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Kratom Association Calls FDA Review of Drug ‘Junk Science’ in Scathing Report

“This was clearly an unprofessional review,” writes expert Jane Babin in new white paper discussing the agency’s recommendation to ban the plant-based supplement

Kratom

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Earlier this year, the FDA announced that kratom — a plant-derived supplement that many users say offers relief from depression and anxiety, as well as a natural way to wean off opioids — has “opioid properties,” and recommended that the DEA classify it as a Schedule I drug. In a statement last February, FDA Commissioner Scott Gottlieb said the natural drug, which is derived from a Southeast Asian plant of the same name, has “potential for abuse, addiction and serious health consequences, including death,” and should consequently be put in the same category as other drugs that have no medically accepted use and a high risk of abuse. While

At the time, many advocates were outraged, with nine scientists sending a letter to then-DEA Acting Administrator Robert W. Patterson, urging him to dismiss the recommendation. “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 family),” they wrote.

Now, the American Kratom Association, a nonprofit that has worked since 2014 to educate the public about the natural drug, is taking it one step further, fighting back with a scathing breakdown of everything the government agency got wrong. Boldly titled “FDA Fails to Follow the Science on Kratom,” the white paper — published on Monday and written by Jane Babin, a lawyer and PhD in molecular biology — eviscerates the scientific process the FDA used to conclude that kratom is a health risk.

Calling their review “junk science,” the paper accuses the agency of misrepresenting the evidence in their favor. “The FDA has relied on a strategy of manipulating, obscuring and ignoring science in its inexplicable zeal to impede public access to the natural botanical kratom,” writes Babin. “This was clearly an unprofessional review … riddled with significant credibility issues.”

In their February recommendation to the DEA, the FDA cited 44 cases of kratom-related deaths, claiming that in each circumstance, despite other substances found in each victim’s system, kratom was a primary cause of death; critics said that it was other drugs that were at fault, not the kratom.

In the paper, Babin goes through many of the individual cases cited by the FDA, pointing out their flaws. Nine deaths, for example, turned out to be from a Swedish batch of kratom that had been contaminated with toxic levels of o-desmethyltramadol, an opioid analgesic. Several more had mixed kratom with opioids, benzodiazepines and/or alcohol. One woman intentionally overdosed on acetaminophen. A man died in Germany with a total of 10 substances in his system, but that was after he fell out a window and refused treatment. Another death initially attributed to kratom was the result of a gunshot to the chest.

When reached for comment, FDA Commissioner Dr. Scott Gottlieb defended the agency’s initial position in a statement to Rolling Stone. “The FDA has done an exhaustive review of adverse event reports, clinical literature and other sources of information related to kratom,” Gottlieb wrote. “Kratom is an opioid and has the addictive features of opioid drugs. In the setting of an opioid epidemic, FDA has deep concerns about the potential for kratom to fuel the addiction crisis.”

Surprisingly, Gottlieb took the statement to Rolling Stone as an opportunity to revise the numbers, claiming that there were a total of 64 deaths between January 2011 and April 2018, of which 47 could be attributed to kratom. “Upon additional assessment of the deaths reported, the FDA has determined that 17 of the 64 deaths reported (some of which were reported as suicides), were not likely caused by kratom,” he wrote. The FDA declined to provide a list of the fatalities they believe to be the result of kratom overdoses.

However, Gottlieb noted, there was more to pay attention to than just fatalities. “These deaths are just one measure of kratom’s risk,” Gottleib wrote. “They don’t account for the many people who may become initiated on, and addicted to, opioids because of the easy access to kratom.” When asked for clarification — was there any documentation of opioid addicts who had began as kratom users? — a spokesperson for the FDA would not list specific examples. The statement is referring to “the traditional thinking of what addiction is and how it works,” the spokesperson wrote. “Kratom is an opioid and addiction to opioids is well-documented.”

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