Stories
Slash Boxes
Comments

SoylentNews is people

SoylentNews is powered by your submissions, so send in your scoop. Only 12 submissions in the queue.
posted by Fnord666 on Monday February 12 2018, @05:09AM   Printer-friendly
from the scheduled-for-elimination dept.

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

 
This discussion has been archived. No new comments can be posted.
Display Options Threshold/Breakthrough Mark All as Read Mark All as Unread
The Fine Print: The following comments are owned by whoever posted them. We are not responsible for them in any way.
  • (Score: 3, Informative) by requerdanos on Monday February 12 2018, @07:09PM

    by requerdanos (5997) on Monday February 12 2018, @07:09PM (#636781) Journal

    No better than legislating the value of Pi to "3"... Kratom's chemical properties are not under the jurisdiction of the FDA. Someone should let them know. This is insanity.

    It's looking bad for kratom, but I don't think it's as bad as the headline makes it sound; it may be misleading.

    Here's why (FTFS):

    FDA Commissioner Scott Gottlieb said in a statement... "compounds in kratom make it so it isn’t just a plant — it’s an opioid."

    This is from a strongly worded press release--a press release that doesn't say that "The FDA" is "Labeling" kratom as an opiod, just that in their opinion, that's what it is (despite evidence that it binds in a different way to the receptors, that it does not depress respiration as do opiods, etc.). And press releases are not the mechanism by which the FDA classifies drugs.

    The regulatory labeling might not be far behind, but it hasn't happened yet.

    Starting Score:    1  point
    Moderation   +1  
       Informative=1, Total=1
    Extra 'Informative' Modifier   0  
    Karma-Bonus Modifier   +1  

    Total Score:   3