This just in from the AKA’s very own Dr. Mathias Schmidt!
Finally some good news: The German administrative court has today issued
its ruling that the ban of kava-containing products in Germany was
unlawful and inappropriate.
On almost 40 pages the court states, that
Mere doubts related to the efficacy of a medicinal product do not
justify the withdrawal of marketing authorizations;
Doubts related to efficacy cannot automatically lead to the conclusion
of an overweight of risk in the benefit-risk-ratio;
Mere hypotheses and assumptions on the causality of adverse events are
per se not a justified suspicion;
The risk must be assessed in the clinical context, especially if the
therapeutic alternatives bear a greater risk – this should have been
counted in favor of kava;
The authorities must demonstrate the risk in a reproducible manner. If
the risk cannot be clearly corroborated, the withdrawal of marketing
authorizations is unlawful:
The risk of kava has not been clearly demonstrated. Consequently, the
benefit-risk-ratio cannot be negative and there is no justification for
the withdrawal of marketing authorizations;
In view of the exposure data the risk does not seem unusually high. The
incidence of liver toxicity would have to rated „rare“ or „very rare“;
BfArM uses duplicate case reports. Quantity of case reports does not
replace quality of the assessment;
BfArM never commented on the doubts related to ist causality assessment;
The court doubts that a pattern of liver toxicity can be derived from
BfArM is wrong to describe benzodiazepines, and SSRI’s as
less harmful alternatives to kava.
In short: The court thinks that the risk – obviously minor – was not
sufficiently substantiated for the ban of kava.
Conclusion: Kava is back to the regulatory status of 2001 – no ban, just
the restrictions to marketing already applied in 2001. The ban is lifted
by the order of the Administrative court!
Dr. Mathias Schmidt”