On November 14, the FDA Commissioner released
a statement warning people about kratom.
I'm going to run through problems with the
FDA's position and problems with those opposing
a ban.
The overall message is that there's evidence
of harm and no evidence of benefit.
In support of this, the FDA cites a significant
rise in kratom-related calls to poison control
centers from 2010 to 2015.
It also cites 36 fatalities associated with
kratom-containing products.
Details of those deaths weren't released,
so they could've involved adulterated products
or mixing it with other drugs.
Given the evidence, those reasons are pretty
likely.
Potentially kratom-involved deaths can be
found, but they usually involve extra substances.
I'm inclined to think that's also true here.
There's evidence the drug can be harmful due
to CNS depression and a higher seizure risk,
yet pure kratom overdose deaths are exceedingly
rare.
The idea that kratom is a supremely concerning
substance causing a wave of fatalities across
America is unsupported.
There are multiple problems with the statement.
First, it's overstating the harms, especially
when viewed in the context of other opioids.
And second, it's a bit disingenuous when it
suggests anecdotal evidence of benefit is
of absolutely no use.
This is nothing new for the FDA and the federal
government at large.
It appears to presume all drugs are guilty
to the point of criminality until millions
of dollars are spent running randomized, controlled
trials.
As the Commissioner says, "To those who believe
in the proposed medicinal uses of kratom,
I encourage you to conduct the research that
will help us better understand kratom’s
risk and benefit profile,
so that well studied and potentially beneficial
products can be considered.
In the meantime, based on the weight of the
evidence, the FDA will continue to take action
on these products in order to protect public
health."
Those actions include cracking down on companies
that inappropriately market kratom and calling
for the detainment of shipments.
The government has been taking those actions
for years, so it's not surprising to see this
letter.
What is concerning, is that it may indicate
there will be a push towards prohibition.
Advocates prevented emergency scheduling in
2016, but the DEA didn't lose interest in
the plant.
Instead, it asked the FDA to review the evidence
and make a recommendation.
If its evaluation suggests kratom is a harmful,
abusable drug with no known medical use, we
could see it become a scheduled drug.
Sadly and expectedly, that's how the agency
is characterizing the substance.
Kratom is currently receiving more attention
than Salvia divinorum, another substance the
DEA treats as a "drug of concern."
Because of that attention and more alleged
safety issues, a federal ban is conceivable,
whereas action against Salvia has seemingly
stopped at the state level.
At the least, more state-level kratom bans
could be triggered by the sort of rhetoric
coming from the FDA and others.
There are many reasons to dislike prohibition.
One is that it's fundamentally a wrong-headed
and inappropriate exercise in government power.
Another is that drug in question isn't just
a recreational substance, it may be a tool
in the fight against the opioid overdose crisis.
There are no randomized, controlled trials,
but we know people are using kratom as an
opioid agonist therapy.
They're taking it to control the withdrawal
symptoms from opioids like heroin, to reduce
craving, and to increase their chance of leading
a better life.
Even without studies, I find it hard to believe
switching from heroin or illicit oxycodone
to kratom isn't a net positive.
It appears significantly less likely to produce
fatal respiratory depression and the dependence
it produces is less severe.
When you consider the adulterants, like fentanils,
in the illicit opioid market, there's yet
another reason to support the switch to kratom.
But the FDA has a different take.
"At a time when we have hit a critical point
in the opioid epidemic, the increasing use
of kratom as an alternative or adjunct to
opioid use is extremely concerning."
"It’s very troubling to the FDA that patients
believe they can use kratom to treat opioid
withdrawal symptoms."
This idea really doesn't make sense.
None of the evidence indicates the use of
kratom as an alternative to other opioids
is concerning.
If anything, it's the opposite.
The FDA also likes it being promoted for other
uses, including pain relief.
Yet animal studies and anecdotal evidence
from humans show it can reduce pain.
Since a core part of its activity is acting
as an opioid, that's not surprising.
Though I do think there are reasons to be
cautious about using it ahead of other drugs.
It is, after all, a minimally studied concoction
of minimally understood drugs.
Perhaps it's a good alternative to typical
opioids, but we need more evidence.
Regardless, a lack of controlled trials isn't
a good reason to ban it.
The FDA and DEA have a negative view of the
plant based on the potential for addiction,
death, liver toxicity, seizures, insomnia,
weight loss, and hallucinations.
Kratom may have a connection to at least most
of these issues.
For example, animal studies show some potential
for liver toxicity and we know people can
use it in a compulsive or reckless way.
But none of the evidence suggests it's common
for a kratom user to destroy their liver,
become psychotic, or die.
Focusing on outlier events is a good way to
demonize a drug and a bad way to create policy
or educate people.
If you look closely at most pharmaceuticals
and over the counter drugs, you'll find uncommon
risks that if elevated for political reasons
would make it seem like those drugs should
be banned.
Kratom is no different.
Though I'm not fond of the FDA's statement
and I oppose a ban, the arguments from the
pro-kratom side are often flawed.
I understand the reasoning for these bad arguments,
but I still don't think they're ethical.
The largest advocacy group for this topic,
the American Kratom Association, is misleading
people about the nature of the drug.
In fact, it claims it's not even a "drug."
This is a pretty strange position to take.
Sure, if you engage in some mental backflips,
you can say the plant isn't a drug per se.
There's no kratom molecule circulating through
your body, but the only reason the plant does
anything is because it contains drugs.
This is why coca, coffee, opium, cannabis,
the areca nut, and psilocybin mushrooms are
also called "drugs."
The AKA also says this:
"Kratom contains no opiates, but it does bind
to the same receptor sites in the brain.
Chocolate, coffee, exercise and even human
breast milk hit these receptor sites in a
similar fashion."
It's accurate to say the primary drugs, mitragynine
and 7-hydroxymitragynine, aren't opiates.
But neither is fentanyl.
The broader class of drugs people actually
care about is "opioids."
Sure enough, that's the best classification
for these substances.
By extension, kratom can be viewed as an opioid,
meaning two things.
One, it exerts its effects, like morphine,
through the mu-opioid receptor.
Two, it offers morphine-like effects, such
as mood enhancement, pain relief, and sedation.
Not only is kratom a drug, it's an opioid.
But guess what, there is absolutely nothing
wrong with that.
People seem highly resistant to this view
of kratom due to unfounded concerns about
opioids and the general idea of drug use.
The plant does have a more diverse pharmacology
extending beyond opioid agonism, but opioid
activity is at its core.
And the comparison to exercise, coffee, and
breast milk is laughable.
Unless you're going to say taking heroin is
like going for a swim, lets not say drinking
kratom is like a high intensity cardio.
Countless things activate the endogenous opioid
system, such as endorphins and enkephalins,
but these kinds of ideas show a disregard
for the science and how drugs are classified.
The AKA and many others also focus on the
fact that kratom isn't a synthetic substance.
They say it's a plant in the Rubiaceae family,
just like coffee plants.
This is true, but why does it matter.
Plants are not inherently safer or more effective
than synthetic drugs.
They're just biosynthetic machines pumping
out chemicals like a naturally occurring Pfizer
laboratory.
Every substance, whether it's created in a
lab or found in a jungle, has to be evaluated
on its own terms.
Otherwise this is just the fallacy of appealing
to nature.
The AKA says, "Kratom is not a synthetic substance.
Naturally occurring Kratom is a safe herbal
supplement that’s more akin to tea and coffee
than any other substances."
Yet the fact that it's not synthetic tells
us nothing about its safety or efficacy.
And the outright categorization of it as "safe"
is dubious.
Harm reduction is necessary just as it is
with other drugs.
It's also misleading to claim it's closer
to tea than any other substance.
It doesn't function like caffeine and users
tend to report opioid-like effects.
Even if those effects are comparatively mild,
saying kratom is more like tea than an opioid
makes little sense.
The same sort of position was shared in a
pro-kratom article.
"It is used as a natural alternative to pharmaceuticals
to manage a wide range of physical and mental
health conditions.
Due to its anxiolytic (anti-anxiety) and analgesic
(pain relieving) properties, it can mitigate
all manner of conditions."
The author goes on to say, "It’s also an
effective panacea to mental health conditions...
[and can] be used as a cognitive enhancer
(study aid) and enjoyed for pleasure."
Again, highlighting its status as a natural
drug is engaging in a specious appeal to nature.
And if you want to stand in opposition to
the FDA, it's probably best not to tout something
as a panacea when you have little research
to back it up.
None of this is to say kratom couldn't be
a good alternative to prescriptions for many
people.
But these kinds of statements from the AKA
and others are misleading.
If you're trying to fight propaganda from
the FDA, DEA, and other authorities, I think
it's best to counter with facts and honesty,
not falsehoods.
There are potentially good reasons to support
kratom as a treatment for opioid addiction
and other conditions.
And we should be encouraging careful scientific
evaluations of its activity so that users
are more informed.
Sadly, a ban could still be coming.
I can picture the FDA and DEA saying it should
be heavily researched before anyone uses the
drug.
And while those trials are underway, it'll
be controlled to enhance public safety.
Yet banning the drug would limit research,
hurt people with opioid addictions, and expand
the unacceptable policy of prohibition.
Restrictions can and should be opposed with
those arguments, not with more misleading
statements.
If you have any questions, feel free to put
them in the comments.
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