PGR News from the Pacific

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 The kava ban was revoked, as the German BfArM itself stated, “for reasons of appropriateness”.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.



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DIVA-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	Archive October 2002 November 2002 December 2002 January 2003 February 2003 March 2003 April 2003 May 2003 June 2003 July 2003 August 2003 September 2003 October 2003 November 2003 December 2003 January 2004 February 2004 March 2004 April 2004 May 2004 June 2004 July 2004 August 2004 September 2004 October 2004 November 2004 December 2004 January 2005 February 2005 March 2005 April 2005 May 2005 June 2005 July 2005 August 2005 September 2005 October 2005 November 2005 December 2005 January 2006 February 2006 March 2006 April 2006 May 2006 June 2006 July 2006 August 2006 September 2006 October 2006 November 2006 December 2006 January 2007 February 2007 March 2007 April 2007 May 2007 June 2007 July 2007 August 2007 September 2007 October 2007 November 2007 December 2007 January 2008 February 2008 March 2008 April 2008 May 2008 June 2008 July 2008 August 2008 September 2008 October 2008 November 2008 December 2008 January 2009 February 2009 March 2009 April 2009 May 2009 June 2009 July 2009 August 2009 September 2009 October 2009 November 2009 January 2010 RSS Feed Alternative feed Contact Tevita Something new: Agrobiodiversity Weblog: For discussions of conservation and sustainable use of the genetic resources of crops, livestock and their wild relatives. 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