German Administrative Court States that the Kava Ban was Unlawful and Inappropriate!!

This just in from the AKA’s very own Dr. Mathias Schmidt!

“Dear all,

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
the data;

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!

Kind regards

Dr. Mathias Schmidt”

2 Comments

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  1. […] German Administrative Court States that the Kava Ban was Unlawful and Inappropriate!! […]

  2. […] A German Court, in 2002, determined that kava was potentially dangerous in terms of liver function failure and resulted in its subsequent banning by that Court. The research that brought about this was later proven to be erroneous. Consequently, the original ban was overturned by the German Court on 11th June this year (see our German Administrative Court States that the Kava Ban was Unlawful and Inappropriate!! article). […]

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