FDA Science Falls Short In The Case Of Kratom

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FDA Science Falls Short In The Case Of
The FDA stated early this February that kratom has “opioid
properties” and is “associated” with 44 deaths. With that
Commissioner Gottlieb also stated that his agency developed
a computational model to identify the possibility of abuse of
designer street drugs for which there is little pharmacological
data. Using this model the FDA scientists analyzed the 25 most
common compounds in kratom and concluded that 22 of
them share the most structural similarities with opioid painkillers
such as morphine derivatives.
It seems the FDA is very concerned with substances having
“opioid properties”, but it appears that very common
substances possess similar characteristics, yet they are not
being demonized like the herb kratom. For instance it was
discovered some time ago in a study titled “Coffee
contains potent opiate receptor binding activity”1 that,
“Opiate receptor-active peptide fragments (exorphins) have
been identified recently in casein and gluten hydrolysates, and
morphine has been found in bovine and human milk.” This
leads to another study titled “Opioids
in milk”2. This study stated that, “In various studies, the milk has
been screened for the presence of free or precursor-bound
opioids.” Even Black Cohosh, a very common herb, has central
opioid activity and has been documented in a study titled
“Black Cohosh has Central Opioid Activity in
Postmenopausal Women: Evidence from Naloxone Blockade
and PET Neuroimaging Studies”3. A very surprising one is
ginger. In a study titled, “Ginger prevents morphine-induced
behaviors in conditioned place preference test in rats”4. The
data in this study indicated that ginger extract has a potential
anti-addictive property against chronic usage of morphine.
These facts about coffee, milk, ginger, and black cohosh have
been known for sometime and yet they remain. The fact is, just
because there is opioid activity for an herb or milk does not
mean it is identical to dangerous substances that are
responsible for the deaths of millions of Americans like Fentanyl
and other highly addictive pharmaceutical painkillers.
Dr. Andrew Kruegel, PhD, Pharmacologist and researcher at
Columbia University stated,
“Research suggests the [7-OH and Mitragynine] result in
associated deaths, and reports revealed that the majority of
the deceased had other harmful drugs in their system that
could have potentially caused respiratory depression. One
teenager in the FDA kratom associated deaths died from
hanging himself while testing positive for prescription drug
abuse, another man with over nine different substances in his
system fell out of a window and refused medical treatment
before passing, then another gentlemen passed from
complications due to deep vein thrombosis while taking 5
different prescription medications. In one listed kratom related
death the individual died by homicide with a gunshot wound
to the chest, and another nine deaths occurred in Sweden
from a concoction of synthetic opioids mixed with other
substances alongside kratom. After viewing the list of
associated deaths it is clear that kratom is not the sole cause
of death.
It has been noted that, “High kratom doses have not been
reported to cause lethality in the toxicological literature;
respiratory depression deaths have not been demonstrated
with kratom and the pharmacological mechanisms of action
of kratom are protective against respiratory depression as
compared to that of opiates.” In fact it was scientifically
determined that the lethal dose of Kratom is 1:233, which
proves that Kratom is safer than caffeine 1:84, nicotine 1:21,
acetaminophen 1:34, and is virtually impossible to overdose
on. Kratom and its constituents have shown no acute toxicity5 ,
displays powerful antioxidant and antibacterial properties6 ,
assists with drug and alcohol withdrawal symptoms7 , contains
several oxindole alkaloids, which have exhibited potent
immunomodulation properties, and even contains constituents
that have
exhibited anti-cancer properties.8 Not to diverge from kratom
but to put things into perspective, energy drinks like Monster,
Red Bull, and
5-Hour energy have 34 direct deaths related to them including
the death of a 16 year old girl Lanna Hamman of AZ. These
can be found the in FDA’s adverse events reporting system
where kratom has zero direct deaths to its name.
The FDA also stated that after analyzing 25 of the most
common compounds in kratom, also known as alkaloids, that
22 of the 25 bind strongly to opioid receptors in the brain. This
could not be further from the truth. Contrary to popular belief
kratom has years if not decades of clinical research, NIH
funded studies, and other thorough scientific data behind it. Its
alkaloids were analyzed and in the detailed list below you’ll
see several of its naturally occurring compounds that do not
bind directly to opioid receptors. To name a few there is
Isorhyncophylline that stimulates the immune system,
Isomitraphylline that is also an immunostimulant and antileukemic,
and Epicatechin that is a antioxidant, antiaggregant,
anti-bacterial and an anti-diabetic while also
being found commonly in chocolate. That is only 3 of the 25
1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5546775/
2. https://www.ncbi.nlm.nih.gov/pubmed/1764604
3. https://www.ncbi.nlm.nih.gov/pubmed/6296693
4. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4137441/
5. S.N. Harizala, b, c, , S.M. Mansorb, , J. Hasnanc, J.K.J. Tharakana
and J. Abdullaha Department of Neurosciences, School of Medical
Sciences, Universiti Sains Malaysia, Centre for Drug Research,
Universiti Sains Malaysia Department of Pathology, School of
Medical Sciences, Universiti Sains Malaysia 2010
6. Evaluation of Antioxidant and Antibacterial Activities of
Aqueous, Methanolic and Alkaloid Extracts from Mitragyna
Speciosa (Rubiaceae Family) Leaves. Suhanya
Parthasarathy,Juzaili Bin Azizi, Surash Ramanathan, , Sabariah
Ismail, Sreenivasan Sasidharan, Mohd Ikram Mohd. Said and Sharif
Mahsufi Mansor.
Universiti Sains Malaysia, Penang, Malaysia Institute for Research in
Molecular Medicine, Malaysia Universiti Kebangsaan Malaysia
7Se. Flaitnogteorra, pMiaa lVaoysluiam 2e0 0798, Issue 3, April 2007, Pages 182-185
8. García Prado, E., et al. “Antiproliferative effects of mitraphylline,
a pentacyclic oxindole alkaloid of Uncaria tomentosa on human
2g8lio0-m4.a and neuroblastoma cell lines.” Phytomedicine. 2007; 14(4):
Tetrahydroalstonine: Hypoglycemic, anti-adrenergic.
Speciophylline: Indole alkaloid. Anti-leukemic.
Speciogynine: Smooth muscle relaxer.
Rhynchophylline: Vasodilator, antihypertensive, calcium channel
blocker, antiaggregant, anti-inflammatory, antipyretic, antiarrhythmic,
Paynantheine: Indole alkaloid. Smooth muscle relaxer.
Mitraphylline: Oxindole alkaloid. Vasodilator, antihypertensive,
muscle relaxer, diuretic, antiamnesic, anti-leukemic, possible
Mitragynine: Indole alkaloid. Analgesic, antitussive, antidiarrheal,
adrenergic, antimalarial. Isorhynchophylline: Immunostimulant
EIspoimcaittraecphhiynll:i nAen:t Iimoxmiduannot,s taimntuialagngt,r eagnatin-let,u aknetmibiacc. terial,
antidiabetic, antihepatitic, anti-inflammatory, anti-leukemic,
antimutagenic, antiperoxidant, antiviral, potential cancer
preventative, alpha-amylase inhibitor. Also found in dark
cChoorycnoalantteh.e idine: μ -opioid antagonist, also found in Yohimbe.
Ciliaphylline: antitussive, analgesic.