Kratom detractors chastened for “embarrassingly poor evidence”

Two federal officials went at it again in late May of this year on Twitter over the FDA’s failed attempt to ban Kratom. 

On one side is Scott Gottlieb, the former Food and Drug Administration (FDA) commissioner. Gottlieb remains convinced that kratom “is fueling the opioid addiction crisis.” On the other side is Brett Giroir, former Assistant Secretary of Health, which oversees the FDA. Giroir struck down Gottlieb’s recommendation in 2018 that kratom be considered a Schedule 1 drug, a substance with “a high potential for abuse," "no currently accepted medical use," and "a lack of accepted safety" even under medical supervision. 

Said Giroir most recently on Twitter: "FDA's recommendation was rejected [because] of embarrassingly poor evidence & data, and a failure to consider overall public health." In another comment, Giroir said: "If #Kratom is fueling opioid addiction, prove it; and then [HHS] should reconsider."

The difference between the two former officials, both medical doctors, resurfaced when Gottlieb tweeted that the Biden administration should follow through on the FDA’s 2016 recommendation to classify kratom as a Schedule 1 substance.

The “failure to consider overall public health,” as Giroir said in his tweet, refers to the large numbers of opioid addicts who contend that kratom has actually been the key to them staying off opiates. Their uproar at the original FDA recommendation prompted the DEA to backtrack and seek the recommendation of HHS. 

Comments on Twitter to both Gottlieb’s and Giroir’s tweets were overwhelmingly in favor of keeping kratom legal. Many offered testimony as to how it had kept them or friends and loved ones off of opiates. Said one Twitter comment: “Kratom actually helps. It saved my life. And opioids don’t work when you take kratom.”

Another asked: “Why are doctors not found responsible for prescribing too many opioids? I didn’t need a 30-day supply when my wisdom teeth were taken out.”

The full article on Reason.com http://bit.ly/kratomtiff makes these additional points:

  • Gottlieb's case for banning kratom is anecdotal. 2 million users a year, 44 deaths in 9 years, all with significant additional substances involved, underlying conditions, and morbidity factors.

  • In one case of the 44 cited, a 22-year-old man consumed kratom along with an "unknown tablet." The patient then had "an incident” in which he “fell from a first floor window.” He went to bed and was found dead the next morning. The man had a history of mental illness, and a prescription drug history that included an antipsychotic for treating schizophrenia, anti-depressent fluoxetine, anti-psychotics queiapine and olanzapine, benzodiazepines orazepam and triazolam, as well as other powerful drugs. Their potential contribution to his death was not mentioned. Instead, the report summarized: "The patient was found dead in his bed on the morning following the consumption of an herbal mixture."

  • Giroir noted in 2018 that the FDA never performed “a scientifically valid assessment of causality in the current few deaths in which kratom was co-utilized with known lethal drugs such as fentanyl.”

  • If the statistics are taken at face value and compared, the case against kratom seems thin. Over nine years, 44 deaths is 5 per year worldwide.

  • Alcohol causes about 88,000 deaths a year in the United States. 

  • The CDC counted nearly 50,000 opioid-related deaths (primarily involving fentanyl and heroin) in 2019 in the U.S.

  • Commonly prescribed benzodiazepines such as Xanax, Valium, and Ativan were involved in nearly 10,000 drug-related deaths in 2019 in the U.S.. 

  • Giroir cited an animal study that found mitragynine, kratom's main psychoactive ingredient, "does not have abuse potential and actually reduced morphine intake," which is consistent with the notion that kratom is a harm-reducing alternative to more dangerous drugs. 

  • Giroir warned in 2018 that banning kratom could cause "adverse consequences" such as "intractable pain, psychological distress, [and] risk of suicide"; "transition to proven deadly opioids"; or "transition to other potent or harmful drugs."