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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

Original Submission

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  • (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.

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

    by takyon (881) <reversethis-{gro ... s} {ta} {noykat}> 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.

    [SIG] 10/28/2017: Soylent Upgrade v14 []
  • (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.