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FDA Labels Kratom an Opioid

posted by Fnord666 on Monday February 12 2018, @05:09AM   Printer-friendly
from the scheduled-for-elimination dept.

takyon writes:

FDA Commissioner Scott Gottlieb has released a new statement denouncing the drug kratom. The statement says that the FDA has learned about new deaths that "involved" kratom use, additional adverse effects associated with its use have been found, and that Public Health Assessment via Structural Evaluation (PHASE) "3-D computer technology" has been used to analyze the chemical compounds in kratom:

Using this computational model, scientists at the FDA first analyzed the chemical structures of the 25 most prevalent compounds in kratom. From this analysis, the agency concluded that all of the compounds share the most structural similarities with controlled opioid analgesics, such as morphine derivatives.

The FDA continues to discourage the use of kratom, which it is calling an opioid.

The American Kratom Association provided a rebuttal of the FDA statement:

Nine leading scientists in substance addiction and safety wrote to White House Opioid Crisis Team Leader Kellyanne Conway and Acting DEA Administrator Robert W. Patterson requesting they disregard the FDA's latest disinformation campaign against kratom. The scientists warned that "four surveys indicate that kratom is presently serving as a lifeline away from strong, often dangerous opioids for many of the several million Americans who use kratom. A ban on kratom that would be imposed by CSA Scheduling would put them at risk of relapse to opioid use with the potential consequence of overdose death. Similar unintended consequences are to be expected in some who would be forced to use opioids to manage acute or chronic pain."

[...] David Herman, Chairman of the AKA, called upon FDA Commissioner Gottlieb to pull back the curtain on the "black box voodoo computer model" that was unveiled by the FDA to justify their continued 'War on Kratom,' this time claiming their computer model conclusively shows kratom is an opioid, and therefore had to be banned.

The nine respected scientists pointed out that "kratom provides a far more favorable safety profile for consumers compared to more dangerously addictive and potentially deadly classical opioid medications." They also pointed out that the FDA's solution – to file a new drug application for kratom – made no sense because "the average time and cost of new drug development is more than 10 years and 2.5 billion dollars."

Previously: DEA Welcomes Kratom to the Schedule I List Beginning September 30
The Calm Before the Kratom Ban
FDA Blocks More Imports of Kratom, Warns Against Use as a Treatment for Opioid Withdrawal

Related: Opioid Commission Drops the Ball, Demonizes Cannabis

Original Submission

 
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  • (Score: 2) by opinionated_science on Monday February 12 2018, @12:17PM (5 children)

    by opinionated_science (4031) on Monday February 12 2018, @12:17PM (#636651)

    Did they publish a list somewhere?

    As someone who *actually* has designed molecules, it would be nice to see their methodology.

    Especially, since this would suggest some new thinking...

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  • (Score: 0) by Anonymous Coward on Monday February 12 2018, @12:51PM (1 child)

    by Anonymous Coward on Monday February 12 2018, @12:51PM (#636664)

    From TFS:

    David Herman, Chairman of the AKA, called upon FDA Commissioner Gottlieb to pull back the curtain on the "black box voodoo computer model" that was unveiled by the FDA to justify their continued 'War on Kratom,' this time claiming their computer model conclusively shows kratom is an opioid, and therefore had to be banned.

    Apparently how the FDA came to the conclusion that kratom was an opioid is based on a black box computer model of some kind.

    • (Score: 2) by Freeman on Monday February 12 2018, @05:40PM

      by Freeman (732) on Monday February 12 2018, @05:40PM (#636747) Journal

      So, a software bug / feature? The only reason to have a "black box" is to protect something. In aviation, it's flight recorder data, which you want to be able to survive practically anything. When applied to software, it's called, making sure I can milk them for all they're worth. I.E. Money.

      --
      Joshua 1:9 "Be strong and of a good courage; be not afraid, neither be thou dismayed: for the Lord thy God is with thee"

  • (Score: 2) by requerdanos on Monday February 12 2018, @07:18PM (2 children)

    by requerdanos (5997) Subscriber Badge on Monday February 12 2018, @07:18PM (#636788) Journal

    a list somewhere?

    I remember reading in a different article that the concerns were mitragynine and 7-hydroxymitragynine, and that of special concern were "enhanced" kratom formulations with a higher proportion of the latter (some of which someone-who-isn't-me may or may not have a good supply of, and might use to help stay active in the face of chronic pain).

    The FDA statement [fda.gov] here is light on details, but does mention mitragynine:

    our scientists analyzed the chemical structure of these kratom compounds against the software to determine its likely biologic targets. The model predicted that 22 (including mitragynine) of the 25 compounds in kratom bind to mu-opioid receptors. This model, together with previously available experimental data, confirmed that two of the top five most prevalent compounds (including mitragynine) are known to activate opioid receptors (“opioid agonists”).