American kratom association accuses FDA of manipulating, obscuring, and ignoring science
“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.” -American Kratom Association Scientists & Attorneys
According to AKA Whitepaper 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 The most egregious examples cited by AKA include cases where:
1. 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.
2. 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).
3. 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.
4. 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.
5. 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 cite kratom as a culprit in these otherwise unrelated deaths sloppy and lacking in scientific integrity, but we 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.”
Original Article (PR News Wire):
American kratom association accuses FDA of manipulating, obscuring, and ignoring science
Artwork Fair Use: Thehealingeast