Kava is a plant whose
peeled root has been safely consumed for thousands of years.
Kava has an extremely high safety record, has been shown to
be non-addictive, and has no side effects beyond a
reversible dry skin condition found only at extremely high
daily consumption levels sustained for long periods of time
-- a condition never found in Western nations.
After thousands of years of safe consumption by Pacific
islanders, a single study was published at the dawn of the
new millennia in Germany trying to blame Kava for liver
injuries found in patients. The manufacturers of such
"study" chose to disregard the fact that, e.g., 70 out of 72
said patients had alternative explanations for their
injuries by being consumers of alcohol and acetaminophen(e.g.
Tylenol); and of other pharmaceutics with liver injury as a
well known side effect. This study pre-publication peer
reviewers depended on the author's failed identification of
patients' concomitant consumption, which was only found upon
publication and review by toxicologists of the alleged
patients in Europe. In conclusion, the study was bad science
and has since been debunked (follow
link to pdf for more on the debunking).
Moreover, several European pharmaceutical companies are
known to have imported Kava root with peel attached from
Pacific islands before 2000. While the traditional
extraction process with water and/or peeled roots raises no
issues, attempting to extract Kava's desirable active
ingredients from a non-peeled root with solvents other than
water can result in the extraction of undesirable peel
compounds, which have nothing to do with Kava itself but the
observance of good manufacturing practices.
The bad science from 2000-2001 has been debunked and Kava's
root very high safety record again affirmed. Indeed, the
German Commission E, a well known and respected authority in
the forefront of herbal science and legislation, calls their
own reaction to the now debunked study as "inappropriate" in
light of the clear scientific evidence.
To better understand how the scare developed, one should
observe the confluence of mass media and pharmaceutical
business interests, which is made apparent by the incentives
created by pharmaceutical advertising expenditures.
When news of the
publication of the since-debunked-study arrived in the USA,
the FDA asked, in an "Advisory" communication, for input
from health professionals as to potential issues related to
the consumption of Kava, "if any". Sadly, when announcing
the FDA "Advisory" in a cable to news media nationwide, the
Associated Press medical director replaced the term
"Warning" for "Advisory" -- with a "Warning" being a
formally distinct form of FDA communication that implies the
identification of evidence-based cause for concern.
Unfortunately, the consequences of such bad science and
journalistic misstatements persist to this day in
professional news and medical databases. Indeed, the
parroting of allegations based in bad data is consistently
repeated in mass media. For example, one can find broad
assaults on the high safety of dietary supplements and
further implicit and explicit misinformation in the
magazines "Time" of June 4, 2008, written by Dr. Gupta, and
in "USAToday" September 3, 2011, by Dr. Ahmed (you can see
my letter to the latter editor
Since the relations between pharma interests, opposed to the
free commercialization of Kava so as to protect their
monopolies and profits, and the media and medical for-profit
establishments, has not been changed a bit in the last
decades, we don't expect change in the status quo. Yet, we
can help pass the word by keep on doing what we know and
believe in. Here we stand.
Pedro Coelho, Esq.
More links and scholarly references:
The European Union Lifts Ban On Kava
[enacted in 2002]
Supplement Review Concludes
Kava Is Safe
Using Science to Dispel Herbal Safety Myths, Misconceptions
One of many since the 2001 scare, a kava study (Gruenwald
2002) commissioned by the Centre for the Development of
Enterprise(CDE www.cde.int) in July 2002 found that there
were no basis for the market recalls or restrictions by
health agencies in Europe in 2001. Moreover, scientific
papers presented at the International Kava Conference (IKC),
Suva, Fiji 2004 (Proceedings of IKC 2004), clearly showed
that there was no correlation between kava consumption and
Gruenwald J. 2002. "In-Depth Investigation into EU Market
Restrictions on Kava Products" In: press statement 58-03
kava study supports the Pacific nations' view. Forum
Secretariat, Suva. May 2003.
Gurley BJ et al. “In vivo effects of goldenseal, kava kava,
black cohosh, and valerian on human cytochrome P450 1A2,
2D6, 2E1, and 3A4/5 phenotypes.” Clin Pharmacol Ther.
Gurley BJ et al. “Effect of goldenseal (Hydrastis canadensis)
and kava kava (Piper methysticum) supplementation on digoxin
pharmacokinetics in humans.” Drug Metab Dispos.
Gurley BJ et al. “Clinical assessment of CYP2D6-mediated
herb-drug interactions in humans: Effects of milk thistle,
black cohosh, goldenseal, kava kava, St. John's wort, and
Echinacea.” Molec Nutr Food Res. 2008;52(7):755.
Sood A et al. “Potential for interactions between dietary
supplements and prescription medications.” Am J Med.
Schmidt M et al. “Kava: A risk benefit assessment.” In: The
Essential Guide to Herbal Safety. 2005; p 115-203. Elsevier,
St. Louis, MO.
Schmidt M. “Is kava really hepatotoxic?” 2007; p. 151.
Accessed March 2010: http://www.uni-muenster.de/imperia/md/content/pharmazeutische_biologie/_v/review.pdf
to USA Today in regards to 9.3.2011 article by Dr. Ahmed:
I'm writing in regards to your post:
Wherein Dr. Qanta Ahmed attacks Dietary Supplements in
general, and some such as Kava quite specifically. He takes
a pro-pharmaceutical industry stance, which I understand as
natural due to a more partial education, and, I imagine, the
general interest of your media corporation to attract pharma
ad revenue -- e.g., a new study by two York University
researchers estimates the U.S. pharmaceutical industry
spends almost twice as much on promotion as it does on
research and development, contrary to the industry’s claim
Here are some of Dr.
Ahmed, specifically inaccurate and misleading,
statements in above mentioned article:
"In the United States these substances are classified as
natural, herbal or dietary supplements and are not subject
to rigorous FDA regulation and so their dosing, and purity
may be very different from product to product. More alarming
is the fact that the vast majority of these products have
never been evaluated in clinical studies prior to becoming
available to the public."
THIS IS SIMPLY NOT TRUE. The FDA, and other agencies such as
the USDA, administer an enormous assortment of laws and
regulations meant to control the accuracy of dosing and the
quality of dietary supplement products, such as the purity
of its ingredients. Moreover, "dosing" and "purity" can vary
according to product label, as with any other commercial
products such as pharmaceutics.
While a product may not
have been tested in the way clearly needed and appropriately
required of synthetic pharmaceutical products, the products
used as ingredients in dietary supplement products have
indeed been controlled for purity, dosing accuracy, and
other factors by many other laws, namely: the mandated US
FDA Good Manufacturing Practices; Independent Laboratory
Analysis; Independent and Governmental Certifications such
as Organic; US Customs and USDA; FDA and FTC on claims and
labeling; to name a few.
Actually, the only thing "alarming" in your article is the
doctor's use of such sensationalist and emotionally loaded
word without reason; but for an education and/or career too
dependent on pharmaceutical companies and their profitable
On the other hand,
herbal supplements are not subject to patent monopolies'
manufactured scarcity; and have been used in one human
culture or another for thousands of years with very high
safety records. Uncompromised until the occasionally bad
scientific study mysteriously reappears and the consequent
Dr. Qanta goes on parroting past lies by specifically
replacing the word "Advisory" with "Warning" when these
terms refer two very different classes of FDA professional
communications, with two very different meanings and
consequences in law and fact. Such word replacement was
first manufactured by the Associated Press Medical Director
upon the FDA's publication of the Advisory in 2002.
Now, such word
replacement is often replicated throughout corporate media
articles written by some medical doctors(e.g. Dr. Gupta at
CNN and others) of limited education and a corporate career.
Maybe because they are restricted in access to databases
that replicate the error of not removing bad studies from
circulation. Pharma does not cares for the fact that Kava
root has never been shown to injure anyone's liver and all
past accusations have been repeatedly debunked by science.
So, unfortunately, doctor Qanta also uses the word "Warning"
instead of the, so much less relevant and alarming, but
accurate and responsible, "Advisory" term used by the FDA.
"As clinicians we are
advised to avoid recommending their use and certain agents
including kava and melatonin [we are told] have been
associated with liver toxicity and in the case of kava the
FDA has issued a specific warning" -- wow, again,
this is specifically NOT TRUE -- the FDA did not issue a
"Warning" but an "Advisory" -- see by yourself in 2002 link
Moreover, since the
FDA's 2002 communication the FDA and many others have found
no such evidence in the past ten years or before -- quite to
the contrary, as you can find in the links immediately
by the publication of this single study in Europe, was an
immediate investigation and debunking of the published study
by leading US toxicologists, plus meta-analysis of previous
clinical studies proving kava's inexpensive efficacy, in
vitro testing, the long history of use amongst Pacific
islanders and the well known lack of side effects, and
non-addictive character. For more see e.g.:
As a final note regarding Kava's effects, I find it most
peculiar that the good doctor knows not that most types of
Kava have a relaxing but non-sedative effect. So, not much
good for sleep, which is the announced topic of the article.
But its great to relax without sedation!
At this juncture, it is
interesting to note that modern society, perhaps influenced
by our limited experience with the effects of alcohol and
pharmaceuticals, normally associates relaxation to sedation.
Nothing could be further from the truth! And how can you
have truth recognized without accuracy in media such as
Thank you for your possible interest in this individual
reader's knowledge. If you find the truth to be of any
interest, you are free to publish a correction. Also, I'd be
happy to develop this letter into a publishable article for
Look forward to hearing from you.
Pedro Coelho, Esq.
September 5, 2011
9.9.2011 Update: for
some reason no particular communication was received as a
reply to this date, and I posted a draft of this letter as a
comment to article.