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FDA Statement Calls Kratom an Opioid

Accepted submission by takyon at 2018-02-10 02:47:02
Science

FDA Commissioner Scott Gottlieb has released a new statement denouncing the drug kratom [wikipedia.org]. The statement [fda.gov] 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 [marketwatch.com].

The American Kratom Association provided a rebuttal [prnewswire.com] of the FDA statement:

Nine leading scientists in substance addiction and safety wrote [americankratom.org] 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 [soylentnews.org]
The Calm Before the Kratom Ban [soylentnews.org]
FDA Blocks More Imports of Kratom, Warns Against Use as a Treatment for Opioid Withdrawal [soylentnews.org]

Related: Opioid Commission Drops the Ball, Demonizes Cannabis [soylentnews.org]


Original Submission