WASHINGTON, DC – August 14, 2018 | AKA
FDA did not independently verify or perform due diligence on death reports cited in an effort to force DEA to list kratom as a Schedule 1 substance.
Peer-reviewed documentation concerning 44 deaths that the Food and Drug Administration (FDA) has cited to persuade the Drug Enforcement Administration (DEA) to place natural kratom on the Federal Government’s Schedule 1 list of illegal substances disclose errors and omissions on the part of the FDA that the American Kratom Association (AKA) claims can only be seen as “deliberate.”
In a detailed white paper released today, AKA scientist claim, “The FDA has also misled the DEA, the Centers for Disease Control (CDC), and the National Institute on Drug Abuse (NIDA) with incomplete, inaccurate, extrapolated, and distorted information on adverse events and deaths allegedly associated with the use of kratom to encourage unwarranted legislative and regulatory restrictions on kratom at the federal, state, and local government levels.”
Among the most significant claims, the AKA offers evidence of duplicated case reports, omissions of “cause of death” conclusions and inaccurate autopsy and toxicology reports, as well as redacted statements from experts contradicting FDA claims. According to AKA, the FDA reports that associate kratom use with 44 deaths are so “poorly documented they could not pass basic standards for publication in any credible scientific journal, even as a letter or comment.”
The most egregious examples cited by AKA include cases where:
· The FDA failed to adequately disclose and account for material facts from the peer-reviewed Case Report of nine deaths in Sweden that were published in 2011 in the Journal of Analytical Toxicology. That report concluded the deaths were actually the result of adulteration of kratom powder with a toxic dose of O-desmethyltramadol.
· Two deaths claimed in the documents released by the FDA are the same death reported twice (FAERS ID No. 14449343 and FAERS ID No. 14254346).
· Other deaths were from abuse of loperamide (FAERS ID Nos. 12665823 and 12665824), heroin (FAERS ID No. 174035), acetaminophen (FAERS ID No. 14554565), and other drugs or drug cocktails.
· The FDA stripped source data (FAERS ID No. 14449343) that cited U-47700 (PINK) as the primary cause of death, when kratom was listed as the fifth of six substances in the toxicology report.
· The FDA even attributed suicides (FAERS ID No. 14554565 and FAERS ID No. 12639556); a homicide, with a gunshot wound to the chest (FAERS ID No. 12639316); cardiac arrhythmia while swimming (FAERS ID No. 191303); deep vein thrombosis (FAERS ID No. 12639594), and the fall from a window (FAERS ID No. 1342166) to kratom.
“Not only is the FDA’s effort to frame kratom as a culprit in these otherwise unrelated deaths sloppy and lacking in scientific integrity, but one can only conclude that it has been done deliberately,” said Dave Herman, Chairman of the AKA. “We invite those who want the truth to go to our white paper, get the information, and join us in our demand that the FDA follow the science.”
According to the AKA, none of the FDA reported 44 deaths document any specific cause that is consistent among the cases that can be linked specifically to kratom; a vast majority of the cases document polydrug use by the decedent and, in a few cases, the possible use of adulterated kratom products. In most cases, the cumulative contributions of multiple drugs and interactions between drugs are not even considered by FDA.
“The DEA, CDC, and NIDA depend on the FDA for accurate information,” said Herman. “This misinformation has already resulted in bans on kratom in six states and in a number of local jurisdictions. Likewise, it creates a completely unjustified bias against kratom by law enforcement officers, coroners and medical examiners, and state prosecuting attorneys’ groups. We call on the FDA to make this right.”
Among measures requested by the AKA, the FDA must:
· review the FAERS database to ensure complete and accurate records of all source documents;
· reevaluate and revise its kratom-related policies based on corrected and accurate scientific evidence;
· work with the DEA, CDC, and NIDA to update policy documents to reflect accurate and unbiased assessment of the risks of kratom use;
· immediately lift the current Import Alert on kratom;
· rescind its November 14, 2017 Public Health Advisory on kratom; and,
· commence appropriate enforcement action against companies and individuals who are producing adulterated kratom products that pose a real and present danger to the public.
In addition, the AKA calls upon the DEA to reject the FDA’s 8-Factor Analysis and scheduling recommendation and return it to FDA for a full scientific reanalysis of the data and conclusions in that submission.
The American Kratom Association (AKA), a consumer-based non-profit organization, focuses on setting the record straight about kratom and gives a voice to those who are suffering by protecting their rights to possess and consume safe and natural kratom. AKA represents millions of Americans, each of whom has a unique story to tell about the virtues of kratom and its positive effects on their lives. www.americankratom.org
Benjamin May, (202) 413-0119 — [email protected]