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posted by Fnord666 on Wednesday November 15, @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


Original Submission

Related Stories

DEA Welcomes Kratom to the Schedule I List Beginning September 30 32 comments

Kratom, an herbal drug made of ground-up tree leaves, is "temporarily" joining other natural substances such as cannabis, psilocybin, and peyote on the schedule I list of the Controlled Substances Act. The active ingredients in kratom, the indole alkaloids mitragynine and 7-hydroxymitragynine, are both being added to the list for up to three years, after which they can be added permanently.

Prior to this move, the U.S. has already been seizing shipments of kratom:

In 2014, the FDA issued an import alert that allowed US Customs agents to detain kratom without a physical examination. "We have identified kratom as a botanical substance that could pose a risk to public health and have the potential for abuse," said Melinda Plaisier, the FDA's associate commissioner for regulatory affairs. According to the DEA, between February 2014 and July 2016, nearly 247,000 pounds of kratom were seized.

Advocates say that kratom is a natural treatment for opioid addiction, an application that the Drug Enforcement Agency dismisses. Meanwhile, the heroin/opioid epidemic continues with "unprecedented" events like the recent 174 heroin overdoses in just six days in Cincinnati, Ohio.

Check out the implosion of this kratom subreddit, which is attempting to get 100,000 signatures on the White House petition site:

APATHY WILL GET US NOWHERE. IF THERE WAS EVER A TIME FOR US TO BAND TOGETHER, ITS NOW. stand with me brothers and sisters. hope is not lost.


Original Submission

The Calm Before the Kratom Ban 27 comments

The blowback against the U.S. Drug Enforcement Administration's decision to ban kratom has caught the attention of a bipartisan group of legislators, but a DEA spokesman has said that "It's not a matter of if. It's simply a matter of when" the DEA bans kratom:

A bipartisan group of nine senators is calling on the Drug Enforcement Administration to delay its "unprecedented" decision to ban kratom, a plant that researchers say holds great potential for mitigating the effects of the opioid epidemic. [...] The Senate letter, spearheaded by Orrin G. Hatch (R-Utah) says: "Congress granted emergency scheduling authority to the DEA based on the need for law enforcement interdiction of new and previously unknown illegal synthetic street drugs that result in injuries and death. The use of this emergency authority for a natural substance is unprecedented, so it is important to determine whether the circumstances here necessitate a jump to Schedule I.

"Given the long reported history of Kratom use," the letter continues, "coupled with the public's sentiment that it is a safe alternative to prescription opioids, we believe using the regular review process would provide for a much-needed discussion among all stakeholders." [...] The DEA cites 600-plus poison-control center calls involving kratom between 2010 and 2015 in its justification for banning the plant, and notes that 15 deaths were linked to the use of the plant between 2014 and 2016. In an interview with The Washington Post, a DEA spokesman later clarified that all but one of those fatalities involved the use of other substances. Earlier this week 51 U.S. representatives similarly called on the DEA and the White House to reconsider or at least delay the ban, which was slated to go into effect as early as Friday. In an interview, DEA spokesman Russell Baer confirmed that the ban was not yet in place. "We have not yet determined a date when we will publish that final order" putting the ban into effect, he said.

There may be a public comment period before the ban takes effect, and the White House is now obligated to respond to the petition about kratom, which has reached over 140,000 signatures.

Text of the Senators' letter. Also at Ars Technica, CBS, and US News & World Report.

Previously: DEA Welcomes Kratom to the Schedule I List Beginning September 30
Heroin, Fentanyl? Meh: Carfentanil is the Latest Killer Opioid
Alcohol Industry Bankrolls Fight Against Legal Pot in Battle of the Buzz [Updated]


Original Submission

FDA to More Strictly Regulate Homeopathic Drugs 47 comments

The FDA is proposing a new, risk-based enforcement approach to homeopathic drug products (alternative medicine):

To protect consumers who choose to use homeopathic products, this proposed new approach would update the FDA's existing policy to better address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but where the products have not been shown to offer clinical benefits. It also covers situations where products labeled as homeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices.

Under the law, homeopathic drug products are subject to the same requirements related to approval, adulteration and misbranding as any other drug product. However, prescription and nonprescription drug products labeled as homeopathic have been manufactured and distributed without FDA approval under the agency's enforcement policies since 1988.

"In recent years, we've seen a large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases and conditions, from the common cold to cancer. In many cases, people may be placing their trust and money in therapies that may bring little to no benefit in combating serious ailments, or worse – that may cause significant and even irreparable harm because the products are poorly manufactured, or contain active ingredients that aren't adequately tested or disclosed to patients," said FDA Commissioner Scott Gottlieb, M.D. "Our approach to regulating homeopathic drugs must evolve to reflect the current complexity of the market, by taking a more risk-based approach to enforcement. We respect that some individuals want to use alternative treatments, but the FDA has a responsibility to protect the public from products that may not deliver any benefit and have the potential to cause harm."

FDA draft guidance (8 pages).

Also at Ars Technica and STAT News.

Related: Probiotics Come with Bold Health Claims, but the Science is Shaky
What a Gottlieb-Led FDA Might Mean for the Pharmaceutical Industry
Supplement Maker on FDA Blacklist After Deadly Bacteria Found in Water System
FDA Designates MDMA as a "Breakthrough Therapy" for PTSD; Approves Phase 3 Trials
Homeopathic "Healing Bracelet" Poisons Baby With High Levels of Lead
FDA: Love is Not an Ingredient
FDA Cracking Down on Unsubstantiated Cannabidiol Health Claims
FDA Blocks More Imports of Kratom, Warns Against Use as a Treatment for Opioid Withdrawal
Biohackers Disregard FDA Warning on DIY Gene Therapy


Original Submission

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

    by Anonymous Coward on Wednesday November 15, @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, @12:02AM

    by Anonymous Coward on Thursday November 16, @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, @12:10AM

    by Anonymous Coward on Thursday November 16, @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, @12:13AM

    by Anonymous Coward on Thursday November 16, @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, @12:20AM

    by Anonymous Coward on Thursday November 16, @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, @12:21AM (5 children)

    by sjames (2882) on Thursday November 16, @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, @01:11AM (3 children)

      by Anonymous Coward on Thursday November 16, @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, @01:37AM (2 children)

        by takyon (881) <takyonNO@SPAMsoylentnews.org> on Thursday November 16, @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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        [SIG] 10/28/2017: Soylent Upgrade v14 [soylentnews.org]
        • (Score: 2) by takyon on Thursday November 16, @01:39AM (1 child)

          by takyon (881) <takyonNO@SPAMsoylentnews.org> on Thursday November 16, @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, @02:28AM

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

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

            --
            The Trump Presidency, an attempt to make Nixon look respectable......
    • (Score: 2) by jcross on Thursday November 16, @02:52AM

      by jcross (4009) Subscriber Badge on Thursday November 16, @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, @12:31AM

    by Anonymous Coward on Thursday November 16, @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, @12:34AM

    by Anonymous Coward on Thursday November 16, @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, @12:40AM

    by Anonymous Coward on Thursday November 16, @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, @12:45AM (4 children)

    by Anonymous Coward on Thursday November 16, @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, @12:46AM

      by takyon (881) <takyonNO@SPAMsoylentnews.org> on Thursday November 16, @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, @01:12AM (2 children)

      by Virindi (3484) on Thursday November 16, @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, @01:43AM

        by Anonymous Coward on Thursday November 16, @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, @06:37PM

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

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

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

    by Entropy (4228) on Thursday November 16, @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, @02:14PM

    by VLM (445) Subscriber Badge on Thursday November 16, @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, @03:49PM

    by Anonymous Coward on Thursday November 16, @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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