New England Journal Of Medicine Publishes Doctors' Letter Debunking FDA Claim Of Kratom Deaths
The esteemed New England Journal of Medicine recently published a letter signed by seven doctors, scientists and public officials defending kratom against the FDA's claims of deaths in Colorado related to the medicine.
The letter explains how it "has been asserted that no deaths solely attributable to mitragynine [one of the primary active compounds in kratom] have been documented." They point out how the FDA issued a warning in February of last year due to the similar structure of mitragynine was similar to some opioids.
The team of medical experts from Colorado, including Medical Doctors, scientists, professors and Boulder County and Denver city medical examiners with the coroner's office reviewed Colorado death certificates for mention of kratom and mitragynine from 1999 to 2017 and and found multidrug ingestions (two to six drugs) in 11 cases, 8 cases with positive test results for other opioids. Four deaths were solely attributed to mitragynine in the coroner's reports.
In three of the four cases of deaths that were attributed solely to kratom residual blood was available to test. From conducting high-performance liquid chromatography (HPLC) and mass spectrometry they team was able to ascertain that 14 of the 15 deaths that were attributed to kratom involved the use of multiple drugs at the time of death.
The letter admits that mitragynine may increase the risk of adverse effects during coingestion of multiple illicit or pharmaceutical drugs, but point out that an important structural difference between kratom and opioids is how it only acts on the mu and delta opioid receptors which is responsible for the reduced risk of respiratory depression.
In December of 2017, we covered how someone had taken the FDA up on their offer to "go FOIA" regarding the exact data they used to back up their advisory calling kratom a "public health hazard."
The FDA claimed their advisory was based on "clear data" and "evidence" supporting their denouncement of the botanical cousin of coffee, the Southeast Asian plant medicine kratom.
Anthony Roberts submitted a Freedom of Information Act request for "copies of all evidence and all validating documents, plus related proof that the FDA relied upon when making all of the claims about kratom" in their November 14, 2017 advisory.
Roberts chain of communication read, in part, as follows:
"How does the FDA know this? Please provide all documents relied upon as support for this claim." Time and again requesting "validation and documentation" and the supporting evidence for what would, otherwise, be completely baseless claims with no scientific supporting evidence.
What evidence? Please provide said evidence. Again, I am seeking the documents the FDA has relied upon, or experts consulted, to come to these conclusions. Additionally, I am also seeking any emails (whether sent to the FDA or any employee or director of the FDA, by a lobbying group, PAC, or any other outside source, as well as internally composed/generated emails). I additionally seek internal documents, including but not limited to memorandum of interviews and white papers, that offer the opinions or facts used to support the preceding, quoted, claims found in the press release.
Here, I am seeking to answer, with specificity, which opioids kratom resembles in terms of risk of death. Here, as "similar risk" has been mentioned, I am seeking the documentation and statistical analysis, used by the FDA, that articulates or provides evidence of the "similar risk" of kratom viz other opioids.
"Calls to U.S. poison control centers regarding kratom have increased 10-fold from 2010 to 2015, with hundreds of calls made each year."
Please provide details and records of these calls and statistics.
"The FDA is aware of reports of 36 deaths associated with the use of kratom-containing products."
How is the FDA aware of these deaths? Please provide correspondence with any outside agencies or agents, whether governmental, private or otherwise concerning these deaths. Additionally, please provide all evidence and documentation of these deaths, and further that they were associated with kratom.
"There have been reports of kratom being laced with other opioids like hydrocodone."
Provide the reports referenced.
"The use of kratom is also associated with serious side effects like seizures, liver damage, and withdrawal symptoms."
Please provide evidence of kratom being associated with "seizures, liver damage, and withdrawal symptoms."
"…FDA has evidence to show that there are significant safety issues associated with its use. "
Again, please provide the evidence FDA utilized and analyzed in the composition of this press announcement to come to this conclusion.
The request was concluded with no responsive records being found for any of the issues that the FDA had mentioned in their dire warning against kratom. In addition to that, as we also previously covered, the FDA has glossed over known dangers of pharmaceuticals that are sometimes rushed to the market without due diligence performed first.
Molecular biologist Dr. Jane Babin and forensic toxicologist Karl Ebner took issue with the "exaggerated claims" from the FDA regarding kratom's potential for toxicity. Despite the number of scientists and medical experts that have spoken out, the FDA has remained firm in their claims that kratom is a danger. That said, we've come a long way in a short time as far as stemming the tide of misinformation related to this plant that has helped millions improve their quality of life.