In November 2016, AKA also released a report by Jack Henningfield, Ph.D., vice president of research, health policy and abuse liability at PinneyAssociates, concluding that there is “insufficient evidence” for the DEA to ban or restrict kratom under the Controlled Substances Act (CSA).

The report, which includes more than 50 pages of testimonies from responsible kratom users, analyzed the eight factors of the CSA, concluding the DEA had no grounds for CSA scheduling of kratom, let alone a ban:

"Based on all lines of evidence considered in the 8-factor analysis, kratom's potential for abuse, tolerance, and dependence is lower than that of many schedule IV and V drugs and is well within the range of many nonscheduled drugs and substances (e.g., caffeine, nasal nicotine spray, fluoxetine, bupropion, dextromethorphan).

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."9

In fact, AKA noted that according to Henningfield’s analysis, “[K]ratom’s potential for abuse and dependence is no greater than such widely used and unscheduled substances as “nutmeg, hops, St. John’s Wort, chamomile, guarana and kola nut.”

Are Kratom Deaths Really Caused by Kratom?

The latest FDA statement cited 44 deaths related to kratom, up from the 36 cited in November. Yet, a closer look at the deaths reveals, at best, sloppy reporting and, at worst, a tendency to blame kratom for deaths it did not cause. According to the Huffington Post:10

"Almost all of the FDA's cases involve subjects who were found to be on multiple substances at the time of their death, with the vast majority including either illicit or prescription drugs that carry well-known fatal risks. One incident describes a teenager who had hanged himself after struggling with depression and prescription drug abuse. He tested positive for a variety of drugs, including kratom, as well as alcohol and a handful of prescription drugs."

The Post revealed numerous cases that were linked to kratom only by a thread, like a man who had “fallen out a window, broken his arm and refused treatment before dying” who was found to have nine substances in his bloodstream, one of which was mitragynine, the primary active substance in kratom. Another “kratom death” was a man who died from complications of deep vein thrombosis and another ruled a “death by homicide due to a gunshot wound to the chest.”11

In another example, a Tennessee news outlet broadcast a quote from a Georgia county coroner claiming there had been 17 deaths linked to kratom in Georgia in 2017. AKA has called on the TV station to retract the “fake news” report, as they say there is nothing in the public medical record showing even one death linked to kratom.12

Henningfield’s report further reiterated the lack of evidence that kratom has led to any deaths, noting, “To date, in the U.S., there have been no confirmed reports of death that can be considered ‘causatively’ due to kratom overdose. How many, if any deaths, are “probably” classified as kratom poisoning deaths is not clear.

This is consistent with the far larger and longer Southeast Asian experience of very few serious adverse events. In both the U.S. and Southeast Asia, the low toxicity of kratom is in striking contrast to the experience with opioids.”13

Is FDA Commissioner Gottlieb Helping Glaxo?

An estimated 3 million to 5 million Americans use kratom, which in the absence of many reports of adverse effects or substance abuse could be evidence in itself of kratom’s safety.14 Further, many of these people rely on kratom because they found opioids to be too dangerous or too addictive. By banning kratom, it could drive more people to seek out prescription opioids, which are known to be deadly, or drive them to purchase kratom on the black market.

If the FDA were really concerned about public health, they would not lump a diverse group of deaths that happened to involve kratom as “kratom-caused deaths.” Instead, the would seek to identify the true culprit as well as conduct a comprehensive review on kratom’s safety profile and potential benefits, particularly in comparison to opioids. Yet, what we’re seeing is a curious push from the FDA to warn the public about kratom, perhaps in preparation for its eventual ban.

FDA Commissioner Scott Gottlieb, it’s important to note, has close ties to Big Pharma, having received more than $400,000 from the industry between 2013 and 2015,15 and millions over the course of his career.16

Prior to joining the FDA, he served on the board of three pharmaceutical companies, including GlaxoSmithKline, whose predecessor Smith Kline & French held patents on certain alkaloids isolated from kratom.17 The patents, which were issued in the 1960s, have since expired, but there is much speculation about whether Gottlieb is targeting kratom to protect GlaxoSmithKline or some of his other Big Pharma allies.

In the FDA warning, it’s mentioned that “[w]e have been especially concerned about the use of kratom to treat opioid withdrawal symptoms” along with a suggestion to use one of three FDA-approved drugs for the treatment of opioid addiction (a vicious cycle in which drug companies profit on both ends of the opioid epidemic, selling drugs that both cause the addiction and treat it).

But, as noted in The Journal of the American Ostepathic Association, in a systematic analysis of kratom user reports, “[T]he vast majority of users reported beneficial effects in the management of opioid withdrawal and pain, depression and anxiety.”18

There is so much beneficial potential suggested by kratom research to date — and such a wealth of science about prescription opioids’ harms — that it would seem remiss for the FDA to brush off or, worse, ban this herbal supplement that appears to be far safer than opioid drugs — unless an ulterior motive was at play. The Journal of the American Ostepathic Association report continued:19

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

Even Kratom Should Be Used With Caution

While kratom appears to have a favorable safety profile compared to opioids, this isn’t to say that kratom usage is without risk. It’s important to recognize that kratom is a psychoactive substance and should not be used carelessly. There's very little research showing how to use it safely and effectively, and it may have a very different effect from one person to the next.

Also, while it may be useful for weaning off opioids, kratom itself may be addictive. So, while it appears to be a far safer alternative to opioids, it's still a powerful and potentially addictive substance. So please, do your own research before trying it. Also, please understand that there are many safe and effective alternatives to prescription and over-the-counter painkillers. If you’re looking for safer options for pain relief than opioid drugs, please see these options for treating pain without drugs.

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