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posted by Fnord666 on Wednesday November 15 2017, @11:36PM   Printer-friendly
from the kratom-latte dept.

The FDA has issued a public health advisory warning of deaths related to kratom (Mitragyna speciosa) and warning against using it to treat opioid withdrawal symptoms. The DEA attempted to temporarily regulate kratom as a schedule I drug in 2016, but stopped short of doing so after a public backlash. From FDA Commissioner Scott Gottlieb's statement on the advisory:

It's very troubling to the FDA that patients believe they can use kratom to treat opioid withdrawal symptoms. The FDA is devoted to expanding the development and use of medical therapy to assist in the treatment of opioid use disorder. However, an important part of our commitment to this effort means making sure patients have access to treatments that are proven to be safe and effective. There is no reliable evidence to support the use of kratom as a treatment for opioid use disorder. Patients addicted to opioids are using kratom without dependable instructions for use and more importantly, without consultation with a licensed health care provider about the product's dangers, potential side effects or interactions with other drugs.

There's clear data on the increasing harms associated with kratom. Calls to U.S. poison control centers regarding kratom have increased 10-fold from 2010 to 2015, with hundreds of calls made each year. The FDA is aware of reports of 36 deaths associated with the use of kratom-containing products. There have been reports of kratom being laced with other opioids like hydrocodone. The use of kratom is also associated with serious side effects like seizures, liver damage and withdrawal symptoms.

Given all these considerations, we must ask ourselves whether the use of kratom – for recreation, pain or other reasons – could expand the opioid epidemic. Alternatively, if proponents are right and kratom can be used to help treat opioid addiction, patients deserve to have clear, reliable evidence of these benefits.

I understand that there's a lot of interest in the possibility for kratom to be used as a potential therapy for a range of disorders. But the FDA has a science-based obligation that supersedes popular trends and relies on evidence. The FDA has a well-developed process for evaluating botanical drug products where parties seek to make therapeutic claims and is committed to facilitating development of botanical products than can help improve people's health. We have issued guidance on the proper development of botanical drug products. The agency also has a team of medical reviewers in the FDA's Center for Drug Evaluation and Research that's dedicated to the proper development of drug applications for botanicals. To date, no marketer has sought to properly develop a drug that includes kratom.

[...] As a physician and FDA Commissioner, I stand committed to doing my part to prevent illegal substances that pose a threat to public health from taking their grip on Americans. While we remain open to the potential medicinal uses of kratom, those uses must be backed by sound-science and weighed appropriately against the potential for abuse. They must be put through a proper evaluative process that involves the DEA and the FDA. To those who believe in the proposed medicinal uses of kratom, I encourage you to conduct the research that will help us better understand kratom's risk and benefit profile, so that well studied and potentially beneficial products can be considered. In the meantime, based on the weight of the evidence, the FDA will continue to take action on these products in order to protect public health.

The FDA Commissioner may want your help to study kratom, but you'll find it hard to do so as imports of the substance are being seized:

The FDA has exercised jurisdiction over kratom as an unapproved drug, and has also taken action against kratom-containing dietary supplements. To fulfill our public health obligations, we have identified kratom products on two import alerts and we are working to actively prevent shipments of kratom from entering the U.S. At international mail facilities, the FDA has detained hundreds of shipments of kratom. We've used our authority to conduct seizures and to oversee the voluntary destruction of kratom products. We're also working with our federal partners to address the risks posed by these imports. In response to a request from the Drug Enforcement Administration (DEA), the FDA has conducted a comprehensive scientific and medical evaluation of two compounds found in kratom. Kratom is already a controlled substance in 16 countries, including two of its native countries of origin, Thailand and Malaysia, as well as Australia, Sweden and Germany. Kratom is also banned in several states, specifically Alabama, Arkansas, Indiana, Tennessee and Wisconsin and several others have pending legislation to ban it.

Also at Reuters, STAT News, Reason, and the Washington Post (archive).

Previously: DEA Welcomes Kratom to the Schedule I List Beginning September 30
The Calm Before the Kratom Ban


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  • (Score: -1, Troll) by Anonymous Coward on Wednesday November 15 2017, @11:55PM

    by Anonymous Coward on Wednesday November 15 2017, @11:55PM (#597508)

    To protect a person from his own stupidity requires Tyranny.

    If there must be a government, its sole role should be to ensure that interaction between individuals is voluntary, as defined by contractual agreements in advance of interaction. (Of course, given that government is founded atop involuntary interaction, I doubt that government would be good at this; indeed, there's little evidence that government is good at anything other than a creep towards Tyranny.)

  • (Score: -1, Troll) by Anonymous Coward on Thursday November 16 2017, @12:02AM

    by Anonymous Coward on Thursday November 16 2017, @12:02AM (#597511)

    To protect a person from his own stupidity requires Tyranny.

    If there must be a government, its sole role should be to ensure that interaction between individuals is voluntary, as defined by contractual agreements in advance of interaction. (Of course, given that government is founded atop involuntary interaction, I doubt that government would be good at this; indeed, there's little evidence that government is good at anything other than creeping towards Tyranny.)

  • (Score: -1, Spam) by Anonymous Coward on Thursday November 16 2017, @12:10AM

    by Anonymous Coward on Thursday November 16 2017, @12:10AM (#597513)

    To protect a person from his own stupidity requires Tyranny.

    If there must be a government, its sole role should be to ensure that interaction between individuals is voluntary, as defined by contractual agreements in advance of interaction. (Of course, given that government is founded atop involuntary interaction, I doubt that government would be good at this; indeed, there's little evidence that government is good at anything other than creeping towards Tyranny.)

  • (Score: -1, Spam) by Anonymous Coward on Thursday November 16 2017, @12:13AM

    by Anonymous Coward on Thursday November 16 2017, @12:13AM (#597514)

    To protect a person from his own stupidity requires Tyranny.

    If there must be a government, its sole role should be to ensure that interaction between individuals is voluntary, as defined by contractual agreements in advance of interaction. (Of course, given that government is founded atop involuntary interaction, I doubt that government would be good at this; indeed, there's little evidence that government is good at anything other than creeping towards Tyranny.)

  • (Score: -1, Spam) by Anonymous Coward on Thursday November 16 2017, @12:20AM

    by Anonymous Coward on Thursday November 16 2017, @12:20AM (#597517)

    T o    p r o t e c t    a    p e r s o n    f r o m     h i s    o w n    s t u p i d i t y    r e q u i r e s    T y r a n n y .

    I f    t h e r e    m u s t    b e    a    g o v e r n m e n t ,    i t s    s o l e    r o l e    s h o u l d    b e    t o    e n s u r e    t h a t    i n t e r a c t i o n    b e t w e e n    i n d i v i d u a l s    i s    v o l u n t a r y ,    a s    d e f i n e d    b y    c o n t r a c t u a l     a g r e e m e n t s    i n    a d v a n c e    o f     i n t e r a c t i o n .    ( O f    c o u r s e ,    g i v e n     t h a t    g o v e r n m e n t    i s    f o u n d e d    a t o p    i n v o l u n t a r y    i n t e r a c t i o n ,    I    d o u b t    t h a t    g o v e r n m e n t    w o u l d    b e     g o o d    a t    t h i s ;    i n d e e d ,    t h e r e ' s    l i t t l e    e v i d e n c e    t h a t    g o v e r n m e n t    i s    g o o d    a t    a n y t h i n g    o t h e r    t h a n    c r e e p i n g    t o w a r d s    T y r a n n y . )

  • (Score: 2) by sjames on Thursday November 16 2017, @12:21AM (5 children)

    by sjames (2882) on Thursday November 16 2017, @12:21AM (#597518) Journal

    In that case Mr. Commissioner, we must:

    1. Eliminate the potential criminal pitfalls that go with admitting an opoid addiction.
    2. Fix our FUBAR mercenary health care system so people can afford the licensed health care providers you recommend.
    • (Score: 2, Insightful) by Anonymous Coward on Thursday November 16 2017, @01:11AM (3 children)

      by Anonymous Coward on Thursday November 16 2017, @01:11AM (#597535)

      Not only that but finally admit that cannabis flower can play a role in treating opiate addiction. If anybody truly cared about the patients instead of just grandstanding and making cynical political moves, cannabis flower would be fast-tracked through the FDA.

      But no. Now cannabis flower is an issue of the patriotically correct team vs. the politically correct team. Nobody gives a shit what the science says. Bullshit like anti-tobacco talking points like the stink being cynically turned around by people who resent the anti-tobacco crusade.

      Personally, though, because I am not an angel, I will admit to taking sick pleasure in deaths from opiate addiction. It's so preventable, and the demographics most affected by the problem are the demographics who are the most vehement about opposing all of these obviously helpful measures we could take, especially when their political sportsball opponents are likely mostly in favor of them.

      But no. Instead they elect politicians to enact policies that kill them. Whatever, so be it.

      • (Score: 3, Interesting) by takyon on Thursday November 16 2017, @01:37AM (2 children)

        by takyon (881) <takyonNO@SPAMsoylentnews.org> on Thursday November 16 2017, @01:37AM (#597544) Journal

        Not only that but finally admit that cannabis flower can play a role in treating opiate addiction.

        Unfortunately, all indications are that they have fucked that up entirely: https://soylentnews.org/submit.pl?op=viewsub&subid=23318 [soylentnews.org]

        Too many old losers hanging around the Trump administration like Jeff "Definitely Not Racist" Sessions and Chris "Fatass But Definitely Not Connected to the Mob" Christie.

        Now cannabis flower is an issue of the patriotically correct team vs. the politically correct team.

        It would probably be a lot worse if Republican support for cannabis wasn't at an all-time high [soylentnews.org].

        It's so preventable, and the demographics most affected by the problem are the demographics who are the most vehement about opposing all of these obviously helpful measures we could take, especially when their political sportsball opponents are likely mostly in favor of them. But no. Instead they elect politicians to enact policies that kill them. Whatever, so be it.

        More along these lines here and links to articles: Opioid Crisis Official; Insys Therapeutics Billionaire Founder Charged; Walgreens Stocks Narcan [soylentnews.org]

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        • (Score: 2) by takyon on Thursday November 16 2017, @01:39AM (1 child)

          by takyon (881) <takyonNO@SPAMsoylentnews.org> on Thursday November 16 2017, @01:39AM (#597545) Journal

          Does the illegality of cannabis help enrich the mobsters Chris Christie allegedly has ties to? Maybe!

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          [SIG] 10/28/2017: Soylent Upgrade v14 [soylentnews.org]
          • (Score: 3, Insightful) by Pslytely Psycho on Thursday November 16 2017, @02:28AM

            by Pslytely Psycho (1218) on Thursday November 16 2017, @02:28AM (#597554)

            Yep, and he's pissed that the entire west coast has stopped making their payments and that that shit is spreading!

            --
            Alex Jones lawyer inspires new TV series: CSI Moron Division.
    • (Score: 2) by jcross on Thursday November 16 2017, @02:52AM

      by jcross (4009) on Thursday November 16 2017, @02:52AM (#597560)

      Or even:

      3. Research how/whether kratom can be used to get off opioids and publish information about safe use.

      I mean, maybe it doesn't work well if used carelessly, but that could be said of nearly any medical intervention. I do know at least one person who used it to get off heroin, so presumably it *can* be effective. But nah, it's not a regulated substance, therefore nobody important is going to be making a profit from it, therefore it ain't gonna happen.

  • (Score: -1, Spam) by Anonymous Coward on Thursday November 16 2017, @12:31AM

    by Anonymous Coward on Thursday November 16 2017, @12:31AM (#597522)

    T o    p r o t e c t    a    p e r s o n    f r o m    h i s    o w n    s t u p i d i t y    r e q u i r e s    T y r a n n y .

    I f    t h e r e    m u s t    b e    a    g  o v e r n m e n t ,    i t s    s o l e    r  o l e    s h o u l d    b e    t o    e n s u r e    t h a t    i n t e r a c t i o n    b  e t w e e n    i n d i v i d u a l s    i s     v o l u n t a r y ,    a s    d e f i n e d    b y    c o n t r a c t u a l    a g r e  e m e n t s    i n    a d v a n c e    o f    i n t e r a c t i o n .    (O f    c o u r s  e ,    g i v e n    t h a t    g o v e r n m  e n t    i s    f o u n d e d    a t o p    i n v o l u n t a r y    i n t e r a c t i o  n ,    I    d o u b t    t h a t    g o v e r n m e n t    w o u l d    b e    g o o d    a t    t h i s ;    i n d e e d ,    t h e r e  ' s    l i t t l e    e v i d e n c e    t h  a t    g o v e r n m e n t    i s    g o o d    a t    a n y t h i n g    o t h e r    t h  a n    c r e e p i n g    t o w a r d s    T  y r a n n y .)

  • (Score: -1, Spam) by Anonymous Coward on Thursday November 16 2017, @12:34AM

    by Anonymous Coward on Thursday November 16 2017, @12:34AM (#597525)

    To protect a person from his own stupidity requires Tyranny. If there must be a government, its sole role should be to ensure that interaction between individuals is voluntary, as defined by contractual agreements in advance of interaction. (Of course, given that government is founded atop involuntary interaction, I doubt that government would be good at this; indeed, there's little evidence that government is good at anything other than creeping towards Tyranny.)

  • (Score: -1, Spam) by Anonymous Coward on Thursday November 16 2017, @12:40AM

    by Anonymous Coward on Thursday November 16 2017, @12:40AM (#597526)

    Government has no business making decisions for people.

    If there must be a government its sole role should be to facilitate voluntary interaction between them (but I doubt government would be very good at that, considering government is founded on involuntary interaction).

  • (Score: -1, Spam) by Anonymous Coward on Thursday November 16 2017, @12:45AM (4 children)

    by Anonymous Coward on Thursday November 16 2017, @12:45AM (#597527)

    If there must be a government its sole role should be to facilitate voluntary interaction between them (but I doubt government would be very good at that, considering government is founded on involuntary interaction).

    Government has no business making decisions for people.

    • (Score: 2) by takyon on Thursday November 16 2017, @12:46AM

      by takyon (881) <takyonNO@SPAMsoylentnews.org> on Thursday November 16 2017, @12:46AM (#597530) Journal

      I'll upmod your first comment if you stop spamming, since it probably doesn't need to be at -1. How's that for voluntary interaction?

      Slightly changing your comment is not going to help you avoid the spam mod. A bot/filter isn't downmodding you.

      --
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    • (Score: 5, Insightful) by Virindi on Thursday November 16 2017, @01:12AM (2 children)

      by Virindi (3484) on Thursday November 16 2017, @01:12AM (#597536)

      Except there are other functions of government involved here which do not interfere with the ability of the individual to do what they wish with their body.

      First, fraud. It is not a violation of the autonomy of the individual to stop those who would lie to him, take his money, and disappear.

      Which leads into the second function: accountability. Voluntary market-based interaction only works when accountability exists. Non-government systems of accountability tend to be weak, not function well with large groups of anonymous people, and lead even more quickly than government courts to abuse.

      The ostensible purpose of the FDA supported both of these goals; the issue here is that people who want them to be mommy took over long ago. But that is a consequence of the fact that that is what the population wants. As long as that public attitude exists no system will prevent that outcome. In other words, your problem is with the culture, not with the structure of the system.

      • (Score: 1, Insightful) by Anonymous Coward on Thursday November 16 2017, @01:43AM

        by Anonymous Coward on Thursday November 16 2017, @01:43AM (#597549)

        Good for you giving an insightful reply that this spammer does not even deserve. For someone who complains of tyranny they sure do try and force their opinions on others.

      • (Score: 0) by Anonymous Coward on Thursday November 16 2017, @06:37PM

        by Anonymous Coward on Thursday November 16 2017, @06:37PM (#597802)

        There need not be an imposed monopoly for the services you list.

  • (Score: 4, Touché) by Entropy on Thursday November 16 2017, @12:43PM

    by Entropy (4228) on Thursday November 16 2017, @12:43PM (#597654)

    So lets eliminate everything else that people can use, and only leave opiates...Then be surprised when people want opiates. Idiots.

  • (Score: 3, Interesting) by VLM on Thursday November 16 2017, @02:14PM

    by VLM (445) on Thursday November 16 2017, @02:14PM (#597700)

    Some revolutionary math:

    The FDA is aware of reports of 36 deaths associated with the use of kratom-containing products.

    OK so 36 "lifetime" deaths... vs some figures I googled up about acute opiate overdoses accounting for 65K deaths per year. So kratom kills about as many people total, ever, as opiate overdoses kill per hour, roughly. Kratom therapy, however unlikely, only has to be about 1% successful to lower the total net death rate.

    Of course the real problem is the government and the "right" people are not making money off kratom but are making stacks of money off opiates...

    As far as demonization campaigns go, this one seems so lame you'd almost think its fake someone monkey wrenching from the inside against the war on some drugs.

  • (Score: 0) by Anonymous Coward on Thursday November 16 2017, @03:49PM

    by Anonymous Coward on Thursday November 16 2017, @03:49PM (#597733)

    drug usage is mostly attributed to hunger. in the case of non-chemical drugs that naturally grows it is a sign of a lazy farmer or overworked farmer that has lost sight of the cause of his profession.
    growning natural drugs is easy. nobody would do it, but every CAN do it.
    these drus are a big bang proven from the soil but from the same area doesnt provide the calories for a drug-free but happy life society.
    drug abuse is thus a direct reflections soil earnings. some people want to be 500 kg. thus the drugs DO have a pig meaning.

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