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 herein below).

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.

Sincerely,
Pedro Coelho, Esq.
pedro@kavazen.com

More links and scholarly references:

The European Union Lifts Ban On Kava [enacted in 2002]  November 2008

Supplement Review Concludes Kava Is Safe  February 2002

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 liver diseases.

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. 2005;77(5):415-26.

Gurley BJ et al. “Effect of goldenseal (Hydrastis canadensis) and kava kava (Piper methysticum) supplementation on digoxin pharmacokinetics in humans.” Drug Metab Dispos. 2007;35(2):240-5.

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. 2008;121(3):207-211.

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

9.5.2011 Letter to USA Today in regards to 9.3.2011 article by Dr. Ahmed:

Dear Sirs,

I'm writing in regards to your post:

http://yourlife.usatoday.com/health/sleepmatters/post/2011/08/Whats-Inside-the-American-Medicine-Cabinet/545438/1

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 -- see www.actupny.org/reports/drugcosts.html and
www.sciencedaily.com/releases/2008/01/080105140107.htm

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 monopolies.

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 misinformation spreads. 

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. She writes:

"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 below: http://www.fda.gov/Food/ResourcesForYou/Consumers/ucm085482.htm

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 below.

Furthermore, prompted 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.:

http://kavazen.com/pages/library.htm#KavaZen%20and%20Kava%20Safety 

http://www.kavazen.com/pages/Facts%20on%20Kava%20Safety.pdf

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 yours?

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 your publication.

Look forward to hearing from you.

Sincerely,
Pedro Coelho, Esq.
September 5, 2011
pedro@kavazen.com

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.