Kratom

American Kratom Association: "FDA Review of Drug ‘Junk Science’"

Rolling Stone reported last year before FDA Commissioner Scott Gottlieb resigned that they were using junk science to villify kratom in the media.

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.