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The FDA Is Still Trying to Ban Kratom, a Potential Solution to the Opioid Epidemic

"No reliable evidence to support the use of kratom as a treatment for opioid use disorder and significant safety issues exist."

KratomPublic DomainLast week, the Food and Drug Administration announced that the herbal supplement kratom possesses the properties of an opioid, thus escalating the government's effort to slow usage of this alternative pain reliever.

Due to the substance's similar chemical structure to traditional opioids, FDA Commissioner Scott Gottlieb suggested using kratom to treat withdrawals poses a public safety risk:

We have been especially concerned about the use of kratom to treat opioid withdrawal symptoms, as there is no reliable evidence to support the use of kratom as a treatment for opioid use disorder and significant safety issues exist. The FDA stands ready to evaluate evidence that could demonstrate a medicinal purpose for kratom. However, to date, we have received no such submissions and are not aware of any evidence that would meet the agency's standard for approval.

While kratom is currently legal under federal law, this announcement follows the FDA's decision to block the importation of kratom products. In 2016, the Drug Enforcement Administration tried to place kratom in the same class of illegal substances as heroin, but a public outcry—and even some Congressional support for kratom—stopped that motion. Now that the FDA has conducted further medical analysis of kratom, the drug is more likely to be added to the "schedule" of restricted drugs.

The FDA states that the number of deaths associated with kratom use has increased to a total of 44, up from a total of 36 since the FDA's November 2017 report. While the report suggests these cases "underscore the serious and sometimes deadly risks of using kratom," it is clear that the FDA is reaching.

In the majority of deaths that FDA attributes to kratom, subjects ingested multiple substances with known risks, including alcohol. The presence of multiple drugs makes it difficult to determine the role any one of them played.

The FDA cites one case where 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."

Another kratom user in the FDA's report died from deep vein thrombosis—a type of blood clot the medical examiner says may have been related to the man suffering from obesity. While there is some research suggesting a correlation between DVT and intravenous opioid use in women, kratom is taken orally and the subject in this report was male. Deep vein thrombosis can also be hereditary, and the man had a long history of medical problems.

As with all the incidents in the FDA's report, these two deaths are associated with kratom only because kratom was found in each man's system. While there is no question that kratom is a drug, the FDA is grasping for a reason to ban this substance. The total number of deaths associated with kratom is dwarfed by those attributed to common over the counter and non-opioid prescription drugs, a point Reason's Jacob Sullum has made before.

Kratom is a popular alternative medicine for those suffering from chronic pain, opioid withdrawal, and mood disorders ranging from depression to PTSD. We don't know exactly why it's good for these ailments, or what the most effective dose is, or even how much is too much. But we have even less evidence that its limited risk merits criminalizing the behavior of hundreds of thousands of American consumers.

Filmmaker Chris Bell talked to Reason TV about his kratom experience last year.

Photo Credit: Public Domain

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  • Fist of Etiquette||

    You know what substance has been found in all death victims but is yet somehow still legal under federal law?

  • sarcasmic||

    Dihydrogen monoxide?

  • mooo||

    Good one!

    First the DEA and now FDA are doing Big Pharma's dirty work. Profit is why.

    The drugs buprenorphine / naltrexone are standard opioid addiction treatment...
    (see statnews.com/2017/06/19/ opioid-addiction-teens-treatment/ )

    ...costing $4-$8 / tablet.
    (see goodrx.com/buprenorphine-naloxone )

    Compare that to kratom at 50 cents / 5g. Another drug it can replace is Viagra costing ~$70 / tablet.
    (see goodrx.com/viagra )

    Price differences with kratom are driving Big Pharma's attempt to ban it.

  • Citizen X - #6||

    STEVE SMITH?

  • Kivlor||

    Human blood?

  • Zeb||

    DNA?

  • MatthewSlyfield||

    Carbon
    Hydrogen
    Oxygen
    Nitrogen
    Sodium
    Chlorine

  • Citizen X - #6||

    1. We must ban this substance until more research can be done!
    2. Hey, quit researching that, it's banned!

  • BestUsedCarSales||

    I'm sick of you libertarian types mocking these people. Don't you understand they care?

  • Citizen X - #6||

    Nope!

  • Don't look at me.||

    They care you to death.

  • MatthewSlyfield||

    If this is what they do when they care, can we ask them to stop caring?

  • Chmeee||

    Did you forget to put the sarcasm font on?

  • Vandalia||

    To add a bit of reason, is it possible that "the total number of deaths associated with kratom is dwarfed by those attributed to common over the counter and non-opioid prescription drugs," is due to the fact that kratom is a very rare substance these days?

    In other words, the question is not how many deaths it CURRENTLY causes, but rather what effect it would have if used at a rate similar to oxycodone or Vioxx (at its height)?

    Plutonium causes maybe one death a decade, but that doesn't mean it is an inherently safe medication.

    There is a fundamental rule of logic; "absence of evidence is not evidence of absence." This is part of the issue with marijuana. It is often touted that it has negligible side-effects. This is i due to the fact that when/where it is illegal those who used it were very unlikely to report its use to their physicians or to go to the ED for treatment. I know in EM we are seeing a dramatic increase in people coming in with serious reactions/issues after marijuana usage. Remember, Vioxx was considered a perfectly safe medicine for over a decade until the reports started rolling in.

    Now, I believe a person should be given the free choice to use anything they like provided they know the risks. There are libertarian reasons to remove the entire Controlled Substance paradigm; if someone wants to use a dangerous drug, fine. But to base the argument on the fact that kratom is safe both ignores the fundamental science and misses the fundamental point.

  • Zeb||

    "absence of evidence is not evidence of absence."

    True, but it goes both ways. Absence of evidence for safety is not any reason to think something is not safe. And Kratom has a long history of use in SE Asia. So it's not as if it is a complete mystery. I think it's ridiculous to be having any kind of discussion about restricting a substance unless there is strong evidence that it is very dangerous.

  • BestUsedCarSales||

    The article does discuss the difficulty of doing that further research due to the FDA. And also, the muddling of it's current danger by blaming kratom for any death involving kratom, even if it's combined with other drugs with significantly higher known lethality.

  • Hank Phillips||

    Given? Given the choice? Whatever happened to enforcing individual rights by stringing up they who presume to dole out or withhold them. This is adopting the language of the enemies of freedom--cowardice, maybe, but reason? Never.

  • Rich||

    "The FDA stands ready to evaluate evidence that could demonstrate a medicinal purpose for kratom. However, to date, we have received no such submissions and are not aware of any evidence that would meet the agency's standard for approval."

    This is eerily reminiscent of Obama's being always open to reasonable suggestions.

  • SQRLSY One||

    See
    http://www.sciencedaily.com/re.....214919.htm
    Knowingly taking placebo pills eases pain, study finds…
    Summary: Tell the patient that they are taking nothing but sugar pills, but that the sugar pills will help them feel less pain, and THEY STILL WORK!!! People underestimate the power of placebos… I am NOT saying that Kratom is nothing but a placebo… I personally tried it, and it did just about nothing for me. But, even if it is "nothing but a placebo", what the hell gave the FDA the power to meddle here?!?! Whose body is it? WHY do we look to "democracy" (or any flavor of Government Almighty) to answer the question of, "Does this medicine work for me?" … If we are going to be THAT stupid, then why not ask Government Almighty, "Does this religion work for me?", "Does this wife work for me?", "Does this method of twinkling my winkie work for me?", ad infinitum…
    FDA, GTFO of judging the efficacy of medicines altogether!!! GTFO of my life!!!!

  • SQRLSY One||

    "That book has NOT been tested to be both safe AND effective for you, so you may NOT read it!"

    WHY do we put up with this in some categories, but not others? WTF!?!??!

  • Bryce928||

    Kratom was the same way for me the first time I tried it. There's always going to be a bit of a placebo effect but the placebo effect isn't strong enough for me to go from shaking and throwing up due to opiate witchdrawl to feeling almost back to normal. I think people also get the wrong idea about kratom's effects. It's pretty mild especially compared to heroin or even pain medication.

  • damikesc||

    The total number of deaths associated with kratom is dwarfed by those attributed to common over the counter and non-opioid prescription drugs, a point Reason's Jacob Sullom has made before.

    While not defending the FDA, this point is asinine. Given the sheer volume of usage of the OTC and prescription drugs as opposed to Kratom, if the fatality rate if the OTC drugs was 1/5 of kratom, they'd STILL have far more deaths.

    Why not a per capita comparison instead of a total numbers comparison?

  • SQRLSY One||

    Because they can't get good and reliable numbers for how many users there are... Because the users ALREADY have to slink around in the dark, and hide their buying habits!!! Even if is still legal today... Do YOU trust Government Almighty to NOT pass "ex post facto" laws?!?! "We outlawed Kratom yesterday, and we see some residue in your blood... Ye are BUSTED!!!!"

    I do NOT trust Government Almighty to NOT pass "ex post facto" laws... Do you?

  • Bryce928||

    Yeah you are right. I think the reason those numbers have any impact is due to the way the FDA sighted them. They didn't give any percentages regarding x number of deaths over x number of users. Since they only said 40 people have died in the US due to kratom, it puts it into perspective of just how many people die anually from low risk activities. I think o read a statistic about how many people die f I'm falling coconuts around the world

  • Zeb||

    Fair point. The real point should be that the incidents they cite are not clearly indicators that kratom has any dangers at all. I think that if the FDA can't provide one case where they can demonstrate that kratom actually is likely to have caused death or injury, they should just shut up.

  • Bryce928||

    Im glad there are people standing up for kratom A ban could be a death sentence to many people. Kratom pulled me out of the darkest period in my life. I took opiate pain medication after a surgery and became dependent on it. I went from almost being homeless and severely depressed to now being back in school and working. I'm happy for the first time in many years and my family is ecstatic. I drink Kratom tea once in the morning and it allows me to function without turning me into a zombie like opiates did. It's hard to believe the FDA really believes it to be a danger. I wound up in the emergency room 4 times when I was using opiates. I've been taking Kratom for a few years now and I haven't experienced any negative effects and I certainly haven't wound up in the emergency room. 40 deaths associated (not necessarily caused) by Kratom is an extremely small amount compared to almost any medication/ substance. Even Tylenol kills over a hundred people annually due to overdose. Many of the deaths the government has pointed to involved people with MULTIPLE drugs in their system. They even included a man who committed suicide. How can you blame a plant for that. I keep hearing the FDA saying it should be banned because there is "no medical use" for the plant. How is alcohol still legal then? How about tobacco? Those don't have any medical uses. A Kratom ban would be detrimental for me and people in my situation.

  • SQRLSY One||

    The FDA does this... Because it can! They can't get away with it with alcohol and tobacco because there are too-too many people using it, who would raise holy hell! There are barely enough Kratom users, so they get no respect...

    The other thing that often gets "lost in the sauce" is... Pharm companies and patents and profits! Anti-smoking drug "Chantix" has a severe side effect (suicide), but is on the market anyway... Because a pharm company has IP rights and profits and can make bribes... Oooops, I mean, campaign donations to politicians. Just look at the "Epi-pen" enabling their company (CEO being the daughter of a Senator), while the FDA "fenced out" competition to the (filthy expensive) Epi-Pen!

    Anyway, Kratom? IP owned by "Momma Nature"... No huge profits here, with which to bribe Congress-Critters... No vested special interests, except "mere" consumers who'd like to fight their opiate addictions, so, tough noogies on the mere peons... (Is one of many reasons I hate the FDA!!!!)

  • Robert||

    FDA does this...because it must. Congress mandated they act like this, including taking evidence of danger as significant even when it isn't scientific the way evidence of safety has to be. So blame Congress. Which means blame voters.

  • UnrepentantCurmudgeon||

    I have 3 letters for you: C B D

  • Intelligent Mr Toad||

    Kratom--isn't that a city in Africa?

  • Ana 777||

    Kratom is not an opioid and doesn't provide a high. It stops you from going into withdraw. Like anything you do too much you overdose. You drink too much alcohol you can overdose take too much medication you can overdose. That is silly everyone knows there is a limit and if you pass that limit you will overdose. I am commenting on here because I'm an ex opioid addict and kratom was used as a tool to get me sober. I'm no longer doing opioids. I lowered my kratom dosage little by little till I was able to get my body to a point the opioid no longer effected my body. Meaning I no longer was going through withdraws. But of course there are irresponsible individuals that don't care to get sober and abuse kratom. Kratom is an excellent tool to stop opioids I tried suboxone and methadone and kratom was the best because you weren't high but were not withdrawing. I never thought I can stop opioids so this is so important for me to say. If you use kratom properly and you get help for your addiction and really just want to stop you can. I don't care what anyone says I lived it. I was hopeless and addict and I really was just do tried of doing the same thing that was messing up my life but physically I couldn't stop when I did for 2 weeks I was really depressed. I got help and did research and came across kratom and am no longer an addict.

  • ||

    The 44 deaths "related to Kratom use" are laughable. Exactly ONE of the cited deaths involved Kratom and only Kratom. One was a suicide by hanging. One was a gunshot wound to the chest. This has absolutely nothing to do with protecting the public and absolutely everything to do with protecting the pharmaceutical companies. They can't patent it, so they can't make money off of it. It also cuts into profits from their existing drugs.

  • working poor||

    I have never even heard of Kratom until a few months ago. I did look it up and joined some group so I could read more about it. After reading about it I don't think I would want to use it. Some people claim that it helps them. Who am I to say that it doesn't? But, I think anyone should be able to use anything they want. I think the real question should be: who owns our bodies?

  • SQRLSY One||

    Well, it seems that the FDA owns our bodies!

  • Hank Phillips||

    Everything is threatening to the organized criminals running the US government as a smack ring! The reason they kidnapped and caged Tim Leary was that he was using psychedelic drugs to cure smokers, alcoholics and junkies! The DemoGOP is a Frankenstein zombie cobbled out of 19th-century slaver and zealot parties, both of the looter persuasion. If you want our boys out of Afghanistan alive, insist their next coffins be opened and searched for heroin in front of live video reporters. As long as the looters ban every alternative so they can secretly push addictive poisons here the way the Brits did in China, the pattern in the rat's maze will never change.

  • jvolpehoo||

    this explains it quite nicely: https://www.youtube.com/watch?v=Jijb5E1XnVc

  • DesparateReasoning||

    Kratom is particularly subjectible to this kind of BS attack because it is often used either by itself or with Lopramide as a "poor man's methadone". Kratom has several opioid antagonistic characteristics. Several of the dead individuals in the report had both of these substances in their system. So, it is easy to blame Kratom for deaths caused by serious opioid abuse or the resulting deaths that can happen when you've severely damaged your body and attempt to ween off of hard drugs.

  • Dumian||

    Big Tobacco went in front of Congress and lied when they stated nicotine is not addictive. Will AKA and BEA do the same? We all deserve to have the undistorted, truth in front of us so that we can make the best decision for ourselves. The FDA is lying, but so is the AKA and BEA because so many of us already know how addictive kratom can be - and even with "normal" amounts. There is still so much about kratom's long-term use that we do not know. But is it deadly? And, that, boys and girls is the million dollar question, but just because it may not kill you does not make it harmless. Look at the bigger picture.

  • Carter Mitchell||

    I'm certain that I'm not the first to point this out, but there is no doubt that the cockroach Scott Gottlieb is a tool of Big Pharma, and will attack anything that threatens the profits of his owners.

  • Carter Mitchell||

    I'm certain that I'm not the first to point this out, but there is no doubt that the cockroach Scott Gottlieb is a tool of Big Pharma, and will attack anything that threatens the profits of his owners.

  • jenniloves||

    Kratom is all natural and not addictive at all. There is a campaign run
    by the FDA and behind that are the big pharma. How such natural leaves
    can kill someone? There are different types of leaves and all are not
    same .. means few are more stronger than others. So, instead of claiming
    it as an opiate, a well research needed. Sufficient time, effort and
    education needed to study this natural and live saving herb.

    https://redstormscientific.com/

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