| yee |
per Skip Bittenbender 11/26/03
Aloha 'Awa leaders and Kava colleagues,
Two reports from Pacific Islands Reports of East West Center. First appeared today, second is an executive summary of the lenghty
Gruenwald report which you received earlier this year.
Skip
PACIFIC ISLANDS REPORT
November 26, 2003
Pacific Islands Development Program/East-West Center
With Support From Center for Pacific Islands Studies/University of
Hawai‘i http://pidp.eastwestcenter.org/pireport/2003/November/11-26-13.htm
PACIFIC KAVA GROWERS REGROUP
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."
Report 2.
PACIFIC ISLANDS REPORT
Pacific Islands Development Program/East-West Center
With Support From Center for Pacific Islands Studies/University of
Hawai‘i
KAVA REPORT 2003 http://166.122.164.43/archive/2003/September/09-23-report.htm
Executive Summary [Download Full Report Here very large file requires
Adobe Acrobat]
Prepared for the Center for the Development of Enterprise by Dr Joerg
Gruenwald
Brussels, Belgium
March 2003
1. Introduction
On behalf of the negatively affected South Pacific member states, the
Pacific Islands Forum Secretariat (Suva, Fiji) requested to the Centre
for Development of Enterprise (CDE, Brussels, Belgium) for assistance,
resulting in the engagement of Phytopharm Consulting (Berlin, Germany)
by CDE to perform the present "In-depth Investigation into EU Member
States Market Restrictions on Kava Products". The objective of this
project is to provide sound scientific background information to
evaluate if the kava restrictions are justified. Phytopharm Consulting
has reviewed and evaluated all available cases and scientific
information on kava, the restrictive measures taken against kava by
health authorities, and the resulting economic consequences for the
negatively affected South Pacific islands. Based on this extensive
analysis a possible future strategy to restore kavas´ reputation as
safe and effective prescription drug was developed.
2. Summary of Results
2.1. Scientific Evaluations
The efficacy and safety of kava in the treatment of conditions of
nervous anxiety, stress, and restlessness has over two thousand years
of traditional use and is proved by 20 clinical trials including more
than 10,000 patients and supported by post marketing experience in
Europe, the USA and other countries and by several expert commissions
implemented by the German Health Ministry. The severe hepatotoxic
effects of kava, claimed by drug regulation authorities, cannot be
regarded as proven. From the 76 reported cases we have examined and
evaluated, only 4 of them may possibly be related to the intake of
kava. All experts criticized the conclusions having been made by
regulation authorities as the German BfArM on the basis of insufficient
data provided by the relevant case reports. Numerous experts and even
health authorities as the American Food and Drug Administration (FDA)
agree with our analysis and confirm kava as being an effective and safe
herbal remedy without the potential of severe hepatotoxic side effects,
if used properly according to the medical instruction. The
benefit-risk-ratio for kava evidently has to be regarded as positive
and the withdrawal of market authorization of kava preparations as
unjustified.
2.2. Economic impact
The current kava restrictions are an economic disaster for the
producers and traders in the South Pacific Islands, particularly those
situated in Fiji, Hawaii, Samoa, Tonga and Vanuatu. In-depth
Investigation into EU Member States Market Restrictions on Kava
Products Executive Summary 3 In recent years, there has been developed
a promising market for kava because of the increased worldwide demand
for kava. In 1998, when the export figures from South Pacific islands
reached its peak level it was among the top-selling herbs in the U.S.
and among the fastest-growing herbs with a growth rate of 473% from
1997 to 1998. In the South Pacific region the annual production of kava
was estimated of about US $200 million. In the U.S., kava was wide
spread in the nutraceutical and food supplement market. The
pharmaceutical market was centered in Germany with an estimated 1.3
million users.
Consequently, the area of land planted with kava in the South Pacific
has augmented to around 10,000 ha. to fulfill the increased worldwide
demand. Therefore, the livelihood of many South Pacific people was/is
heavily dependent on a productive kava business. But the negative
publicity from the kava bans and market recalls has greatly
disadvantaged the growing kava industry, and exports from the South
Pacific to the European and U.S. markets came to a halt in late 2001.
In consequence, the domestic price of kava has severely declined and
important export earnings for the South Pacific islands have been lost.
The Pacific Islands Forum Secretariat has been actively supporting its
affected member states since the end of 2001 in order to find solutions
to the economic kava crisis.
Also many pharmaceutical companies using kava were confronted with
severe profit setbacks. The negative economic consequences are also
clearly documented by our communication with South Pacific kava
producers and traders as well as kava-using pharmaceutical companies.
3. Future Strategy
Based on our detailed scientific analysis we developed an argumentation
chain and strategic action plan to rebut the ban on kava in most
European states.
First we suggest focusing primarily on the most realistic goal: to
regain the market authorization for kava products as prescription drug
with the respective labels providing its safe and controlled use. This
long-term objective needs several strategic steps to be realized. In
the first place we recommend claiming for the official opening of the
evaluation of the kava case reports carried out by BfArM and used by
the health authority to justify the withdrawal of marketing
authorization of all kava-containing food and medicinal products with
immediate execution. The documents then should be reevaluated by an
independent and officially acknowledged scientific expert committee.
This counter report, if coming to opposite conclusions, would be of
highest priority to achieve a legally accepted positive re-assessment
of kava as safe and effective remedy. Since it was univocally
criticized by numerous renowned scientists and experts that the
In-depth Investigation into EU Member States Market Restrictions on
Kava Products Executive Summary BfArM report is bearing fundamental
shortcomings and inconsistencies, which must not have been used as
lawful argumentation basis to ban kava.
This claim for the opening of the documents against the health
authorities should be initiated and coordinated by a yet to be
implemented "Kava Executive Committee" consisting of delegates from
relevant organizations and associations, the Pacific Islands Forum
Secretariat, the CDE, kava-exporting FICs (Forum Island Countries),
respectively Pacific ACP member states, scientific experts, the
phytopharmaceutical and herbal products industry, and ourselves
(Phytopharm Consulting).
This international committee should organize and coordinate all further
actions. Among others the committee should submit a dossier including
the present expert report of Dr. Gruenwald including his "Comments on
the BfArM Decision" to the World Health Organization (WHO) requesting a
positive scientific evaluation of kava by an independent expert
commission.
Based on this positive evaluation of the WHO together with our
evaluation, one of the affected Pacific ACP member states should turn
to the Advisory Centre of the WTO Law (ACWL) and ask for legal advice
and support in WTO dispute settlement proceedings. Simultaneously, a
strong, internationally coordinated, PR campaign should be initiated to
draw public attention on the Kava "tragedy".
All these actions by CDE, the Pacific Islands Forum Secretariat, WHO,
WTO, the Pacific ACP member states (respectively FICs), Phytopharm
Consulting, the hytopharmaceutical and herbal products industry as well
as the public should finally result in the positive re-evaluation of
kava by European Health authorities leading to the rebuttal of the
worldwide kava bans and the restoring of the financially stricken kava
producers and traders in the South Pacific islands.
September 23, 2003
Pacific Islands Forum Secretariat: www.forumsec.org.fj
The kava study by Dr Joerg Gruenwald titled "In-Depth Investigation
into EU Market Restrictions on Kava Products" was commissioned by the
Center for the Development of Enterprise (CDE), a facility of the
European Union based in Brussels, at the request of the Forum
Secretariat in July 2002.
H.C. "Skip" Bittenbender, Ph.D.
Extension Specialist for Coffee, Kava and Cacao
Tropical Plant and Soil Sciences
CTAHR/ University of Hawaii
3190 Maile Way
Honolulu, HI 96822
tel. 808-956-6043
fax. 808-956-3894
office location is 112 St. John Hall http://www2.ctahr.hawaii.edu/ctahr2001/
Hawaiian Kava Center, LLC
http://hawaiiankava.com |