A blog maintained by Tevita Kete, PGR Officer
Secretariat of the Pacific Community (SPC), Suva, Fiji Islands
This weblog documents the activities of Pacific Agricultural Genetic Resources Network (PAPGREN), along with other information on plant genetic resources (PGR) in the Pacific.
The myriad varieties found within cultivated plants are fundamental to the present and future productivity of agriculture. PAPGREN, which is coordinated by the Land Resources Division of the Secretariat of the Pacific Community (SPC), helps Pacific countries and territories to conserve their crop genetic diversity sustainably, with technical assistance from the Bioversity International (BI) and support from NZAID and ACIAR.
SPC also hosts the Centre of Pacific Crops and Trees (CEPaCT). The CEPaCT maintains regional in vitro collections of crops important to the Pacific and carries out research on tissue culture technology. The CEPaCT Adviser is Dr Mary Taylor (MaryT@spc.int), the CEPaCT Curator is Ms Valerie Tuia (ValerieT@spc.int).
PAPGREN coordination and support
Mr William Wigmore
Mr Adelino S. Lorens
Dr Lois Englberger
Mr Apisai Ucuboi
Dr Maurice Wong
Mr Tianeti Beenna Ioane
Mr Frederick Muller
Mr Herman Francisco
Ms Rosa Kambuou
Ms Laisene Samuelu
Mr Jimi Saelea
Mr Tony Jansen
Mr Finao Pole
Mr Frazer Bule Lehi
Interested in GIS?
Tuesday, May 24, 2005
Posted 2:33 PM by Luigi
German Kava discussion re-opened
From Dr Joerg Gruenwald, Executive Director, International Kava Executive Council (IKEC), 24 May 2005.
By letter of May 12, 2005, the German health authorities finally decided on the appeal of kava producers against the ban of German registered kava drug products of 2002. The kava ban was revoked, as the German BfArM itself stated, “for reasons of appropriateness”. The decision to revoke the cancellation of drug registrations does, however, not mean that kava is again available on the markets. The registrations in question are inactivated until further notice. The decision to temporarily inactivate kava registrations was based on a riskbenefit evaluation, where the BfArM came to the conclusion of a lack of proofs of anxiolytic efficacy of kava products, with all existing studies either performed with higher than registered dosage schemes, in different indications, or otherwise with a non-controlled study design. The producers were asked to provide new clinical data until June, 2007, in which case a reinstitution of the kava products on the market might again be possible.
The International Kava Executive Council, which presents the interests of the South Pacific kava producing countries in a fair evaluation of kava risks based on a scientific discussion of facts, has been working hard to provide new data to underline the inappropriateness of the kava ban. A tremendous mass of positive scientific evidence on kava safety was assembled by international scientists, and presented on the occasion of the International Kava Conference in Suva, Fiji, in December 2004.
“We believe that the new scientific evidence and the constant political background work of the governments of the South Pacific states contributed to this new development”, said Dr. Joerg Gruenwald, Executive Director of the IKEC. The new decision is of course not the end of the story, mainly because there does not seem to be a change for the situation of the consumers and physicians. When kava was banned, the withdrawal of the products from the market created a distinct gap in the therapeutic arsenal of the physicians for the treatment of mild to moderate stress and anxiety related disorders. With the new decision, kava is still not made available to therapy. “Despite kava not being put back on the shelves for now, the decision is still a milestone, as now the administrative way to regular kava registrations is again open”, explained the kava scientist Dr. Mathias Schmidt from the IKEC. Only a few days ago, an application would not even have been considered for the registration process. “We are glad that the discussion is now re-opened, and we hope to finally come to a constructive dialogue with the BfArM”.
The question of efficacy of kava is still a matter of debate. Among scientists, there is no question that kava is efficacious, and that the quantity and quality of clinical evidence is high enough to prove efficacy. This, however, reflects the general picture. Gruenwald: “The doubts raised by the BfArM do not concern efficacy of kava as such, but of individual products, based on technical flaws in published data.” The offer to re-evaluate the risk-benefit ratio based on valid new clinical data shifts the focus from toxicity to efficacy. If proper clinical evidence of efficacy is enough to overcome the current unavailability of kava products, the dangers from potential kava toxicity finally seem to be regarded as acceptable. Scientist always pointed to the fact that kava toxicity – if existing – occurred in an extremely low number of patients, by far below the incidence rates observed with many other freely available drugs. The kava drug producers will now discuss the possible ways forward, and evaluate the chances to provide data from a new and state of the art clinical trial.
* Comments:Post a Comment
Agrobiodiversity Weblog: For discussions of conservation and sustainable use of the genetic resources of crops, livestock and their wild relatives.