International expert calls for kava clinical trial to establish safety

Dr. Matthias Schmidt, a consultant on herbal drug safety and a member of the International Kava Executive Council (IKEC), believes the only way to convince European governments on the safety and efficacy of kava kava and to restore the industry in the South Pacific is to conduct clinical trials and further study the herb’s mechanism.

In light of the UK’s recent upholding of the existing ban on kava, Schmidt said, “The only way forward I can see is to provide a clinical trial in the area.” Although his study plan is geared toward fully restoring the German market, he said it will send a strong signal to other nations as well.

Schmidt praised the depth of the reports used to form the opinions of the UK’s Medicines and Healthcare products Regulatory Authority (MHRA) and Food Standards Agency (FSA), noting only a small number of errors, but said the decision to uphold the ban is “a typical story of benefit of the doubt – and benefit of the doubt is not a scientific question.”

He went on to say, “MHRA’s motto is to safeguard public health, but the question is whether such a ban may actually have the opposite effect.”

Since the German ban on kava in 2001, Dr. Schmidt said he has become aware of cases in which people have turned to Valium or even alcohol to deal with occasional anxiety and anxiety caused by specific situations, now that they are unable to obtain kava to ease their stress.

“The ban on kava has left a gap that has not been filled,” he explained.

The UK kava market differs from Germany in that licensed products under the remit of the MHRA were intended for bladder discomfort. There may be alternative methods for this indication, but unlicensed products directed for anxiety disorders and foods fall within the scope of the FSA.

In Germany, as in the US, there is not the same duality within the herbals sector. Kava kava is indicated for anxiety disorders.

German officials ultimately ruled that the kava ban was inappropriate because of the risk of toxicity was low, but there has still been no definitive proof of efficacy in the indication, for stress-related anxiety, so no products have been licensed to date.

Dr. Schmidt said the problem is that the indication is no longer relevant in modern diagnostic tools – that is, in the DSM-IV and the World Health Organization’s (WHO) International Classification of Diseases, the indication no longer exists.

He went on to say that while people do still suffer from it, it is seen as a chronic disorder requiring treatment of 12 weeks or longer. Short-term approaches do not exist.

His study plan is at an advanced stage, but as a pharmacist he has need of clinical assistance. Discussions are underway with University professors with interest in the area.

Schmidt said the timescale is unknown, but that studies should begin fairly soon if financing is available. The funding requirements projected are from €1 million to €1.5 million.

He added that the mechanism of action of kava toxicity needs to be researched, and stressed that the toxicity is not obligatory in every instance of kava consumption, but rather is idiosyncratic – that is, it occurs in rare and unpredictable cases but not all.

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“Any food will have some risk of allergy,” Schmidt said.

Fiji, a major exporter of kava kava, saw 30 to 35% of its revenues wiped out by the bans. Dr. Schmidt reported visiting the island in 2004 and seeing first-hand evidence of many small existences obliterated when the markets “broke down without any warning in 2001.”

As well, the island nation of Vanuatu has no alternative cash crops in the smallholder area, according to Kava Kompanu, and 80% of the population are subsistence small holders.

© Copyright 2007 Insight Journal Online Magazine.

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