As related to ADC from Dr. Jonathan “JD” Baker, 6/10/14:
Breaking kava news: the German administrative court today issued its ruling that the ban of kava-containing products in Germany was unlawful and inappropriate. Kava has returned to its 2001 status, and the ban has been lifted by order of the court.
Here are the main points from the 40 page court ruling, summarized in English by Mathias Schmidt:
“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 the benzodiazepines, buspirone of SSRI 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!”