By Robert Keith-Reid.

Islands Business Magazine

SUVA, Fiji (November) - Pacific Islands producers of kava will meet next year to decide the next step for repairing their ruined European pharmaceutical market for kava.

The market, previously worth at least US$50 million a year to growers in mainly Vanuatu, Samoa and Fiji, collapsed late in 2001 after German medical authorities published what growers, now backed by some scientists, have attacked as a completely unproven report claiming that kava causes serious and sometimes fatal liver damage.

Germany, the largest market, then banned kava-containing products and other European governments followed.

Kava products vanished from the herbal medicine shops and pharmaceutical stores that had sold them.

A European-Pacific strategy meeting just held in Brussels declared that kava is a safe and effective herbal medicinal product and that the attacks on it by European health authorities to ban kava imports are inappropriate and unjustified.

The meeting was attended by kava manufacturers, exporters and researchers and was intended to move towards the restoration of kava's reputation as a safe and effective anti-depressant and tranquillizer medicine.

The University of the South Pacific's (USP) Professor in Organic Chemistry, Professor Subramanium Sotheeswaran and the director of its Institute of Applied Sciences, Professor Bill Aalbersberg attended the meeting. It was agreed that an international kava conference be held in Fiji next year to discuss the latest research results and to press for a complete removal of the kava import ban in Europe.

USP has been selected as the primary research institution for finger printing and certifying correct varieties of kava for future export. Professor Sotheeswaran says kava has been used in the Pacific without harm for 2000 years.

Its confirmed positive effects for suffers of anxiety disorders and stress and high tolerability make it globally a highly appreciated medicine, he says.

He presented the Brussels meeting with the views of a kava research symposium held in Suva in November 2002.

These included the findings at the Fiji School of Medicine and the Colonial War Memorial Hospital in Suva by Dr Joji Malani and Professor Robert Moulds, who concluded that Pacific hospitals had not observed any obvious cases of liver damage caused by kava.

Sotheeswaran says that only one out of 76 German reported cases of liver toxicity in kava pill users can be linked to kava.

"This figure is insignificant when one compares it with the number of people who use kava products with no adverse effects of liver toxicity. In contrast, one out of 100,000 people who drink Canadian beer can contract cancer due to the levels of the cancer causative agent, nitrosamines, in beers."

Delegates agreed that some varieties of kava may not be good for making kava pills and that it may be possible that a wrong variety of kava or the wrong parts of the kava plant have been used by European manufacturers of kava pills and powders.

A legal challenge against the prohibition of kava product sales in Britain by the National Association of Health Stores is due to be heard by a British court on November 11, 12 and 13.

Ralph Pike, the association's director, says a British Government ban on the sale of kava can't be justified on public health grounds. In the United Kingdom, once a substance has been prohibited, there is a very tight window of opportunity‹three months‹to launch a legal challenge to such a prohibition.

The National Association of Health Stores took the decision to prepare for the challenge without having time to find industry support or financial backing.

The association's case stands on ten separate issues.

The ban was imposed by both the Food Standards Agency (FSA) and by the Medicines and Healthcare products Regulatory Agency (MHRA). It is thus completely prohibited from the United Kingdom in any form.

The association said the ban is illegal because it breaks European Community's import rule that makes them so unless there is at least one justifiable ground.

A ban must be "non-discriminatory, proportionate and not interfering with human rights at the individual and business level. Clearly, the bans fail on all three counts."

Some of the other arguments to support the association's case, Pike says, is that two British authorities appear to have reached their conclusions on the basis of material misdirections of fact, which is now increasingly recognised by the English courts as a distinct ground for a judicial review. In relation to the MHRA, it seems to have proceeded on the basis that there were 70 cases of "possible" adverse effects from kava products worldwide in the past 13 years, whereas it is clear that there were only 69 cases that had been assessed at all, of which 24 were classified as either "unlikely" or "unassessable", leaving only 45 cases as either "possible" or "probable". The FSA made equally significant errors of factual appreciation.

The clear inequality of treatment of kava products and other foods and medicines is demonstrated in the evidence of the NAHS.

The MHRA's assertion that it has taken a similar approach to licensed pharmaceuticals cannot be accepted.

There are numerous examples of medicines with much more significant and well-established adverse effects on the liver that remain licensed. They include:

Zyban: more than 7600 adverse reactions reported by July 2002;

Benzodiazepines, which have a much higher level of adverse reactions even if all the suspected adverse reactions for kava products were accepted as "certain".

Troglitazone and Talcapone, referred to by the MHRA itself as comparators, neither of which has in fact been withdrawn from the market, despite a much higher level of adverse reactions.

"The NAHS statement makes the obvious point that several well-known products are much more dangerous than kava. They include peanuts, many forms of alcoholic drink and tobacco products."

Pike says if his association wins its case "it will put regulatory authorities around the world on notice that they cannot continue to treat our industry with disinterest and/or contempt."

November 26, 2003

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