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."
A copy of the letter from the nine scientists and supporting documents can be found at: https://www.americankratom.org/science-letter-on-kratom.
These scientists were united in their "collective judgment that placing kratom into Schedule I will potentially increase the number of deaths of Americans caused by opioids . . ."
The nine leading scientists directly challenged the claims by FDA Commissioner Scott Gottlieb that kratom is an opioid by pointing out the "available science is clear that kratom, although having effects on opioid receptors in the brain, is distinct from classical opioids (e.g. morphine, heroin, oxycodone, etc.) in its chemistry, biological effects, and origin (kratom is a tree in the coffee family, not the opium poppy family). Importantly, as commonly used in raw plant form, it does not appear to produce the highly addictive euphoria or lethal respiratory depressing effects of classical opioids."
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."
The scientists also attacked the bad science the FDA used to claim deaths from kratom use, pointing out that "the fatalities that the FDA lists as having been associated with kratom include deaths with a wide variety of apparent causes in people suffering from various diseases and/or taking other substances that also likely contributed to their deaths. For example, it includes 9 fatalities in Sweden that resulted from an adulterated product that included the active substance of the prescription opioid tramadol (leading Swedish authorities to conclude that those deaths were caused by O-desmethyltramadol, not kratom).
The assertion that a scheduling recommendation can be based on a claim of deaths 'associated with kratom' rather than deaths 'caused by kratom' is not, in our judgment, either scientifically valid nor the standard that was contemplated by the U.S. Congress for the scheduling of any substance under the CSA."
Finally, the nine scientists argued that American consumers should continue to have access to kratom. "We affirm our belief that the existing science on kratom does not justify its placement into Schedule I of the CSA, nor for kratom to be added to any local or state Controlled Substances list that would effectively remove it from consumer access."
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